Vietnam: Detailed application dossier for registration of marketing authorization of bioproducts

According to Decree No. 60/2016/NĐ-CP of Vietnam’s Government, application dossier for registration of marketing authorization of bioproducts includes:

- Application form for registration of marketing authorization of bioproducts.

- Copy of enterprise registration certificate.

- Bioproduct manufacturing process.

- The certified copy or the copy with attachment of the original copy for verification purpose (if an organization or individual submits registration dossier in person) of test result report or analysis of quality of bioproduct, issued by local or foreign accredited testing bodies.

- The description of bioproduct.

- The certified copy or the copy with attachment of the original copy for verification purpose (if an organization or individual submits registration dossier in person) of evaluation report made by managerial-level Science Council with respect to bioproducts which are results of scientific research projects (where appropriate).

- Testing results of bioproduct (where appropriate).

- Official label and packaging form that require authorization with attachment of storage and use instruction leaflets and warnings of health risks to human beings and living organisms.

- The certified copy or the copy with attachment of the original copy for verification purpose (if an organization or individual submits registration dossier in person) of patents on inventions or commitments to compliance with regulations on intellectual property rights for locally-manufactured bioproducts in question.

- The certified copy or the copy with attachment of the original copy for verification purpose (if an organization or individual submits registration dossier in person) of the certificate of marketing authorization of bioproducts, issued by a manufacturing country’s competent regulatory authority with respect to imported bioproducts.

- Detailed testing schedule, including important information such as testing contents, time, location and agency of testing with respect to bioproducts which have not had recognized test results.

View more details at Decree No. 60/2016/NĐ-CP of Vietnam’s Government, effective from July 01, 2016.

- Thanh Lam -

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