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“Standing orders on import restrictions” In the mid-1990s, Bangladesh faced considerable challenges in managing its pharmaceutical sector, necessitating significant governmental interventions. The Prime Minister’s standing orders on import restrictions for pharmaceutical products in 1994 and 1998 were pivotal measures aimed at regulating the market, ensuring drug quality, and promoting local industry growth. The 1994 order introduced several key measures: 1. Quality Control: Implementing rigorous testing and certification processes for all imported pharmaceutical products. 2. Encouraging Local Production: The government aimed to reduce dependence on imported drugs by promoting the development of the local pharmaceutical sector. This included providing incentives such as tax breaks and subsidies to local manufacturers. 3. Essential Medicines: Prioritizing the import of essential medicines, particularly those not produced domestically, while restricting non-essential imports to encourage local production. In 1998, Prime Minister introduced another standing order that further tightened import restrictions. This policy was part of a broader strategy to protect local industries and ensure the availability of high-quality medicines. The 1998 order built upon the earlier regulations with additional measures: 1. Strengthened Regulatory Framework: Enhancing the capabilities of the DGDA to monitor and enforce quality standards more effectively in collaboration with international regulatory bodies to align local standards with global best practices. 2. Support for Domestic Industry: Continued incentives for local pharmaceutical companies, including increased investment in research and development and infrastructure improvements to boost production capacity. 3. Public Health Focus: Ensuring that essential medicines remained accessible and affordable, particularly for chronic and life-threatening conditions. 4. Import Quotas and Tariffs: Implementing quotas and tariffs on imported pharmaceuticals to protect local manufacturers while ensuring sufficient supply of essential drugs. The import restriction orders of 1994 and 1998 had a significant impact on the pharmaceutical industry in Bangladesh. These measures successfully reduced the influx of substandard and counterfeit drugs, thereby improving public health outcomes. Local companies began to flourish, benefiting from government support and a more predictable regulatory environment. This growth not only increased the availability of medicines but also created jobs and contributed to economic development. In summary, the Prime Minister’s standing orders on pharmaceutical import restrictions in 1994 and 1998 were critical in shaping the pharmaceutical landscape in Bangladesh. These policies underscored the government’s commitment to public health, quality assurance, and the development of domestic capabilities, laying the foundation for a more self-reliant and robust pharmaceutical sector.

To continue on the topic as one of the most actively discussed minding the realities of today's geopolitical movements, we summarized most recent opinions of our commercial front line partners, #healthcare professionals and patients themselves across #EU/CEE and #UK. Parallel Import Opportunities for Pharmacy Chains and Patients: 1. Cost Savings: Pharmacy Chains: Parallel imports allow pharmacy chains to source medicines from countries where prices are lower. By doing so, they can offer cost-effective alternatives to patients without compromising quality. Patients: Lower-priced medications mean reduced out-of-pocket expenses for #patients. Access to affordable treatments improves patient #compliance and overall health outcomes. 2. Broader Product Range: #PharmacyChains: #ParallelImports expand the range of available pharmaceuticals. Pharmacy chains can diversify their offerings, catering to a wider patient base. Patients: Patients benefit from a broader selection of medications, ensuring they find the most suitable treatment for their specific needs. 3. Competitive Advantage: Pharmacy Chains: Offering parallel-imported products sets pharmacy chains apart from competitors. Patients appreciate affordability and choice. Patients: Access to competitively priced medicines enhances patient loyalty to specific pharmacy chains. Key Risks and Considerations for Branded Manufacturers: 1. Brand Reputation: Risk: Parallel imports may lead to confusion among patients regarding the origin of the product. If a parallel-imported medicine performs poorly, it could negatively impact the brand’s reputation. Consideration: Branded manufacturers must maintain stringent quality control to safeguard their reputation. 2. Pricing Pressure: Risk: Parallel imports create pricing pressure for branded manufacturers. They may need to adjust prices to remain competitive. Consideration: Manufacturers should strategically manage pricing while balancing profitability and market share. 3. Regulatory Challenges: Risk: Different countries have varying regulatory requirements for parallel-imported products. Manufacturers must navigate complex legal frameworks. Consideration: Staying informed about regulations and collaborating with legal experts is crucial. 4. Intellectual Property Concerns: Risk: Parallel imports may infringe on intellectual property rights. Manufacturers should protect their patents and trademarks. Consideration: Regional licensing agreements, IP risks mitigation. Conclusion: Parallel importation offers a win-win scenario: affordable options for patients and business opportunities for pharmacy chains. However, branded manufacturers require balancing risks and rewards. 🌟🏥Quality control on reducing the risks of the shelf life expiry or counterfeit are still most important. NB: UAE and MENA are showing good example on managing non-registered branded products supply as well as parallel import related matters. Questions: info@globalbridgepharma.eu

Parallel Import of Pharmaceuticals and Disposables in EU: Opportunities and Challenges Intro The European Union (EU) is a single market that allows the free movement of goods, services, capital, and people. This principle also applies to the #pharmaceuticalsector, where #parallel #importers can buy #medicines and #disposables in one EU country where prices are lower and resell them in another EU country where prices are higher. Parallel import of pharmaceuticals and disposables is a legal and regulated practice that aims to enhance competition, lower prices, and increase access to medicines and health products for patients and health professionals. However, parallel import of pharmaceuticals and disposables also poses some challenges and risks for the stakeholders involved, such as the original manufacturers, the parallel importers, the national authorities, and the consumers. These challenges and risks include the issues of quality, safety, efficacy, intellectual property, pricing, and supply of medicines and disposables. In this article, we will explore the opportunities and challenges of parallel import of pharmaceuticals and disposables in the EU, based on the recent rulings and developments in this field. https://lnkd.in/dSevUhbk Andrzej Siwiec and Katarzyna Bajer of DBS Law discuss recent rulings on the parallel import of medicinal products in the European Union. Parallel import of medicinal products is one of the basic and admissible forms of international trade in the EU market, based on the principle of free movement of goods established by the Treaty on the Functioning of the European Union. It allows parallel importers to purchase medicinal products in EU countries where prices are lower and then resell them in other countries where the prices are higher. However, this practice often involves interference with the exclusive rights of trademark proprietors due to regulatory requirements imposed on parallel imported medicinal products in various Member States.

Phase 1 | Pharmaceutical Law for Imported Food The first time I encountered this law, it took me by surprise. I was unprepared, unfamiliar with the regulations, and quite confused. The customs broker asked me if the products I was trying to import had been checked for pharmaceutical ingredients. Naturally, I said no, thinking, "This is food. It's sold legally in Europe and should be good for import." However, that answer wasn't sufficient. I was directed to a Japanese government website and had to navigate through several Japanese PDFs listing ingredients that might or might not classify my products under pharmaceutical law. Then, I had to find the correct office to call in Japanese, which depended on whether my product was already at the terminal or if I was consulting prior to import. After verifying this information with an officer from the pharmaceutical department, I needed to contact the quarantine station, which required a declaration of our findings. If this all sounds intimidating and confusing, you're not alone. This is a step in the import process that many importers struggle with, and it's understandable. That's why I wrote a white paper on navigating these laws, and at JML Group Japan, we are developing new tools, templates, and databases to simplify the import process. You can read and download the white paper here: https://lnkd.in/gsQRuCcz JML | Inspire to Progress - We make market entry easy #MarketEntry #PharmaceuticalLaw #ImportRegulations #JapaneseMarket #InternationalTrade #FandBIndustry #BusinessDevelopment #GlobalTrade #SustainableGrowth #JMLGroup #FoodImports #ExportToJapan #Compliance #WhitePaper #BusinessSupport #MarketAccess #TradeCompliance

#LifeScience Parallel Import of Medicines in Ukraine to launch from 2025 🗓 Ukrainian law that enables parallel import of medicines in Ukraine from 1 January 2025 has entered into force (Law of July 16, 2024 No. 3860-IX). The possibility of parallel import was already provided for by the Law of Ukraine "On Medicines", but this mechanism should have started working much later. In times of war, the need for this mechanism is very acute, so Ukrainian parliament decided to launch parallel import from 2025. Parallel import provides the import of medicines into the Ukraine not only through official exporting manufacturers, but also through dealers authorized by the manufacturer. 💊 Conditions. Parallel import applies only under the following conditions: 1) the imported medicines are identical or similar to those registered in Ukraine; or 2) the imported medicines are simultaneously reference medicines or generics both in Ukraine and in the exporting country. 🏥 Distribution channels. Parallel imported medicines cannot be sold in pharmacies, so they can only be distributed through the hospitals or through the state tenders. 🌍 Exporting countries. It will be possible to import medicines into Ukraine from EU member states and Iceland, Liechtenstein and Norway (being the states-members of the European Free Trade Association, that are parties to the Agreement on the European Economic Area). The Cabinet of Ministers of Ukraine may expand the list of exporting countries after Ukraine becomes member of the European Union. 📜 Licensing. Parallel importers having a license for import of medicines must obtain a permit for parallel import, to be renewed every 5 years, and must ensure the functioning of the pharmacovigilance system. The Law provides for the creation of the State Register of Parallel Import Medicinal Products, which will become an integral part of the State Register of Medicinal Products. 🏷 Labeling and packaging. A parallel importer may (1) repack the outer packaging of the medicine, or (2) use the original foreign packaging with additional labeling in Ukrainian, or (3) use the original foreign packaging and supplement it with a copy of the Ukrainian translation. Repackaging and/or relabeling can be carried out in Ukraine if the importer has a manufacturing license. #ImagineLawyers #LifeScience

PharmaBusiness How Trump Presidency Could Reshape the U.S. Pharmaceutical Landscape and Influence Indian Generic Drug Exports Donald Trump presidency could impact the U.S. pharmaceutical industry and Indian exports in several ways. Trump’s administration previously focused on reducing drug prices, which included measures like encouraging drug imports, pushing for pricing transparency, and supporting generics to create competition for high-priced branded drugs. He may resume similar stance, which could affect profit margins for U.S.-based pharmaceutical companies but might benefit generics-focused exporters from countries like India. For Indian exports to the U.S.: Increased Demand for Generics Trump’s push for lower drug prices and access to affordable medications could create a favorable environment for Indian generics, which are a cost-effective alternative. If there’s continued support for generics and biosimilars, Indian companies could see an increase in demand. FDA Inspections and Compliance: Under previous administrations, the FDA intensified scrutiny of overseas manufacturing facilities, including those in India. This may continue or increase, especially if regulatory reforms are emphasized. Indian exporters may face pressure to meet stringent U.S. regulatory standards. Trade Policies and Tariffs: Trade and tariff policies could change depending on Trump’s approach to trade relations with India. A protectionist stance could lead to higher tariffs on imports, which might impact the cost competitiveness of Indian drugs in the U.S. market. IP and Patent Policies: Trump’s administration might also influence intellectual property policies. A favorable shift toward strengthening IP rights could impact Indian generics manufacturers, who often depend on challenging patents to bring generics to the market. In summary, a Trump presidency might create both opportunities and challenges for the U.S. pharmaceutical industry and Indian exporters. It could benefit Indian generics due to an emphasis on cost reduction, but compliance, tariffs, and IP protections could pose potential hurdles. www.pharmsstar.com

❗Unsafe overseas products without certification are banned from import The government has announced measures to enhance consumer safety and improve corporate competitiveness due to the surge in overseas direct purchases. By June 2024, overseas direct purchases of products that pose significant risks to public safety and health, such as those without safety certifications, will be prohibited. This includes medicines and medical devices, for which the management of existing prohibited products will also be strengthened. -Overseas direct purchases of 34 types of children's products used by children under the age of 13 will be prohibited if they do not have KC certification. -Overseas direct purchases of 34 types of electrical and household items will be prohibited if they do not have KC certification. -Overseas direct purchases of 12 types of household chemical products will be prohibited if they are not declared or approved. -The overseas direct purchase of pharmaceuticals and veterinary medicines will be clarified as prohibited through amendments to the Pharmaceutical Affairs Act. Until the law is revised, there will be a focused block on medicines that pose significant concerns. -For medical devices, the inspection collaboration at customs and the use of customs data analysis for special and planned inspections will be strengthened. If you have any inquiries or need information regarding Korean KC certification, please visit the website www.gca-global.com #GCA #GCAKOREA #typeapproval #Homologation #KoreaCertification #KC #KCMark #KCcertification #KoreaRRA #overseasdirectpurchase #childrenproduct #householdproduct #chemicalproduct #medicaldevice #customs

❗Unsafe overseas products without certification are banned from import The government has announced measures to enhance consumer safety and improve corporate competitiveness due to the surge in overseas direct purchases. By June 2024, overseas direct purchases of products that pose significant risks to public safety and health, such as those without safety certifications, will be prohibited. This includes medicines and medical devices, for which the management of existing prohibited products will also be strengthened.   -Overseas direct purchases of 34 types of children's products used by children under the age of 13 will be prohibited if they do not have KC certification. -Overseas direct purchases of 34 types of electrical and household items will be prohibited if they do not have KC certification. -Overseas direct purchases of 12 types of household chemical products will be prohibited if they are not declared or approved.   -The overseas direct purchase of pharmaceuticals and veterinary medicines will be clarified as prohibited through amendments to the Pharmaceutical Affairs Act. Until the law is revised, there will be a focused block on medicines that pose significant concerns. -For medical devices, the inspection collaboration at customs and the use of customs data analysis for special and planned inspections will be strengthened. If you have any inquiries or need information regarding Korean KC certification, please visit the website www.gca-global.com #GCA #GCAKOREA #typeapproval #Homologation #KoreaCertification #KC #KCMark #KCcertification #KoreaRRA #overseasdirectpurchase #childrenproduct #householdproduct #chemicalproduct #medicaldevice #customs

Irish exports up as pharma rebounds in January 🌏 🇨🇮 Goods exports rose to €18.9bn in January, according to new data from the Central Statistics Office The increase was driven by growth in exports of medical and pharmaceutical products, the report showed 👇 #ireland #export #irishexports #irishbusinesses #economicgrowth #internationaltrade #pharma #medicaldevices #food #drink https://lnkd.in/dGN4VgNC

Importing & Exporting Pharmaceutical & Medical Supplies: A Comprehensive Guide https://zurl.co/2jOH In today's interconnected world, the timely and efficient transportation of pharmaceutical and medical supplies is crucial for maintaining public health. Movements International Fiji stands as a dedicated logistics provider, offering a comprehensive range of services to meet the unique demands of this industry. Our team of experienced professionals understands the complexities of healthcare logistics, including temperature-controlled transportation, regulatory compliance, and customs clearance. We leverage our deep knowledge of the Pacific region to ensure that your shipments reach their destination safely and on time. Key services offered by Movements International Fiji: 💯 Temperature-controlled transportation: Our fleet of specialized vehicles is equipped with advanced technology to maintain the integrity of temperature-sensitive medications. 💯 Regulatory compliance: We stay up-to-date with the latest regulations and standards governing the import and export of healthcare products. 💯 Customs clearance: Our experienced customs brokers streamline the clearance process, minimizing delays and reducing associated costs. 💯 Supply chain visibility: Our advanced tracking systems provide real-time visibility into your shipments, allowing you to monitor their progress and anticipate any potential issues. 💯 Competitive pricing: We offer competitive pricing without compromising on quality. By choosing Movements International Fiji, you can rest assured that your pharmaceutical and medical supplies are in safe hands. Our commitment to excellence and customer satisfaction sets us apart as a leading logistics provider in the Pacific region. Contact us today to learn more about our services and how we can assist you with your healthcare logistics needs. #healthcarelogistics #pharmaceuticallogistics #medicalsupplies #imports #exports #Fiji #PacificIslands #MovementsInternationalFiji [healthcare logistics, pharmaceutical logistics, medical supplies logistics, international shipping, freight forwarding, supply chain management, Movements International Fiji, Fiji logistics, Pacific Islands logistics, temperature-controlled transportation, customs clearance, pharmaceutical import, pharmaceutical export, medical supplies import, medical supplies export, supply chain visibility, regulatory compliance, pharmaceutical and medical supplies logistics in Fiji, importing medical supplies to Fiji, exporting pharmaceuticals from Fiji, temperature-controlled shipping for healthcare products, customs clearance for pharmaceutical shipments, supply chain management for medical devices, logistics solutions for the Pacific Islands]