According to Dr. Vu Tuan Cuong - Director of the Ministry of Health, in the latest round of new issuance and renewal of circulation registration certificates according to the provisions of the 2016 Pharmacy Law, 498 foreign drug products were newly issued and renewed by the Ministry of Health.
Of these, 219 foreign drugs were newly granted circulation registration certificates valid for 5 years; 09 foreign drugs were granted circulation registration certificates valid for 3 years;
Regarding the extension, 231 foreign drugs had their circulation registration certificates extended for 5 years; 39 foreign drugs had their circulation registration certificates extended for 3 years.
The foreign pharmaceutical products newly granted and renewed registration certificates this time are quite diverse in terms of pharmacological effects such as drugs for treating respiratory tract infections; drugs for treating osteoarthritis; drugs for treating cardiovascular diseases, hypertension, diabetes, cancer treatment, antiviral drugs, antibiotics, pain relievers, anti-inflammatory drugs...
In addition, the Drug Administration also requires drug manufacturing and registration facilities to comply with regulations to meet the needs and ensure safety for consumers.
The Drug Administration of Vietnam requires that drug manufacturing and registration establishments are responsible for manufacturing and supplying drugs to Vietnam in accordance with the records and documents registered with the Ministry of Health and must print or affix the registration number issued by the Ministry of Health on the drug label;
Fully comply with Vietnamese laws and regulations of the Ministry of Health on drug production, import and circulation in Vietnam. If there is any change in the process of drug circulation in the home country and in Vietnam, it must be reported immediately to the Department of Drug Administration.
At the same time, update the quality standards of drugs 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.
The Drug Administration of Vietnam requires drug manufacturers and drug registration establishments to update drug labels and drug instructions in accordance with Circular 01/2018/TT-BYT of the Minister of Health regulating the labeling of drugs, drug ingredients and drug instructions in the form of changing and supplementing the drug circulation registration certificate prescribed in Circular 08/2022/TT-BYT of the Minister of Health for drugs that have not updated the content of drug labels and drug instructions in accordance with Circular 01/2018/TT-BYT of the Minister of Health.
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.
The drug registration facility must report to the Ministry of Health (Drug Administration) on the updated status of compliance with Good Manufacturing Practices of the drug and drug ingredient manufacturing facility. In case the manufacturing facility has its manufacturing license revoked or fails to comply with Good Manufacturing Practices of drugs and drug ingredients in the home country, the facility must make a report within 15 days from the date of notification by the competent management agency of the home country as prescribed in Point d, Clause 1, Article 100 of Decree No. 54/2017/ND-CP of the Government detailing a number of articles and measures for implementing the Law on Pharmacy.
Drugs whose circulation registration certificates have been extended under this Decision shall continue to use the registration number granted before the extension for a maximum period of 12 months from the date of issuance of the extension registration number as prescribed in Appendix VI issued with Circular No. 08/2022/TT-BYT.
The Drug Administration of Vietnam requires drug manufacturing and registration establishments to 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...
