Vietnam eases access to EU pharmaceuticals

For the next two years, EU exporters of pharmaceuticals will thus avoid having to go through complex procedures for the renewal of their marketing authorisation. 

A more transparent and predictable system of marketing authorisation benefits both EU operators and consumers’ unhampered access to high quality pharmaceuticals.

This positive result for EU industry and Vietnamese consumers shows the value of the free trade agreement between the EU and Vietnam, which provided the framework for solving this important market access issue. It comes after extensive constructive engagement with the Vietnamese authorities and follows decisions last October ending discrimination among EU regulatory authorities for pharmaceutical products.

Together, both measures will considerably facilitate access of EU pharmaceutical products to the Vietnamese market.

On 8 February 2023 Vietnam’s Ministry of Health (MOH) published and enacted Decision 62/ QD-QLD on the 'Announcement of the List of Medicines and Medicinal Materials with Market Authorisations Allowed to be Used under the Clause 1 Article 3 of the National Assembly Resolution 80/ 2023/ QH15 dated 9 January 2023'. The Decision contains three annexes, which provide the detailed lists of medicines whose market authorisations are extended until December 2024, i.e. Annex I with the list of domestic medicines; Annex II with the list of medicines imported into Vietnam; and Annex III with the list of vaccines. 1,856 imported medicines will now enjoy extended market authorisation validity until the end of 2024. The lists are published on the Ministry of Health website.

The complex and time-consuming renewal of expiring marketing authorisations over recent years hampered EU industry’s access to Vietnam’s market and affected the continued supply of high-quality pharmaceuticals to Vietnam and their availability to its consumers. By extending the validity of marketing authorisations for pharmaceutical products until the end of 2024, transparency and predictability are re-established. In parallel, Vietnam is also in the process of amending its Pharma Law 2016 to provide a long-term, predictable system.

With the entry into force on 20 October 2022 of Circular 08/2022/TT-BYT (Circular 8), Vietnam had already recognised the EU Single Market for pharmaceuticals and the unity of the EU regulatory framework, by ending the discrimination among EU members states’ regulatory authorities of pharmaceuticals. This resulted in equal treatment of all EU pharmaceuticals, including from pharmaceutical companies established in Spain, Poland, Italy and Hungary, which were previously facing longer and more burdensome approval processes because of difference in the treatment of EU Member States’ regulatory authorities. 

The EU exported EUR 2.47 billion pharmaceutical products to Vietnam between January and October 2022, 24% of all EU exports to Vietnam in that period. The Trade Agreement between the European Union and Vietnam is in force since 1 August 2020.

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EU trade relations with Vietam