Extending the registration of 700 pharmaceutical products for bidding and procurement

The Drug Administration of Vietnam ( Ministry of Health ) has just announced the list of drugs granted with a certificate of drug circulation registration extension; the list of drugs with documents proving bioequivalence has changed, supplemented drug information for a total of more than 700 drug products.

According to the Drug Administration of Vietnam, of these more than 700 drugs, 603 domestically produced drugs have their circulation registration certificates extended, including 395 domestically produced drugs whose circulation registration certificates have been extended for 5 years; 175 domestically produced drugs whose circulation registration certificates have been extended for 3 years; 33 domestically produced drugs whose circulation registration certificates have been extended until December 31, 2025.

The remaining 109 drugs in the list of drugs with documents proving bioequivalence have changed and supplemented drug information. This is the second announcement in 2025 for drugs in the list of drugs with documents proving bioequivalence with changed and supplemented drug information of the Ministry of Health , up to this point.

The Drug Administration of Vietnam requires drug manufacturing and registration establishments to be responsible for: Producing drugs in accordance with the records and documents registered with the Ministry of Health and must print or affix the registration number issued by the Vietnamese Ministry of Health on the drug label.

Drug manufacturing and registration establishments are only allowed to manufacture and circulate specially controlled drugs when they have a Certificate of eligibility for pharmaceutical business. The scope of business of specially controlled drugs is suitable for the scope of operation of the establishment, meeting the provisions in Clause 5, Article 143 of Decree No. 54/2017/ND-CP dated May 8, 2017 of the Government detailing a number of articles and measures to implement the Law on Pharmacy...

Previously, at the end of March 2025, the Drug Administration of Vietnam also granted drug circulation registration certificates and announced the list of generic drugs for 750 drugs, including 51 generic drugs./.

(Vietnam+)

Source: https://www.vietnamplus.vn/gia-han-dang-ky-luu-hanh-700-san-pham-thuoc-phuc-vu-dau-thau-mua-sam-post1027574.vnp