Of the 699 domestically produced drugs granted a certificate of circulation in Vietnam by the Drug Administration of Vietnam - Ministry of Health this time, 696 drugs were granted a certificate of validity of 5 years; the remaining 3 drugs were granted a certificate of validity of 3 years.
The Department of Drug Administration requires drug manufacturing facilities and drug registration facilities to be responsible for producing drugs in accordance with the records and documents registered with the Ministry of Health and must print or stick the registration number issued by the Ministry of Health of Vietnam on the drug label;
Only special control drugs can be produced and put into circulation when there is a Certificate of eligibility for pharmaceutical business, especially controlled drugs, in accordance with the scope of operation of the facility that meets 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 Pharmacy Law;
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, Circular No. 03/2020/TT-BYT dated January 22, 2020 of the Minister of Health amending and supplementing a number of articles of Circular 11/2018/TT-BYT regulating the quality of drugs and pharmaceutical ingredients;
Update drug labels and drug instructions according to the provisions of Circular No. 01/2018/TT-BYT dated January 18, 2018 of the Minister of Health regulating the labeling of drugs, drug ingredients and drug instructions for use within 06 months from the date of signing and issuance of this Decision, in the form of changing and supplementing the drug circulation registration certificate;
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 the provisions of Article 5 of Circular No. 08/2022/TT-BYT for drugs in Appendix II issued with this Decision;
The drug registration facility must ensure to maintain operating conditions within the validity period of the drug and drug ingredient registration certificate. In case the registration facility no longer meets the operating conditions, the registered facility must be responsible for implementing the change of the registered facility according to the provisions of Circular No. 08/2022/TTBYT within 30 days from the date the registered facility no longer meets the operating conditions;
The drug manufacturing facility must ensure the operating conditions of the manufacturing facility within the validity period of the drug and pharmaceutical ingredient circulation registration certificate.
In 2024, the Department of Drug Administration - Ministry of Health has announced 17 renewals of the validity of drug and pharmaceutical ingredient registration certificates with nearly 14,000 published drugs and pharmaceutical ingredients; Handling 1,160 dossiers for granting import licenses for drugs, 5,603 dossiers for granting import licenses for raw materials, packaging, and capsules; Awarding and renewing 12,333 drugs according to the Pharmacy Law, equal to the total number of issued and renewed drugs in the last 5 years (2019-2023) combined.
