09 cases of granting a license to import drugs without certificate of marketing authorization in Vietnam

09 cases of granting a license to import drugs without certificate of marketing authorization in Vietnam (Illustrative image)

Article 60 of the Law on Pharmacy 2016 stipulates that a drug that does not have a certificate of marketing authorization in Vietnam shall be licensed for import with a quantity not exceeding that written on the import license in the following cases:

+ It contains an active ingredient that is not granted a certificate of marketing authorization or granted a certificate of marketing authorization but the quantity is not sufficient for treatment;

+ It contains an active ingredient that is medicinally used in Vietnam for the first time or was medicinally used in Vietnam, but the quantity is not sufficient for treatment;

+ It serves purposes related to national defense and security, prevention and elimination of epidemics, disaster recovery, or need for special treatment;

+ It is a rare drug;

+ It has the same trade name, active ingredients, concentrations, dosage form as a original brand name drug which is granted a certificate of marketing authorization in Vietnam, manufactured by the same manufacturer of the original brand name drug or an authorized manufacturer, and its price is lower than that of the original brand name drug being sold in Vietnam at the request of the Minister of Health of Vietnam;

+ It serves a health program of the State;

+ It serves as humanitarian aid;

+ It is used for clinical trial, bioequivalence study, bioavailability assessment, as a sample for registration, testing, scientific research, or display at a fair or exhibition;

+ It is used for other non-commercial purposes.

Details are found in the Law on Pharmacy 2016 effective from January 1, 2017.

Ty Na

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