Official Journal L 324/2007

10.12.2007

Official Journal of the European Union

L 324/1

REGULATION (EC) No 1392/2007 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 13 November 2007

amending Council Regulation (EC) No 2223/96 with respect to the transmission of national accounts data

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 285(1) thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Central Bank (1),

Acting in accordance with the procedure laid down in Article 251 of the Treaty (1),

Whereas:

(1)

Council Regulation (EC) No 2223/96 of 25 June 1996 on the European system of national and regional accounts in the Community (2) contains the reference framework of common standards, definitions, classifications and accounting rules for drawing up the accounts of the Member States for the statistical requirements of the Community, in order to obtain comparable results between Member States. The European System of Accounts 1995, set up by that Regulation, is known as ‘ESA 95’.

(2)	A comprehensive set of comparable, pertinent and timely national accounts data is needed for the conduct of monetary policy within the Economic and Monetary Union (EMU), for the effective coordination of economic policies and for the purposes of structural and macroeconomic policies.

(3)

Annex B to Regulation (EC) No 2223/96 provides for a set of tables of national accounts data to be transmitted for Community purposes within specified time limits. Furthermore, the following Regulations provide that a range of additional data has to be transmitted to the Commission: Commission Regulation (EC) No 264/2000 of 3 February 2000 on the implementation of Council Regulation (EC) No 2223/96 with respect to short-term public finance statistics (3), Regulation (EC) No 1221/2002 of the European Parliament and of the Council of 10 June 2002 on quarterly non-financial accounts for general government (4), Regulation (EC) No 501/2004 of the European Parliament and of the Council of 10 March 2004 on quarterly financial accounts for general government (5), Council Regulation (EC) No 1222/2004 of 28 June 2004 concerning the compilation and transmission of data on the quarterly government debt (6) and Regulation (EC) No 1161/2005 of the European Parliament and of the Council of 6 July 2005 on the compilation of quarterly non-financial accounts by institutional sector (7). This Regulation does not cover the data included in those Regulations but, together, all the tables and data provided for in all six Regulations referred to in this recital constitute the complete transmission programme of national accounts data.

(4)	The transmission programme of national accounts data should be updated to take into account changing user needs and new policy priorities, and the development of new economic activities in the European Union.

(5)	The transmission programme of national accounts data should take into consideration the fundamental political and statistical changes that have occurred in some Member States during the reference periods of the programme.

(6)	The Economic and Financial Committee’s Status Report on Information Requirements in EMU of 25 May 2004, endorsed by the Council on 2 June 2004, underlined the need to amend the transmission programme so as to comply with the requirements of the EMU Action Plan and the Lisbon strategy.

(7)

A sound statistical basis for the composition of public budgets is crucial for economic reform in line with the Lisbon strategy and the transmission of health, education and social protection data would help in its achievement. The provision of such data should become mandatory after a phase of provision on a voluntary basis.

(8)

Since the objective of this Regulation, namely the creation of common statistical standards that permit the production of harmonised national accounts data, cannot be sufficiently achieved by the Member States and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.

(9)	The measures provided for in this Regulation are in accordance with the opinion of the Statistical Programme Committee (SPC) and of the Committee on Monetary, Financial and Balance of Payments Statistics (CMFB),

HAVE ADOPTED THIS REGULATION:

Article 1

Article 3(1) of Regulation (EC) No 2223/96 shall be replaced by the following:

‘1. The Member States shall transmit to the Commission (Eurostat) the accounts and tables set out in Annex B within the time limits specified for each table, subject to the derogations set out therein.’

Article 2

Annex B to Regulation (EC) No 2223/96 shall be replaced by the text set out in the Annex to this Regulation.

Article 3

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Strasbourg, 13 November 2007.

For the European Parliament

The President

H.-G. PÖTTERING

For the Council

The President

M.LOBO ANTUNES

(1) OJ C 55, 7.3.2006, p. 61.

(1) Opinion of the European Parliament of 25 April 2007 (not yet published in the Official Journal) and Council Decision of 22 October 2007.

(2) OJ L 310, 30.11.1996, p. 1. Regulation as last amended by Regulation (EC) No 1267/2003 of the European Parliament and of the Council (OJ L 180, 18.7.2003, p. 1).

(3) OJ L 29, 4.2.2000, p. 4.

(4) OJ L 179, 9.7.2002, p. 1.

(5) OJ L 81, 19.3.2004, p. 1.

(6) OJ L 233, 2.7.2004, p. 1.

(7) OJ L 191, 22.7.2005, p. 22.

ANNEX

‘ANNEX B

TRANSMISSION PROGRAMME OF NATIONAL ACCOUNTS DATA

Overview of the tables

Table No	Subject of the tables	Deadline t + months (days where specified)	First transmission	Period covered (*1)
1	Main aggregates, annual	70 days	2007	1990 onwards
1	Main aggregates, annual	70 days	2008	1980-1989
1	Main aggregates, quarterly	70 days	2007	1990 Q1 onwards
1	Main aggregates, quarterly	70 days
2	Main aggregates general government, annual	3/9	2007	1995 onwards
3	Tables by industry	9/21	2007	1990 onwards
3	Tables by industry	9/21	2008	1980-1989
5	Household final consumption expenditure by purpose	9	2007	1990 onwards
5	Household final consumption expenditure by purpose	9	2008	1980-1989
6	Financial accounts by sector (transactions)	9	2007	1995 onwards
7	Balance sheets for financial assets and liabilities	9	2007	1995 onwards
8	Non-financial accounts by sector, annual	9	2007	1995 onwards
9	Detailed tax receipts by sector	9	2007	1995 onwards
10	Tables by industry and by region, NUTS II	24	2007	1995 onwards
11	General government expenditure by function	12	2007	1995 onwards
12	Tables by industry and by region, NUTS III	24	2007	1995 onwards
13	Household accounts by region, NUTS II	24	2007	1995 onwards
15	Supply table at basic prices including transformation into purchasers’ prices, A60 × P60	36	2007	2000 onwards
16	Use table at purchasers’ prices, A60 × P60	36	2007	2000 onwards
17	Symmetric input-output table at basic prices, P60 × P60, five yearly	36	2008	2000 onwards
18	Symmetric input-output table for domestic output at basic prices, P60 × P60, five yearly	36	2008	2000 onwards
19	Symmetric input-output table for imports at basic prices P60 × P60, five yearly	36	2008	2000 onwards
20	Cross classification of fixed assets by industry and by asset, A17 × AN_F6†, yearly	24	2007	2000 onwards
22	Cross classification of gross fixed capital formation by industry and by asset, A17 × AN_F6†, yearly	24	2007	1995 onwards
26	Balance sheets for non-financial assets	24	2007	1995 onwards
t = Reference period (year or quarter).

Table 1 – Main aggregates — quarterly (1) and annual exercise

Code

List of variables

Breakdown (2)

Current prices

Previous year's prices and chain-linked volumes

Value added and Gross Domestic Product

B.1g

Gross value added at basic prices

A6†

D.21

a)	Taxes on products (3)

D.31

b)	Subsidies on products (3)

B.1*g

Gross domestic product at market prices

Expenditure side of Gross Domestic Product

P.3

Total final consumption expenditure

P.3

a)	Household final consumption expenditure (domestic concept)

Durability (4)

P.3

b)	Household final consumption expenditure (national concept)

P.3

Final consumption expenditure of NPISHs

P.3

Government final consumption expenditure

P.31

a)	Individual consumption expenditure

P.32

b)	Collective consumption expenditure

P.4

Actual final consumption of households

P41

a)	Actual individual consumption

P.5

Gross capital formation

P.51

a)	Gross fixed capital formation

AN_F6 (5)

P.52

b)	Changes in inventories

x (6)

P.53

c)	Acquisitions less disposals of valuables

x (6)

P.6

10.

Exports of goods (fob) and services

P.61

Goods

P.62

Services

Member States of the EU and Institutions of the EU (7)

Member States of the EU (7)

Members of the EMU (7)

Institutions of the EU (7) (8)

Third countries and international organisations (7)

P.7

11.

Imports of goods (fob) and services

P.71

Goods

P.72

Services

Member States of the EU and Institutions of the EU (7)

Member States of the EU (7)

Members of the EMU (7)

Institutions of the EU (7) (8)

Third countries and international organisations (7)

B.11

12.

External balance of goods and services

Income, Saving and Net Lending

B.2g + B.3g

13.

Gross operating surplus and mixed income

D.2

14.

Taxes on production and imports

D.3

15.

Subsidies on production and imports

D.1_D.4

16.

a)	Primary income receivable from the rest of the world

(x)

D.1_D.4

b)	Primary income payable to the rest of the world

(x)

B.5*g

17.

Gross national income at market prices

(x)

K.1

18.

Consumption of fixed capital

B.5*n

19.

Net national income at market prices

(x)

D.5, D.6, D.7

20.

a)	Current transfers receivable from the rest of the world

(x)

D.5, D.6, D.7

b)	Current transfers payable to the rest of the world

(x)

B.6n

21.

a)	Disposable income, net

(x)

B.6g

b)	Disposable income, gross

(x)

D.8

22.

Adjustments for the change in net equity of households in pension funds reserves

(x)

B.8n

23.

National saving, net

D.9

24.

a)	Capital transfers receivable from the rest of the world

D.9

b)	Capital transfers payable to the rest of the world

K.2

25.

Acquisitions less disposals of non-financial non-produced assets

B.9

26.

Net lending or net borrowing of the nation

Population, Employment, Compensation of employees

27.

Population and employment data

a)	Total population (thousands of persons)

b)	Unemployed persons (thousands of persons) (8)

c)	Employment in resident production units (thousands of persons employed, thousands of hours worked and thousands of jobs (8)) and employment of residents (thousands of persons)

A6† (9)

d)	Self employed

A6† (9)

Employees

A6† (9)

D.1

28.

Compensation of employees working in resident production units and compensation of resident employees

A6† (9)

D.11

a)	Gross wages and salaries

A6† (9)

(x) In real terms.

A6† NACE A6 including “of which manufacturing”. Backward data for “manufacturing” starting in 1990.

Table 2 — Main aggregates of general government

Code

Transaction

Sectors and sub-sectors (10) (11)

P.1

Output

S.13, S.1311, S.1312, S.1313, S.1314

P.11 + P.12

—	Market output and output for own final use,

S.13, S.1311, S.1312, S.1313, S.1314

P.13

—	Other non-market output,

S.13, S.1311, S.1312, S.1313, S.1314

P.131

Payments for other non-market output

S.13, S.1311, S.1312, S.1313, S.1314

P.132

Other non-market output, other

S.13, S.1311, S.1312, S.1313, S.1314

P.11 + P.12 + P.131

Market output, output for own final use and payments for other non-market output

S.13, S.1311, S.1312, S.1313, S.1314

P.2

Intermediate consumption

S.13, S.1311, S.1312, S.1313, S.1314

B.1g

Value added, gross

S.13, S.1311, S.1312, S.1313, S.1314

K.1

Consumption of fixed capital

S.13, S.1311, S.1312, S.1313, S.1314

B.1n

Value added, net

S.13, S.1311, S.1312, S.1313, S.1314

D.1

Compensation of employees, payable

S.13, S.1311, S.1312, S.1313, S.1314

D.29

Other taxes on production, payable

S.13, S.1311, S.1312, S.1313, S.1314

D.39

Other subsidies on production, receivable

S.13, S.1311, S.1312, S.1313, S.1314

B.2n

Operating surplus, net

S.13, S.1311, S.1312, S.1313, S.1314

D.2

Taxes on production and imports, receivable

S.13, S.1311, S.1312, S.1313, S.1314

D.4

Property income, receivable (11)

S.13, S.1311, S.1312, S.1313, S.1314

D.3

Subsidies, payable

S.13, S.1311, S.1312, S.1313, S.1314

D.4

Property income, payable (11)

S.13, S.1311, S.1312, S.1313, S.1314

D.4_S.1311

of which, payable to sub-sector Central Government (S.1311)

S.1312, S.1313, S.1314

D.4_S.1312

of which, payable to sub-sector State Government (S.1312)

S.1311, S.1313, S.1314

D.4_S.1313

of which, payable to sub-sector Local Government (S.1313)

S.1311, S.1312, S.1314

D.4_S.13.14

of which, payable to sub-sector Social Security Funds (S.1314)

S.1311, S.1312, S.1313

D. 41

—	Interest, payable,

S.13, S.1311, S.1312, S.1313, S.1314

D.42 + D.43 + D.44 + D.45

—	Other property income, payable,

S.13, S.1311, S.1312, S.1313, S.1314

B.5n

Balance of primary incomes, net

S.13, S.1311, S.1312, S.1313, S.1314

D.5

Current taxes on income, wealth etc., receivable

S.13, S.1311, S.1312, S.1313, S.1314

D.61

Social contributions, receivable

S.13, S.1311, S.1312, S.1313, S.1314

D.611

—	Actual social contributions,

S.13, S.1311, S.1312, S.1313, S.1314

D.612

—	Imputed social contributions,

S.13, S.1311, S.1312, S.1313, S.1314

D.7

Other current transfers, receivable (11)

S.13, S.1311, S.1312, S.1313, S.1314

D.5

Current taxes on income, wealth etc., payable

S.13, S.1311, S.1312, S.1313, S.1314

D.62

Social benefits other than social transfers in kind, payable

S.13, S.1311, S.1312, S.1313, S.1314

D.6311 + D.63121 + D.63131

Social transfers in kind related to expenditure on products supplied to households via market producers, payable

S.13, S.1311, S.1312, S.1313, S.1314

D.62 + D.6311 + D.63121 + D.63131

Social benefits other than social transfers in kind and social transfers in kind related to expenditure on products supplied to households via market producers, payable

S.13, S.1311, S.1312, S.1313, S.1314

D.7

Other current transfers, payable (11)

S.13, S.1311, S.1312, S.1313, S.1314

D.7_S.1311

of which, payable to sub-sector Central Government (S.1311)

S.1312, S.1313, S.1314

D.7_S.1312

of which, payable to sub-sector State Government (S.1312)

S.1311, S.1313, S.1314

D.7_S.1313

of which, payable to sub-sector Local Government (S.1313)

S.1311, S.1312, S.1314

D.7_S.13.14

of which, payable to sub-sector Social Security Funds (S.1314)

S.1311, S.1312, S.1313

B.6n

Disposable income, net

S.13, S.1311, S.1312, S.1313, S.1314

P.3

Final consumption expenditure

S.13, S.1311, S.1312, S.1313, S.1314

P.31

—	Individual consumption expenditure,

S.13, S.1311, S.1312, S.1313, S.1314

P.32

—	Collective consumption expenditure,

S.13, S.1311, S.1312, S.1313, S.1314

D.8

Adjustment for the change in net equity of households in pension funds reserves

S.13, S.1311, S.1312, S.1313, S.1314

B.8g

Saving, gross

S.13, S.1311, S.1312, S.1313, S.1314

B.8n

Saving, net

S.13, S.1311, S.1312, S.1313, S.1314

D.9

Capital transfers, receivable (11)

S.13, S.1311, S.1312, S.1313, S.1314

D.91

—	Capital taxes,

S.13, S.1311, S.1312, S.1313, S.1314

D.92 + D.99

—	Other capital transfers and investment grants, receivable,

S.13, S.1311, S.1312, S.1313, S.1314

D.9

Capital transfers, payable (11)

S.13, S.1311, S.1312, S.1313, S.1314

D.9_S.1311

of which, payable to sub-sector Central Government (S.1311)

S.1312, S.1313, S.1314

D.9_S.1312

of which, payable to sub-sector State Government (S.1312)

S.1311, S.1313, S.1314

D.9_S.1313

of which, payable to sub-sector Local Government (S.1313)

S.1311, S.1312, S.1314

D.9_S.1314

of which, payable to sub-sector Social Security Funds (S.1314)

S.1311, S.1312, S.1313

P.5

Gross capital formation

S.13, S.1311, S.1312, S.1313, S.1314

P.51

—	Gross fixed capital formation,

S.13, S.1311, S.1312, S.1313, S.1314

P.52 + P.53

—	Changes in inventories and acquisitions less disposals of valuables,

S.13, S.1311, S.1312, S.1313, S.1314

Acquisitions less disposals of non-financial non-produced assets

S.13, S.1311, S.1312, S.1313, S.1314

P.5 + K.2

Gross capital formation and Acquisitions less disposals of non-financial non-produced assets

S.13, S.1311, S.1312, S.1313, S.1314

B.9

Net lending (+)/Net borrowing (-)

S.13, S.1311, S.1312, S.1313, S.1314

Total expenditure

S.13, S.1311, S.1312, S.1313, S.1314

Total revenue

S.13, S.1311, S.1312, S.1313, S.1314

D.995

Capital transfers from general government to relevant sectors representing taxes and social contributions assessed but unlikely to be collected (12)

S.13, S.1311, S.1312, S.1313, S.1314

EDP_D41

Interest including flows on swaps and FRAs

S.13, S.1311, S.1312, S.1313, S.1314

EDP_B9

Net lending (+)/Net borrowing (-) under the Excessive Deficit Procedure (EDP)

S.13, S.1311, S.1312, S.1313, S.1314

Table 3 — Tables by industry

Code

List of variables

Breakdown (13) (14)

Current prices

Previous year's prices and chain-linked volumes

Output

P.1

Output at basic prices by industry

A31/A60

P.2

Intermediate consumption at purchaser's prices by industry

A31/A60

B.1g

Gross value added at basic prices by industry

A31/A60

K.1

Consumption of fixed capital by industry

A31/A60

B.2n + B.3n

Net operating surplus and net mixed income

A31/A60

D.29-D.39

Other taxes less other subsidies on production

A31/A60

Capital formation

P.5

Gross capital formation by industry (15)

P.51

a)	Gross fixed capital formation by industry

A31/A60

Breakdown by fixed asset AN_F6†

of which dwellings and other buildings and structures

A31/A60

P.52 + P.53

b)	Changes in inventories and acquisition less disposals of valuables by industry (15)

x (16)

P.52

of which changes in inventories (17)

x (16)

P.53

of which acquisitions less disposals of valuables (17)

x (16)

Employment and compensation of employees

Employment by industry

(thousands of persons, thousands of hours worked (18) and thousands of jobs (17))

A31/A60

a)	self employed by industry

A31/A60

b)	employees by industry

A31/A60

of which in the Government sector (S.13) (19)

of which in the other sectors (S.11 + S.12 + S.14 + S.15) (19)

D.1

Compensation of employees by industry

A31/A60

D.11

a)	Wages and salaries by industry

A31/A60

AN_F6†

Breakdown fixed assets:

AN1111	dwellings
AN1112	other buildings and structures
AN11131	transport equipment
AN11132	other machinery and equipment
of which:	AN111321 office machinery and hardware
AN111322	radio, TV and communication equipment
AN1114	cultivated assets
AN112	intangible fixed assets
of which:	AN1122 computer software

Table 5 — Household final consumption expenditure

Code	List of variables		Breakdown	Current prices	Previous year's prices and chain-linked volumes
P.3	1.	Household final consumption expenditure by purpose	COICOP groups	x	x
P.3	2	Final consumption expenditure of resident and non-resident households on the economic territory		x	x
P.33	3	Final consumption expenditure of resident households in the rest of the world		x	x
P.34	4	Final consumption expenditure of non-resident households on the economic territory		x	x
P.3	5	Final consumption expenditure of resident households on the economic territory and abroad		x	x

Table 6 — Financial accounts by sector

(Transactions, other changes in volume and revaluation accounts — consolidated and non-consolidated — and counterpart information (*2))

		Total economy	Non-financial corporations	Financial corporations including all sub-sectors (20)	General government including all sub-sectors (21)	Households and non-profit institutions serving households (22)	Rest of the world including all sub-sectors (23)
Transactions/Changes in volume (3)/revaluation of financial instruments (3)	ESA	S.1	S.11	S.12	S.13	S.14 + S.15	S.2
Financial assets	F.A	x	x	x	x	x	x
Monetary gold and special drawing rights (SDRs)	F.1	x	x	x	x	x	x
Monetary gold	F.11	x	x	x	x	x	x
SDRs	F.12	x	x	x	x	x	x
Currency and deposits	F.2	x	x	x	x	x	x
Currency	F.21	x	x	x	x	x	x
Transferable deposits	F.22	x	x	x	x	x	x
Other deposits	F.29	x	x	x	x	x	x
Securities other than shares	F.3	x	x	x	x	x	x
Securities other than shares, excluding financial derivatives	F.33	x	x	x	x	x	x
Short-term securities other than shares, excluding financial derivatives	F.331	x	x	x	x	x	x
Long-term securities other than shares, excluding financial derivatives	F.332	x	x	x	x	x	x
Financial derivatives	F.34	x	x	x	x	x	x
Loans	F.4	x	x	x	x	x	x
Short-term	F.41	x	x	x	x	x	x
Long-term	F.42	x	x	x	x	x	x
Shares and other equity	F.5	x	x	x	x	x	x
Shares and other equity, excluding mutual funds shares	F.51	x	x	x	x	x	x
Quoted shares	F.511	x	x	x	x	x	x
Unquoted shares	F.512	x	x	x	x	x	x
Other equity	F.513	x	x	x	x	x	x
Mutual funds shares	F.52	x	x	x	x	x	x
Insurance technical reserves	F.6	x	x	x	x	x	x
Net equity of households in life insurance and pension funds reserves	F.61	x	x	x	x	x	x
Net equity of households in life insurance reserves	F.611	x	x	x	x	x	x
Net equity of households in pension funds reserves	F.612	x	x	x	x	x	x
Prepayment of insurance premiums and reserves for outstanding claims	F.62	x	x	x	x	x	x
Other accounts receivable	F.7	x	x	x	x	x	x
Trade credits and advances	F.71	x	x	x	x	x	x
Other	F.79	x	x	x	x	x	x
Liabilities	F.L	x	x	x	x	x	x
Currency and deposits	F.2	x	x	x	x	x	x
Currency	F.21	x	x	x	x	x	x
Transferable deposits	F.22	x	x	x	x	x	x
Other deposits	F.29	x	x	x	x	x	x
Securities other than shares	F.3	x	x	x	x	x	x
Securities other than shares, excluding financial derivatives	F.33	x	x	x	x	x	x
Short-term securities other than shares, excluding financial derivatives	F.331	x	x	x	x	x	x
Long-term securities other than shares, excluding financial derivatives	F.332	x	x	x	x	x	x
Financial derivatives	F.34	x	x	x	x	x	x
Loans	F.4	x	x	x	x	x	x
Short-term	F.41	x	x	x	x	x	x
Long-term	F.42	x	x	x	x	x	x
Shares and other equity	F.5	x	x	x	x	x	x
Shares and other equity, excluding mutual funds shares	F.51	x	x	x	x	x	x
Quoted shares	F.511	x	x	x	x	x	x
Unquoted shares	F.512	x	x	x	x	x	x
Other equity	F.513	x	x	x	x	x	x
Mutual funds shares	F.52	x	x	x	x	x	x
Insurance technical reserves	F.6	x	x	x	x	x	x
Net equity of households in life insurance and pension funds reserves	F.61	x	x	x	x	x	x
Net equity of households in life insurance reserves	F.611	x	x	x	x	x	x
Net equity of households in pension funds reserves	F.612	x	x	x	x	x	x
Prepayment of insurance premiums and reserves for outstanding claims	F.62	x	x	x	x	x	x
Other accounts payable	F.7	x	x	x	x	x	x
Trade credits and advances	F.71	x	x	x	x	x	x
Other	F.79	x	x	x	x	x	x
Net acquisition of Financial assets (24)	F.A	x	x	x	x	x	x
Net incurrence of Liabilities (24)	F.L	x	x	x	x	x	x
Net financial transactions (24)		x	x	x	x	x	x
Statistical discrepancy (24)		x	x	x	x	x	x
Net lending (+)/Net borrowing (-) (24)	B.9	x	x	x	x	x	x

Table 7 – Balance sheets for financial assets and liabilities

(Stock of financial instruments — consolidated and non-consolidated — and counterpart information (*4))

		Total economy	Non-financial corporations	Financial corporations including all sub-sectors (25)	General government including all sub-sectors (26)	Households and non-profit institutions serving households (27)	Rest of the world including all sub-sectors (28)
Stock of financial instruments	ESA	S.1	S.11	S.12	S.13	S.14 + S.15	S.2
Financial assets	AF.A	x	x	x	x	x	x
Monetary gold and special drawing rights (SDRs)	AF.1	x	x	x	x	x	x
Monetary gold	AF.11	x	x	x	x	x	x
SDRs	AF.12	x	x	x	x	x	x
Currency and deposits	AF.2	x	x	x	x	x	x
Currency	AF.21	x	x	x	x	x	x
Transferable deposits	AF.22	x	x	x	x	x	x
Other deposits	AF.29	x	x	x	x	x	x
Securities other than shares	AF.3	x	x	x	x	x	x
Securities other than shares, excluding financial derivatives	AF.33	x	x	x	x	x	x
Short-term securities other than shares, excluding financial derivatives	AF.331	x	x	x	x	x	x
Long-term securities other than shares, excluding financial derivatives	AF.332	x	x	x	x	x	x
Financial derivatives	AF.34	x	x	x	x	x	x
Loans	AF.4	x	x	x	x	x	x
Short-term	AF.41	x	x	x	x	x	x
Long-term	AF.42	x	x	x	x	x	x
Shares and other equity	AF.5	x	x	x	x	x	x
Shares and other equity, excluding mutual funds shares	AF.51	x	x	x	x	x	x
Quoted shares	AF.511	x	x	x	x	x	x
Unquoted shares	AF.512	x	x	x	x	x	x
Other equity	AF.513	x	x	x	x	x	x
Mutual funds shares	AF.52	x	x	x	x	x	x
Insurance technical reserves	AF.6	x	x	x	x	x	x
Net equity of households in life insurance and pension funds reserves	AF.61	x	x	x	x	x	x
Net equity of households in life insurance reserves	AF.611	x	x	x	x	x	x
Net equity of households in pension funds reserves	AF.612	x	x	x	x	x	x
Prepayment of insurance premiums and reserves for outstanding claims	AF.62	x	x	x	x	x	x
Other accounts receivable	AF.7	x	x	x	x	x	x
Trade credits and advances	AF.71	x	x	x	x	x	x
Other	AF.79	x	x	x	x	x	x
Liabilities	AF.L	x	x	x	x	x	x
Currency and deposits	AF.2	x	x	x	x	x	x
Currency	AF.21	x	x	x	x	x	x
Transferable deposits	AF.22	x	x	x	x	x	x
Other deposits	AF.29	x	x	x	x	x	x
Securities other than shares	AF.3	x	x	x	x	x	x
Securities other than shares, excluding financial derivatives	AF.33	x	x	x	x	x	x
Short-term securities other than shares, excluding financial derivatives	AF.331	x	x	x	x	x	x
Long-term securities other than shares, excluding financial derivatives	AF.332	x	x	x	x	x	x
Financial derivatives	AF.34	x	x	x	x	x	x
Loans	AF.4	x	x	x	x	x	x
Short-term	AF.41	x	x	x	x	x	x
Long-term	AF.42	x	x	x	x	x	x
Shares and other equity	AF.5	x	x	x	x	x	x
Shares and other equity, excluding mutual funds shares	AF.51	x	x	x	x	x	x
Quoted shares	AF.511	x	x	x	x	x	x
Unquoted shares	AF.512	x	x	x	x	x	x
Other equity	AF.513	x	x	x	x	x	x
Mutual funds shares	AF.52	x	x	x	x	x	x
Insurance technical reserves	AF.6	x	x	x	x	x	x
Net equity of households in life insuranceand pension funds reserves	AF.61	x	x	x	x	x	x
Net equity of households in life insurance reserves	AF.611	x	x	x	x	x	x
Net equity of households in pension funds reserves	AF.612	x	x	x	x	x	x
Prepayment of insurance premiums and reserves for outstanding claims	AF.62	x	x	x	x	x	x
Other accounts payable	AF.7	x	x	x	x	x	x
Trade credits and advances	AF.71	x	x	x	x	x	x
Other	AF.79	x	x	x	x	x	x
Financial assets (29)	AF.A	x	x	x	x	x	x
Liabilities (29)	AF.L	x	x	x	x	x	x
Net financial assets (29)	BF.90	x	x	x	x	x	x

Table 8 – Non-financial accounts by sector

Code

Transactions and Balancing items

Sectors

S.1

S.11

S.12

S.13

S.14/S.15

S.14 (30)

S.15 (30)

S.1N

S.2

S.21

S.211

S.2111

S.2112

S.212

S.22

Total Economy

Non-financial corporations

Financial corporations

General government

Households + non-profit institution serving households

Households

Non-profit institution serving households

Not sectorised

Rest of the world

European Union

Member States of the EU

Members of the Monetary Union

Non-member of the Monetary Union

Institutions of the EU

Third countries and international organisations

I. Production account/External account of goods and services

Resources

P.1

Output

P.11

—	Market Output

P.12

—	Output for own final use

P.13

—	Other non-market output

P.7

Imports of goods and services

P.71

—	Imports of goods

P.72

—	Imports of services

P.72F

—	Imports of FISIM

D.21 — D.31

Taxes less subsidies on products

Total resources

Uses

P.2

Intermediate consumption

P.6

Exports of goods and services

P.61

—	Exports of goods

P.62

—	Exports of services

P.62F

—	Exports of FISIM

B.1g

Gross domestic product/Gross value added

B.11

External balance of goods and services

Total uses

K.1

Consumption of fixed capital

B.1n

Net domestic product/Net value added

II.1.1. Generation of income account

Resources

B.1g

Gross domestic product/Gross value added

D.3

Subsidies, received

D.31

—	Subsidies on products

D.39

—	Other subsidies on production

R211

Total resources

Uses

D.1

Compensation of employees

D.2

Taxes on production and imports, paid

D.21

—	Taxes on products

D.29

—	Other taxes on production

B.2g_B.3g

Gross operating surplus plus gross mixed income

B.3g

—	Gross mixed income

U211

Total uses

II.1.2. Allocation of primary income account

Resources

B.2g_B.3g

Gross operating surplus plus gross mixed income

B.3g

—	Gross mixed income

D.1

Compensation of employees

D.11

—	Wages and salaries

D.12

—	Employers’ social contributions

D.2

Taxes on production and imports, received

D.21

—	Taxes on products

D.211

—	Value added type taxes (VAT)

D.212

—	Taxes and duties on imports excluding VAT

D.214

—	Taxes on products, except VAT and import taxes

D.29

—	Other taxes on production

D.4

Property income

D.41

—	Interest (31) (32)

D.42

—	Distributed income of corporations

D.43

—	Reinvested earnings on direct foreign investment

D.44

—	Property income attributed to insurance policy holders

D.45

—

Rents

R212

Total resources

TINT

Total interest (including FISIM)

Uses

D.3

Subsidies, paid

D.31

—	Subsidies on products

D.39

—	Other subsidies on production

D.4

Property income

D.41

—	Interest (31) (32)

D.42

—	Distributed income of corporations

D.43

—	Reinvested earnings on direct foreign investment

D.44

—	Property income attributed to insurance policy holders

D.45

—

Rents

B.5g

Gross national income/Balance of primary income, gross

U212

Total uses

TINT

Total interest (including. FISIM)

II.2. Secondary distribution of income account

Resources

B.5g

Gross national income/Balance of primary income, gross

D.5

Current taxes on income, wealth, etc.

D.51

—	Taxes on income

D.59

—	Other current taxes

D.6

Social contributions and benefits

D.61

—	Social contributions

D.611

—	Actual social contributions

D.612

—	Imputed social contributions

D.62

—	Social benefits other than social transfers in kind

D.63

—	Social transfers in kind

D.7

Other current transfers

D.71

—	Net non-life insurance premiums

D.72

—	Non-life insurance claims

D.74

—	Current international cooperation

D.75

—	Miscellaneous current transfers (32)

D.751

—	GNI based fourth own resource

R22

Total resources

Uses

D.5

Current taxes on income, wealth, etc.

D.51

—	Taxes on income

D.59

—	Other current taxes

D.6

Social contributions and benefits

D.61

—	Social contributions

D.611

—	Actual social contributions

D.612

—	Imputed social contributions

D.62

—	Social benefits other than social transfers in kind

D.63

—	Social transfers in kind

D.7

Other current transfers

D.71

—	Net non-life insurance premiums

D.72

—	Non-life insurance claims

D.74

—	Current international cooperation

D.75

—	Miscellaneous current transfers (32)

D.751

—	GNI based fourth own resource

B.7g

Adjusted disposable income

U22

Total uses

D.63

—	(minus) Social transfers in kind

B.6g

Gross disposable income

II.4.1. Use of disposable income account

Resources

B.6g

Gross disposable income

D.8

Adjusted for the change in net equity of households in pension funds

R241

Total resources

Uses

P.3

Final consumption expenditure

P.31

—	Individual consumption expenditure

P.32

—	Collective consumption expenditure

D.8

Adjusted for the change in net equity of households in pension funds

B.8g

Gross saving

B.12

Current external balance

U241

Total uses

III.1.1. Change in net worth due to saving and capital transfers account

Changes in net worth

B.8g

Gross saving

B.12

Current external balance

D.9

Capital transfers

D.91

—	Capital taxes

D.92

—	Investment grants (32)

D.92 from S212 to S13

—	Investment grants from EU Institutions to General Government

D.99

—	Other capital transfers (32)

R311

Total change net worth

Changes in assets

D.9

Capital transfers

D.91

—	Capital taxes

D.92

—	Investment grants (32)

D.92 from S212 to S13

—	Investment grants from EU Institutions to General Government

D.99

—	Other capital transfers (32)

K.1

Consumption of fixed capital

B.10.1

Changes in net worth due to saving and capital transfers

U311

Total changes in assets

III.1.2. Acquisitions of non-financial assets account

Changes net worth

B.10.1

Changes in net worth due to saving and capital transfers

K.1

Consumption of fixed capital

R312

Total change net worth

Changes in assets

P.5

Gross capital formation

P.51

—	Gross fixed capital formation

P.52

—	Changes in inventories

P.53

—	Acquisitions less disposals of valuables

K.2

Acquisitions less disposals of non-produced non financial assets

B.9

Net lending (+)/Net borrowing (-)

U312

Total changes in assets

DB.9

Discrepancy with net lending/net borrowing of financial accounts

= non relevant cells

= required

= voluntary

Table 9 — Detailed Tax and Social Contribution Receipts by Type of Tax or Social Contribution and Receiving Sub-sector (*5)

Code	Transaction
D.2	Taxes on production and imports
D.21	Taxes on products
D.211	Value added type taxes
D.212	Taxes and duties on imports excluding VAT
D.2121	Import duties
D.2122	Taxes on imports, excluding VAT and import duties
D.2122a	Levies on imported agricultural products
D.2122b	Monetary compensatory amounts on imports
D.2122c	Excise duties
D.2122d	General sales taxes
D.2122e	Taxes on specific services
D.2122f	Profits of import monopolies
D.214	Taxes on products, except VAT and import taxes
D.214a	Excise duties and consumption taxes
D.214b	Stamp taxes
D.214c	Taxes on financial and capital transactions
D.214d	Car registration taxes
D.214e	Taxes on entertainment
D.214f	Taxes on lotteries, gambling and betting
D.214g	Taxes on insurance premiums
D.214h	Other taxes on specific services
D.214i	General sales or turnover taxes
D.214j	Profits of fiscal monopolies
D.214k	Export duties and monetary comp. amounts on exports
D.214l	Other taxes on products n.e.c.
D.29	Other taxes on production
D.29a	Taxes on land, buildings or other structures
D.29b	Taxes on the use of fixed assets
D.29c	Total wage bill and payroll taxes
D.29d	Taxes on international transactions
D.29e	Business and professional licences
D.29f	Taxes on pollution
D.29g	Under-compensation of VAT (flat rate system)
D.29h	Other taxes on production n.e.c.
D.5	Current taxes on income wealth, etc.
D.51	Taxes on income
D.51a + D.51c1	Taxes on individual or household income including holding gains
D.51a	Taxes on individual or household income excluding holding gains (*6)
D.51c1	Taxes on individual or household holding gains (*6)
D.51b + D.51c2	Taxes on the income or profits of corporations including holding gains
D.51b	Taxes on the income or profits of corporations excluding holding gains (*6)
D.51c2	Taxes on holding gains of corporations (*6)
D.51c3	Other taxes on holding gains (*6)
D.51C	Taxes on holding gains
D.51D	Taxes on winnings from lottery or gambling
D.51E	Other taxes on income n.e.c.
D.59	Other current taxes
D.59a	Current taxes on capital
D.59b	Poll taxes
D.59c	Expenditure taxes
D.59d	Payments by households for licences
D.59e	Taxes on international transactions
D.59f	Other current taxes n.e.c.
D.91	Capital Taxes
D.91a	Taxes on capital transfers
D.91b	Capital levies
D.91c	Other capital taxes n.e.c.
D.2 + D.5 + D.91	Total tax receipts
D.611	Actual social contributions
D.6111	Employers' actual social contributions
D.61111	Compulsory employers' actual social contributions
D.61112	Voluntary employers' actual social contributions
D.6112	Employees' social contributions
D.61121	Compulsory employees' social contributions
D.61122	Voluntary employees' social contributions
D.6113	Social contributions by self- and non-employed persons
D.61131	Compulsory social contributions by self- and non-employed persons
D.61132	Voluntary social contributions by self- and non-employed persons
D.612	Imputed social contributions
D.995	Capital transfers from general government to relevant sectors representing taxes and social contributions assessed but unlikely to be collected (33)
D.99521	Taxes on products assessed but unlikely to be collected (33)
D.99529	Other taxes on production assessed but unlikely to be collected (33)
D.99551	Taxes on income assessed but unlikely to be collected (33)
D.99559	Other current taxes assessed but unlikely to be collected (33)
D.9956111	Employers' actual social contributions assessed but unlikely to be collected (33)
D.9956112	Employees' social contributions assessed but unlikely to be collected (33)
D.9956113	Social contributions by self- and unemployed persons assessed but unlikely to be collected (33)
D.99591	Capital taxes assessed but unlikely to be collected (33)
D.2 + D.5 + D.91 + D.611 – D.995	Total receipts from taxes and social contributions after deduction of amounts assessed but unlikely to be collected
D.2 + D.5 + D.91 + D.611 + D.612 – D.995	Total receipts from taxes and social contributions (including imputed social contributions) after deduction of amounts assessed but unlikely to be collected
In addition, the full detail of the national classification of taxes and social contributions, with corresponding amounts and ESA95 codes, will be provided.

Table 10 — Tables by industry and by region (NUTS II), current prices

Code

List of variables

Breakdown

D.1

Compensation of employees

P.51

Gross fixed capital formation

Employment in thousands of hours worked

ETO

—

Total

EEM

—

Employees

Table 11 — Expenditure of General Government by function

Code	List of variables	Function	Sub-sector breakdown (34)
P.5 + K.2	Gross capital formation + Acquisitions less disposals of non-financial non-produced assets	COFOG divisions COFOG groups (35)	S.13, S.1311, S.1312, S.1313, S.1314
P.5	Gross capital formation	COFOG divisions COFOG groups (35)	S.13, S.1311, S.1312, S.1313, S.1314
P.51	of which, gross fixed capital formation (35)	COFOG divisions COFOG groups	S.13
K.2	Acquisitions less disposals of non-financial non-produced assets	COFOG divisions COFOG groups (35)	S.13, S.1311, S.1312, S.1313, S.1314
D.1	Compensation of employees	COFOG divisions COFOG groups (35)	S.13, S.1311, S.1312, S.1313, S.1314
D.3	Subsidies	COFOG divisions COFOG groups (35)	S.13, S.1311, S.1312, S.1313, S.1314
D.4	Property income (36)	COFOG divisions COFOG groups (35)	S.13, S.1311, S.1312, S.1313, S.1314
D.4_S.1311	of which, payable to sub-sector Central Government (S.1311) (35) (36)	COFOG divisions	S.1312, S.1313, S.1314
D.4_S.1312	of which, payable to sub-sector State Government (S.1312) (35) (36)	COFOG divisions	S.1311, S.1313, S.1314
D.4_S.1313	of which, payable to sub-sector Local Government (S.1313) (35) (36)	COFOG divisions	S.1311, S.1312, S.1314
D.4_S.13.14	of which, payable to sub-sector Social Security Funds (S.1314) (35) (36)	COFOG divisions	S.1311, S.1312, S.1313
D.62 + D.6311 + D.63121 + D.63131	Social benefits other than social transfers in kind and social transfers in kind related to expenditure on products supplied to households via market producers, payable	COFOG divisions COFOG groups (35)	S.13, S.1311, S.1312, S.1313, S.1314
P.2 + D.29 + D.5 + D.8	Intermediate consumption + Other taxes on production + Current taxes on income, wealth, etc.+ Adjustment for the change in net equity of households in pension funds reserves	COFOG divisions COFOG groups (35)	S.13, S.1311, S.1312, S.1313, S.1314
P.2	Intermediate consumption	COFOG divisions COFOG groups (35)	S.13, S.1311, S.1312, S.1313, S.1314
D.29 + D.5 + D.8	Other taxes on production + Current taxes on income, wealth, etc.+ Adjustment for the change in net equity of households in pension funds reserves	COFOG divisions COFOG groups (35)	S.13, S.1311, S.1312, S.1313, S.1314
D.7	Other current transfers (36)	COFOG divisions COFOG groups (35)	S.13, S.1311, S.1312, S.1313, S.1314
D.7_S.1311	of which, payable to sub-sector Central Government (S.1311) (35) (36)	COFOG divisions	S.1312, S.1313, S.1314
D.7_S.1312	of which, payable to sub-sector State Government (S.1312) (35) (36)	COFOG divisions	S.1311, S.1313, S.1314
D.7_S.1313	of which, payable to sub-sector Local Government (S.1313) (35) (36)	COFOG divisions	S.1311, S.1312, S.1314
D.7_S.13.14	of which, payable to sub-sector Social Security Funds (S.1314) (35) (36)	COFOG divisions	S.1311, S.1312, S.1313
D.9	Capital transfers (36)	COFOG divisions COFOG groups (35)	S.13, S.1311, S.1312, S.1313, S.1314
D.92	of which, investment grants (35)	COFOG divisions COFOG groups	S.13
D.9_S.1311	of which, payable to sub-sector Central Government (S.1311) (35) (36)	COFOG divisions	S.1312, S.1313, S.1314
D.9_S.1312	of which, payable to sub-sector State Government (S.1312) (35) (36)	COFOG divisions	S.1311, S.1313, S.1314
D.9_S.1313	of which, payable to sub-sector Local Government (S.1313) (35) (36)	COFOG divisions	S.1311, S.1312, S.1314
D.9_S.1314	of which, payable to sub-sector Social Security Funds (S.1314) (35) (36)	COFOG divisions	S.1311, S.1312, S.1313
TE	Total expenditure	COFOG divisions COFOG groups (35)	S.13, S.1311, S.1312, S.1313, S.1314
P.3	Final consumption expenditure	COFOG divisions COFOG groups (35)	S.13, S.1311, S.1312, S.1313, S.1314

Table 12 — Tables by industry and by region (NUTS III)

Code

List of variables

Breakdown

B1.g

Gross value added at basic prices (current prices)

Employment (thousands of persons)

ETO

—

Total

EEM

—

Employees

Table 13 — Households accounts by region (NUTS II)

Allocation of primary income account of households (S.14)
Code	Uses		Code	Resources
D.4	1.	Property income	B.2/B.3	3.	Operating surplus/mixed income
B.5n	2.	Balance of primary income, net	D.1	4.	Compensation of employees
			D.4	5.	Property income

Secondary distribution of income account of households (S.14)
Code	Uses		Code	Resources
D.5	6.	Current taxes on income, wealth, etc.	B.5	10.	Balance of primary income, net
D.61	7.	Social contributions	D.62	11.	Social benefits other than social benefits in kind
D.7	8.	Other current transfers	D.7	12.	Other current transfers
B.6n	9.	Disposable income, net

Table 15 — Supply table at basic prices, including transformation into purchasers' prices (current prices and prices of the previous year)

n = 60, m = 60

Industries (NACE A60)

1 2 3 4 … n

Σ (1)

Imports cif

Total supply at basic prices

Trade and transport margins

Taxes less subsidies on products

Total supply at purchasers' prices

(1)

(2)

(3)

(4)

(5)

(6)

(7)

—

Products (CPA)

—

(1)

Output by product and by industry at basic prices

a)	Intra EU cif (37) (38)

b)	From members of the EMU cif (37)

c)	From non-members of the EMU cif (37)

d)	Extra EU cif (37) (38)

Total

Σ (1)

Total output by industry

Adjust. Items:

(2)

—	Cif/fob adjustments on imports

—

—	Direct purchase abroad by residents

—

(1) + (2)

Total of which:

(3)

—	Market output,

—

—	Output for own final use,

—	Other non-market output,

—

Table 16 — Use table at purchasers' prices (current prices and prices of the previous year)

n = 60, m = 60

Industries (NACE A60)

1 2 3 … n

Σ (1)

Final uses

a) b) c) d) e) f) g) h) i) j)

Σ (3)

Σ (1) + Σ (3)

(1)

(2)

(3)

(4)

(5)

—

Products

(CPA)

—

(1)

Intermediate consumption at purchasers' prices by product and by industry

Final uses at purchasers' prices:

Final consumption expenditure:

a)	by households

by NPISH

c)	by government

total

Gross capital formation:

e)	gross fixed capital formation

f)	changes in inventories

g)	acquisitions less disposals of valuables (39)

Exports fob (40):

intra EU (39)

—	to members of the EMU (39)

—	to non-members of the EMU (39)

i)	extra EU (39)

total

Σ (1)

(2)

Total intermediate consumption by industry

Total final uses by type

Total use

Adjustment items:

(3)

—	Cif/fob adjustments on exports,

—

only exports

—	Direct purchases abroad by residents,

—

only final consumption expenditure of households

—	Purchases on the domestic territory by non-resident,

—

only final consumption expenditure of households and exports

Σ (2) + Σ (3)

(4)

—	Compensation of employees (41), Wages and salaries (41)

—	Other net taxes on production (41),

—	Consumption of fixed capital (41),

—	Operating surplus, net (41),

—	Operating surplus, gross (41),

—	Mixed income, gross (39) (41),

(5)

Value added at basic prices

(6)

Total output at basic prices

(7)

Supplementary data:

—	Fixed capital formation (39) (41),

—	Fixed capital stock (39) (41),

—	Labour input (thousands of persons) (39),

(8)

Table 17 — Symmetric input-output table at basic prices (product by product (*7))

(current prices)

n = 60

Products

1 2 3 … n

Σ (1)

Final uses

a) b) c) d) e) f) g) h) i) j)

Σ (3)

Σ (1) + Σ (3)

(1)

(2)

(3)

(4)

(5)

—

Products

—

(1)

Intermediate consumption at basic prices (product by product)

Final uses at basic prices:

Final consumption expenditure:

a)	by households

by NPISH

c)	by government

total

Gross capital formation:

e)	gross fixed capital formation

f)	changes in inventories

g)	changes in valuables (42)

Exports fob (43):

intra EU (42)

—	to members of the EMU (42)

—	to non-members of the EMU (42)

i)	extra EU (42)

total

Σ (1)

(2)

Total intermediate consumption at basic prices by product

Final use by type at basic prices

Total use at basic prices

Taxes less subsidies on products

(3)

Net taxes on products by product

Net taxes on products by type of final use

Total net taxes on production

Σ (1) + (3)

(4)

Total intermediate consumption at purchasers' prices by product

Total final uses by type at purchasers' prices

Total use at purchasers' prices

Compensation of employees

Wages and salaries

—	Other net taxes on production,

—	Consumption of fixed capital,

—	Operating surplus, net,

—	Operating surplus, gross,

—	Mixed income, gross (42),

(5)

Value added at basic prices

(6)

Total output at basic prices

(7)

Imports intra EU (42) (43)

—	imports from members of the EMU (42),

—	imports from non-members of the EMU (42),

Imports extra EU (42) (43)

(8)

Σ (8)

(9)

Imports cif by product

Total supply at basic prices

(10)

Supply at basic prices by product

Table 18 — Symmetric input-output table for domestic output at basic prices (product by product (*8))

(current prices)

n = 60

Products

1 2 3 … n

Σ (1)

Final uses

a) b) c) d) e) f) g) h) i) j)

Σ (3)

Σ (1) + Σ (3)

(1)

(2)

(3)

(4)

(5)

—

Products

—

(1)

For domestic output: Intermediate consumption at basic prices (product by product)

Final uses at basic prices:

Final consumption expenditure:

a)	by households

by NPISH

c)	by government

total

Gross capital formation:

e)	gross fixed capital formation

f)	changes in inventories

g)	changes in valuables (44)

Exports fob (45):

intra EU (44)

—	to members of the EMU (44)

—	to non-members of the EMU (44)

i)	extra EU (44)

total

Σ (1)

(2)

Total intermediate consumption of domestic output at basic prices by product

Final use of domestic output at basic prices

Total domestic output at basic prices

Use of imported products

(3)

Total intermediate consumption of imported products by product, cif

Final use of imported products, cif

Total imports

Taxes les subsidies on products

(4)

Net taxes on products for intermediate consumption by product

Net taxes on products by type of final use

Total net taxes on products

Σ (1) + (3) + (4)

(5)

Total intermediate consumption at purchasers' prices by product

Total final uses by type at purchasers' prices

Total use at purchasers' prices

Compensation of employees

Wages and salaries

—	Other net taxes on production,

—	Consumption of fixed capital,

—	Operating surplus, net,

—	Mixed income, gross (44),

—	Operating surplus, gross,

(6)

Value added at basic prices

(7)

Total output at basic prices

(8)

Table 19 — Symmetric input-output table for imports at basic prices (product by product (*9)) cif

(current prices)

n = 60

Products

1 2 3 … n

Σ (1)

Final uses

a) b) c) d) e) f) g) h) i) j)

Σ (3)

Σ (1) + Σ (3)

(1)

(2)

(3)

(4)

(5)

—

Products

—

(1)

For imports: Intermediate consumption at basic prices (product by product)

Final uses at basic prices cif:

Final consumption expenditure:

a)	by households

by NPISH

c)	by government

total

Gross capital formation:

e)	gross fixed capital formation

f)	changes in inventories

g)	changes in valuables (46)

Exports fob (47)

intra EU (46)

—	to members of the EMU (46)

—	to non-members of the EMU (46)

i)	extra EU (46)

total

Σ (1)

(2)

Total intermediate consumption of imports at basic prices by product

Final use of imports at basic prices

Total import

Table 20 – Cross classification of fixed assets by industry and by asset

Code

List of variables

Breakdown Industries (*10)

Breakdown Assets

Unit

AN.11g

1. Fixed assets, gross

A17/A31/A60

AN_F6†

—	Current replacement costs,

—	Constant replacement costs,

AN.11n

2. Fixed assets, net

A17/A31/A60

AN_F6†

—	Current replacement costs,

—	Constant replacement costs,

Table 22 – Cross classification of gross fixed capital formation by industry and by product

Code

List of variables

Breakdown Industries (*11)

Breakdown Assets

Unit

P.51

1.	Gross fixed capital formation

A17/A31/A60

AN_F6†

—	Current prices,

—	Previous year's prices and chain-linked volumes,

Table 26 – Balance sheets for non-financial assets

Code	List of variables (*12)		Breakdown Sectors
AN.1	1.	Produced assets	S.1, S.11, S.12, S.13, S.14 + S.15
AN.11	2.	Fixed assets	S.1, S.11, S.12, S.13, S.14 + S.15
AN.111	3.	Tangible fixed assets	S.1, S.11, S.12, S.13, S.14 + S.15
AN.1111	4.	Dwellings	S.1, S.11, S.12, S.13, S.14 + S.15
AN.1112	5.	Other buildings and structures	S.1, S.11, S.12, S.13, S.14 + S.15
AN.11121	6.	Non-residential buildings	S.1, S.11, S.12, S.13, S.14 + S.15
AN.11122	7.	Other structures	S.1, S.11, S.12, S.13, S.14 + S.15
AN.1113	8.	Machinery and equipment	S.1, S.11, S.12, S.13, S.14 + S.15
AN.1114	9.	Cultivated assets	S.1, S.11, S.12, S.13, S.14 + S.15
AN.112	10.	Intangible fixed assets	S.1, S.11, S.12, S.13, S.14 + S.15
AN.1121	11.	Mineral exploration	S.1, S.11, S.12, S.13, S.14 + S.15
AN.1122	12.	Computer software	S.1, S.11, S.12, S.13, S.14 + S.15
AN.1123	13.	Entertainment, literary or artistic originals	S.1, S.11, S.12, S.13, S.14 + S.15
AN.1129	14.	Other intangible fixed assets	S.1, S.11, S.12, S.13, S.14 + S.15
AN.12	15.	Inventories	S.1, S.11, S.12, S.13, S.14 + S.15
AN.13	16.	Valuables	S.1, S.11, S.12, S.13, S.14 + S.15
AN.2	17.	Non-produced assets	S.1, S.11, S.12, S.13, S.14 + S.15
AN.21	18.	Tangible non-produced assets	S.1, S.11, S.12, S.13, S.14 + S.15
AN.211	19.	Land	S.1, S.11, S.12, S.13, S.14 + S.15
AN.212	20.	Subsoil assets	S.1, S.11, S.12, S.13, S.14 + S.15
AN.213 + AN.214	21.	Non-cultivated biological resources and water resources	S.1, S.11, S.12, S.13, S.14 + S.15
AN.22	22.	Intangible non-produced assets	S.1, S.11, S.12, S.13, S.14 + S.15

DEROGATIONS BY MEMBER STATE

1. BELGIUM

1.1. Derogations for tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
1	All variables/items: previous year's prices and chain-linked volumes — quarterly	Years 1990-1994: first transmission in 2008	1990-1994	2008
1	All variables/items: previous year's prices and chain-linked volumes — annual	Years 1980-1994: first transmission in 2008	1980-1994	2008
3	All variables/items: previous year's prices and chain-linked volumes	Years 1980-1994: first transmission in 2008	1980-1994	2008
3	Industry breakdown A60	Years 1990-1994: not to be transmitted	1990-1994	Not to be transmitted
5	All variables/items: previous year's prices and chain-linked volumes	Years 1980-1994: first transmission in 2008	1980-1994	2008
5	COICOP groups and divisions	Years 1980-1994: not to be transmitted	1980-1994	Not to be transmitted

1.2. Derogations for single variables/items in the tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
1	Gross Fixed Capital Formation: breakdown AN_F6	First transmission in 2015	1990-2014	2015
1	Hours worked for self-employed — quarterly	Years 2000-2006: first transmission in 2008	2000-2006	2008
1	Hours worked for self-employed — quarterly	Years 1990-1999: not to be transmitted	1990-1999	Not to be transmitted
1	Households final consumption: breakdown by durability — quarterly	Years 1995-2007: first transmission 2008	1995-2007	2008
1		Years 1990-1994: not to be transmitted	1990-1994	Not to be transmitted
3	P.1, P.2, K.1, B.2n + B.3n, D.29-D.39, D.11: breakdown A31	Years 1980-1994: first transmission 2008	1980-1994	2008
3	Capital formation: breakdown A31	Years 1980-1994: first transmission in 2008	1980-1994	2008
3	Employees and self-employed: breakdown A31 — hours worked	Years 1990-1994: not to be transmitted	1990-1994	Not to be transmitted
6, 7	Flows and stocks of derivatives (F.34, A.F.34)	First transmission in 2015	1995-2014	2015
10	Gross Fixed Capital Formation: regional breakdown of P.51 for industries L-P	First transmission in 2008	1995-2006	2008
10	Employment total: hours worked	Years 2000-2008: first transmission 2010	2000-2008	2010
10	Employment total: hours worked	Years 1995-1999: not to be transmitted	1995-1999	Not to be transmitted
20	Fixed assets: breakdown AN_F6†	First transmission in 2015	2000-2013	2015

2. BULGARIA

2.1. Derogations for tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
All tables concerned	All variables/items	Backward data before 1995: not to be transmitted	Before 1995	Not to be transmitted
1	All variables/items seasonally and working days — adjusted	Years 1995-1997: not to be transmitted	1995-1997	Not to be transmitted
1	All variables/items seasonally and working days — adjusted	Years 1998-2007: first transmission in 2008	1998-2007	2008
2	All variables/items	Years 1999-2001: first transmission in 2008	1999-2001	2008
		Years 1998: first transmission in 2009	1998	2009
		Years 1995-1997: first transmission in 2010	1995-1997	2010
3	All variables/item	Years 1995-1997: not to be transmitted	1995-1997	Not to be transmitted
5	All variables/item — Previous year's prices and chain-linked volumes	Years 1995-1997: first transmission in 2010	1995-1997	2010
6	All variables/item	Years 1995-2000 not to be transmitted	1995-2000	Not to be transmitted
		Year 2005: transmission at T + 21 months	2005
		Years 2006-2009: transmission at T + 13 months	2006-2009
		First transmission at T + 9 months in 2011		2011
7	All variables/item	Years 1995-1999 not to be transmitted	1995-1999	Not to be transmitted
		Year 2005: transmission at T + 21 months	2005
		Years 2006-2009: transmission at T + 13 months	2006-2009
		First transmission at T + 9 months in 2011		2011
8	All variables/item	Years 2002-2005: first transmission in 2007	2002-2005	2007
		Years 1999-2001: first transmission in 2008	1999-2001	2008
		Years 1998: first transmission in 2009	1998	2009
		Years 1995-1997: first transmission in 2010	1995-1997	2010
		Year 2006, 2007: transmission at T + 20 months
		Year 2008, 2009: transmission at T + 12 months
		First transmission at T + 9 months in 2011		2011
9	All variables/item	Year 1999: first transmission in 2008	1999	2008
		Year 1998: first transmission in 2009	1998	2009
		Years 1995-1997: first transmission in 2010	1995-1997	2010
10	All variables	Year 1995: first transmission in 2009	1995	2009
11	All variables	Years 2003: first transmission in 2007	2003	2007
		Years 2000-2002: first transmission in 2008	2000-2002	2008
		Years 1998-1999: first transmission in 2010	1998-1999	2010
		Years 1995-1997: not to be transmitted	1995-1997	Not to be transmitted
12	All variables	Year 1995: first transmission in 2009	1995	2009
13	All variables	Year 1995-1999: Not to be transmitted	1995-1999	Not to be transmitted
		Year 2000-2005: first transmission in 2008	2000-2005	2008
		Year 2005-2006: transmission at T + 36 months	2005-2006
		First transmission at T + 24 months in 2009		2009
15, 16	All variables: current prices	Years 2000-2004: first transmission in 2008	2000-2004	2008
15, 16	All variables: current prices	Years 2005-2006: first transmission in 2009	2005-2006	2009
15, 16	All variables: prices of the previous year	Year 2000: not to be transmitted	2000	Not to be transmitted
15, 16	All variables: prices of the previous year	Years 2001-2007: first transmission in 2010	2001-2007	2010
17, 18	All variables	Year 2005: first transmission in 2009	2005	2009
19	All variables	Year 2005: first transmission in 2009	2005	2009
20	All variables	Years 2000-2002: not to be transmitted	2000-2002	Not to be transmitted
20	All variables	Years 2003-2009: first transmission in 2012	2003-2009	2012
22	All variables	Years 2005: first transmission in 2008	2005	2008
		Years 2000-2004: first transmission in 2010	2000-2004	2010
		Years 1998-1999: first transmission in 2011	1998-1999	2011
		Years 1995-1997: not to be transmitted	1995-1997	Not to be transmitted
26	All variables	Years 1995-2002: not to be transmitted	1995-2002	Not to be transmitted
26	All variables	Years 2003-2009: first transmission in 2012	2003-2009	2012

2.2. Derogations for single variables/items in the tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
1	Gross Fixed Capital Formation: breakdown AN_F6	Years 2000-2009: first transmission in 2010	2000-2009	2010
1	Gross Fixed Capital Formation: breakdown AN_F6	Years 1995-1999: first transmission in 2012	1995-1999	2012
1	Households final consumption expenditure (P.3): breakdown by durability — quarterly	Years 2001-2007: first transmission in 2008	2001-2007	2008
1		Years 1995-2000: first transmission in 2010	1995-2000	2010
1	Households final consumption expenditure (P.3): breakdown by durability — annual	Years 2001-2007: first transmission in 2008	2001-2007	2008
1		Years 1995-2000: first transmission in 2010	1995-2000	2010
1	Acquisitions less disposals of valuables (P.53)	Years 1995-2008: not to be transmitted	1995-2008	Not to be transmitted
1	Acquisitions less disposals of valuables (P.53)	First transmission in 2010	2009	2010
1	Exports (P.6) and imports (P.7): geographical breakdown for services	Years 2005-2006: first transmission in 2008	2005-2006	2008
1	Consumption of fixed capital (K.1) — previous year's prices and chain-linked volumes	Years 1995-2008: first transmission in 2009	1995-2008	2009
1	Population and employment data	Years 1995-1999: first transmission in 2008	1995-1999	2008
1	Compensation of employees working in resident production units and compensation of resident employees (D.1) Gross wages and salaries (D.11)	Years 1995-1999: first transmission in 2008	1995-1999	2008
1	Adjustments for the change in net equity of households in pension funds reserves (D.8) — quarterly	Years 1995-2010: not to be transmitted	1995-2010	Not to be transmitted
1		First transmission in 2012	2011	2012
1	FISIM allocation to all accounts — quarterly	Years 1995-2001: first transmission in 2011	1995-2001	2011
1	FISIM allocation to all accounts — annual	Years 1995-2001: first transmission in 2011	1995-2001	2011
2	Payments for other non-market output (P.131)	Years 2000-2008: first transmission in 2009	2000-2008	2009
2	Payments for other non-market output (P.131)	Years 1995-1999: first transmission in 2011	1995-1999	2011
3	Net operating surplus and net mixed income: breakdown by industry	Years 1998-1999: first transmission in 2009	1998-1999	2009
3	Other taxes less other subsidies on production (D.29-D.39): breakdown by industry	Years 2000-2001: first transmission in 2008	2000-2001	2008
3		Years 1998-1999: first transmission in 2009	1998-1999	2009
3	Consumption of fixed capital (K.1): breakdown by industry — previous year's prices and chain-linked volumes	Years 1998-2008: first transmission in 2009	1998-2008	2009
3	Gross capital formation: breakdown by industry (P.5)	Years 2005-2009: first transmission in 2010	2005-2009	2010
	Gross capital formation: breakdown by industry (P.5)	Years 2000-2004: first transmission in 2012	2000-2004	2012
	Gross fixed capital formation: breakdown by industry (P.51)	Years 1998-1999: first transmission in 2013	1998-1999	2013
3	Changes in inventories and acquisition less disposals of valuables (P.52 + P.53): breakdown by industry	Years 2005-2009: first transmission in 2010	2005-2009	2010
		Years 2000-2004: first transmission in 2012	2000-2004	2012
		Years 1998-1999: first transmission in 2013	1998-1999	2013
3	Employment by industry –breakdown A17	Years 1998-1999: first transmission in 2008	1998-1999	2008
3	Employment by industry –breakdown A60	Years 2000-2006: first transmission in 2009	2000-2006	2009
3	Compensation of employees: breakdown by industry (D.1)	Years 1998-1999: first transmission in 2009	1998-1999	2009
3	Wages and salaries: breakdown by industry (D.11)
5	Narcotics (CP023)	First transmission in 2016	2015	2016
5	Prostitution (CP122)	Years 1995-2014 not to be transmitted	1995-2014	Not to be transmitted
6	Variables:
	F.34 Financial derivatives: sectors S.11, S.123, S.124, S.125, S.13, S.15, S.2	Years 2001-2007: not to be transmitted	2001-2007	Not to be transmitted
	F.34 Financial derivatives: sectors S.121 and S.122	Years 2001-2003: not to be transmitted	2001-2003	Not to be transmitted
	F.52 Mutual funds shares	Years 2001-2007: not to be transmitted	2001-2007	Not to be transmitted
7	Variables:
	AF.34 Financial derivatives: sectors S.11, S.123, S.124, S.125, S.13, S.15, S.2	Years 2000-2006: not to be transmitted	2000-2006	Not to be transmitted
	AF.34 Financial derivatives: sectors S.121 and S.122	Years 2000-2002: not to be transmitted	2000-2002	Not to be transmitted
	AF.52 Mutual funds shares	Years 2000-2006: not to be transmitted	2000-2006	Not to be transmitted
8	Acquisitions less disposals of valuables (P.53)	Year 1995-2008: not to be transmitted	1995-2008	Not to be transmitted
8	Acquisitions less disposals of valuables (P.53)	First transmission in 2010	2009	2010
8	Investment grants	Years 1995-1999: not to be transmitted	1995-1999	Not to be transmitted
9	Variables:
	D.29F Taxes on pollution	Backward data 1995-1999 not to be transmitted	1995-1999	Not to be transmitted
	D.214F Taxes on lotteries, gambling and betting	Backward data 1995-1998 not to be transmitted	1995-1998	Not to be transmitted
10	Gross fixed capital formation (P.51)	Years 2005-2006: first transmission in 2009	2005-2006	2009
		Years 2000-2004: first transmission in 2011	2000-2004	2011
		Years 1998-1999: first transmission in 2012	1998-1999	2012
		Years 1995-1997: not to be transmitted	1995-1997	Not to be transmitted

3. CZECH REPUBLIC

3.1. Derogations for tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
All tables concerned	All variables/items	Backward data before 1995: not to be transmitted	Before 1995	Not to be transmitted
6, 7	All variables — consolidated	Years 1995-2007: first transmission in 2008	1995-2007	2008
6, 7	All variables — non consolidated	Year 2006: first transmission in 2008	2006	2008
11	All variables	Years 1995-2001: first transmission in 2008	1995-2001	2008

3.2. Derogations for single variables/items in the tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
8	Sector S.2: geographical breakdown	Years 2002-2003: first transmission in 2008	2002-2003	2008
3	Changes in inventories (P.52): previous year's prices and chain-linked volumes	Years 1995-2007: first transmission in 2008	1995-2007	2008

4. DENMARK

4.1. Derogations for tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
8	All variables	Years 2006-2007: transmission at t + 12	2006-2007
13	Household sector	S.14 + S.15 to be provided	1995 onwards

4.2. Derogations for single variables/items in the tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
1	Split between taxes (D.21) and subsidies (D.31) on products: previous year's prices and chain-linked volumes — annual	Years 1990-2009: first transmission in 2010	1990-2009	2010
1		Years 1980-1989: not to be transmitted	1980-1989	Not to be transmitted
2	Variables:	First transmission in 2015	2014	2015
2	Market output and output for own final use (P.11 + P.12) Other non-market output (P.13) Payment for other non-market output (P.131)	Years 1995-2013: not to be transmitted	1995-2013	Not to be transmitted
5	Narcotics (023) and Prostitution (122)	Years 1980-2013: first transmission in 2014	1980-2013	2014
5	Split of Education (100) into pre-primary and primary education (101), secondary education (102), Post-secondary non-tertiary education (103), Tertiary education (104)	First transmission in 2015	2014	2015
5		Years 1980-2013: not to be transmitted	1980-2013	Not to be transmitted
6, 7	Variables: F.11 Monetary gold F.12 Special drawing rights (SDRs) F.21 Currency F.22 Transferable deposits F.29 Other deposits F.33 Securities other than shares, excluding financial derivatives F.331 Short-term securities other than shares, excluding financial derivatives F332 Long-term securities other than shares, excluding financial derivatives F.34 Financial derivatives F.41 Short-term F.42 Long- term F.51 Shares and other equity, excluding mutual fund shares F.511 Quoted shares F.512 Unquoted shares F.513 Other equity F.52 Mutual funds shares F.611 Net equity of households in life insurance reserves F.612 Net equity of households pension funds reserves F.71 Trade credits and advances F.79 Other	Years 2004-2007: first transmission in 2008	2004 onwards	2008
6, 7		Years 1995-2003: not to be transmitted	1995-2003	Not to be transmitted
8	Split between taxes and duties on import excluding VAT (D.212) and taxes on products except VAT and import taxes (D.214)	First transmission in 2015	2014	2015
8	Split of output (P.1) for sectors S.13 general government and S.1 total economy	Year 1995-2013 not to be transmitted	1995-2013	Not to be transmitted
9	Split between taxes and duties on import excluding VAT (D.212) and taxes on products except VAT and import taxes (D.214)	First transmission in 2015	2014	2015
9	Taxes on imports, excluding VAT and import duties (D2122) for general government (S13) and sub-sectors. Excise duties (D.2122C)	Years 1995-2013: not to be transmitted	1995-2014	Not to be transmitted
15	Market output	First transmission in 2015	2014	2015
15	Other non-market output	Years 1995-2013: not to be transmitted	1995-2013	Not to be transmitted

5. GERMANY

5.1. Derogations for tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
All tables concerned	All variables/items	Backward data before 1991: Former territory of the Federal Republic of Germany before unification	Before 1991
3	Breakdown A17	Transmission at T + 9 months	1980 onwards
3	Breakdown A31	Transmission at T + 21 months	1980 onwards

5.2. Derogations for single variables/items in the tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
1	AN_F6 breakdown of Gross Fixed Capital Formation (P.51) in AN11131 Transport equipment and AN11132 Other machinery and equipment	Transmission in August of year t + 1	1991 onwards	Not to be transmitted
1		Year 1990: not to be transmitted	1990	Not to be transmitted
2	Breakdown of other non-market output (P.13) into P.131 and P.132	Years 1995 onwards: not to be transmitted	1995 onwards	Not to be transmitted
3	Gross capital formation (P.5), changes in inventories and net acquisition of valuables (sum of P.52 + P.53): breakdowns	Not to be transmitted	1980 onwards	Not to be transmitted
3	Gross fixed capital formation (P.51): breakdown	Breakdown by industry only for “new fixed assets”	1980 onwards
3	Employment: breakdown A31 — hours worked	Backward data before 2002 not to be transmitted	1980-2001	Not to be transmitted
3	Employees for sector “Government”, persons	Transmission at T + 12 months	1980 onwards
6	F.511 Quoted shares F.512 Unquoted shares F.71 Trade credits and advances F.79 Other	Years 1995-2007: first transmission in 2008	1995-2007	2008
7	AF.511 Quoted shares AF.512 Unquoted shares AF.71 Trade credits and advances AF.79 Other	Years 1995-2007: first transmission in 2008	1995-2007	2008
9	All variables: breakdown by letter	Not to be transmitted		Not to be transmitted
10	Employment in hours worked at NUTS II	Years 1995-2003: not to be transmitted	1995-2003	Not to be transmitted
10	Compensation of employees (D.1)	Year 1995: not to be transmitted	1995	Not to be transmitted
10	Gross fixed capital formation	Years 1995-2001: not to be transmitted Breakdown by industry only for “new fixed assets”	1995-2001	Not to be transmitted
12	Value added (B.1g): breakdown by industry; Employment: breakdown A6	Year 1995: breakdown A3 only	1995
13	Household sector	S.14 + S.15 to be provided
20, 22	Breakdown AN_F6†	Not to be transmitted; AN_F6 breakdown transmitted instead		Not to be transmitted

6. ESTONIA

6.1. Derogations for tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
All tables concerned	All variables/items	Backward data before 1995: not to be transmitted	Before 1995	Not to be transmitted
3	All variables except employment (persons)	Years 1995-1999: not to be transmitted	1995-1999	Not to be transmitted
5	All variables; breakdown by purpose	Years 1995-1996: not to be transmitted	1995-1996	Not to be transmitted
12	All variables	Year 1995: not to be transmitted	1995	Not to be transmitted
15, 16	All variables: previous year's prices	Year 2000: not to be transmitted	2000	Not to be transmitted
15, 16	All variables: previous year's prices	Years 2001-2006: first transmission in 2009	2001-2006	2009
22	All variables	Years 1995-1999: not to be transmitted	1995-1999	Not to be transmitted
26	All variables	First transmission in 2008	2000-2006	2008
26	All variables	Years 1995-1999: not to be transmitted	1995-1999	Not to be transmitted

6.2. Derogations for single variables/items in the tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
1	Employment: hours worked	Years 1995-1999: not to be transmitted	1995-1999	Not to be transmitted
1	Households final consumption expenditure (P.3): breakdown by durability — quarterly	Years 1995-1999: not to be transmitted	1995-1999	Not to be transmitted
1	Households final consumption expenditure (P.3): breakdown by durability — annual	Years 1995-1997: not to be transmitted	1995-1997	Not to be transmitted
1	Exports (P.6) and imports (P.7): geographical breakdown	Years 1995-2002: not to be transmitted	1995-2002	Not to be transmitted
8	Sector S.2: geographical breakdown	Year 2002: not to be transmitted	2002	Not to be transmitted
10	Employment: hours worked	Years 1995-1999: not to be transmitted	1995-1999	Not to be transmitted

7. GREECE

7.1. Derogations for tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
1	All variables — quarterly	Years 1990-1994: first transmission in 2008	1990-1994	2008
1	All variables — annual	Years 1988-1994: first transmission in 2008	1988-1994	2008
1	All variables (excluding items 2, 3, 4, 9, 10, 11, 16, 17, 18, 19, 20, 21, 23, 27 total) — annual	Years 1980-1987: not to be transmitted	1980-1987	Not to be transmitted
3	All variables	Years 1988-1994: first transmission in 2008	1988-1994	2008
3	All variables	Years 1980-1987: not to be transmitted	1980-1987	Not to be transmitted
5	All variables	Years 1988-1994: first transmission in 2008	1988-1994	2008
5	All variables	Years 1980-1987: not to be transmitted	1980-1987	Not to be transmitted
15, 16	All variables	Years 2000-2005: first transmission in 2008	2000-2005	2008
17, 18, 19	All variables	Years 2000 and 2005: first transmission in 2008	2000 and 2005	2008

7.2. Derogations for single variables/items in the tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
1	Income, saving and net lending: items 16 to 26 — quarterly	First transmission at T + 70 days in 2008	1995 onwards	2008
1	Income, saving and net lending: items 16 to 26 — quarterly	Years 1990-1994: first transmission in 2011	1990-1994	2011
1	Income, saving and net lending: items from 16 to 25 — annual	Years 1988-1994: first transmission in 2010	1988-1994	2010
1	Population, employment of residents — quarterly	Years 1990-1994: first transmission in 2008	1990-1994	2008
1	Population, employment of residents, — annual	Years 1988-1994: first transmission in 2008	1988-1994	2008
1	Employment — quarterly	Years 1990-1994: first transmission in 2011	1990-1994	2011
1	Employment — annual	Years 1988-1994: first transmission in 2010	1988-1994	2010
1	Household consumption expenditure: breakdown by durability — quarterly	Years 1990-1999: not to be transmitted	1990-1999	Not to be transmitted
1	Household consumption expenditure: breakdown by durability — annual	Years 1980-1989: not to be transmitted	1980-1989	Not to be transmitted
1	Exports (P.6) and imports (P.7): geographical breakdown: quarterly	Years 1990-1994: not to be transmitted	1990-1994	Not to be transmitted
1	Final consumption expenditure of NPISH — quarterly	Years 1990-1993: not to be transmitted	1990-1993	Not to be transmitted
1	Final consumption expenditure of NPISH — annual	Years 1988-1993: not to be transmitted	1988-1993	Not to be transmitted
1	Acquisition less disposals of valuables	Year 2014: first transmission in 2015	2014	2015
1	Acquisition less disposals of valuables	Years 1990-2013: not to be transmitted	1990-2013	Not to be transmitted
1	Adjustments for the changes in net equity of households in pension funds reserves — quarterly	First transmission in 2015	2014	2015
1	Acquisition less disposals of non-financial non-produced assets — quarterly	Years 1990-2013: not to be transmitted	1990	Not to be transmitted
1	Adjustments for the changes in net equity of households in pension funds reserves — annual	First transmission in 2010	1995-2009	2010
1		Backward data 1980-1994: not to be transmitted	1980-1994	Not to be transmitted
1	Acquisition less disposals of non-financial non-produced assets — annual	First transmission in 2010	1995-2009	2010
1		Backward data 1980-1994: not to be transmitted	1980-1994	Not to be transmitted
3	Acquisitions less disposals of valuables	First transmission in 2015	2014	2015
3	Acquisitions less disposals of valuables	Years 1980-2013: not to be transmitted	1980-2013	Not to be transmitted
8	Sector S.2 geographical breakdown	Years 1999-2007: first transmission in 2008	1999-2007	2008
26	Dwellings (AN.1111)	Years 1995-2006: first transmission in 2008	1995-2006	2008

8. SPAIN

8.1. Derogations for tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
3	All variables except consumption of fixed capital (K.1), net operating surplus and net mixed income (B.2n + B.3n)	Years 1990-1994: first transmission in 2008	1990-1994	2008
3		Years 1980-1989: first transmission in 2009	1980-1989	2009
5	All variables	Years 1980-1994: first transmission in 2008	1980-1994	2008
8	All variables	Years 1995-1999: first transmission in 2007	1995-1999	2007
15, 16	All variables: previous year's prices	Years 2002-2004: first transmission in 2008	2002-2004	2008
17, 18, 19	All variables	Year 2005: transmission in 2009	2005	2009
20	All variables	Years 2000-2008: first transmission in 2010	2000-2008	2010
22	All variables	Years 2000-2006: first transmission in 2008	2000-2006	2008
22	All variables	Years 1995-1999: first transmission in 2009	1995-1999	2009
26	All variables	Years 2000-2008: first transmission in 2010	2000-2008	2010
26	All variables	Years 1995-1999 not to be transmitted	1995-1999	Not to be transmitted

8.2. Derogations for single variables/items in the tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
1	Income, saving and net lending: items 16 to 26 — quarterly	Years 1990-1994: first transmission in 2008	1990-1994	2008
1	Employment: breakdown A6 — annual	Years 1990-1994: first transmission in 2008	1990-1994	2008
1	Employment: breakdown A6 –quarterly	Years 1990-1994: first transmission in 2008	1990-1994	2008
1	Imports and exports: geographical breakdown — annual	Transmission at t + 160
1	Split between taxes and subsidies on products: previous year's prices and chain-linked volumes -annual	Years 1990-1999: first transmission in 2008	1990-1999	2008
1		Years 1980-1989: first transmission in 2009	1980-1989	2009
1	Acquisition less disposals of valuables (P.53) — quarterly	Years 1990-1999: first transmission in 2008	1990-1999	2008
1	Acquisition less disposals of valuables (P.53) — annual	Years 1990-1999: first transmission in 2008	1990-1999	2008
1	Acquisition less disposals of valuables (P.53) — annual	Years 1980-1989: first transmission in 2009	1980-1989	2009
3	Consumption of fixed capital (K.1), net operating surplus and net mixed income (B.2n + B.3n)	Years 2000-2007: first transmission in 2008	2000-2007	2008
3		Years 1980-1999: not to be transmitted	1980-1999	Not to be transmitted
16	Consumption of fixed capital (K.1)	First transmission in 2008	2000-2005	2008
17, 18	Consumption of fixed capital (K.1)	Year 2000: first transmission in 2008	2000	2008
17, 18	Consumption of fixed capital (K.1)	Year 2005 first transmission in 2009	2005	2009

9. FRANCE

9.1. Derogations for tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
3	All variables: breakdown by industry A31, A60	Years 1980-1998: first transmission in 2011	1980-1998	2011
20	All variables: breakdown AN_F6† by industry A17	Years 2000-2008: first transmission 2011	2000-2008	2011

9.2. Derogations for single variables/items in the tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
1	Employment: breakdown by industry, A6 — annual	Years 1980-1989: first transmission in 2011	1980-1989	2011
1	Gross value added (B.1g): breakdown A6 — annual	Years 1980-1998: first transmission in 2011	1980-1998	2011
1	Gross Fixed Capital Formation (P.51): breakdown by AN_F6: annual	Years 1980-2007: first transmission 2008	1980-2007	2008
1	Gross Fixed Capital Formation (P.51): breakdown by AN_F6: quarterly	Years 1990-2011: first transmission in 2011	1990-2011	2011
1	Compensation of employees (D.1), wages and salaries (D.11): breakdown A6 — annual	Years 1980-1998: first transmission in 2011	1980-1998	2011
3	Gross fixed capital formation, of which dwellings and other buildings and structures	First transmission in 2015	2014	2015
3		Years 1990-2013 not to be transmitted	1990-2013	Not to be transmitted
5	Breakdown of education (CP101, CP102, CP103, CP104, CP105)	First transmission in 2015	2014	2015
5	Narcotics (CP023) Prostitution (CP122)	Years 1990-2013: not to be transmitted	1980-2013	Not to be transmitted
6	For all sectors: F.3, F.33, F.3331, F.332, F.5, F.51, F.511, F.512, F.513, F.52, F.612 (consolidated)	Years 1995-2007: first transmission in 2008	1995-2007	2008
6	For all sectors F.612 (non consolidated)	Years 1995-2007: first transmission in 2008	1995-2007	2008
7	For all sectors: AF.3, AF.33, AF.3331, AF.332, AF.5, AF.51, AF.511, AF.512, AF.513, AF.52, AF.612 (consolidated)	Years 1995-2007: first transmission in 2008	1995-2007	2008
7	For all sectors AF.612 (non consolidated)	Years 1995-2007: first transmission in 2008	1995-2007	2008
8	Sub-sectors of S.2: S.211, S.2112, S.212 for variables: D.1, D.4, D.5, D.6, D.7, D.8.	Years 1995-2009: first transmission of sub-sectors S.211, S2112, S212 in 2011	1995-2009	2011
9	D.995 breakdown	First transmission in 2015	2014	2015
9	D.995 breakdown	Years 1995-2013 not to be transmitted	1980-2013	Not to be transmitted

10. IRELAND

10.1. Derogations for tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
1	All variables — quarterly	Transmission at T + 90 days,	1997-2008Q3
		First transmission at T + 70 days in 2009	2008Q4 onwards	2009
		Years 1990-1996: not to be transmitted	1990-1996	Not to be transmitted
1	All variables — annual	Transmission at T + 90 days	1995-2007
		First transmission at T + 70 days in 2009	2008	2009
		Years 1980-1994: not to be transmitted	1980-1994	Not to be transmitted
3	All variables: breakdown A60	Years 1990-1999: not to be transmitted	1990-1999	Not to be transmitted
3	All variables: breakdown A31	Years 1980-1994: not to be transmitted	1980-1994	Not to be transmitted
5	All variables	Years 1980-1994: not to be transmitted	1980-1994	Not to be transmitted
6, 7	All variables (excluding sector S.13 and sub-sectors)	Years 1995-2001: not to be transmitted	1995-2001	Not to be transmitted
6, 7	All variables (sector S.13 and sub-sectors)	Years 1995-1997: not to be transmitted	1995-1997	Not to be transmitted
15, 16	All variables	Year 2004: first transmission in 2008	2004	2008
		Year 2005: first transmission in 2009	2005	2009
		Year 2006: first transmission in 2010	2006	2010
15, 16	All variables, previous year's prices	Years 2000-2012: first transmission 2015	2000-2012	2015
17, 18, 19	All variables	Year 2005: first transmission in 2009	2005	2009
20	All variables	Years 2000-2008: first transmission in 2010	2000-2008	2010

10.2. Derogations for single variables/items in the tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
1	Population, employment, compensation of employees, gross operating surplus and mixed income	Years 1990-1997: not to be transmitted	1990-1997	Not to be transmitted
1	Consumption of fixed capital (K.1): previous year's prices and chain-linked volumes — quarterly	Years 1990-1996: not to be transmitted	1990-1996	Not to be transmitted
1	Consumption of fixed capital (K.1): previous year's prices and chain-linked volumes — annual	Years 1995-2009: first transmission in 2010	1995-2009	2010
1		Years 1980-1994: not to be transmitted	1980-1994	Not to be transmitted
1	Employment: employees and self-employed, hours worked — quarterly	Years 1990-1997: not to be transmitted	1990-1997	Not to be transmitted
1	Employment: employees and self-employed, hours worked — annual	Years 1980-1997: not to be transmitted	1980-1997	Not to be transmitted
3	Output at basic prices (P.1) and intermediate consumption (P.2) at purchasers prices	Years 2000-2009: first transmission in 2010	2000-2009	2010
3		Years 1980-1999: not to be transmitted	1980-1999	Not to be transmitted
3	Consumption of fixed capital (K.1): previous year's prices and chain-linked volumes	Years 1995-2009: first transmission in 2010	1995-2009	2010
3		Years 1980-1994: not to be transmitted	1980-1994	Not to be transmitted
3	Breakdown AN_F6† for total economy	Year 2008: first transmission in 2009	2008	2009
3	Breakdown AN_F6† for total economy	Years 1980-2007: not to be transmitted	1980-2007	Not to be transmitted
3	Dwellings and other buildings and structures: breakdown A31 and A60	Year 2008: first transmission in 2009	2008	2009
3		Years 1980-2007: not to be transmitted	1980-2007	Not to be transmitted
3	Employment: employees and self-employed, hours worked	Years 1980-1997: not to be transmitted	1980-1997	Not to be transmitted
8	All variables, excluding sector S.13 and S.2	Year 2003: first transmission in 2008	2003	2008
8	All variables, excluding sector S.13 and S.2	Years 1995-2001: not to be transmitted	1995-2001	Not to be transmitted
8	All variables: sector S.2	Years 1995-1999: not to be transmitted	1995-1999	Not to be transmitted
10	Employment: hours worked	Years 1995-1997: not to be transmitted	1995-1997	Not to be transmitted
13	Household sector	S.14 + S.15 to be provided
13	Social contributions (D.61) and social benefits (D.62)	Years 2000-2007: first transmission in 2009	2000-2007	2009
22	Breakdown AN_F6†: of which items (AN111321, AN111322, AN1122)	Year 2008: first transmission in 2009	2008	2010
22		Years 2000-2007: not to be transmitted	2000-2007	Not to be transmitted

11. ITALY

11.1. Derogations for tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
12	All variables	Years 1995-1999: first transmission in 2008	1995-1999	2008
15, 16	All variables: previous year's prices	Years 2000-2004: first transmission in 2008	2000-2004	2008
26	All variables	Years 1995-2008: first transmission in 2010	1995-2008	2010

11.2. Derogations for single variables/items in the tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
1	Exports (P.6) and imports (P.7): geographical breakdown — quarterly	Transmission at T + 160 days
1	Population	Transmission at T + 180 days
3	Consumption of fixed capital (K1): breakdown A60	Years 1980-1994: not to be transmitted	1980-1994	Not to be transmitted
3	Consumption of fixed capital (K1): breakdown A60	Years 1995-2014 first transmission 2015	1995-2014	2015
5	Breakdown of education (CP101, CP102, CP103, CP104, CP105)	Years 1980-1999: not to be transmitted	1980-1999	Not to be transmitted
5	Narcotics (CP023) Prostitution (CP122)	Years 2000-2014: first transmission 2015	1995-2014	2015
6, 7	F.511 Quoted shares F.512 Unquoted shares F.513 Other equity F611 — Net equity of households in life insurance reserves F612 — Net equity of households in pension funds reserves	Years 1995-2007: first transmission in 2008	1995-2007	2008
10	Employment: hours worked	Years 1995-2003: not to be transmitted	1995-2003	Not to be transmitted
10	Employment: hours worked	Years 2004-2008: first transmission in 2010	2004-2008	2010

12. CYPRUS

12.1. Derogations for tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
All tables concerned	All variables/items	Backward data before 1995: not to be transmitted	Before 1995	Not to be transmitted
1	All variables: previous year's prices, chain-linked volumes — quarterly	Years 1995-2007: first transmission in 2008	1995-2007	2008
6, 7	All variables	Years 1995-2008: first transmission in 2009	1995-2008	2009
15, 16	All variables, current prices	Years 2004: transmission 2008	2004	2008
15, 16	All variables: previous year's prices	Years 2002-2003: transmission in 2008	2002-2003	2008
		Years 2004-2005: transmission in 2009	2004-2005	2009
		Years 2006-2007: transmission in 2010	2006-2007	2010
17, 18, 19	All variables	Year 2000: transmission in 2009	2000	2009
17, 18, 19	All variables	Year 2005: transmission in 2011	2005	2011
22	All variables: previous year's prices and chain-linked volumes	Years 1995-2006: first transmission in 2008	1995-2006	2008

12.2. Derogations for single variables/items in the tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
1	Exports (P.61) and imports (P.71) of goods, exports (P.62) and imports (P.72) of services — quarterly	Years 1995-2008: first transmission in 2009	1995-2008	2009
1	Taxes on production and imports (D.2), subsidies on production and imports (D.3) — quarterly	Years 1995-2008: first transmission in 2009	1995-2008	2009
1	FISIM allocation to all accounts — quarterly	Years 1995-2008: first transmission in 2009	1995-2008	2008
1	Acquisitions less disposals of non-financial non-produced assets (K.2) — quarterly	Years 2000-2010: first transmission in 2011	2000-2010	2011
1		Years 1995-1999: not to be transmitted	1995-1999	Not to be transmitted
1	Income, saving and net lending: items 16 to 26, current prices — quarterly	Years 2000-2008: first transmission in 2009	2000-2008	2009
1		Years 1995-1999: first transmission in 2011	1995-1999	2011
1	Income, saving and net lending: items 16 to 26, current prices — annual	Years 1995-2007: first transmission in 2008	1995-2007	2008
1	Income, saving and net lending: items 16 to 26, real terms — quarterly	Years 2000-2010: first transmission in 2011	2000-2010	2011
1		Years 1995-1999: not to be transmitted	1995-1999	Not to be transmitted
1	Income, saving and net lending: items 16 to 26, real terms — annual	Years 2000-2009: first transmission in 2010	2000-2009	2010
1		Years 1995-1999: first transmission in 2012	1995-1999	2012
1	Households final consumption expenditure: breakdown by durability — previous year's prices, chain-linked volumes — annual	Years 2000-2007: first transmission in 2008	2000-2007	2008
1		Years 1995-1999: not to be transmitted	1995-1999	Not to be transmitted
1	Households final consumption expenditure: breakdown by durability — all variables — quarterly	Years 2000-2008: first transmission in 2009	2000-2008	2009
1		Years 1995-1999: not to be transmitted	1995-1999	Not to be transmitted
1	Exports (P.6) and imports (P.7): geographical breakdown — previous year's prices, chain-linked volumes — annual	Years 1995-2007: first transmission in 2008	1995-2007	2008
1	Exports (P.6) and imports (P.7): geographical breakdown — current prices — quarterly	Years 2000-2008: first transmission 2009	2000-2008	2009
1		Years 1995-1999: first transmission 2011	1995-1999	2011
1	Exports (P.6) and imports (P.7): geographical breakdown — previous year's prices, chain-linked volumes- quarterly	Years 2000-2008: first transmission in 2009	2000-2008	2009
1		Years 1995-1999: first transmission 2011	1995-1999	2011
3	Output, all variables: breakdowns A31 and A60 — previous year's prices, chain-linked volumes	Years 1995-2007 (A31): first transmission in 2008	1995-2007	2008
3		Years 1995-2006 (A60): first transmission in 2008	1995-2006	2008
3	Capital formation, all variables: breakdowns A31 and A60 — previous year's prices, chain-linked volumes	Years 1995-2007 (A31): first transmission in 2008	1995-2007	2008
3	Employment and compensation of employees, all variables: breakdowns A31 and A60 — persons	Years 1995-1999: first transmission in 2008 (A31)	1995-1999	2008
3		Years 1995-1999: first transmission in 2009 (A60)	1995-1999	2009
3	Employment and compensation of employees, all variables: breakdowns A6 — hours worked	Years 1995-2007: first transmission in 2008	1995-2007	2008
8	II.1.2 Allocation of primary income account	First transmission 2008	1995-2007	2008
8	II.2 Secondary distribution of income account II.4.1 Use of disposable income account III.1.1 Change in net worth due to saving and capital transfer account III.1.2 Acquisition of non-financial assets account	First transmission 2010	1995-2009	2010

13. LATVIA

13.1. Derogations for tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
All tables concerned	All variables/items	Backward data before 1995: not to be transmitted	Before 1995	Not to be transmitted
1	All variables: previous year's prices, chain-linked volumes	Years 1995-2007: first transmission in 2008	1995-2007	2008
2	Breakdown by sub-sectors	Years 1995-1999: first transmission in 2008	1995-1999	2008
3	All variables: previous year's prices, chain-linked volumes	Years 1995-2007: first transmission in 2008	1995-2007	2008
5	All variables: previous year's prices, chain-linked volumes	Years 1998-2007: first transmission at T + 9 in 2008	1998-2007	2008
5	All variables: previous year's prices, chain-linked volumes	Years 1995-1997: not to be transmitted	1995-1997	Not to be transmitted
6, 7	All variables	Years 1995-2001: first transmission in 2008	1995-2001	2008
8	All variables	Year 2006: transmission at T + 14 in 2008	2006	2008
8	All variables	Years 2007-2008: transmission at T + 12 in 2008	2007-2008	2008
11	All variables	Years 1996-1999: first transmission in 2008	1996-1999	2008
11	All variables	Year 1995: not to be transmitted	1995	Not to be transmitted
15, 16	All variables: current prices	Years 2000-2003: not to be transmitted	2000-2003	Not to be transmitted
	All variables: previous year's prices	Years 2000-2011: not to be transmitted	2000-2011	Not to be transmitted
	All variables: previous year's prices	Year 2012: transmission in 2015	2012	2015
17, 18, 19	All variables	Year 2000: not to be transmitted	2000	Not to be transmitted
20	All variables	Year 2006: first transmission in 2009	2006	2009
20	All variables	Years 2000-2005: not to be transmitted	2000-2005	Not to be transmitted
22	All variables: current prices	Years 2000-2006: first transmission in 2008	2000-2006	2008
	All variables: current prices	Years 1995-1999: not to be transmitted	1995-1999	Not to be transmitted
	All variables: previous year's prices, chain-linked volumes	Years 2000-2006: first transmission in 2008	2000-2006	2008
	All variables: previous year's prices, chain-linked volumes	Years 1995-1999: not to be transmitted	1995-1999	Not to be transmitted

13.2. Derogations for single variables/items in the tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
1	Expenditure side of gross domestic product: all variables — current prices	Years 1995-2006: transmission at T + 90 days	1995-2006
1	Variables: Gross operating surplus and mixed income (B.2g + B.3g) Taxes (D.2) and subsidies (D.3) on production and imports Compensation of employees (D.1)	Years 1995-1997: not to be transmitted	1995-1997	Not to be transmitted
1	Income, saving and net lending: items 16 to 26: real terms	Years 2000-2007: first transmission in 2008	2000-2007	2008
1	Income, saving and net lending: items 16 to 26: real terms	Years 1995-1999: not to be transmitted	1995-1999	Not to be transmitted
1	Employment of residents: persons — quarterly	Years 1995-2001: not to be transmitted	1995-2001	Not to be transmitted
1	Employment in resident production units — persons and hours worked — quarterly	Years 1995-2001: not to be transmitted	1995-2001	Not to be transmitted
1	Employment in resident production units: hours worked — annual	Years 1995-1999: not to be transmitted	1995-1999	Not to be transmitted
1	Households final consumption expenditure: breakdown by durability — current prices and previous year's prices, chain-linked volumes	Years 1998-2007: transmission at T + 90 days	1998-2007	Not to be transmitted
1		Years 1995-1997: not to be transmitted	1995-1997	Not to be transmitted
1	Exports (P.6) and imports (P.7): geographical breakdown — current prices, previous year's prices, chain-linked volumes	Years 2000-2007: transmission at T + 90 days	2000-2007	Not to be transmitted
1		Backward data before 2000: not to be transmitted	1995-1999	Not to be transmitted
3	Output (P.1); intermediate consumption (P.2); gross value added (B.1G): current prices	Years 1995-2007: first transmission at T + 14 in 2008	1995-2007	2008
3	K.1; B2N + B3N; D29-D39; D1; D2: current prices	Years 2001-2007: first transmission in 2008	2001-2007	2008
3	K.1; B2N + B3N; D29-D39; D1; D2: current prices	Years 1995-2000: not to be transmitted	1995-2000	Not to be transmitted
3	Consumption of fixed capital (K.1): previous year's prices, chain-linked volumes	Years 2005-2009: first transmission in 2010	2005-2009	2010
3		Years 1995-2004: not to be transmitted	1995-2004	Not to be transmitted
3	Changes in inventories plus acquisitions less disposals of valuables (P.52 + P.53)	Years 2000-2007: first transmission in 2008	2000-2007	2008
3		Years 1995-1999: not to be transmitted	1995-1999	Not to be transmitted
3	Employment by industry: breakdown A31	Years 2002-2007: first transmission in 2008	2002-2007	2008
3	Employment by industry: breakdown A31	Years 1995-2001: not to be transmitted	1995-2001	Not to be transmitted
3	Employment by industry: breakdown A60	Years 2007-2009: first transmission in 2010	2007-2009	2010
3	Employment by industry: breakdown A60	Years 1995-2006: not to be transmitted	1995-2006	Not to be transmitted

14. LITHUANIA

14.1. Derogations for tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
All tables concerned	All variables/items	Backward data before 1995: not to be transmitted	Before 1995	Not to be transmitted
8	All variables	Years 2006-2008: transmission at T + 11 months	2006-2008	2010
8	All variables	First transmission at T + 9: in 2010	2009	2010
11	All variables	Years 2000-2001: first transmission in 2008	2000-2001	2008
11	All variables	Years 1995-1999: first transmission in 2012	1995-1999	2012
15, 16	All variables: previous year's prices	Years 2005-2007: first transmission 2010	2005-2007	2010
15, 16	All variables: previous year's prices	Years 2000-2004: first transmission in 2012	2000-2004	2012
22	All variables	Years 2000-2006: first transmission in 2008	2000-2006	2008
22	All variables	Years 1995-1999: first transmission in 2010	1995-1999	2010
22	All variables: previous year's prices and chain-linked volumes	Years 1995-2008: first transmission 2010	1995-2008	2010

14.2. Derogations for single variables/items in the tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
1	Households final consumption expenditure: breakdown by durability — previous year's prices and chain linked volumes — quarterly	Years 1995-2007: first transmission in 2008	1995-2007	2008
2	All variables: breakdown by sub-sector of sector S.13	Years 1995-1999: first transmission in 2010	1995-1999	2010
3	Gross Fixed Capital Formation (P.51) — current prices	Years 1995-2005: first transmission in 2010	1995-2005	2010
3	Gross Fixed Capital Formation (P.51) — previous year's prices and chain-linked volumes	Years 1995-2009: first transmission in 2010	1995-2009	2010
3	Changes in inventories (P.52) and acquisitions less disposals of valuables, breakdown by industry A6 — current prices	Years 1995-2006: first transmission in 2010	1995-2006	2010
3	Changes in inventories (P.52) and acquisitions less disposals of valuables, breakdown by industry A6 — previous year's prices and chain-linked volumes	Years 1995-2009: first transmission in 2010	1995-2009	2010
3	Employment: breakdown by industry A31 — hours worked	Years 1995-1998: first transmission in 2009	1995-1998	2009
3	Employees: breakdown by sector	Years 1995-2007: first transmission in 2009	1995-2007	2009
8	Geographical breakdown of sector S.2	Years 2002-2003: first transmission in 2008	2002-2003	2008

15. LUXEMBOURG

15.1. Derogations for tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
1	All variables — quarterly	Transmission at T + 90 days
1	All variables — quarterly	Years 1990-1994: not to be transmitted	1990-1994	Not to be transmitted
1	All variables — annual	Transmission at T + 90 days
1	All variables — annual	Years 1980-1984: first transmission in 2010	1980-1984	2010
3	All variables	Years 1980-1984: first transmission in 2010	1980-1984	2010
5	All variables	Years 1980-1984: not to be transmitted	1980-1984	Not to be transmitted
6, 7	All variables	Years 1995-2009: first transmission in 2010	1995-2009	2010

15.2. Derogations for single variables/items in the tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
1	Acquisition less disposals of valuables (P.53) — quarterly	Only non-monetary gold included
1	Acquisition less disposals of valuables (P.53) — quarterly	Years 1995-2009: first transmission in 2010	1995-2009	2010
1	Acquisition less disposals of valuables (P.53) — annual	Only non-monetary gold included
1	Acquisition less disposals of valuables (P.53) — annual	Years 1980-2009: first transmission in 2010	1980-2009	2010
3	Industry breakdown NACE A31	Transmission at T + 21 months
		Years 1985-2006: first transmission in 2008	1985-2006	2008
		Years 1980-1984: first transmission in 2010	1980-1984	2010
	Industry breakdown NACE A60	Transmission at T + 33 months
		Years 1985-2005: first transmission in 2008	1985-2005	2008
		Years 1980-1984: first transmission in 2010	1980-1984	2010
8	Variables in the accounts II.1.2, II.2, II.4.1, III.1.1, III.1.2 for sectors S.11, S.12 and S.2	Years 1995-2007: first transmission in 2008	1995-2007	2008
	Variables in the accounts I and II.1 for sectors S.14 and S.15	Years 1995-2007: first transmission in 2008	1995-2007	2008
	Variables in the accounts II.1.2, II.2, II.4.1, III.1.1, III.1.2 for sectors S.14, and S.15	Years 1995-2009: first transmission in 2010	1995-2009	2010

16. HUNGARY

16.1. Derogations for tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
All tables concerned	All variables/items	Backward data before 1995: not to be transmitted	Before 1995	Not to be transmitted
1	All variables: previous year's prices and chain-linked volumes — quarterly	Years 1995-1999: first transmission in 2008	1995-1999	2008
1	All variables: previous year's prices and chain-linked volumes — annual	Years 1995-1999: first transmission in 2008	1995-1999	2008
1	All variables: FISIM allocation	Years 1995-1999: first transmission in 2008	1995-1999	2008
3	All variables: chain-linked volumes	Years 1995-1999: first transmission in 2008	1995-1999	2008
5	All variables: chain-linked volumes	Years 1995-1999: first transmission in 2008	1995-1999	2008
8	All variables	Transmission at T + 12 months
8	All variables	Years 1995-2007: first transmission in 2009	1995-2007	2009
13	All variables	Years 1995-2000: not to be transmitted	1995-2000	Not to be transmitted
22	All variables	Years 1995-1999: not to be transmitted	1995-1999	Not to be transmitted

16.2. Derogations for single variables/items in the tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
1	Value added and gross domestic product: breakdown A6 — quarterly	Years 1995-1999: first transmission in 2008	1995-1999	2008
1	Split between taxes (D.21) and subsidies (D.31) on products at previous year's prices and chain-linked volumes — annual	Years 2000-2009: first transmission in 2010	2000-2009	2010
1		Years 1995-1999: not to be transmitted	1995-1999	Not to be transmitted
1	Acquisition less disposals of valuables (P.53) — quarterly	Years 1995-2009: first transmission in 2010	1995-2009	2010
1	Income, saving and net lending: items 13, 14, 15 and 28 — quarterly	Years 1995-2009: first transmission in 2010	1995-2009	2010
1	Income, saving and net lending: items 16 to 26 — quarterly	Years 2000-2009: first transmission in 2010	2000-2009	2010
1	Income, saving and net lending: items 16 to 26 — quarterly	Years 1995-1999: not to be transmitted	1995-1999	Not to be transmitted
1	Income, saving and net lending: items 16 to 26 — annual	Years 2000-2007: first transmission in 2008	2000-2007	2008
1	Income, saving and net lending: items 16 to 26 — annual	Years 1995-1999: not to be transmitted	1995-1999	Not to be transmitted
1	Income, saving and net lending: items 16 to 26 except consumption of fixed capital (K1), net national income (B5N), acquisition less disposals of non-financial non-produced assets (K2), net lending/borrowing (B9) — annual	Transmission at T + 100 days
1	Income, saving and net lending: items 16 to 25: real terms	Years 1995-2009: first transmission in 2010	1995-2009	2010
1	Employment	Year 2008: transmission in 2009	2008	2009
1	Employment	Years 1995-2007: first transmission in 2010	1995-2007	2010
1	Households final consumption expenditure: breakdown by durability — previous year's prices and chain-linked volumes	Years 1995-1999: first transmission in 2008	1995-1999	2008
1	Households final consumption expenditure: breakdown by durability — FISIM allocation	Years 1995-1999: first transmission in 2008	1995-1999	2008
3	Employment: breakdown by industry A60	Years 1995-2008: first transmission in 2010	1995-2008	2010
3	Employment: hours worked and persons	Year 2008: first transmission in 2009	2008	2009
	Employment: hours worked and persons	Years 1995-2007: first transmission in 2010	1995-2007	2010
	Employees by sectors	Years 1995-2009: first transmission in 2010	1995-2009	2010
10	Employment in hours worked	Years 1995-2008: first transmission in 2010	1995-2008	2010
10	Compensation of employees	Years 1995-1999: not to be transmitted	1995-1999	Not to be transmitted
12	Employment in persons	Years 1995-2008: first transmission in 2010	1995-2008	2010

17. MALTA

17.1. Derogations for tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
All tables concerned	All variables/items	Backward data before 1995: not to be transmitted	Before 1995	Not to be transmitted
All tables concerned	All variables: previous year's prices and chain-linked volumes	Backward data before 2000: not to be transmitted	Before 2000	Not to be transmitted
1	All variables/items: quarterly	Years 1995-1999: not to be transmitted	1995-1999	Not to be transmitted
5	All variables at previous year's prices, chain-linked volumes	Years 1995-1999: not to be transmitted	1995-1999	Not to be transmitted
6, 7	All variables except for sector S.13	Years 2003-2009: first transmission in 2010	2003-2009	2010
		Years 2000-2002: first transmission in 2011	2000-2002	2011
		Years 1995-1999: not to be transmitted	1995-1999	Not to be transmitted
8	All variables	Years 2000-2007: first transmission in 2008	2000-2007	2008
8	All variables	Years 1995-1999: not to be transmitted	1995-1999	Not to be transmitted
12	All variables	Years 2000-2005: first transmission in 2008	2000-2005	2008
12	All variables	Years 1995-1999: not to be transmitted	1995-1999	Not to be transmitted
13	All variables	Years 2000-2006: first transmission in 2008	2000-2006	2008
13	All variables	Years 1995-1999: not to be transmitted	1995-1999	Not to be transmitted
20	All variables — current prices	Years 2000-2008: first transmission in 2010	2000-2008	2010
22	All variables	Years 2000-2008: first transmission in 2010	2000-2008	2010
22	All variables	Years 1995-1999: not to be transmitted	1995-1999	Not to be transmitted
26	All variables	Years 2000-2008: first transmission in 2010	2000-2008	2010
26	All variables	Years 1995-1999: not to be transmitted	1995-1999	Not to be transmitted

17.2. Derogations for single variable/item in the tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
1	Income, saving and net lending: items 16 to 25: real terms	Years 2000-2009: first transmission in 2010	2000-2009	2010
1	Income, saving and net lending: items 16 to 25: real terms	Years 1995-1999: not to be transmitted	1995-1999	Not to be transmitted
1	Population and employment — quarterly	Years 2000-2007: first transmission in 2008	2000-2007	2008
1	Population and employment — annual	Years 1995-2007: first transmission in 2008	1995-2007	2008
1	Variables D.5, D.6, D.7, D.8, D.9, K.2 at current prices — quarterly	Years 2000-2007: first transmission in 2009	2000-2007	2009
1	Variables D.5, D.6, D.7, D.8, D.9, K.2 at current prices — annual	Years 1995-2007: first transmission in 2009	1995-2007	2009
1	Variables B.1g, D.21, D.31, D.8 at previous year's prices and chain-linked volumes	Years 2000-2009: first transmission in 2010	2000-2009	2010
3	Variables B.1g, K.1, P.5 — previous year's prices and chain-linked volumes	Years 2000-2009: first transmission in 2010	2000-2009	2010
8	Variables D.4, D.5, D.6, D.7, D.8, D.9, P.5, K.2	Years 1995-2007: first transmission in 2009	1995-2007	2009

18. NETHERLANDS

18.2. Derogations for single variables/items in the tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
1	Taxes less subsidies on products (D.21-D.31) — annual	Years 1980-1987: not to be transmitted	1980-1987	Not to be transmitted
1	Exports and imports of goods and services (P.61, P.62, P.71, P.72),	Years 1980-1986: not to be transmitted	1980-1986	Not to be transmitted
1	Final consumption expenditure of NPISH, final consumption expenditure of government (individual P.31 and collective P.32), Actual individual consumption (P.41), changes in inventories (P.52) and acquisitions less disposals of valuables (P.53) … imports and exports of goods and services (P.61, P.62, P.71, P.72) previous year's prices and chain-linked volumes — annual	Years 1980-1987: not to be transmitted	1980-1987	Not to be transmitted
1	Real disposable income (table 109) real terms — quarterly	Years 1990-1994: not to be transmitted	1990-1994	Not to be transmitted
1	Population and employment (table 110) — quarterly	Years 1990-1994: not to be transmitted	1990-1994	Not to be transmitted
1	Employment by industry (table 111) — quarterly	Years 1990-1994: not to be transmitted	1990-1994	Not to be transmitted
1	Active population (PEA), unemployment (EUN), employment (ETO), employees (EEM), self-employed (ESE) — annual	Years 1980-1986: not to be transmitted	1980-1986	Not to be transmitted
1	Employed and self-employed in resident production units: industry J to K and L to P, persons — annual	Years 1980-1986: not to be transmitted	1980-1986	Not to be transmitted
1	Employment — hours worked	Years 1980-1994: not to be transmitted	1980-1994	Not to be transmitted
1	Household consumption expenditure: breakdown by durability (table 117) — annual	Years 1980-1989: not to be transmitted	1980-1989	Not to be transmitted
1	Exports (P.6) and imports (P.7): geographical breakdown (tables 120, 121) — quarterly	Years 1995-2000: not to be transmitted	1995-2000	Not to be transmitted
3	Current prices:
	Variables P.1, P.2, B.1G, D.29-D.39, D.1, D.11 for industries B, DC_DD, DI, DN	Years 1980-1986: not to be transmitted	1980-1986	Not to be transmitted
	Variables B.2N + B.3N for industries B, CA_CB, DC_DD, DH_DI, DK_DN, DH, DO	Years 1980-1986: not to be transmitted	1980-1986	Not to be transmitted
3	Previous year's prices and chain-linked volumes:
	Variables B.1G for industries B, CA_CB, DB_DE, DH_DN, J_K, O_P	Years 1980-1987: not to be transmitted	1980-1987	Not to be transmitted
	Variable K.1 for industries B, CA_ CB, DC_DD, DH_DI, DK_DN, H_O	Years 1980-1995: not to be transmitted	1980-1995	Not to be transmitted
3	Current prices:
	Variables P.5, P.52, P.53 breakdown by industry	Years 1980-1994: not to be transmitted	1980-1994	Not to be transmitted
	Variable P.51 for industries B, CA_CB, DC_DD, DI	Years 1980-1986: not to be transmitted	1980-1986	Not to be transmitted
3	Previous year's prices and chain-linked volumes:
	Variables P.5, P.52, P.53	Years 1980-1987: not to be transmitted	1980-1987	Not to be transmitted
	Variables P.5, P.52, P.53 breakdown by industry	Years 1988-1995: not to be transmitted	1988-1995	Not to be transmitted
	Variable P.51 for industries B, CA_CB, DC_DD, DI	Years 1980-1987: not to be transmitted	1980-1987	Not to be transmitted
3	Employment, persons: breakdown A31	Years 1980-1986: not to be transmitted	1980-1986	Not to be transmitted
5	All variables: COICOP breakdown	Years 1980-1986: not to be transmitted	1980-1986	Not to be transmitted
6, 7	Variables:	Not to be transmitted for years 1995-2000	1995-2000
	F71, F79 for (sub)sectors S1, S11, S12, S121 + 122, S121, S122, S123, S124, S125, S14 + 15, S14, S15, S2	First transmission of year 2008 for F34 in 2009	2008
	F34 for (sub-sectors S1, S11, S12, S121 + 122, S121, S122, S123, S124, S125, S14 + 15, S14, S15, S2	F 34 not to be transmitted for years 1995-2007	1995-2007

19. AUSTRIA

19.1. Derogations for tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
1, 3, 5, 22	Annual data: chain-linked volumes	Year 2014: first transmission in 2015	2014	2015
1, 3, 5, 22	Annual data: chain-linked volumes	Years 1980-2013: not to be transmitted	1980-2013	Not to be transmitted

19.2. Derogations for single variables/items in the tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
1	Employment: hours worked — quarterly	Years 1990-1994: not to be transmitted	1990-1994	Not to be transmitted
1	Employment: hours worked — annual	Years 1980-1994: not to be transmitted	1980-1994	Not to be transmitted
3	Employment: hours worked	Years 1980-1994: not to be transmitted	1980-1994	Not to be transmitted
13	Household sector	S.14 + S.15 to be provided
6, 7	Variables:
6, 7	F.511 Quoted shares F.512 Unquoted shares F.513 Other equity	Years 1995-2007: first transmission in 2008	1995-2007	2008
10	Employment: hours worked	Years 2000-2007: first transmission in 2009	2000-2007	2009
10	Employment: hours worked	Years 1995-1999: not to be transmitted	1995-1999	Not to be transmitted
20	Variables AN111321 and AN111322	Years 2000-2013: first transmission in 2012	2000-2013	2015
22	Variables AN111321 and AN111322	Years 2000-2013: first transmission in 2015	2000-2013	2015
22	Variables AN111321 and AN111322	Years 1995-1999: not to be transmitted	1995-1999	Not to be transmitted
26	Variable AN1111 Dwellings	Years 2000-2010: first transmission in 2012	2000-2010	2012
26	Variable AN1111 Dwellings	Years 1995-1999: not to be transmitted	1995-1999	Not to be transmitted

20. POLAND

20.1. Derogations for tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
All tables concerned	All variables/items	Backward data before 1995: not to be transmitted	Before 1995	Not to be transmitted
8	All variables/items	Years 2006-2007: transmission in T + 12 months	2006-2007	2008
8	All variables/items	First transmission in T + 9 months in 2009	2008	2009
15, 16	All variables: previous year's prices	Years 2000-2006: first transmission in 2009	2000-2006	2009

20.2. Derogations for single variables/items in the tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
1	Income, saving and net lending: (items 13 to 26): current prices and real terms	Years 1995-1998: first transmission in 2010	1995-1998	2010
1	Wages and salaries (D.11) — quarterly	Year 2007: first transmission in 2008	2007	2008
		Years 2001-2006: first transmission in 2009	2001-2006	2009
		Years 1995-2001: not to be transmitted	1995-2001	Not be transmitted
1	Acquisition less disposals of non-financial non-produced assets (K.2)	Year 2010: first transmission in 2011	2010	2011
1		Years 1995-2009: not to be transmitted	1995-2009	Not to be transmitted
1	Employment, self-employed and employees: breakdown by industry A6	Year 2007: first transmission in 2008	2007	2008
		Years 2001-2006: first transmission in 2009	2001-2006	2009
		Years 1995-2000: not to be transmitted	1995-2000	Not to be transmitted
2	Acquisition less disposals of non-financial non-produced assets (K.2)	Year 2010: first transmission in 2011	2010	2011
2		Years 1995-2009: not to be transmitted	1995-2009	Not to be transmitted
3	Changes in inventories (P.52)	Years 1995-1998: first transmission in 2010	1995-1998	2010
3	Employment breakdown by industry	Data for year 2007: first transmission in 2008	2007	2008
		Data for years 2001-2006: first transmission in 2009	2001-2006	2009
		Backward data before 2001: not to be transmitted	1995-2000	Not to be transmitted
3	Compensation of employees breakdown by industry	Data for year 2007: first transmission in 2008	2007	2008
		Data for years 2001-2006: first transmission in 2009	2001-2006	2009
		Backward data before 2001: not to be transmitted	1995-2000	Not to be transmitted
8	Acquisition less disposals of non-financial non-produced assets (K.2)	Year 2010: first transmission in 2011	2010	2011
8		Years 1995-2009: not to be transmitted	1995-2009	Not to be transmitted
10	Employment — hours worked	Year 2008: first transmission in 2009	2008	2009
10	Employment — hours worked	Years 1995-2007: not to be transmitted	1995-2007	Not to be transmitted
11	All variables: COFOG groups	Years 1995-2001: not to be transmitted	1995-2001	Not to be transmitted
11	Acquisition less disposals of non-financial non-produced assets (K.2)	Year 2010: first transmission in 2011	2010	2011
11		Years 1995-2009: not to be transmitted	1995-2009	Not to be transmitted
11	All variables: sub-sector breakdown	Years 1995-2001: first transmission in 2010	1995-2001	2010
22	Breakdown AN_F6†	Years 1995-1999: first transmission in 2008	1995-1999	2008

21. PORTUGAL

21.1. Derogations for tables

Table No

Variable/item

Derogation

Period covered by the derogation

First transmission in

All variables:

—	breakdown A60

Transmission at T + 36 months

Years 1980-1999: not to be transmitted

1980-1999

Not to be transmitted

—	breakdown A31

Years 1990-2007: first transmission in 2008

1990-2007

2008

Years 1980-1989: not to be transmitted

1980-1989

Not to be transmitted

All variables

Transmission at T + 12 months

Years 1980-1989: not to be transmitted

1980-1989

Not to be transmitted

21.2. Derogations for single variables/items in the tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
1	Gross operating surplus and mixed income (B.2g + B.3g), taxes on production and imports (D.2) subsidies on production and imports (D.3), compensation of employees (D.1), wages and salaries (D.11) — quarterly	Years 1995-2007: first transmission in 2008	1995-2007	2008
1		Years 1990-1994: first transmission in 2010	1990-1994	2010
1	Gross value added (B.1g): manufacturing — quarterly	Years 1995-2009: first transmission in 2010	1995-2009	2010
1	Gross value added (B.1g): manufacturing — quarterly	Years 1990-1994: not to be transmitted	1990-1994	Not to be transmitted
1	Gross fixed capital formation (P.51): breakdown AN_F6 — quarterly	Years 1995-2009: first transmission in 2010	1995-2009	2010
1	Population and employment of residents — quarterly	Years 1990-1994: first transmission in 2010	1990-1994	2010
1	Employment: breakdown by industry — persons — quarterly	Years 1995-2007: first transmission in 2008	1995-2007	2008
1	Employment: breakdown by industry — persons — quarterly	Years 1990-1994: first transmission in 2010	1990-1994	2010
1	Employment: breakdown by industry — hours worked — quarterly	Years 2000-2009: first transmission in 2010	2000-2009	2010
1		Years 1990-1999: not to be transmitted	1990-1999	Not to be transmitted
1	Employment: hours worked — annual	Years 2000-2007: first transmission in 2008	2000-2007	2008
1	Employment: hours worked — annual	Years 1980-1999: not to be transmitted	1980-1999	Not to be transmitted
1	Households consumption expenditure: breakdown by durability — quarterly	Years 1995-2009: first transmission in 2010	1995-2009	2010
1		Years 1990-1994: not to be transmitted	1990-1994	Not to be transmitted
1	Exports (P.6) and imports (P.7): geographical breakdown: previous year's prices and chain-linked volumes	Year 2007: first transmission in 2008	2007	2008
3	Capital formation: breakdown AN_F6	Transmission at T + 36 months
3	Capital formation: breakdown AN_F6	Years 1980-1999: not to be transmitted	1980-1999	Not to be transmitted
3	Employment: hours worked	Years 2000-2007: first transmission in 2008	2000-2007	2008
3	Employment: hours worked	Years 1980-1989: not to be transmitted	1980-1989	Not to be transmitted
6, 7	Variables: F.511 Quoted shares F.512 Unquoted shares F.513 Other equity	Years 1995-2007: first transmission in 2008	1995-2007	2008
8	Geographical breakdown sector S.2	Transmission at T + 12	1999-2009
8	Geographical breakdown sector S.2	Years 1999-2009: first transmission in 2010	1999-2009	2010
10	Employment: breakdown A6 — hours worked	Years 2000-2006: first transmission in 2008	2000-2006	2008
20	Construction and split into dwellings and other buildings	Years 2000-2007: first transmission in 2009	2000-2007	2009
22	Construction and split into dwellings and other buildings	Years 1995-2007: first transmission in 2009	1995-2007	2009

22. ROMANIA

22.1. Derogations for tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
All tables concerned	All variables/items — quarterly	Backwards data before 1995: not to be transmitted	Before 1995	Not to be transmitted
All tables concerned	All variables/items — annual	Backwards data before 1990: not to be transmitted	Before 1990	Not to be transmitted
1	All variables/items — quarterly	Years 1995-1997: first transmission in 2008	1995-1997	2008
1	All variables/items — annual	Years 1995-1997: first transmission in 2008	1995-1997	2008
2	All variables: sub-sectors S1311, S1313 and S1314	Years 1995-2000: first transmission in 2008	1995-2000	2008
6, 7	All variables	Years 1995-1997: not to be transmitted	1995-1997	Not to be transmitted
6, 7	All variables, sub-sectors of S.13	Years 1998-2005: not to be transmitted	1998-2005	Not to be transmitted
10	All variables	Years 1995-1997: first transmission in 2008	1995-1997	2008
12	All variables	Years 1995-1997: first transmission in 2008	1995-1997	2008
13	All variables	Years 1995-1997: first transmission in 2008	1995-1997	2008
15	All variables: previous year's prices	Years 2000-2003: first transmission in 2008	2000-2003	2008
16	All variables: previous year's prices	Years 2000-2003: first transmission in 2008	2000-2003	2008
20	All variables	Years 2000-2004: not to be transmitted	2000-2004	Not to be transmitted
22	All variables	Years 1995-2008: first transmission in 2010	1995-2008	2010

22.2. Derogations for single variables/items in the tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
1	Income, saving and net lending (items 13 to 26) — quarterly	Years 1995-2008: first transmission in 2010	1995-2008	2010
1	Population, employment, compensation of employees — quarterly	Years 2000-2007: first transmission in 2008	2000-2007	2008
1		Years 1995-1999: not to be transmitted	1995-1999	Not to be transmitted
1	Population, employment, compensation of employees — annual	Years 2000-2007: first transmission in 2008	2000-2007	2008
1	Population, employment, compensation of employees — annual	Years 1995-1999: first transmission in 2010	1995-1999	2010
3	Employment	Years 2000-2001: first transmission in 2008	2000-2001	2008
3	Employment	Backwards data before 2000: not to be transmitted	Before 2000	Not to be transmitted
10	Employment in thousand of hours worked	Years 2000-2001: first transmission in 2008	2000-2001	2008
10	Employment in thousand of hours worked	Backwards data before 2000: not to be transmitted	Before 2000	Not to be transmitted
12	Employment in thousand persons	Years 2000-2001: first transmission in 2008	2000-2001	2008
12	Employment in thousand persons	Backwards data before 2000: not to be transmitted	Before 2000	Not to be transmitted

23. SLOVENIA

23.1. Derogations for tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
All tables concerned	All variables/items	Backward data before 1995: not to be transmitted	Before 1995	Not to be transmitted
6, 7	All variables	Years 1995-2001: not to be transmitted	1995-2001	Not to be transmitted
11	All variables	Years 1995-1998: not to be transmitted	1995-1998	Not to be transmitted
15, 16	All variables: previous year's prices	Years 2000-2003: not to be transmitted	2000-2003	Not to be transmitted
20	All variables	Years 2000-2008: first transmission in 2010	2000-2008	2010
22	All variables	Years 1995-1999: first transmission in 2008	1995-1999	2008

23.2. Derogations for single variables/items in the tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
1	Gross value added (B.1g), current prices — quarterly	Years 1995-1999: not to be transmitted	1995-1999	Not to be transmitted
1	Employment, employees and self-employed: hours worked	Years 2005-2007: first transmission in 2008	2005-2007	2008
		Years 2000-2004: first transmission in 2010	2000-2004	2010
		Years 1995-1999: not to be transmitted	1995-1999	Not to be transmitted
2	All variables: sub-sectors S.1311, S.1313 and S.1314	Years 1995-1998: first transmission in 2008	1995-1998	2008
3	Capital formation, all variables: breakdown A6/A31/A60	Transmission at T + 14 months
3	Capital formation, all variables: breakdown A6/A31/A60	Years 1995-1999: first transmission in 2008	1995-1999	2008
3	Employment: hours worked	Years 2005-2007: first transmission in 2008	2005-2007	2008
		Years 2000-2004: first transmission in 2010	2000-2004	2010
		Years 1995-1999: not to be transmitted	1995-1999	Not to be transmitted
8	All variables	Transmission at T + 12 months until 2010	2006-2009
8	All variables	Years 1995-1999: first transmission in 2010	1995-1999	2010
26	Dwellings	First transmission in 2010	1995 onwards	2010

24. SLOVAKIA

24.1. Derogations for tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
All tables concerned	All variables/items	Backward data before 1995: not to be transmitted	Before 1995	Not to be transmitted
1, 3, 5, 15, 16, 22	All variables: previous year's prices and chain-linked volumes	Years 1995-1999: first transmission in 2008	1995-1999	2008
11	All variables	Years 1995-2002: first transmission in 2008	1995-2002	2008
20	All variables	Years 2000-2004: not to be transmitted	2000-2004	Not to be transmitted
22	All variables	Years 1995-2003: not to be transmitted	1995-2003	Not to be transmitted

24.2. Derogations for single variables/items in the tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
3	Capital formation: breakdown AN_F6†	Years 1995-2003: not to be transmitted	1995-2003	Not to be transmitted
6, 7	Variables (transaction consolidated and non-consolidated, balance sheets consolidated and non-consolidated): F.34 Financial derivatives F.51 Shares and other equity, excluding mutual fund shares F.511 Quoted shares F.512 Unquoted shares F.513 Other equity F.52 Mutual funds shares F.611 Net equity of households in life insurance reserves F.612 Net equity of households pension funds reserves	Years 1995-2004: not to be transmitted	1995-2004	Not to be transmitted
6, 7	All variables for sub-sectors S.123 Other Financial Institutions — S.124 Financial Auxiliaries	Years 1995-2010: first transmission in 2011	1995-2010	2011

25. FINLAND

25.2. Derogations for single variables/items in the tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
1	Variables (quarterly):
	Acquisition less disposals of valuables (P.53)	Backward data before 1995: not to be transmitted	1990-1994	Not to be transmitted
	Individual final consumption expenditure of general government (P.31)	Not to be transmitted	1990 onwards	Not to be transmitted
	Collective final consumption expenditure of general government (P.32)	Not to be transmitted	1990 onwards	Not to be transmitted
	Actual individual consumption (P.41)	Not to be transmitted	1990 onwards	Not to be transmitted
1	Acquisition less disposals of valuables — annual	Years 1980-1994: not to be transmitted	1980-1994	Not to be transmitted
3	Changes in inventories and acquisition less disposals of valuables by industry	Years 1980-1999: first transmission in 2009	1980-1999	2009
3	Split between office machinery (AN.111321) and radio, TV and communication (AN111322)	Years 1980-1994: not to be transmitted	1980-1994	Not to be transmitted
5	Subdivisions of CP100 Education	Year 2014: transmission in 2015	2014	2015
5	Subdivisions of CP100 Education	Years 1980-2013: not to be transmitted	1980-2013	Not to be transmitted
6, 7	F.41, F.42: breakdown for sectors S.11, S.12, S.14, S.15 and S.2	Years 1995-2004: not to be transmitted	1995-2004	Not to be transmitted
20	Office machinery (AN.111321) and radio, TV and communication (AN.111322)	Years 2000-2004: not to be transmitted	2000-2004	Not to be transmitted
22	Office machinery (AN.111321) and radio, TV and communication (AN.111322)	Years 1995-2004: not to be transmitted	1995-2004	Not to be transmitted

26. SWEDEN

26.1. Derogations for tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
3	All variables	Transmission at T + 11
3	All variables	Years 1980-1992: first transmission in 2009	1980-1992	2009
3	Breakdown A60	Transmission at T + 23 months
5	All variables	Years 1980-1992: first transmission in 2009	1980-1992	2009
8	All variables	Transmission at T + 11

26.2. Derogations for single variables/items in the tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
1	Variables (quarterly): Individual consumption expenditure (P.31) Collective consumption expenditure (P.32) Actual final consumption of households (P.4) Actual individual consumption (P.41)	Years 1990-2007: first transmission in 2008	1990-2007	2008
1	Exports (P.6): geographical breakdown — quarterly	Years 1990-2007: first transmission in 2008	1990-2007	2008
1	Imports (P.7): geographical breakdown — quarterly	Years 1990-2007: first transmission in 2008	1990-2007	2008
3	Split of industries 50-52	Years 1980-2003: not to be transmitted	1980-2003	Not to be transmitted
13	Household sector	S.14 + S.15 to be provided
15, 16	Split of industries 50-52 Geographical split	Years 2000-2003: not to be transmitted	2000-2003	Not to be transmitted
17, 18, 19	Split of industries 50-52 Geographical split	Year 2000: not to be transmitted	2000	Not to be transmitted

27. UNITED KINGDOM

27.1. Derogations for tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
1	All variables concerned: A6 breakdown — quarterly	Years 1990-2008: first transmission in 2009	1990-2008	2009
1	All variables concerned: A6 breakdown — annual	Years 1980-2008: first transmission in 2009	1980-2008	2009
15, 16	All variables: previous year's prices	Years 2000-2007: first transmission in 2009	2000-2007	2009
17, 18, 19	All variables	Years 2000, 2005: first transmission in 2011	2000, 2005	2011
20	All variables	Years 2000-2008: first transmission in 2010	2000-2008	2010
22	All variables	Years 1995-2008: first transmission in 2010	1995 onwards	2010

27.2. Derogations for single variables/items in the tables

Table No	Variable/item	Derogation	Period covered by the derogation	First transmission in
3	Variables: Output (P.1) Intermediate consumption (P.2) Gross value added (B.1g)	Years 1980-2008: first transmission in 2009	1980-2008	2009
6	All variables — consolidated accounts	Years 1995-2009: first transmission in 2010	1995-2009	2010
10	Gross fixed capital formation, employment in thousands of hours worked	Years 1995-2007: first transmission in 2009	1995-2007	2009
13	Household sector	S.14 + S.15 to be provided’

(*1) Applicable to the entire table with the exception of selected items (see table details).

(1) Quarterly data are to be provided in non-adjusted, as well as seasonally and working-day adjusted format. Gross domestic product (B.1*g) and total gross value added (B.1g) must also be provided in working-day adjusted format. The provision of other aggregates in working-day adjusted format is voluntary.

(2) If no breakdown is indicated that means total economy.

(3) Split between taxes and subsidies for quarterly accounts on a voluntary basis.

(4) Breakdown by durability for annual accounts: durable goods, semi-durable goods, non-durable goods, services.

Breakdown by durability for quarterly accounts: durable goods and others.

Backward data starting in 1990.

(5) AN_F6: Breakdown of fixed assets:

—	AN1111	dwellings
—	AN1112	other buildings and structures
—	AN11131	transport equipment
—	AN11132	other machinery and equipment
—	AN1114	cultivated assets
—	AN112	intangible fixed assets.

(6) Only in previous year's prices.

(7) Data (current and constant prices) to be provided for reference periods after 2006 must reflect the compositions of the EU and the EMU as at the end of the period reported in this Table. Only members of the EMU during the reference period are required to provide a split of the EMU; for non-members the split is voluntary.

Backward data (aggregates in current prices, reference periods up to and including 2006):

a)	To be provided by all Member States that, in 2006, were members of the EU but not members of the EMU: 2002-2006: total/EU-25/Institutions of the EU (voluntary)/third countries and international organisations

b)	To be provided by all Member States that, in 2006, were members of the EMU: 1999-2001: total/EMU12 2002-2006: total/EMU12/EU-25/Institutions of the EU (voluntary)/third countries and international organisations EMU12 = Economic and Monetary Union with 12 Member States as at 1.1.2001

For future countries joining the EU and the EMU:

—	Any country joining the EU in year t after 2006 must provide backward data (in current prices) from t-2 on transactions with the EU (in the composition before EU enlargement).

—	Any country joining the EMU in year t after 2006 must provide backward data (in current prices) from t-2 on transactions with the EMU (in the composition before EMU enlargement).

(8) On a voluntary basis.

(9) A6† only for total employment, self employed and employees in resident production units.

(10) General government sub-sectors breakdown:

—	S.13	General Government
—	S.1311	Central Government
—	S.1312	State Government
—	S.1313	Local Government
—	S.1314	Social Security Funds.

(11) Sector S.13 data equal the sum of sub-sectors data, except items D.4, D.7 and D.9 (and their sub-items) for which consolidation between sub-sectors should be made (with counterpart information).

Data for sub-sectors S.1312, S.1313 and S.1314 to be transmitted on a voluntary basis for the t + 3 months transmission for the latest year transmitted.

Backward data for sub-sectors S.1311, S.1312, S.1313 and S.1314 and counterpart information for D.4, D.7 and D.9 starting in 1995.

(12) Split between receiving sub-sectors on a voluntary basis.

(13) If no breakdown is indicated that means total economy.

(14)

A6/A31:	time limit for transmission t + 9 months. Backward data starting in 1980.
A60:	time limit for transmission t + 21 months. Backward data starting in 1990.

(15) A31/A60 on a voluntary basis.

(16) Only in previous year's prices.

(17) On a voluntary basis.

(18) Backward data for hours worked:

—	from 1990: A31 mandatory, A60 voluntary;

—	before 1990: A6 mandatory, A31 voluntary.

(19) Only number of persons; backward data starting in 1995.

(*2) Non-consolidated counterpart information: table on a voluntary basis limited to the following counterpart sectors:

—	S.11	Non-financial corporations
—	S.12	Financial corporations
—	S.13	General government
—	S.14 + S.15	Households and non-profit institutions serving households
—	S.2	Rest of the world

(*3) Changes in volume, revaluation of financial instruments: tables on a voluntary basis

(20) Financial corporations:

—	S.12	Financial corporations — total
—	S.121 + S.122	Monetary financial institutions
—	S.121	Central Bank (Institutional sectors and sub-sectors to be provided on a voluntary basis.)
—	S.122	Other monetary financial institutions (Institutional sectors and sub-sectors to be provided on a voluntary basis.)
—	S.123	Other financial intermediaries
—	S.124	Financial auxiliaries
—	S.125	Insurance corporations and pension funds

(21) General government sub-sectors breakdown:

—	S.13	General Government — total
—	S.1311	Central Government
—	S.1312	State Government
—	S.1313	Local Government
—	S.1314	Social Security Funds

(22) Households and non-profit institutions serving households:

—	S.14 + S.15	Households + non-profit institutions serving households — total
—	S.14	Households (Institutional sectors and sub-sectors to be provided on a voluntary basis.)
—	S.15	Non-profit institutions serving households (Institutional sectors and sub-sectors to be provided on a voluntary basis.)

(23) Rest of the world:

—	S.2	Rest of the world — total
—	S.21	European Union (Institutional sectors and sub-sectors to be provided on a voluntary basis.)
—	S.2111	Members of the EMU (Institutional sectors and sub-sectors to be provided on a voluntary basis.)
—	S.22	Others (not EU) (Institutional sectors and sub-sectors to be provided on a voluntary basis.)

(24) Only for “transactions in financial instruments” but not meaningful for “changes in volume”, “revaluation of financial instruments” and counterpart sector information.

(*4) Non-consolidated counterpart information: table on a voluntary basis limited to the following counterpart sectors:

—	S.11	Non-financial corporations
—	S.12	Financial corporations
—	S.13	General government
—	S.14 + S.15	Households and non-profit institutions serving households
—	S.2	Rest of the world

(25) Financial corporations:

—	S.12	Financial corporations — total
—	S.121 + S.122	Monetary financial institutions
—	S.121	Central Bank (Institutional sectors and sub-sectors to be provided on a voluntary basis.)
—	S.122	Other monetary financial institutions (Institutional sectors and sub-sectors to be provided on a voluntary basis.)
—	S.123	Other financial intermediaries
—	S.124	Financial auxiliaries
—	S.125	Insurance corporations and pension funds

(26) General government sub-sectors breakdown:

—	S.13	General Government — total
—	S.1311	Central Government
—	S.1312	State Government
—	S.1313	Local Government
—	S.1314	Social Security Funds

(27) Households and non-profit institutions serving households:

—	S.14 + S.15	Households + non-profit institutions serving households — total
—	S.14	Households (Institutional sectors and sub-sectors to be provided on a voluntary basis.)
—	S.15	Non-profit institutions serving households (Institutional sectors and sub-sectors to be provided on a voluntary basis.)

(28) Rest of the world:

—	S.2	Rest of the world — total
—	S.21	European Union (Institutional sectors and sub-sectors to be provided on a voluntary basis.)
—	S.2111	Members of the EMU (Institutional sectors and sub-sectors to be provided on a voluntary basis.)
—	S.22	Others (not EU) (Institutional sectors and sub-sectors to be provided on a voluntary basis.)

(29) Only for stocks of financial instruments but not meaningful for counterpart sector information.

(30) Split between sector S.14 and S.15 on a voluntary basis.

(31) Interest will be recorded after adjustment for FISIM

(32) For the transaction of the sector S.13, consolidation should be made within each sub-sector and between all sub-sectors of general government; i.e. central government, state government, local government and social security funds.

Breakdown of sector S.2: Data to be provided for reference periods after 2006 must reflect the membership of the EU and the EMU as at the end of the period reported in this Table. Only members of the EMU during the reference period are required to provide a breakdown of the EMU — for non-members the split is voluntary.

Provision of data for S.212 (Institutions of the EU) voluntary

Backward data (reference periods up to and including 2006):

To be provided by all Member States, which, in 2006, were not members of the EMU:

—	2002-2006: total/EU-25/Institutions of the EU (voluntary)/third countries and international organisations,

To be provided by all Member States, which, in 2006, were members of the EMU:

—	1999-2001: total/EMU12,

—	2002-2006: total/EMU12/EU-25/Institutions of the EU (voluntary)/third countries and international organisations,

For future countries joining the EU and the EMU:

—	Any country joining the EU in year t after 2006 must provide backward data from t-2 on transactions with the EU (in the composition before EU enlargement)

—	Any country joining the EMU in year t after 2006 must provide backward data from t-2 on transactions with the EMU (in the composition before EMU enlargement)

(*5) Sector and sub-sectors:

S.13	General Government. Sub-sectors breakdown:
	—	S.13	General Government
	—	S.1311	Central Government
	—	S.1312	State Government
	—	S.1313	Local Government
	—	S.1314	Social Security Funds
S.212	Institutions of the EU

(*6) On a voluntary basis.

(33) Split by receiving sub-sector on a voluntary basis.

(34) Breakdown of sub-sectors:

—	S.13	General Government
—	S.1311	Central Government
—	S.1312	State Government
—	S.1313	Local Government
—	S.1314	Social Security Funds

(35) On a voluntary basis.

(36) For sub-sector data, consolidation should be made within each sub-sector but not between sub-sectors. Sector S13 data equal the sum of sub-sector data, except items D4, D7 and D9 (and their sub-items) for which consolidation between sub-sectors should be made.

(37) On a voluntary basis.

(38) Breakdown of imports: — EU/EMU/Member States not members of the EMU/third countries. Composition of the EU and the EMU as at the end of the period reported in this table.

(39) On a voluntary basis.

(40) Breakdown of exports: — EU/EMU/Member States not members of the EMU/third countries. Composition of the EU and the EMU as at the end of the period reported in this table.

(41) Only at current prices.

(*7) Industry by industry provided that industry by industry is a good approximation of product by product.

(42) On a voluntary basis.

(43) Breakdown of exports/imports: — EU/EMU/Member States not members of the EMU/third countries. Composition of the EU and the EMU as at the end of the period reported in this table.

(*8) Industry by industry provided that industry by industry is a good approximation of product by product.

(44) On a voluntary basis.

(45) Breakdown of exports/imports: — EU/EMU/Member States not members of the EMU/third countries. Composition of EU and EMU as at the end of the period reported in this table.

(*9) Industry by industry provided that industry by industry is a good approximation of product by product.

(46) On a voluntary basis.

(47) Breakdown of exports: — EU/EMU/Member States not members of the EMU/third countries. Composition of EU and EMU as at the end of the period reported in this table.

(*10) A17 mandatory

A31/A60: on a voluntary basis.

(*11) A31/A60: on a voluntary basis.

(*12) Voluntary: all items except AN.1111, dwellings.

Unit: current replacement costs.

10.12.2007

Official Journal of the European Union

L 324/79

REGULATION (EC) No 1393/2007 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 13 November 2007

on the service in the Member States of judicial and extrajudicial documents in civil or commercial matters (service of documents), and repealing Council Regulation (EC) No 1348/2000

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 61(c) and Article 67(5), second indent, thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and Social Committee (1),

Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),

Whereas:

(1)

The Union has set itself the objective of maintaining and developing the Union as an area of freedom, security and justice, in which the free movement of persons is assured. To establish such an area, the Community is to adopt, among others, the measures relating to judicial cooperation in civil matters needed for the proper functioning of the internal market.

(2)	The proper functioning of the internal market entails the need to improve and expedite the transmission of judicial and extrajudicial documents in civil or commercial matters for service between the Member States.

(3)

The Council, by an Act dated 26 May 1997 (3), drew up a Convention on the service in the Member States of the European Union of judicial and extrajudicial documents in civil or commercial matters and recommended it for adoption by the Member States in accordance with their respective constitutional rules. That Convention has not entered into force. Continuity in the results of the negotiations for conclusion of the Convention should be ensured.

(4)	On 29 May 2000 the Council adopted Regulation (EC) No 1348/2000 on the service in the Member States of judicial and extrajudicial documents in civil or commercial matters (4). The main content of that Regulation is based on the Convention.

(5)

On 1 October 2004 the Commission adopted a report on the application of Regulation (EC) No 1348/2000. The report concludes that the application of Regulation (EC) No 1348/2000 has generally improved and expedited the transmission and the service of documents between Member States since its entry into force in 2001, but that nevertheless the application of certain provisions is not fully satisfactory.

(6)

Efficiency and speed in judicial procedures in civil matters require that judicial and extrajudicial documents be transmitted directly and by rapid means between local bodies designated by the Member States. Member States may indicate their intention to designate only one transmitting or receiving agency or one agency to perform both functions, for a period of five years. This designation may, however, be renewed every five years.

(7)

Speed in transmission warrants the use of all appropriate means, provided that certain conditions as to the legibility and reliability of the document received are observed. Security in transmission requires that the document to be transmitted be accompanied by a standard form, to be completed in the official language or one of the official languages of the place where service is to be effected, or in another language accepted by the Member State in question.

(8)	This Regulation should not apply to service of a document on the party’s authorised representative in the Member State where the proceedings are taking place regardless of the place of residence of that party.

(9)	The service of a document should be effected as soon as possible, and in any event within one month of receipt by the receiving agency.

(10)	To secure the effectiveness of this Regulation, the possibility of refusing service of documents should be confined to exceptional situations.

(11)	In order to facilitate the transmission and service of documents between Member States, the standard forms set out in the Annexes to this Regulation should be used.

(12)

The receiving agency should inform the addressee in writing using the standard form that he may refuse to accept the document to be served at the time of service or by returning the document to the receiving agency within one week if it is not either in a language which he understands or in the official language or one of the official languages of the place of service. This rule should also apply to the subsequent service once the addressee has exercised his right of refusal. These rules on refusal should also apply to service by diplomatic or consular agents, service by postal services and direct service. It should be established that the service of the refused document can be remedied through the service on the addressee of a translation of the document.

(13)

Speed in transmission warrants documents being served within days of receipt of the document. However, if service has not been effected after one month has elapsed, the receiving agency should inform the transmitting agency. The expiry of this period should not imply that the request be returned to the transmitting agency where it is clear that service is feasible within a reasonable period.

(14)

The receiving agency should continue to take all necessary steps to effect the service of the document also in cases where it has not been possible to effect service within the month, for example, because the defendant has been away from his home on holiday or away from his office on business. However, in order to avoid an open-ended obligation for the receiving agency to take steps to effect the service of a document, the transmitting agency should be able to specify a time limit in the standard form after which service is no longer required.

(15)

Given the differences between the Member States as regards their rules of procedure, the material date for the purposes of service varies from one Member State to another. Having regard to such situations and the possible difficulties that may arise, this Regulation should provide for a system where it is the law of the Member State addressed which determines the date of service. However, where according to the law of a Member State a document has to be served within a particular period, the date to be taken into account with respect to the applicant should be that determined by the law of that Member State. This double date system exists only in a limited number of Member States. Those Member States which apply this system should communicate this to the Commission, which should publish the information in the Official Journal of the European Union and make it available through the European Judicial Network in Civil and Commercial Matters established by Council Decision 2001/470/EC (5).

(16)

In order to facilitate access to justice, costs occasioned by recourse to a judicial officer or a person competent under the law of the Member State addressed should correspond to a single fixed fee laid down by that Member State in advance which respects the principles of proportionality and non-discrimination. The requirement of a single fixed fee should not preclude the possibility for Member States to set different fees for different types of service as long as they respect these principles.

(17)	Each Member State should be free to effect service of documents directly by postal services on persons residing in another Member State by registered letter with acknowledgement of receipt or equivalent.

(18)	It should be possible for any person interested in a judicial proceeding to effect service of documents directly through the judicial officers, officials or other competent persons of the Member State addressed, where such direct service is permitted under the law of that Member State.

(19)

The Commission should draw up a manual containing information relevant for the proper application of this Regulation, which should be made available through the European Judicial Network in Civil and Commercial Matters. The Commission and the Member States should do their utmost to ensure that this information is up to date and complete especially as regards contact details of receiving and transmitting agencies.

(20)	In calculating the periods and time limits provided for in this Regulation, Regulation (EEC, Euratom) No 1182/71 of the Council of 3 June 1971 determining the rules applicable to periods, dates and time limits (6) should apply.

(21)	The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (7).

(22)

In particular, power should be conferred on the Commission to update or make technical amendments to the standard forms set out in the Annexes. Since those measures are of general scope and are designed to amend/delete non-essential elements of this Regulation, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

(23)

This Regulation prevails over the provisions contained in bilateral or multilateral agreements or arrangements having the same scope, concluded by the Member States, and in particular the Protocol annexed to the Brussels Convention of 27 September 1968 (8) and the Hague Convention of 15 November 1965 (9) in relations between the Member States party thereto. This Regulation does not preclude Member States from maintaining or concluding agreements or arrangements to expedite or simplify the transmission of documents, provided that they are compatible with this Regulation.

(24)

The information transmitted pursuant to this Regulation should enjoy suitable protection. This matter falls within the scope of Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (10), and of Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) (11).

(25)	No later than 1 June 2011 and every five years thereafter, the Commission should review the application of this Regulation and propose such amendments as may appear necessary.

(26)

Since the objectives of this Regulation cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale or effects of the action, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.

(27)	In order to make the provisions more easily accessible and readable, Regulation (EC) No 1348/2000 should be repealed and replaced by this Regulation.

(28)	In accordance with Article 3 of the Protocol on the position of the United Kingdom and Ireland, annexed to the Treaty on European Union and to the Treaty establishing the European Community, the United Kingdom and Ireland are taking part in the adoption and application of this Regulation.

(29)	In accordance with Articles 1 and 2 of the Protocol on the position of Denmark, annexed to the Treaty on European Union and to the Treaty establishing the European Community, Denmark does not take part in the adoption of this Regulation and is not bound by it or subject to its application,

HAVE ADOPTED THIS REGULATION:

CHAPTER I

GENERAL PROVISIONS

Article 1

Scope

1. This Regulation shall apply in civil and commercial matters where a judicial or extrajudicial document has to be transmitted from one Member State to another for service there. It shall not extend in particular to revenue, customs or administrative matters or to liability of the State for actions or omissions in the exercise of state authority (acta iure imperii).

2. This Regulation shall not apply where the address of the person to be served with the document is not known.

3. In this Regulation, the term ‘Member State’ shall mean the Member States with the exception of Denmark.

Article 2

Transmitting and receiving agencies

1. Each Member State shall designate the public officers, authorities or other persons, hereinafter referred to as ‘transmitting agencies’, competent for the transmission of judicial or extrajudicial documents to be served in another Member State.

2. Each Member State shall designate the public officers, authorities or other persons, hereinafter referred to as ‘receiving agencies’, competent for the receipt of judicial or extrajudicial documents from another Member State.

3. A Member State may designate one transmitting agency and one receiving agency, or one agency to perform both functions. A federal State, a State in which several legal systems apply or a State with autonomous territorial units shall be free to designate more than one such agency. The designation shall have effect for a period of five years and may be renewed at five-year intervals.

4. Each Member State shall provide the Commission with the following information:

(a)	the names and addresses of the receiving agencies referred to in paragraphs 2 and 3;

(b)	the geographical areas in which they have jurisdiction;

(c)	the means of receipt of documents available to them; and

(d)	the languages that may be used for the completion of the standard form set out in Annex I.

Member States shall notify the Commission of any subsequent modification of such information.

Article 3

Central body

Each Member State shall designate a central body responsible for:

(a)	supplying information to the transmitting agencies;

(b)	seeking solutions to any difficulties which may arise during transmission of documents for service;

(c)	forwarding, in exceptional cases, at the request of a transmitting agency, a request for service to the competent receiving agency.

A federal State, a State in which several legal systems apply or a State with autonomous territorial units shall be free to designate more than one central body.

CHAPTER II

JUDICIAL DOCUMENTS

Section 1

Transmission and service of judicial documents

Article 4

Transmission of documents

1. Judicial documents shall be transmitted directly and as soon as possible between the agencies designated pursuant to Article 2.

2. The transmission of documents, requests, confirmations, receipts, certificates and any other papers between transmitting agencies and receiving agencies may be carried out by any appropriate means, provided that the content of the document received is true and faithful to that of the document forwarded and that all information in it is easily legible.

3. The document to be transmitted shall be accompanied by a request drawn up using the standard form set out in Annex I. The form shall be completed in the official language of the Member State addressed or, if there are several official languages in that Member State, the official language or one of the official languages of the place where service is to be effected, or in another language which that Member State has indicated it can accept. Each Member State shall indicate the official language or languages of the institutions of the European Union other than its own which is or are acceptable to it for completion of the form.

4. The documents and all papers that are transmitted shall be exempted from legalisation or any equivalent formality.

5. When the transmitting agency wishes a copy of the document to be returned together with the certificate referred to in Article 10, it shall send the document in duplicate.

Article 5

Translation of documents

1. The applicant shall be advised by the transmitting agency to which he forwards the document for transmission that the addressee may refuse to accept it if it is not in one of the languages provided for in Article 8.

2. The applicant shall bear any costs of translation prior to the transmission of the document, without prejudice to any possible subsequent decision by the court or competent authority on liability for such costs.

Article 6

Receipt of documents by receiving agency

1. On receipt of a document, a receiving agency shall, as soon as possible and in any event within seven days of receipt, send a receipt to the transmitting agency by the swiftest possible means of transmission using the standard form set out in Annex I.

2. Where the request for service cannot be fulfilled on the basis of the information or documents transmitted, the receiving agency shall contact the transmitting agency by the swiftest possible means in order to secure the missing information or documents.

3. If the request for service is manifestly outside the scope of this Regulation or if non-compliance with the formal conditions required makes service impossible, the request and the documents transmitted shall be returned, on receipt, to the transmitting agency, together with the notice of return using the standard form set out in Annex I.

4. A receiving agency receiving a document for service but not having territorial jurisdiction to serve it shall forward it, as well as the request, to the receiving agency having territorial jurisdiction in the same Member State if the request complies with the conditions laid down in Article 4(3) and shall inform the transmitting agency accordingly using the standard form set out in Annex I. That receiving agency shall inform the transmitting agency when it receives the document, in the manner provided for in paragraph 1.

Article 7

Service of documents

1. The receiving agency shall itself serve the document or have it served, either in accordance with the law of the Member State addressed or by a particular method requested by the transmitting agency, unless that method is incompatible with the law of that Member State.

2. The receiving agency shall take all necessary steps to effect the service of the document as soon as possible, and in any event within one month of receipt. If it has not been possible to effect service within one month of receipt, the receiving agency shall:

(a)	immediately inform the transmitting agency by means of the certificate in the standard form set out in Annex I, which shall be drawn up under the conditions referred to in Article 10(2); and

(b)	continue to take all necessary steps to effect the service of the document, unless indicated otherwise by the transmitting agency, where service seems to be possible within a reasonable period of time.

Article 8

Refusal to accept a document

1. The receiving agency shall inform the addressee, using the standard form set out in Annex II, that he may refuse to accept the document to be served at the time of service or by returning the document to the receiving agency within one week if it is not written in, or accompanied by a translation into, either of the following languages:

(a)	a language which the addressee understands; or

(b)	the official language of the Member State addressed or, if there are several official languages in that Member State, the official language or one of the official languages of the place where service is to be effected.

2. Where the receiving agency is informed that the addressee refuses to accept the document in accordance with paragraph 1, it shall immediately inform the transmitting agency by means of the certificate provided for in Article 10 and return the request and the documents of which a translation is requested.

3. If the addressee has refused to accept the document pursuant to paragraph 1, the service of the document can be remedied through the service on the addressee in accordance with the provisions of this Regulation of the document accompanied by a translation into a language provided for in paragraph 1. In that case, the date of service of the document shall be the date on which the document accompanied by the translation is served in accordance with the law of the Member State addressed. However, where according to the law of a Member State, a document has to be served within a particular period, the date to be taken into account with respect to the applicant shall be the date of the service of the initial document determined pursuant to Article 9(2).

4. Paragraphs 1, 2 and 3 shall also apply to the means of transmission and service of judicial documents provided for in Section 2.

5. For the purposes of paragraph 1, the diplomatic or consular agents, where service is effected in accordance with Article 13, or the authority or person, where service is effected in accordance with Article 14, shall inform the addressee that he may refuse to accept the document and that any document refused must be sent to those agents or to that authority or person respectively.

Article 9

Date of service

1. Without prejudice to Article 8, the date of service of a document pursuant to Article 7 shall be the date on which it is served in accordance with the law of the Member State addressed.

2. However, where according to the law of a Member State a document has to be served within a particular period, the date to be taken into account with respect to the applicant shall be that determined by the law of that Member State.

3. Paragraphs 1 and 2 shall also apply to the means of transmission and service of judicial documents provided for in Section 2.

Article 10

Certificate of service and copy of the document served

1. When the formalities concerning the service of the document have been completed, a certificate of completion of those formalities shall be drawn up in the standard form set out in Annex I and addressed to the transmitting agency, together with, where Article 4(5) applies, a copy of the document served.

2. The certificate shall be completed in the official language or one of the official languages of the Member State of origin or in another language which the Member State of origin has indicated that it can accept. Each Member State shall indicate the official language or languages of the institutions of the European Union other than its own which is or are acceptable to it for completion of the form.

Article 11

Costs of service

1. The service of judicial documents coming from a Member State shall not give rise to any payment or reimbursement of taxes or costs for services rendered by the Member State addressed.

2. However, the applicant shall pay or reimburse the costs occasioned by:

(a)	recourse to a judicial officer or to a person competent under the law of the Member State addressed;

(b)	the use of a particular method of service.

Costs occasioned by recourse to a judicial officer or to a person competent under the law of the Member State addressed shall correspond to a single fixed fee laid down by that Member State in advance which respects the principles of proportionality and non-discrimination. Member States shall communicate such fixed fees to the Commission.

Section 2

Other means of transmission and service of judicial documents

Article 12

Transmission by consular or diplomatic channels

Each Member State shall be free, in exceptional circumstances, to use consular or diplomatic channels to forward judicial documents, for the purpose of service, to those agencies of another Member State which are designated pursuant to Articles 2 or 3.

Article 13

Service by diplomatic or consular agents

1. Each Member State shall be free to effect service of judicial documents on persons residing in another Member State, without application of any compulsion, directly through its diplomatic or consular agents.

2. Any Member State may make it known, in accordance with Article 23(1), that it is opposed to such service within its territory, unless the documents are to be served on nationals of the Member State in which the documents originate.

Article 14

Service by postal services

Each Member State shall be free to effect service of judicial documents directly by postal services on persons residing in another Member State by registered letter with acknowledgement of receipt or equivalent.

Article 15

Direct service

Any person interested in a judicial proceeding may effect service of judicial documents directly through the judicial officers, officials or other competent persons of the Member State addressed, where such direct service is permitted under the law of that Member State.

CHAPTER III

EXTRAJUDICIAL DOCUMENTS

Article 16

Transmission

Extrajudicial documents may be transmitted for service in another Member State in accordance with the provisions of this Regulation.

CHAPTER IV

FINAL PROVISIONS

Article 17

Implementing rules

Measures designed to amend non-essential elements of this Regulation relating to the updating or to the making of technical amendments to the standard forms set out in Annexes I and II shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 18(2).

Article 18

Committee

1. The Commission shall be assisted by a committee.

2. Where reference is made to this paragraph, Article 5a(1) to (4), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

Article 19

Defendant not entering an appearance

1. Where a writ of summons or an equivalent document has had to be transmitted to another Member State for the purpose of service under the provisions of this Regulation and the defendant has not appeared, judgment shall not be given until it is established that:

(a)	the document was served by a method prescribed by the internal law of the Member State addressed for the service of documents in domestic actions upon persons who are within its territory; or

(b)	the document was actually delivered to the defendant or to his residence by another method provided for by this Regulation;

and that in either of these cases the service or the delivery was effected in sufficient time to enable the defendant to defend.

2. Each Member State may make it known, in accordance with Article 23(1), that the judge, notwithstanding the provisions of paragraph 1, may give judgment even if no certificate of service or delivery has been received, if all the following conditions are fulfilled:

(a)	the document was transmitted by one of the methods provided for in this Regulation;

(b)	a period of time of not less than six months, considered adequate by the judge in the particular case, has elapsed since the date of the transmission of the document;

(c)	no certificate of any kind has been received, even though every reasonable effort has been made to obtain it through the competent authorities or bodies of the Member State addressed.

3. Notwithstanding paragraphs 1 and 2, the judge may order, in case of urgency, any provisional or protective measures.

4. When a writ of summons or an equivalent document has had to be transmitted to another Member State for the purpose of service under the provisions of this Regulation and a judgment has been entered against a defendant who has not appeared, the judge shall have the power to relieve the defendant from the effects of the expiry of the time for appeal from the judgment if the following conditions are fulfilled:

(a)	the defendant, without any fault on his part, did not have knowledge of the document in sufficient time to defend, or knowledge of the judgment in sufficient time to appeal; and

(b)	the defendant has disclosed a prima facie defence to the action on the merits.

An application for relief may be filed only within a reasonable time after the defendant has knowledge of the judgment.

Each Member State may make it known, in accordance with Article 23(1), that such application will not be entertained if it is filed after the expiry of a time to be stated by it in that communication, but which shall in no case be less than one year following the date of the judgment.

5. Paragraph 4 shall not apply to judgments concerning the status or capacity of persons.

Article 20

Relationship with agreements or arrangements to which Member States are party

1. This Regulation shall, in relation to matters to which it applies, prevail over other provisions contained in bilateral or multilateral agreements or arrangements concluded by the Member States, and in particular Article IV of the Protocol to the Brussels Convention of 1968 and the Hague Convention of 15 November 1965.

2. This Regulation shall not preclude individual Member States from maintaining or concluding agreements or arrangements to expedite further or simplify the transmission of documents, provided that they are compatible with this Regulation.

3. Member States shall send to the Commission:

(a)	a copy of the agreements or arrangements referred to in paragraph 2 concluded between the Member States as well as drafts of such agreements or arrangements which they intend to adopt; and

(b)	any denunciation of, or amendments to, these agreements or arrangements.

Article 21

Legal aid

This Regulation shall not affect the application of Article 23 of the Convention on civil procedure of 17 July 1905, Article 24 of the Convention on civil procedure of 1 March 1954 or Article 13 of the Convention on international access to justice of 25 October 1980 between the Member States party to those Conventions.

Article 22

Protection of information transmitted

1. Information, including in particular personal data, transmitted under this Regulation shall be used by the receiving agency only for the purpose for which it was transmitted.

2. Receiving agencies shall ensure the confidentiality of such information, in accordance with their national law.

3. Paragraphs 1 and 2 shall not affect national laws enabling data subjects to be informed of the use made of information transmitted under this Regulation.

4. This Regulation shall be without prejudice to Directives 95/46/EC and 2002/58/EC.

Article 23

Communication and publication

1. Member States shall communicate to the Commission the information referred to in Articles 2, 3, 4, 10, 11, 13, 15 and 19. Member States shall communicate to the Commission if, according to their law, a document has to be served within a particular period as referred to in Articles 8(3) and 9(2).

2. The Commission shall publish the information communicated in accordance with paragraph 1 in the Official Journal of the European Union with the exception of the addresses and other contact details of the agencies and of the central bodies and the geographical areas in which they have jurisdiction.

3. The Commission shall draw up and update regularly a manual containing the information referred to in paragraph 1, which shall be available electronically, in particular through the European Judicial Network in Civil and Commercial Matters.

Article 24

Review

No later than 1 June 2011, and every five years thereafter, the Commission shall present to the European Parliament, the Council and the European Economic and Social Committee a report on the application of this Regulation, paying special attention to the effectiveness of the agencies designated pursuant to Article 2 and to the practical application of Article 3(c) and Article 9. The report shall be accompanied if need be by proposals for adaptations of this Regulation in line with the evolution of notification systems.

Article 25

Repeal

1. Regulation (EC) No 1348/2000 shall be repealed as from the date of application of this Regulation.

2. References made to the repealed Regulation shall be construed as being made to this Regulation and should be read in accordance with the correlation table in Annex III.

Article 26

Entry into force

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

It shall apply from 13 November 2008 with the exception of Article 23 which shall apply from 13 August 2008.

This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaty establishing the European Community.

Done at Strasbourg, 13 November 2007.

For the European Parliament

The President

H.-G. PÖTTERING

For the Council

The President

M. LOBO ANTUNES

(1) OJ C 88, 11.4.2006, p. 7.

(2) Opinion of the European Parliament of 4 July 2006 (OJ C 303 E, 13.12.2006, p. 69), Council Common Position of 28 June 2007 (OJ C 193 E, 21.8.2007, p. 13) and Position of the European Parliament of 24 October 2007.

(3) OJ C 261, 27.8.1997, p. 1. On the same day as the Convention was drawn up the Council took note of the explanatory report on the Convention which is set out on page 26 of the aforementioned Official Journal.

(4) OJ L 160, 30.6.2000, p. 37.

(5) OJ L 174, 27.6.2001, p. 25.

(6) OJ L 124, 8.6.1971, p. 1.

(7) OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 11).

(8) Brussels Convention of 27 September 1968 on Jurisdiction and the Enforcement of Judgments in Civil and Commercial Matters (OJ L 299, 31.12.1972, p. 32; consolidated version, OJ C 27, 26.1.1998, p. 1).

(9) Hague Convention of 15 November 1965 on the Service Abroad of Judicial and Extrajudicial Documents in Civil or Commercial Matters.

(10) OJ L 281, 23.11.1995, p. 31. Directive as amended by Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).

(11) OJ L 201, 31.7.2002, p. 37. Directive as amended by Directive 2006/24/EC (OJ L 105, 13.4.2006, p. 54).

ANNEX I

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ANNEX II

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ANNEX III

CORRELATION TABLE

Regulation (EC) No 1348/2000	This Regulation
Article 1(1)	Article 1(1) first sentence
—	Article 1(1) second sentence
Article 1(2)	Article 1(2)
—	Article 1(3)
Article 2	Article 2
Article 3	Article 3
Article 4	Article 4
Article 5	Article 5
Article 6	Article 6
Article 7(1)	Article 7(1)
Article 7(2) first sentence	Article 7(2) first sentence
Article 7(2) second sentence	Article 7(2) second sentence (introductory phrase) and Article 7(2)(a)
—	Article 7(2)(b)
Article 7(2) third sentence	—
Article 8(1) introductory phrase	Article 8(1) introductory phrase
Article 8(1)(a)	Article 8(1)(b)
Article 8(1)(b)	Article 8(1)(a)
Article 8(2)	Article 8(2)
—	Article 8(3) to (5)
Article 9(1) and (2)	Article 9(1) and (2)
Article 9(3)	—
—	Article 9(3)
Article 10	Article 10
Article 11(1)	Article 11(1)
Article 11(2)	Article 11(2) first subparagraph
—	Article 11(2) second subparagraph
Article 12	Article 12
Article 13	Article 13
Article 14(1)	Article 14
Article 14(2)	—
Article 15(1)	Article 15
Article 15(2)	—
Article 16	Article 16
Article 17, introductory phrase	Article 17
Article 17(a) to (c)	—
Article 18(1) and (2)	Article 18(1) and (2)
Article 18(3)	—
Article 19	Article 19
Article 20	Article 20
Article 21	Article 21
Article 22	Article 22
Article 23(1)	Article 23(1) first sentence
—	Article 23(1) second sentence
Article 23(2)	Article 23(2)
—	Article 23(3)
Article 24	Article 24
Article 25	—
—	Article 25
—	Article 26
Annex	Annex I
—	Annex II
—	Annex III

10.12.2007

Official Journal of the European Union

L 324/121

REGULATION (EC) No 1394/2007 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 13 November 2007

on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the Opinion of the European Economic and Social Committee (1),

After consulting the Committee of the Regions,

Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),

Whereas:

(1)

New scientific progress in cellular and molecular biotechnology has led to the development of advanced therapies, such as gene therapy, somatic cell therapy, and tissue engineering. This nascent field of biomedicine offers new opportunities for the treatment of diseases and dysfunctions of the human body.

(2)

Insofar as advanced therapy products are presented as having properties for treating or preventing diseases in human beings, or that they may be used in or administered to human beings with a view to restoring, correcting or modifying physiological functions by exerting principally a pharmacological, immunological or metabolic action, they are biological medicinal products within the meaning of Annex I to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (3), read in conjunction with the definition of medicinal products in Article 1(2) thereof. Thus, the essential aim of any rules governing their production, distribution and use must be to safeguard public health.

(3)

For reasons of clarity, complex therapeutic products require precise legal definitions. Gene therapy medicinal products and somatic cell therapy medicinal products have been defined in Annex I to Directive 2001/83/EC, but a legal definition of tissue engineered products remains to be laid down. When products are based on viable cells or tissues, the pharmacological, immunological or metabolic action should be considered as the principal mode of action. It should also be clarified that products which do not meet the definition of a medicinal product, such as products made exclusively of non-viable materials which act primarily by physical means, cannot by definition be advanced therapy medicinal products.

(4)

According to Directive 2001/83/EC and the Medical Device Directives the basis for deciding which regulatory regime is applicable to combinations of medicinal products and medical devices is the principal mode of action of the combination product. However, the complexity of combined advanced therapy medicinal products containing viable cells or tissues requires a specific approach. For these products, whatever the role of the medical device, the pharmacological, immunological or metabolic action of these cells or tissues should be considered to be the principal mode of action of the combination product. Such combination products should always be regulated under this Regulation.

(5)	Because of the novelty, complexity and technical specificity of advanced therapy medicinal products, specially tailored and harmonised rules are needed to ensure the free movement of those products within the Community, and the effective operation of the internal market in the biotechnology sector.

(6)

This Regulation is a lex specialis, which introduces additional provisions to those laid down in Directive 2001/83/EC. The scope of this Regulation should be to regulate advanced therapy medicinal products which are intended to be placed on the market in Member States and either prepared industrially or manufactured by a method involving an industrial process, in accordance with the general scope of the Community pharmaceutical legislation laid down in Title II of Directive 2001/83/EC. Advanced therapy medicinal products which are prepared on a non-routine basis according to specific quality standards, and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient, should be excluded from the scope of this Regulation whilst at the same time ensuring that relevant Community rules related to quality and safety are not undermined.

(7)

The regulation of advanced therapy medicinal products at Community level should not interfere with decisions made by Member States on whether to allow the use of any specific type of human cells, such as embryonic stem cells, or animal cells. It should also not affect the application of national legislation prohibiting or restricting the sale, supply or use of medicinal products containing, consisting of or derived from these cells.

(8)

This Regulation respects the fundamental rights and observes the principles reflected in the Charter of Fundamental Rights of the European Union and also takes into account the Council of Europe Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine.

(9)

All other modern biotechnology medicinal products currently regulated at Community level are already subject to a centralised authorisation procedure, involving a single scientific evaluation of the quality, safety and efficacy of the product, which is carried out to the highest possible standard by the European Medicines Agency as established by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use (4) (hereinafter referred to as the Agency). This procedure should also be compulsory for advanced therapy medicinal products in order to overcome the scarcity of expertise in the Community, ensure a high level of scientific evaluation of these medicinal products in the Community, preserve the confidence of patients and medical professions in the evaluation and facilitate Community market access for these innovative technologies.

(10)

The evaluation of advanced therapy medicinal products often requires very specific expertise, which goes beyond the traditional pharmaceutical field and covers areas bordering on other sectors such as biotechnology and medical devices. For this reason, it is appropriate to create, within the Agency, a Committee for Advanced Therapies, which should be responsible for preparing a draft opinion on the quality, safety and efficacy of each advanced therapy medicinal product for final approval by the Agency’s Committee for Medicinal Products for Human Use. In addition, the Committee for Advanced Therapies should be consulted for the evaluation of any other medicinal product which requires specific expertise falling within its area of competence.

(11)

The Committee for Advanced Therapies should gather the best available expertise on advanced therapy medicinal products in the Community. The composition of the Committee for Advanced Therapies should ensure appropriate coverage of the scientific areas relevant to advanced therapies, including gene therapy, cell therapy, tissue engineering, medical devices, pharmacovigilance and ethics. Patient associations and clinicians with scientific experience of advanced therapy medicinal products should also be represented.

(12)

To ensure scientific consistency and the efficiency of the system, the Agency should ensure the coordination between the Committee for Advanced Therapies and its other Committees, advisory groups and working parties, notably the Committee for Medicinal Products for Human Use, the Committee on Orphan Medicinal Products, and the Scientific Advice Working Party.

(13)

Advanced therapy medicinal products should be subject to the same regulatory principles as other types of biotechnology medicinal products. However, technical requirements, in particular the type and amount of quality, pre-clinical and clinical data necessary to demonstrate the quality, safety and efficacy of the product, may be highly specific. While those requirements are already laid down in Annex I to Directive 2001/83/EC for gene therapy medicinal products and somatic cell therapy medicinal products, they need to be established for tissue engineered products. This should be done through a procedure that provides for sufficient flexibility, so as to easily accommodate the rapid evolution of science and technology.

(14)

Directive 2004/23/EC of the European Parliament and of the Council (5) sets standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. This Regulation should not derogate from the basic principles laid down in Directive 2004/23/EC, but should supplement them with additional requirements, where appropriate. Where an advanced therapy medicinal product contains human cells or tissues, Directive 2004/23/EC should apply only as far as donation, procurement and testing are concerned, since the further aspects are covered by this Regulation.

(15)

As regards the donation of human cells or tissues, principles such as the anonymity of both donor and recipient, altruism of the donor and solidarity between donor and recipient should be respected. As a matter of principle, human cells or tissues contained in advanced therapy medicinal products should be procured from voluntary and unpaid donation. Member States should be urged to take all necessary steps to encourage a strong public and non-profit sector involvement in the procurement of human cells or tissues, as voluntary and unpaid cell and tissue donations may contribute to high safety standards for cells and tissues and therefore to the protection of human health.

(16)

Clinical trials on advanced therapy medicinal products should be conducted in accordance with the overarching principles and the ethical requirements laid down in Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (6). However, Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (7) should be adapted by laying down rules tailored to fully take into account the specific technical characteristics of advanced therapy medicinal products.

(17)

The manufacture of advanced therapy medicinal products should be in compliance with the principles of good manufacturing practice, as set out in Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (8), and adapted, where necessary, to reflect the specific nature of those products. Furthermore, guidelines specific to advanced therapy medicinal products should be drawn up, so as to properly reflect the particular nature of their manufacturing process.

(18)

Advanced therapy medicinal products may incorporate medical devices or active implantable medical devices. Those devices should meet the essential requirements laid down in Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (9) and Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (10), respectively, in order to ensure an appropriate level of quality and safety. The results of the assessment of the medical device part or the active implantable medical device part by a notified body in accordance with those Directives should be recognised by the Agency in the evaluation of a combined advanced therapy medicinal product carried out under this Regulation.

(19)

The requirements in Directive 2001/83/EC as regards the summary of product characteristics, labelling and the package leaflet should be adapted to the technical specificities of advanced therapy medicinal products by laying down specific rules on those products. These rules should comply fully with the patient’s right to know the origin of any cells or tissues used in the preparation of advanced therapy medicinal products, while respecting donor anonymity.

(20)

Follow-up of efficacy and adverse reactions is a crucial aspect of the regulation of advanced therapy medicinal products. The applicant should therefore detail in its marketing authorisation application whether measures are envisaged to ensure such follow-up and, if so, what those measures are. Where justified on public health grounds, the holder of the marketing authorisation should also be required to put in place a suitable risk management system to address risks related to advanced therapy medicinal products.

(21)

The operation of this Regulation requires the establishment of guidelines to be drawn up either by the Agency or by the Commission. Open consultation with all interested parties, in particular Member State authorities and the industry, should be carried out in order to allow a pooling of the limited expertise in this area and ensure proportionality. The guidelines on good clinical practice and good manufacturing practice should be laid down as soon as possible, preferably during the first year after entry into force and before the date of application of this Regulation.

(22)

A system allowing complete traceability of the patient as well as of the product and its starting materials is essential to monitor the safety of advanced therapy medicinal products. The establishment and maintenance of that system should be done in such a way as to ensure coherence and compatibility with traceability requirements laid down in Directive 2004/23/EC in respect of human tissues and cells, and in Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components (11). The traceability system should also respect the provisions laid down in Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and the free movement of such data (12).

(23)

As science evolves very rapidly in this field, undertakings developing advanced therapy medicinal products should be enabled to request scientific advice from the Agency, including advice on post-authorisation activities. As an incentive, the fee for that scientific advice should be kept at a minimal level for small and medium-sized enterprises, and should also be reduced for other applicants.

(24)

The Agency should be empowered to give scientific recommendations on whether a given product based on genes, cells or tissues meets the scientific criteria which define advanced therapy medicinal products, in order to address, as early as possible, questions of borderline with other areas such as cosmetics or medical devices, which may arise as science develops. The Committee for Advanced Therapies, with its unique expertise, should have a prominent role in the provision of such advice.

(25)

Studies necessary to demonstrate the quality and non-clinical safety of advanced therapy medicinal products are often carried out by small and medium-sized enterprises. As an incentive to conduct those studies, a system of evaluation and certification of the resulting data by the Agency, independently of any marketing authorisation application, should be introduced. Even though the certification would not be legally binding, this system should also aim at facilitating the evaluation of any future application for clinical trials and marketing authorisation application based on the same data.

(26)

In order to take into account scientific and technical developments, the Commission should be empowered to adopt any necessary changes regarding the technical requirements for applications for marketing authorisation of advanced therapy medicinal products, the summary of product characteristics, labelling, and the package leaflet. The Commission should ensure that relevant information on envisaged measures is made available to interested parties without delay.

(27)	Provisions should be laid down to report on the implementation of this Regulation after experience has been gained, with a particular attention to the different types of advanced therapy medicinal products authorised.

(28)	The opinions of the Scientific Committee for Medicinal Products and Medical Devices concerning tissue engineering and that of the European Group on Ethics in Science and New Technologies have been taken into account, as well as international experience in this field.

(29)	The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (13).

(30)

In particular, the Commission should be empowered to adopt amendments to Annexes I to IV to this Regulation and to Annex I to Directive 2001/83/EC. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation and of Directive 2001/83/EC, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. Those measures are essential for the proper operation of the whole regulatory framework and should therefore be adopted as soon as possible.

(31)	Directive 2001/83/EC and Regulation (EC) No 726/2004 should therefore be amended accordingly,

HAVE ADOPTED THIS REGULATION:

CHAPTER 1

SUBJECT MATTER AND DEFINITIONS

Article 1

Subject matter

This Regulation lays down specific rules concerning the authorisation, supervision and pharmacovigilance of advanced therapy medicinal products.

Article 2

Definitions

1. In addition to the definitions laid down in Article 1 of Directive 2001/83/EC and in Article 3, points (a) to (l) and (o) to (q) of Directive 2004/23/EC, the following definitions shall apply for the purposes of this Regulation:

(a)

‘Advanced therapy medicinal product’ means any of the following medicinal products for human use:

—	a gene therapy medicinal product as defined in Part IV of Annex I to Directive 2001/83/EC,

—	a somatic cell therapy medicinal product as defined in Part IV of Annex I to Directive 2001/83/EC,

—	a tissue engineered product as defined in point (b).

(b)

‘Tissue engineered product’ means a product that:

—	contains or consists of engineered cells or tissues, and

—	is presented as having properties for, or is used in or administered to human beings with a view to regenerating, repairing or replacing a human tissue.

A tissue engineered product may contain cells or tissues of human or animal origin, or both. The cells or tissues may be viable or non-viable. It may also contain additional substances, such as cellular products, bio-molecules, bio-materials, chemical substances, scaffolds or matrices.

Products containing or consisting exclusively of non-viable human or animal cells and/or tissues, which do not contain any viable cells or tissues and which do not act principally by pharmacological, immunological or metabolic action, shall be excluded from this definition.

(c)

Cells or tissues shall be considered ‘engineered’ if they fulfil at least one of the following conditions:

—

the cells or tissues have been subject to substantial manipulation, so that biological characteristics, physiological functions or structural properties relevant for the intended regeneration, repair or replacement are achieved. The manipulations listed in Annex I, in particular, shall not be considered as substantial manipulations,

—	the cells or tissues are not intended to be used for the same essential function or functions in the recipient as in the donor.

(d)

‘Combined advanced therapy medicinal product’ means an advanced therapy medicinal product that fulfils the following conditions:

—	it must incorporate, as an integral part of the product, one or more medical devices within the meaning of Article 1(2)(a) of Directive 93/42/EEC or one or more active implantable medical devices within the meaning of Article 1(2)(c) of Directive 90/385/EEC, and

—	its cellular or tissue part must contain viable cells or tissues, or

—	its cellular or tissue part containing non-viable cells or tissues must be liable to act upon the human body with action that can be considered as primary to that of the devices referred to.

2. Where a product contains viable cells or tissues, the pharmacological, immunological or metabolic action of those cells or tissues shall be considered as the principal mode of action of the product.

3. An advanced therapy medicinal product containing both autologous (emanating from the patient himself) and allogeneic (coming from another human being) cells or tissues shall be considered to be for allogeneic use.

4. A product which may fall within the definition of a tissue engineered product and within the definition of a somatic cell therapy medicinal product shall be considered as a tissue engineered product.

5. A product which may fall within the definition of:

—	a somatic cell therapy medicinal product or a tissue engineered product, and

—	a gene therapy medicinal product,

shall be considered as a gene therapy medicinal product.

CHAPTER 2

MARKETING AUTHORISATION REQUIREMENTS

Article 3

Donation, procurement and testing

Where an advanced therapy medicinal product contains human cells or tissues, the donation, procurement and testing of those cells or tissues shall be made in accordance with Directive 2004/23/EC.

Article 4

Clinical trials

1. The rules set out in Article 6(7) and Article 9(4) and (6) of Directive 2001/20/EC in respect of gene therapy and somatic cell therapy medicinal products shall apply to tissue engineered products.

2. The Commission shall, after consulting the Agency, draw up detailed guidelines on good clinical practice specific to advanced therapy medicinal products.

Article 5

Good manufacturing practice

The Commission shall, after consulting the Agency, draw up guidelines in line with the principles of good manufacturing practice and specific to advanced therapy medicinal products.

Article 6

Issues specific to medical devices

1. A medical device which forms part of a combined advanced therapy medicinal product shall meet the essential requirements laid down in Annex I to Directive 93/42/EEC.

2. An active implantable medical device which forms part of a combined advanced therapy medicinal product shall meet the essential requirements laid down in Annex 1 to Directive 90/385/EEC.

Article 7

Specific requirements for advanced therapy medicinal products containing devices

In addition to the requirements laid down in Article 6(1) of Regulation (EC) No 726/2004, applications for the authorisation of an advanced therapy medicinal product containing medical devices, bio-materials, scaffolds or matrices shall include a description of the physical characteristics and performance of the product and a description of the product design methods, in accordance with Annex I to Directive 2001/83/EC.

CHAPTER 3

MARKETING AUTHORISATION PROCEDURE

Article 8

Evaluation procedure

1. The Committee for Medicinal Products for Human Use shall consult the Committee for Advanced Therapies on any scientific assessment of advanced therapy medicinal products necessary to draw up the scientific opinions referred to in Article 5(2) and (3) of Regulation (EC) No 726/2004. The Committee for Advanced Therapies shall also be consulted in the event of re-examination of the opinion pursuant to Article 9(2) of Regulation (EC) No 726/2004.

2. When preparing a draft opinion for final approval by the Committee for Medicinal Products for Human Use, the Committee for Advanced Therapies shall endeavour to reach a scientific consensus. If such consensus cannot be reached, the Committee for Advanced Therapies shall adopt the position of the majority of its members. The draft opinion shall mention the divergent positions and the grounds on which they are based.

3. The draft opinion given by the Committee for Advanced Therapies under paragraph 1 shall be sent to the Chairman of the Committee for Medicinal Products for Human Use in a timely manner so as to ensure that the deadline laid down in Article 6(3) or Article 9(2) of Regulation (EC) No 726/2004 can be met.

4. Where the scientific opinion on an advanced therapy medicinal product drawn up by the Committee for Medicinal Products for Human Use under Article 5(2) and (3) of Regulation (EC) No 726/2004 is not in accordance with the draft opinion of the Committee for Advanced Therapies, the Committee for Medicinal Products for Human Use shall annex to its opinion a detailed explanation of the scientific grounds for the differences.

5. The Agency shall draw up specific procedures for the application of paragraphs 1 to 4.

Article 9

Combined advanced therapy medicinal products

1. Where a combined advanced therapy medicinal product is concerned, the whole product shall be subject to final evaluation by the Agency.

2. The application for a marketing authorisation for a combined advanced therapy medicinal product shall include evidence of conformity with the essential requirements referred to in Article 6.

3. The application for a marketing authorisation for a combined advanced therapy medicinal product shall include, where available, the results of the assessment by a notified body in accordance with Directive 93/42/EEC or Directive 90/385/EEC of the medical device part or active implantable medical device part.

The Agency shall recognise the results of that assessment in its evaluation of the medicinal product concerned.

The Agency may request the relevant notified body to transmit any information related to the results of its assessment. The notified body shall transmit the information within a period of one month.

If the application does not include the results of the assessment, the Agency shall seek an opinion on the conformity of the device part with Annex I to Directive 93/42/EEC or Annex 1 to Directive 90/385/EEC from a notified body identified in conjunction with the applicant, unless the Committee for Advanced Therapies advised by its experts for medical devices decides that involvement of a notified body is not required.

CHAPTER 4

SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET

Article 10

Summary of product characteristics

By way of derogation from Article 11 of Directive 2001/83/EC, the summary of the product characteristics for advanced therapy medicinal products shall contain the information listed in Annex II to this Regulation, in the order indicated therein.

Article 11

Labelling of outer/immediate packaging

By way of derogation from Articles 54 and 55(1) of Directive 2001/83/EC, the particulars listed in Annex III to this Regulation shall appear on the outer packaging of advanced therapy medicinal products or, where there is no outer packaging, on the immediate packaging.

Article 12

Special immediate packaging

In addition to the particulars mentioned in Article 55(2) and (3) of Directive 2001/83/EC, the following particulars shall appear on the immediate packaging of advanced therapy medicinal products:

(a)	the unique donation and product codes, as referred to in Article 8(2) of Directive 2004/23/EC;

(b)	in the case of advanced therapy medicinal products for autologous use, the unique patient identifier and the statement ‘For autologous use only’.

Article 13

Package leaflet

1. By way of derogation from Article 59(1) of Directive 2001/83/EC, the package leaflet for an advanced therapy medicinal product shall be drawn up in accordance with the summary of product characteristics and shall include the information listed in Annex IV to this Regulation, in the order indicated therein.

2. The package leaflet shall reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use.

CHAPTER 5

POST-AUTHORISATION REQUIREMENTS

Article 14

Post-authorisation follow-up of efficacy and adverse reactions, and risk management

1. In addition to the requirements for pharmacovigilance laid down in Articles 21 to 29 of Regulation (EC) No 726/2004, the applicant shall detail, in the marketing authorisation application, the measures envisaged to ensure the follow-up of efficacy of advanced therapy medicinal products and of adverse reactions thereto.

2. Where there is particular cause for concern, the Commission shall, on the advice of the Agency, require as part of the marketing authorisation that a risk management system designed to identify, characterise, prevent or minimise risks related to advanced therapy medicinal products, including an evaluation of the effectiveness of that system, be set up, or that specific post-marketing studies be carried out by the holder of the marketing authorisation and submitted for review to the Agency.

In addition, the Agency may request submission of additional reports evaluating the effectiveness of any risk management system and the results of any such studies performed.

Evaluation of the effectiveness of any risk management system and the results of any studies performed shall be included in the periodic safety update reports referred to in Article 24(3) of Regulation (EC) No 726/2004.

3. The Agency shall forthwith inform the Commission if it finds that the marketing authorisation holder has failed to comply with the requirements referred to in paragraph 2.

4. The Agency shall draw up detailed guidelines relating to the application of paragraphs 1, 2 and 3.

5. If serious adverse events or reactions occur in relation to a combined advanced therapy medicinal product, the Agency shall inform the relevant national competent authorities responsible for implementing Directives 90/385/EEC, 93/42/EEC and 2004/23/EC.

Article 15

Traceability

1. The holder of a marketing authorisation for an advanced therapy medicinal product shall establish and maintain a system ensuring that the individual product and its starting and raw materials, including all substances coming into contact with the cells or tissues it may contain, can be traced through the sourcing, manufacturing, packaging, storage, transport and delivery to the hospital, institution or private practice where the product is used.

2. The hospital, institution or private practice where the advanced therapy medicinal product is used shall establish and maintain a system for patient and product traceability. That system shall contain sufficient detail to allow linking of each product to the patient who received it and vice versa.

3. Where an advanced therapy medicinal product contains human cells or tissues, the marketing authorisation holder, as well as the hospital, institution or private practice where the product is used, shall ensure that the traceability systems established in accordance with paragraphs 1 and 2 of this Article are complementary to, and compatible with, the requirements laid down in Articles 8 and 14 of Directive 2004/23/EC as regards human cells and tissues other than blood cells, and Articles 14 and 24 of Directive 2002/98/EC as regards human blood cells.

4. The marketing authorisation holder shall keep the data referred to in paragraph 1 for a minimum of 30 years after the expiry date of the product, or longer if required by the Commission as a term of the marketing authorisation.

5. In case of bankruptcy or liquidation of the marketing authorisation holder, and in the event that the marketing authorisation is not transferred to another legal entity, the data referred to in paragraph 1 shall be transferred to the Agency.

6. In the event that the marketing authorisation is suspended, revoked or withdrawn, the holder of the marketing authorisation shall remain subject to the obligations laid down in paragraphs 1, 3 and 4.

7. The Commission shall draw up detailed guidelines relating to the application of paragraphs 1 to 6, in particular the type and amount of data referred to in paragraph 1.

CHAPTER 6

INCENTIVES

Article 16

Scientific advice

1. The applicant or holder of a marketing authorisation may request advice from the Agency on the design and conduct of pharmacovigilance and of the risk management system referred to in Article 14.

2. By way of derogation from Article 8(1) of Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products (14), a 90 % reduction for small and medium-sized enterprises and 65 % for other applicants shall apply to the fee for scientific advice payable to the Agency for any advice given in respect of advanced therapy medicinal products pursuant to paragraph 1 of this Article and Article 57(1)(n) of Regulation (EC) No 726/2004.

Article 17

Scientific recommendation on advanced therapy classification

1. Any applicant developing a product based on genes, cells or tissues may request a scientific recommendation of the Agency with a view to determining whether the referred product falls, on scientific grounds, within the definition of an advanced therapy medicinal product. The Agency shall deliver this recommendation after consultation with the Commission and within 60 days after receipt of the request.

2. The Agency shall publish summaries of the recommendations delivered in accordance with paragraph 1, after deletion of all information of commercial confidential nature.

Article 18

Certification of quality and non-clinical data

Small and medium-sized enterprises developing an advanced therapy medicinal product may submit to the Agency all relevant quality and, where available, non-clinical data required in accordance with modules 3 and 4 of Annex I to Directive 2001/83/EC, for scientific evaluation and certification.

The Commission shall lay down provisions for the evaluation and certification of such data, in accordance with the regulatory procedure referred to in Article 26(2).

Article 19

Reduction of the fee for marketing authorisation

1. By way of derogation from Regulation (EC) No 297/95, the fee for marketing authorisation shall be reduced by 50 % if the applicant is a hospital or a small or medium-sized enterprise and can prove that there is a particular public health interest in the Community in the advanced therapy medicinal product concerned.

2. Paragraph 1 shall also apply to fees charged by the Agency for post-authorisation activities in the first year following the granting of the marketing authorisation for the advanced therapy medicinal product.

3. Paragraphs 1 and 2 shall apply during the transitional periods laid down in Article 29.

CHAPTER 7

COMMITTEE FOR ADVANCED THERAPIES

Article 20

Committee for Advanced Therapies

1. A Committee for Advanced Therapies shall be established within the Agency.

2. Save where otherwise provided in this Regulation, Regulation (EC) No 726/2004 shall apply to the Committee for Advanced Therapies.

3. The Executive Director of the Agency shall ensure appropriate coordination between the Committee for Advanced Therapies and the other Committees of the Agency, in particular the Committee for Medicinal Products for Human Use and the Committee for Orphan Medicinal Products, their working parties and any other scientific advisory groups.

Article 21

Composition of the Committee for Advanced Therapies

1. The Committee for Advanced Therapies shall be composed of the following members:

(a)

five members or co-opted members of the Committee for Medicinal Products for Human Use from five Member States, with alternates either proposed by their respective Member State or, in the case of co-opted members of the Committee for Medicinal Products for Human Use, identified by the latter on the advice of the corresponding co-opted member. These five members with their alternates shall be appointed by the Committee for Medicinal Products for Human Use;

(b)	one member and one alternate appointed by each Member State whose national competent authority is not represented among the members and alternates appointed by the Committee for Medicinal Products for Human Use;

(c)	two members and two alternates appointed by the Commission, on the basis of a public call for expressions of interest and after consulting the European Parliament, in order to represent clinicians;

(d)	two members and two alternates appointed by the Commission, on the basis of a public call for expressions of interest and after consulting the European Parliament, in order to represent patients’ associations.

The alternates shall represent and vote for the members in their absence.

2. All members of the Committee for Advanced Therapies shall be chosen for their scientific qualification or experience in respect of advanced therapy medicinal products. For the purposes of paragraph 1(b), the Member States shall cooperate, under the coordination of the Executive Director of the Agency, in order to ensure that the final composition of the Committee for Advanced Therapies provides appropriate and balanced coverage of the scientific areas relevant to advanced therapies, including medical devices, tissue engineering, gene therapy, cell therapy, biotechnology, surgery, pharmacovigilance, risk management and ethics.

At least two members and two alternates of the Committee for Advanced Therapies shall have scientific expertise in medical devices.

3. The members of the Committee for Advanced Therapies shall be appointed for a renewable period of three years. At meetings of the Committee for Advanced Therapies, they may be accompanied by experts.

4. The Committee for Advanced Therapies shall elect its Chairman from among its members for a term of three years, renewable once.

5. The names and scientific qualifications of all members shall be made public by the Agency, in particular on the Agency’s website.

Article 22

Conflicts of interest

In addition to the requirements laid down in Article 63 of Regulation (EC) No 726/2004, members and alternates of the Committee for Advanced Therapies shall have no financial or other interests in the biotechnology sector and medical device sector that could affect their impartiality. All indirect interests that could relate to these sectors shall be entered in the register referred to in Article 63(2) of Regulation (EC) No 726/2004.

Article 23

Tasks of the Committee for Advanced Therapies

The Committee for Advanced Therapies shall have the following tasks:

(a)	to formulate a draft opinion on the quality, safety and efficacy of an advanced therapy medicinal product for final approval by the Committee for Medicinal Products for Human Use and to advise the latter on any data generated in the development of such a product;

(b)	to provide advice, pursuant to Article 17, on whether a product falls within the definition of an advanced therapy medicinal product;

(c)	at the request of the Committee for Medicinal Products for Human Use, to advise on any medicinal product which may require, for the evaluation of its quality, safety or efficacy, expertise in one of the scientific areas referred to in Article 21(2);

(d)	to provide advice on any question related to advanced therapy medicinal products, at the request of the Executive Director of the Agency or the Commission;

(e)	to assist scientifically in the elaboration of any documents related to the fulfilment of the objectives of this Regulation;

(f)	at the Commission’s request, to provide scientific expertise and advice for any Community initiative related to the development of innovative medicines and therapies which requires expertise in one of the scientific areas referred to in Article 21(2);

(g)	to contribute to the scientific advice procedures referred to in Article 16 of this Regulation and in Article 57(1)(n) of Regulation (EC) No 726/2004.

CHAPTER 8

GENERAL AND FINAL PROVISIONS

Article 24

Adaptation of Annexes

The Commission shall, after consulting the Agency and in accordance with the regulatory procedure with scrutiny referred to in Article 26(3), amend Annexes I to IV in order to adapt them to scientific and technical evolution.

Article 25

Report and review

By 30 December 2012, the Commission shall publish a general report on the application of this Regulation, which shall include comprehensive information on the different types of advanced therapy medicinal products authorised pursuant to this Regulation.

In this report, the Commission shall assess the impact of technical progress on the application of this Regulation. It shall also review the scope of this Regulation, including in particular the regulatory framework for combined advanced therapy medicinal products.

Article 26

Committee procedure

1. The Commission shall be assisted by the Standing Committee on Medicinal Products for Human Use set up by Article 121(1) of Directive 2001/83/EC.

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

Article 27

Amendments to Regulation (EC) No 726/2004

Regulation (EC) No 726/2004 is hereby amended as follows:

1.	in the first subparagraph of Article 13(1), the first sentence shall be replaced by the following: ‘Without prejudice to Article 4(4) and (5) of Directive 2001/83/EC, a marketing authorisation which has been granted in accordance with this Regulation shall be valid throughout the Community.’;

Article 56 shall be amended as follows:

(a)

in paragraph 1, the following point shall be inserted:

‘(da)

the Committee for Advanced Therapies;’

(b)	in the first sentence of the first subparagraph of paragraph 2, the words ‘paragraph 1(a) to (d)’ shall be replaced by ‘paragraph 1(a) to (da)’;

the Annex shall be amended as follows:

(a)

the following point shall be inserted:

‘1a.	Advanced therapy medicinal products as defined in Article 2 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products (*1).

(*1) OJ L 324, 10.12.2007, p. 121 ’;"

(b)

In point 3, the second subparagraph shall be replaced by the following:

‘After 20 May 2008, the Commission, having consulted the Agency, may present any appropriate proposal to amend this point and the European Parliament and the Council shall take a decision thereon in accordance with the Treaty.’

Article 28

Amendments to Directive 2001/83/EC

Directive 2001/83/EC is hereby amended as follows:

in Article 1, the following point shall be inserted:

‘4a.	Advanced therapy medicinal product: A product as defined in Article 2 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products (*2).

(*2) OJ L 324, 10.12.2007, p. 121 ’;"

in Article 3, the following point shall be added:

‘7.

Any advanced therapy medicinal product, as defined in Regulation (EC) No 1394/2007, which is prepared on a non-routine basis according to specific quality standards, and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient.

Manufacturing of these products shall be authorised by the competent authority of the Member State. Member States shall ensure that national traceability and pharmacovigilance requirements as well as the specific quality standards referred to in this paragraph are equivalent to those provided for at Community level in respect of advanced therapy medicinal products for which authorisation is required pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (*3).

(*3) OJ L 136, 30.4.2004, p. 1. Regulation as amended by Regulation (EC) No 1901/2006 (OJ L 378, 27.12.2006, p. 1).’;"

in Article 4, the following paragraph shall be added:

‘5. This Directive and all Regulations referred to therein shall not affect the application of national legislation prohibiting or restricting the use of any specific type of human or animal cells, or the sale, supply or use of medicinal products containing, consisting of or derived from these cells, on grounds not dealt with in the aforementioned Community legislation. The Member States shall communicate the national legislation concerned to the Commission. The Commission shall make this information publicly available in a register.’;

in Article 6(1), the first subparagraph shall be replaced by the following:

‘No medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued by the competent authorities of that Member State in accordance with this Directive or an authorisation has been granted in accordance with Regulation (EC) No 726/2004, read in conjunction with Regulation (EC) No 1394/2007.’

Article 29

Transitional period

1. Advanced therapy medicinal products, other than tissue engineered products, which were legally on the Community market in accordance with national or Community legislation on 30 December 2008, shall comply with this Regulation no later than 30 December 2011.

2. Tissue engineered products which were legally on the Community market in accordance with national or Community legislation on 30 December 2008 shall comply with this Regulation no later than 30 December 2012.

3. By way of derogation from Article 3(1) of Regulation (EC) No 297/95, no fee shall be payable to the Agency in respect of applications submitted for the authorisation of the advanced therapy medicinal products mentioned in paragraphs 1 and 2 of this Article.

Article 30

Entry into force

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

It shall apply from 30 December 2008.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Strasbourg, 13 November 2007.

For the European Parliament

The President

H.-G. PÖTTERING

For the Council

The President

M. LOBO ANTUNES

(1) OJ C 309, 16.12.2006, p. 15.

(2) Opinion of the European Parliament of 25 April 2007 (not yet published in the Official Journal) and Council Decision of 30 October 2007.

(3) OJ L 311, 28.11.2001, p. 67. Directive as last amended by Regulation (EC) No 1901/2006 (OJ L 378, 27.12.2006, p. 1).

(4) OJ L 136, 30.4.2004, p. 1. Regulation as amended by Regulation (EC) No 1901/2006.

(5) OJ L 102, 7.4.2004, p. 48.

(6) OJ L 121, 1.5.2001, p. 34. Directive as amended by Regulation (EC) No 1901/2006.

(7) OJ L 91, 9.4.2005, p. 13.

(8) OJ L 262, 14.10.2003, p. 22.

(9) OJ L 169, 12.7.1993, p. 1. Directive as last amended by Directive 2007/47/EC of the European Parliament and of the Council (OJ L 247, 21.9.2007, p. 21).

(10) OJ L 189, 20.7.1990, p. 17. Directive as last amended by Directive 2007/47/EC.

(11) OJ L 33, 8.2.2003, p. 30.

(12) OJ L 281, 23.11.1995, p. 31. Directive as amended by Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).

(13) OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 11).

(14) OJ L 35, 15.2.1995, p. 1. Regulation as last amended by Regulation (EC) No 1905/2005 (OJ L 304, 23.11.2005, p. 1).

ANNEX I

Manipulations referred to in the first indent of Article 2(1)(c)

—

cutting,

—

grinding,

—

shaping,

—	centrifugation,

—	soaking in antibiotic or antimicrobial solutions,

—	sterilization,

—	irradiation,

—	cell separation, concentration or purification,

—	filtering,

—	lyophilization,

—

freezing,

—	cryopreservation,

—	vitrification.

ANNEX II

Summary of product characteristics referred to in Article 10

1. Name of the medicinal product.

Composition of the product:

2.1. general description of the product, if necessary with explanatory drawings and pictures,

2.2. qualitative and quantitative composition in terms of the active substances and other constituents of the product, knowledge of which is essential for proper use, administration or implantation of the product. Where the product contains cells or tissues, a detailed description of these cells or tissues and of their specific origin, including the species of animal in cases of non-human origin, shall be provided,

For a list of excipients, see point 6.1.

3. Pharmaceutical form.

Clinical particulars:

4.1. therapeutic indications,

4.2. posology and detailed instructions for use, application, implantation or administration for adults and, where necessary, for children or other special populations, if necessary with explanatory drawings and pictures,

4.3. contra-indications,

4.4. special warnings and precautions for use, including any special precautions to be taken by persons handling such products and administering them to or implanting them in patients, together with any precautions to be taken by the patient,

4.5. interaction with other medicinal products and other forms of interactions,

4.6. use during pregnancy and lactation,

4.7. effects on ability to drive and to use machines,

4.8. undesirable effects,

4.9. overdose (symptoms, emergency procedures).

Pharmacological properties:

5.1. pharmacodynamic properties,

5.2. pharmacokinetic properties,

5.3. preclinical safety data.

Quality particulars:

6.1. list of excipients, including preservative systems,

6.2. incompatibilities,

6.3. shelf life, when necessary after reconstitution of the medicinal product or when the immediate packaging is opened for the first time,

6.4. special precautions for storage,

6.5. nature and contents of container and special equipment for use, administration or implantation, if necessary with explanatory drawings and pictures,

6.6. special precautions and instructions for handling and disposal of a used advanced therapy medicinal product or waste materials derived from such product, if appropriate and, if necessary, with explanatory drawings and pictures.

7. Marketing authorisation holder.

8. Marketing authorisation number(s).

9. Date of the first authorisation or renewal of the authorisation.

10. Date of revision of the text.

ANNEX III

Labelling of outer/immediate packaging referred to in Article 11

(a)	The name of the medicinal product and, if appropriate, an indication of whether it is intended for babies, children or adults; the international non-proprietary name (INN) shall be included, or, if the product has no INN, the common name;

(b)

A description of the active substance(s) expressed qualitatively and quantitatively, including, where the product contains cells or tissues, the statement ‘This product contains cells of human/animal [as appropriate{] origin’ together with a short description of these cells or tissues and of their specific origin, including the species of animal in cases of non-human origin;

(c)	The pharmaceutical form and, if applicable, the contents by weight, by volume or by number of doses of the product;

(d)	A list of excipients, including preservative systems;

(e)	The method of use, application, administration or implantation and, if necessary, the route of administration. If applicable, space shall be provided for the prescribed dose to be indicated;

(f)	A special warning that the medicinal product must be stored out of the reach and sight of children;

(g)	Any special warning necessary for the particular medicinal product;

(h)	The expiry date in clear terms (month and year; and day if applicable);

(i)	Special storage precautions, if any;

(j)	Specific precautions relating to the disposal of unused medicinal products or waste derived from medicinal products, where appropriate, as well as reference to any appropriate collection system in place;

(k)	The name and address of the marketing authorisation holder and, where applicable, the name of the representative appointed by the holder to represent him;

(l)	Marketing authorisation number(s);

(m)	The manufacturer’s batch number and the unique donation and product codes referred to in Article 8(2) of Directive 2004/23/EC;

(n)	In the case of advanced therapy medicinal products for autologous use, the unique patient identifier and the statement ‘For autologous use only’.

ANNEX IV

Package leaflet referred to in Article 13

(a)

For the identification of the advanced therapy medicinal product:

(i)	the name of the advanced therapy medicinal product and, if appropriate, an indication of whether it is intended for babies, children or adults. The common name shall be included;

(ii)	the therapeutic group or type of activity in terms easily understandable for the patient;

(iii)

where the product contains cells or tissues, a description of those cells or tissues and of their specific origin, including the species of animal in cases of non-human origin;

(iv)	where the product contains medical devices or active implantable medical devices, a description of those devices and their specific origin;

(b)	The therapeutic indications;

(c)

A list of information which is necessary before the medicinal product is taken or used, including:

(i)	contra-indications;

(ii)	appropriate precautions for use;

(iii)

forms of interaction with other medicinal products and other forms of interaction (e.g. alcohol, tobacco, foodstuffs) which may affect the action of the medicinal product;

(iv)	special warnings;

(v)	if appropriate, possible effects on the ability to drive vehicles or to operate machinery;

(vi)	the excipients, knowledge of which is important for the safe and effective use of the medicinal product and which are included in the detailed guidance published pursuant to Article 65 of Directive 2001/83/EC.

The list shall also take into account the particular condition of certain categories of users, such as children, pregnant or breastfeeding women, the elderly, persons with specific pathological conditions;

(d)

The necessary and usual instructions for proper use, and in particular:

(i)	the posology;

(ii)	the method of use, application, administration or implantation and, if necessary, the route of administration; and, as appropriate, depending on the nature of the product:

(iii)

the frequency of administration, specifying if necessary the appropriate time at which the medicinal product may or must be administered;

(iv)	the duration of treatment, where it should be limited;

(v)	the action to be taken in case of an overdose (such as symptoms, emergency procedures);

(vi)	information on what to do when one or more doses have not been taken;

(vii)

a specific recommendation to consult the doctor or the pharmacist, as appropriate, for any clarification on the use of the product;

(e)

A description of the adverse reactions which may occur under normal use of the medicinal product and, if necessary, the action to be taken in such a case; the patient should be expressly asked to communicate any adverse reaction which is not mentioned in the package leaflet to his doctor or pharmacist;

(f)

A reference to the expiry date indicated on the label, with:

(i)	a warning against using the product after that date;

(ii)	where appropriate, special storage precautions;

(iii)

if necessary, a warning concerning certain visible signs of deterioration;

(iv)	the full qualitative and quantitative composition;

(v)	the name and address of the marketing authorisation holder and, where applicable, the name of his appointed representatives in the Member States;

(vi)	the name and address of the manufacturer;

(g)	The date on which the package leaflet was last revised.

		ISSN 1725-2555
Official Journal of the European Union		L 324

English edition	Legislation	Volume 50 10 December 2007

Contents		I Acts adopted under the EC Treaty/Euratom Treaty whose publication is obligatory	page
		REGULATIONS
	*	Regulation (EC) No 1392/2007 of the European Parliament and of the Council of 13 November 2007 amending Council Regulation (EC) No 2223/96 with respect to the transmission of national accounts data ( 1 )	1
	*	Regulation (EC) No 1393/2007 of the European Parliament and of the Council of 13 November 2007 on the service in the Member States of judicial and extrajudicial documents in civil or commercial matters (service of documents), and repealing Council Regulation (EC) No 1348/2000	79
	*	Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 ( 1 )	121