Vietnam’s Circular 32: Guidelines for procedures for granting marketing authorization of drugs

Procedures for granting marketing authorization are guided in Article 38 of Circular No. 32/2018/TT-BYT of the Ministry of Health of Vietnam, specifically as follows:

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Step 1: Within 12 months from the day on which adequate documents are received (except for the case specified in Article 41 of this Circular), the Drug Administration of Vietnam shall issue marketing authorization. If the application is rejected, the Drug Administration of Vietnam shall respond in writing and provide explanation. Deadlines:

- Within 03 months from the day on which adequate documents are received, the Drug Administration of Vietnam shall transfer it to the validating official or validating unit. Within 06 months from the receipt of the application from Drug Administration of Vietnam, the validating official or validating unit shall send a validation record to Drug Administration of Vietnam in accordance with Clause 4 Article 37 of this Circular;

- Within 02 months from the receipt of the validation record, the Drug Administration of Vietnam shall make a written response if the application is rejected and provide explanation. Drug Administration of Vietnam shall make the proposals or obtain comments from the Advisory Board in the nearest meeting;

- Within 30 days from the meeting, the Drug Administration of Vietnam shall issue the decision to grant the marketing authorization to the satisfactory application; the Drug Administration of Vietnam shall send written response and provide explanation for rejected applications according to comments of the Advisory Board.

Step 2: Within 36 months from the day on which the Drug Administration of Vietnam requests submission of additional non-clinical and clinical documents, bioequivalence documents, stability study documents are required (or 12 months for other documents), the applicant shall provide the additional documents. Otherwise, the application will be rejected.

The applicant shall send a written notification to the Drug Administration of Vietnam of updated information about safety and efficacy of the drug during the validation period.

The period from the date Drug Administration of Vietnam issues the request to the date the applicant submits the additional documents is not included in the time limit specified in Clause 5 Article 56 of the Law on Pharmacy.

Step 3: Within 06 days from the receipt of additional documents, the Drug Administration of Vietnam shall issue the decision to grant the marketing authorization if the application is satisfactory; Drug Administration of Vietnam shall send written response and provide explanation for rejected applications according to comments of the Advisory Board.

More details can be found 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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