According to the Drug Administration of Vietnam, of the nearly 320 foreign drugs, vaccines, and medical biological products whose circulation registration certificates were newly granted and renewed this time, two-thirds of foreign drugs, vaccines, and biological products were newly granted; the rest had their circulation registration certificates renewed.
Illustration photo.
Of which, 171 foreign drugs were newly granted circulation registration certificates in Vietnam, with 164 foreign drugs newly granted registration certificates within 5 years; 7 drugs newly granted circulation registration certificates within 3 years;
There are 71 foreign drugs, of which 37 are newly granted for 5 years, 3 are newly granted for 3 years; 26 foreign drugs are extended for 5 years, 5 foreign drugs are extended for 3 years; 69 vaccines and medical biological products are 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: Producing 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 immediately reported to the Department of Drug Administration, Ministry of Health.
The Drug Administration also requires drug manufacturing and registration establishments to update drug quality standards, drug labels and drug instructions... according to regulations; Drug registration establishments must ensure that they maintain operating conditions during the validity period of the drug and drug ingredient circulation registration certificate. In case they no longer meet the operating conditions, the registration establishment must be responsible for changing the registration establishment according to regulations within 30 days from the date the registration establishment no longer meets the operating conditions...
Two weeks ago, the Drug Administration of Vietnam also issued decisions to issue new licenses and extend nearly 500 domestically and internationally produced drugs and pharmaceutical ingredients, and drugs with proven bioequivalence...
Source: https://www.baogiaothong.vn/bo-y-te-tiep-tuc-cap-moi-gia-han-gan-320-thuoc-vaccine-va-sinh-pham-y-te-192241210134614784.htm
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