This positive result for EU industry and Vietnamese citizens shows the value of having a free trade agreement with Vietnam. It is the result of months of continuous efforts by the European Commission and constructive engagement with the Vietnamese authorities.
Pharmaceuticals from all EU member states will now see simpler and faster registration procedures and easier participation in government procurement. This will allow better market access for EU pharmaceutical products to Vietnam, greatly benefitting Vietnamese consumers in terms of access to medicines. EU pharmaceutical exports to Vietnam are worth EUR 1.5 billion a year, contributing to EU jobs and economic resilience.
The EU calls on Vietnam to also ensure a more transparent and predictable system of marketing authorisations without delay.
With the entry into force on 20 October 2022 of Circular 08/2022/TT-BYT (Circular 8), Vietnam now fully recognises the EU Single Market for pharmaceuticals and the unity of the EU regulatory framework.
In future, all EU producers will be treated equally, including 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 previous legislation (Circular 32) differentiated among Member States’ regulatory authorities, listing some as 'Reference Regulatory Authorities' (RRA) and others as 'Stringent Regulatory Authorities' (SRA). This differentiation implied simplified and shorter registration procedures for pharmaceutical products registered by RRAs, including exemptions for clinical trials. This discrimination also affected participation in government procurement for pharmaceutical products, through a better scoring for medicines approved by RRAs, thereby reducing opportunities for products registered by SRAs. The new Circular 8 now recognises all EU Member States’ regulatory authorities as 'Reference Regulatory Authorities'.
Circular 8 also brings Vietnam’s regulatory framework closer to international practices. It now fully recognises the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) as the relevant standard and guidelines. Circular 8 is therefore an important step for Vietnam to develop competitive and business-friendly conditions that will allow Vietnam to integrate better into global pharmaceutical value chains.
There are still important further procedural reforms in the sector required for Vietnam. In particular, the EU calls on Vietnam to ensure a more transparent and predictable framework for extending the validity of marketing authorisations. The EU stands ready to accompany Vietnam further in its modernisation of the pharmaceutical sector for the benefit of Vietnamese patients.
In 2021, the export of EU pharmaceutical products to Vietnam amounted to about EUR 1.5 billion, or about 14% of total EU exports to Vietnam of EUR 10,6 billion.
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- Дата на публикуване
- 20 Oктомври 2022 г.
- Генерална дирекция „Търговия“
- Country or region
- Trade topics
- EU companies accessing world marketsNegotiations and agreements