Dr. Vu Tuan Cuong - Director of the Department of Drug Administration, Ministry of Health - said: Of the nearly 1,500 drugs and pharmaceutical ingredients whose circulation registration certificates have been extended this time, 1,095 domestically produced drugs and pharmaceutical ingredients have had their circulation registration certificates extended for a period of 5 years; 335 domestically produced drugs have had their circulation registration certificates extended for a period of 3 years; 57 domestically produced drugs have had their circulation registration certificates extended for a period of 3 years until December 31, 2025.
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.
Specially controlled drugs may only be produced and put into circulation when there is a Certificate of eligibility for pharmaceutical business. The scope of business of specially controlled drugs is suitable for the scope of operation of the facility, meeting the provisions of 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.
Implement the updating of drug quality standards according to the provisions of Circular No. 11/2018/TT-BYT dated May 4, 2018 of the Minister of Health regulating the quality of drugs and pharmaceutical ingredients.
Drugs whose circulation registration certificate has been extended under this Decision but have not yet submitted a dossier to update the content of the drug label and instructions for use according to the provisions of Circular 01/2018/TT-BYT dated January 18, 2018 of the Minister of Health must update according to the provisions at Point b, Clause 1, Article 37 of Circular No. 01/2018/TT-BYT within 12 months from the date of extension of the circulation registration certificate.
The drug registration facility must ensure that the operating conditions are maintained during the validity period of the drug and drug ingredient registration certificate. In case the operating conditions are no longer met, the registration facility must be responsible for changing the registration facility according to the provisions of Circular No. 08/2022/TT-BYT within 30 days from the date the registration facility no longer meets the operating conditions.
At the same time, drug manufacturing facilities must ensure the operating conditions of the manufacturing facility during the validity period of the drug and drug ingredient circulation registration certificate.
Drugs whose circulation registration certificates have been extended this time may continue to use the registration number issued before the extension for a maximum period of 12 months from the date of issuance of the extension registration number according to the provisions of Appendix VI issued with Circular No. 08/2022/TT-BYT.
According to the request of the Drug Administration, drug manufacturing and registration establishments must coordinate with treatment facilities to comply with current regulations on prescription drugs, monitor the safety, effectiveness, and adverse effects of drugs on Vietnamese people, and synthesize and report according to regulations...
