Vietnam: Cases eligible for quick validation of applications for import of drugs without marketing authorization

According to Circular No. 32/2018/TT-BYT of the Ministry of Health of Vietnam, drugs eligible for quick validation include:

Illustration (Internet)

- Rare drugs listed by the Minister of Health.

- Drugs serving urgent needs for national defense and security, epidemic control or disaster relief.

- Domestic drugs that are manufactured by production lines that satisfy GMP, GMP-EU, GMP-PIC/S standards and equivalent standards within 18 months from the issuance date of the GMP certificate.

- Vaccines that are approved by WHO; vaccines used for national expanded immunization programs.

- Specialty drugs, drugs with special dosage forms where not more than 02 similar drugs (with the same active ingredients, dosage form, content or concentration) have an unexpired marketing authorization in Vietnam when the application is submitted, including:

+ Antineoplastic drugs;

+ Next-gen antiviral drugs;

+ Next-gen antibiotics;

+ Drugs for treatment of hemorrhagic fever, tuberculosis, malaria.

- Drugs that can be domestically manufactured, including:

+ Antineoplastic drugs, vaccines, biologicals, next-gen antiviral drugs that are manufactured in Vietnam under a processing agreement or technology transfers agreement;

+ Herbal drugs under a national, ministerial or provincial research which has been accepted; drugs wholly obtained from domestic herbal ingredients that satisfy GACP standards;

+ New domestic drugs that have undergone clinical trial in Vietnam;

- New antineoplastic drugs, next-gen antiviral drugs, next-gen antibiotics, biologicals.

- Proprietary drugs that are manufactured in Vietnam under a processing agreement or technology transfer agreement.

View full text in Circular No. 32/2018/TT-BYT of the Ministry of Health of Vietnam, which takes effect from September 01, 2019.

Thu Ba

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