Extension of more than 6,000 drug registration certificates

The Drug Administration of Vietnam, the Ministry of Health has just announced the extension of drug registration for 4,631 domestically produced drugs, 1,427 foreign drugs and 193 vaccines and medical biological products that expire before June 30.

Accordingly, the list of more than 6,000 of these drugs belongs to the group of expired registration for circulation from December 30, 2021 to before June 30, 2022. Other drugs that meet the requirements of Decree No. 29/2022/ND-CP are being continuously updated and supplemented at the next publication. The list of drugs is posted on the portal of the Ministry of Health and the Drug Administration of Vietnam.

For drugs and medicinal ingredients on the list that have changed, supplemented or corrected information related to the circulation registration certificate, the enterprise shall present a written certification of the Ministry of Health to the relevant agents. related to carrying out legal procedures.

In early April, the Ministry of Health said that 9,797 drug registration numbers will expire by December 31, 2022. Many businesses are concerned that the delay in extending the circulation certificate may disrupt the drug supply.

The reason for the delay is said to be the delay in the health sector’s focus on fighting the epidemic, and the delay in production, assessment, certification and other legal papers. The pharmaceutical business enterprise failed to prepare enough documents to request the extension. In this situation, on the part of the management agency, many experts refused to appraise the dossiers because of concerns about fake dossiers and difficulties when working in a state of distance.

Previously, the National Assembly Standing Committee issued Resolution No. 12/2021 on allowing the implementation of a number of mechanisms and policies in the health sector to serve the prevention and control of the Covid-19 epidemic.

Clause 5, Article 6 of Resolution 12 stipulates: “With regard to the certificate of free sale of drugs and medicinal ingredients, the validity expires from the effective date of this resolution to before December 31, 2022 without If it is possible to promptly carry out the procedures for extending the circulation registration due to the impact of the epidemic, it can continue to be used until the end of December 31, 2022 to ensure medical examination and treatment.”

On April 29, 2022, Deputy Prime Minister Vu Duc Dam signed and promulgated Decree 29/2022/ND-CP “Detailing regulations and measures to implement Resolution No. 12/2021/UBTVQH15 dated December 30” 2021 by the National Assembly Standing Committee on allowing the implementation of a number of mechanisms and policies in the health sector to serve the prevention and control of the Covid-19 epidemic.

Linh Giao

Risk of drug supply disruptionThe risk of breaking the supply chain of drugs for treatment is warned by experts and the pharmaceutical business community in advance, when thousands of domestic and foreign drugs have expired and are about to expire.