June 10, 2022

Ministry of Health’s Drug Administration of Vietnam (DAV) issued its first batch of pharmaceutical marketing authorizations

On 2 June, the Ministry of Health’s Drug Administration of Vietnam (DAV) issued its first batch of pharmaceutical marketing authorizations (MAs) to be implemented under the terms of Decree 29, which guides the implementation of Resolution 12.  This progress follows months and months of intensive dialogue between government authorities and EuroCham.

In Vietnam, pharmaceutical MAs are issued on a temporary basis. For more than two years, the Ministry of Health has not been issuing timely MA renewals. This has created concerns about possible supply chain disruptions and pharmaceutical shortages. To rectify this, the Standing Committee of the National Assembly issued Resolution 12/2021/UBTVQH15 on 30 December 2021, enabling the continued use of expiring MAs until the end of 2022, and then the government issued Decree 29/2022/ND-CP on 29 April 2022 implementing Resolution 12. Regardless, Resolution 12’s implementation has been inadequate due to the absence of a list of specific MAs receiving validity extensions.

The list issued on 2 June under OL 4781/QLD-DK of the DAV partly rectified this by clarifying which MAs are to be granted extensions. It covered MAs slated to expire before 30 June 2022, including 1,427 for imported drugs and 193 for vaccines and biologics. A number of MA extensions clarified on the list were for EuroCham members.

EuroCham is pleased with this development after all the work the Chamber put into achieving this milestone. EuroCham also anticipates the DAV’s upcoming lists of MAs that will expire after the 30th of June.

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