Of the nearly 320 drugs, vaccines, and medical biological products newly granted or having their circulation registrations extended this time, two-thirds are foreign drugs, vaccines, and biological products newly granted; the rest have their circulation registrations extended.
The Drug Administration of Vietnam, Ministry of Health, said it has just issued new or extended circulation registration certificates for nearly 320 foreign drugs, vaccines, and medical biological products for a period of 3-5 years.
Of the nearly 320 foreign drugs, vaccines, and medical biological products whose circulation registration certificates were newly granted or extended this time, two-thirds of foreign drugs, vaccines, and biological products were newly granted; the rest had their circulation registration certificates extended. Of these, 171 foreign drugs were newly granted circulation registration certificates in Vietnam, with 164 foreign drugs newly granted registration certificates for 5 years; 7 drugs newly granted circulation registration certificates for 3 years. There were 71 foreign drugs, of which 37 were newly granted for 5 years, 3 were newly granted for 3 years; 26 foreign drugs were extended for 5 years, 5 foreign drugs were extended for 3 years; 69 vaccines and medical biological products were extended for a period of 3-5 years.
The Drug Administration of Vietnam requires that drug, vaccine, and biological product 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.
In addition, 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 Drug Administration.
The Drug Administration of Vietnam also requires drug manufacturing and registration establishments to update 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 01/2018/TT-BYT dated January 18, 2018 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 dated September 5, 2022 of the Minister of Health for drugs that have not updated the content of drug labels and drug instructions according to the provisions of Circular 01/2018/TT-BYT dated January 18, 2018 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 Department) 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 dated May 8, 2017 of the Government detailing a number of articles and measures to implement the Law on Pharmacy.
Drug registration facilities 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 in Article 5 of Circular No. 08/2022/TT-BYT for drugs in Appendix II issued with the Decision.
Previously, the Drug Administration of Vietnam also issued decisions to grant new licenses and extend nearly 500 domestically and internationally produced drugs and pharmaceutical ingredients, and drugs with proven bioequivalence./.
Source: https://www.vietnamplus.vn/gan-320-san-pham-thuoc-vaccine-va-sinh-pham-y-te-duoc-cap-moi-gia-han-luu-hanh-post1000108.vnp
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