New regulations to manage Vietnam pharmaceutical industry

12 April 2013

The Vietnam Ministry of Health has issued Circular No 10/2013/TT-BYT amending and supplementing a number of articles of Circular No 02/2007/TT-BYT on conditions for the nation’s pharmaceutical sector, reports VietNamNet.

Among other things, the amendment circular clarifies so-called "technology documents" in applications for issuance/amendment of licences for drugs businesses under Decree No 89/2012/ND-CP. Accordingly, the technology document will be the Good Practice Certificate corresponding to the drug business sector that the applicant applies for. If this Good Practice Certificate is not yet available, an application must be submitted simultaneously with an application for issuance/amendment of a licence for a drugs business.

Under the Law on Pharmacy 2005, the licensing agency for pharmacy practices that are individual practitioners working for a foreign-owned enterprise will be the Health Ministry.

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