Using the EVFTA for pharmaceutical imports

With a compound annual growth rate of 7.3% and a total value of US$7 billion as of 2024¹, Vietnam's pharmaceutical market is demonstrating significant expansion, fueled by a growing emphasis on healthcare and the well-being of its population.

Consequently, there's an increasing demand for premium pharmaceutical products, encompassing advanced medications and innovative therapies. For businesses aiming to participate in this expanding sector, a clear understanding of the import processes is essential for effective market entry.

This is where the EU-Vietnam Free Trade Agreement (EVFTA) comes in, emerging as a pivotal instrument in facilitating the import and export of pharmaceutical products. This comprehensive agreement is designed to dismantle trade obstacles and cultivate stronger economic links between the European Union (EU) and Vietnam.

By strategically using the EVFTA, businesses can establish more streamlined routes for introducing high-quality pharmaceuticals from the EU, and satisfy the Vietnamese markets’ escalating demands.

How to import pharmaceutical products from the EU to Vietnam

Importing pharmaceuticals from the EU to Vietnam involves navigating a specific regulatory landscape to ensure safety and quality, including:

Licensing and permits

Some of the key licenses and permits required are:

• Import license: Obtained from Vietnam’s Ministry of Health (MOH), specifically the Drug Administration of Vietnam (DAV), allowing the legal importation of pharmaceutical products.

• Certificate of Pharmaceutical Product (CPP): Issued by the EU regulatory authority, confirming the quality and regulatory status of the exported pharmaceutical product in the EU.

• Certificate of Conformity to Good Manufacturing Practice (GMP): Typically required for the manufacturing site, though the EVFTA aims to simplify this for EU GMP-certified facilities.

• Registered Exporter System (REX) Statement of Origin: EU exporters use this to claim preferential tariff treatment under the EVFTA.

• Marketing Authorization (MA): Essential for legally selling the pharmaceutical product within Vietnam, granted by the DAV after the review of safety, efficacy, and quality data.

• Certificate of Satisfaction of Conditions (CSC): A Vietnamese certification required for pharmaceutical importers to demonstrate compliance with local business and operational standards.

• Certificate of Goods Storage Practice (GSP): Required for pharmaceutical storage facilities in Vietnam, ensuring proper handling and storage conditions to maintain product quality.

Quality control and safety standards

Imported pharmaceuticals must meet Vietnam's quality control and safety standards, which are progressively aligning with international norms. The EVFTA intends to facilitate this by recognizing EU certifications, potentially decreasing the need for extensive additional testing in Vietnam for already EU-approved products.

However, importers are still required to submit comprehensive documentation to the DAV to obtain the MA. This documentation includes details on the product's composition, the manufacturing process, and stability data.

Specific regulations for temperature-sensitive products

Pharmaceuticals requiring specific temperature conditions during transit and storage are subject to stringent regulations to maintain their efficacy and safety. This necessitates specialized temperature-controlled logistics and solutions, validated packaging, and continuous temperature monitoring throughout the supply chain. Importers must also demonstrate compliance with Good Distribution Practice (GDP) guidelines, and local storage facilities also require GSP certification.

It’s important to remember that while these guidelines provide an overview of the importation process, thorough research and consultation with Vietnam’s MOH are crucial for the most current and specific pharmaceutical import requirements, as regulations can change.

The benefits of the EVFTA for pharmaceutical imports

The EVFTA significantly impacts pharmaceutical trade between the EU and Vietnam, offering several key advantages such as:

• Reduced tariffs and trade barriers: The EVFTA eliminates tariffs on a substantial percentage of pharmaceutical products immediately upon entry into force, with the remaining tariffs being phased out over a defined period, making the import and export of pharmaceutical products more cost-effective. Crucially, this phased reduction of duties also lowers the financial burden on businesses shipping into Vietnam.

• Simplified customs procedures: The agreement aims to streamline customs processes, reducing red tape and facilitating faster clearance of pharmaceutical goods. This includes the potential for pre-arrival processing and simplified documentation, making the overall import process in Vietnam more efficient and predictable for both EU exporters and Vietnamese importers.

• Alignment with international standards: Vietnam has committed under the EVFTA to align its MA procedures with international standards, meaning that products already certified in the EU may not require extensive additional testing and certification in Vietnam. This can significantly reduce the time and costs associated with gaining market access for EU pharmaceuticals.

Navigating the pharmaceutical export process from the EU

Navigating the export of pharmaceutical products from the EU to Vietnam requires a systematic approach to ensure compliance and efficiency. This includes:

• Selecting reputable EU suppliers: Begin by identifying and vetting potential EU suppliers who adhere to GMP standards and who possess a proven track record of quality and reliability. Verify their experience in international trade, particularly with Vietnam, and their understanding of both EU and Vietnamese regulations.
• Preparing comprehensive export documentation: Accurately prepare all required export documentation, which typically includes a commercial invoice, packing list, Certificate of Origin (potentially using the REX system under the EVFTA), and the CPP issued by the relevant EU regulatory authority.
• Adhering to EU export controls and guidelines: Strictly follow all applicable EU export regulations, which may include obtaining export licenses for certain pharmaceutical products or destinations. Pay close attention to guidelines concerning packaging, labeling in accordance with EU standards, and any specific certifications or declarations required by EU authorities for the global shipping of pharmaceuticals.

DHL Express Vietnam: Your partner for seamless pharmaceutical imports

DHL Express Vietnam possesses extensive experience in handling the unique requirements of shipping pharmaceuticals, with their key services in this field including:

• Temperature-controlled shipping solutions: Maintaining the integrity of many pharmaceuticals demands strict temperature control. DHL Express Vietnam offers its specialized Medical Express (WMX) service, providing advanced temperature-controlled solutions for pharmaceutical supply chains. This encompasses specialized packaging and transport options, along with proactive monitoring to ensure shipments remain within the necessary temperature range throughout their journey to Vietnam.

• Customs clearance expertise: Navigating the import process into Vietnam can be complex. DHL Express Vietnam offers expert customs clearance services, with in-depth knowledge of both Vietnamese and EU regulations. They can assist with the accurate preparation of documentation, ensuring a smooth and efficient clearance process, minimizing potential delays for your critical pharmaceutical shipments.

• Real-time tracking and monitoring: Transparency and control are vital for pharmaceutical shipments. DHL Express Vietnam provides state-of-the-art real-time tracking and monitoring systems, allowing you to have full visibility of your shipment's location and status at every stage of its journey. This provides peace of mind and enables the proactive management of your pharmaceutical goods.

Optimizing your pharmaceutical supply chain

Optimizing your pharmaceutical supply chain is important in ensuring the timely delivery of your pharmaceutical goods. Some ways to achieve this include:

• Effective inventory management: Implement robust inventory management systems to accurately forecast demand, optimize stock levels, and minimize the risk of shortages or expired medications. Consider utilizing DHL Express Vietnams’ warehousing solutions if needed for strategic storage and distribution within Vietnam.

• Proactive risk mitigation: Identify potential risks within your supply chain, such as temperature excursions, customs delays, or supplier disruptions. Develop contingency plans and consider insurance options to minimize the impact of unforeseen events on your pharmaceutical shipments.

• Building strong supplier relationships: Cultivate transparent and collaborative relationships with your EU suppliers. Clear communication, shared information, and mutual understanding can lead to more efficient processes, better forecasting, and proactive problem-solving in the export of your pharmaceutical products.

Embracing the opportunities of pharmaceutical imports

Maximizing the EVFTA for your pharmaceutical shipments from the EU to Vietnam can lead to reduced tariffs, simplified customs procedures, and the potential for streamlined regulatory processes. This creates a more accessible and cost-effective pathway for bringing high-quality medications to the growing Vietnamese market, while fostering stronger international trade ties along the way.

DHL Express Vietnam is a reliable and experienced partner ready to facilitate entry into this promising sector. Their expertise in pharmaceutical logistics, coupled with temperature-controlled global shipping solutions and customs clearance proficiency, ensures a seamless import experience.

Ready to explore the potential of importing pharmaceuticals from the EU to Vietnam? Contact their customer care team to learn more about DHL’s logistics services, or create a DHL Express business account today and unlock a world of efficient and reliable global shipping solutions!