Information with reporters Health & Life Newspaper, Director of the Drug Administration of Vietnam, Ministry of Health Vu Tuan Cuong said, implementing the direction of the leaders of the Ministry of Health on implementing Resolution No. 80 dated January 9, 2023 of the National Assembly, on the 8th day of the National Assembly. /2 The Drug Administration has decided to publish the List Drugs and medicinal ingredients that have a certificate of circulation registration may continue to be used according to the provisions of Clause 1, Article 3 of Resolution No. 80/2023/QH15.
Accordingly, in Decision No. 62/QD-QLD, the Director of the Drug Administration of Vietnam renewed nearly 8,880 drugs, medicinal ingredients, vaccines and medical biological products. This means that all circulation registration certificates of nearly 8,880 drugs, medicinal ingredients, vaccines and medical biological products will continue to be used from the date of expiration until December 31, 2024.
Among nearly 8,880 drugs, medicinal ingredients, vaccines and medical biological products extended this time, there are 6,819 domestic drugs, 1,856 foreign drugs and 203 vaccines and medical biological products.
The drugs and medicinal ingredients announced for this extension include drugs for treating common diseases and treating specialized diseases such as cardiovascular, digestive, diabetes, musculoskeletal, respiratory, and infectious diseases. bacteria, cancer…
In case the drug or medicinal ingredient has been changed or supplemented during the circulation process or has corrected or modified information related to the issued circulation registration certificate, the enterprise shall present a written approval. or confirmation from the Drug Administration of Vietnam with relevant agencies and units to carry out procedures according to legal regulations.
Previously, on the morning of January 9, 2023, under the direction of Vice Chairman of the National Assembly Tran Thanh Man, the National Assembly voted to pass a Resolution on continuing to implement a number of policies in epidemic prevention and control. Allows continued use of registration papers for circulation of drugs and medicinal ingredients that expire from January 1, 2023 without being renewed according to the provisions of the Pharmacy Law.
The voting results showed that there were 468/473 National Assembly deputies present who voted in favor (accounting for 94,35%), the National Assembly officially passed the Resolution.
Regarding this issue, at the group discussion session of the 2nd Extraordinary Session, 15th National Assembly, morning of January 6, 2023 on evaluating the implementation of regulations in Resolution No. 30/2021/QH15 dated July 28, 2021 First session, 15th National Assembly on policies to prevent and control the COVID-19 epidemic ; Proposing content to be included in the National Assembly's Resolution on transitioning the implementation of a number of policies as prescribed in Resolution No. 30/2021/QH15 on policies to prevent and control the COVID-19 epidemic and allowing it to continue Using the registration certificate for circulation of drugs or medicinal ingredients whose validity period has expired from January 1, 2023 but has not yet been renewed according to the provisions of the Pharmacy Law, Minister of Health Dao Hong Lan information, the Ministry also issued a very clear regulation that after the National Assembly agrees, all criteria and drugs subject to extension will be published on the Electronic Information Portal for businesses and people. , management agencies can monitor to ensure openness and transparency.
In particular, the head of the health sector affirmed that to fundamentally solve the problem of renewing drug circulation certificates, in addition to the immediate solution to speed up drug renewal, the Ministry is developing a Pharmacy Law (amended). . It also proposes a number of mechanisms that the international community is working on, such as the automatic renewal of drugs. The draft Pharmacy Law (amended) has been submitted to the Government, and is currently completing documents to submit to the Ministry of Justice for appraisal and send for registration with the National Assembly in the near future.
In 2022, the Drug Administration of Vietnam and the Ministry of Health have also renewed over 10,000 drugs, medicinal ingredients, vaccines and medical biological products.
Source: Ministry of Health
