Vietnam: Guidelines for procedures for renewal of applications for the marketing authorization of drug from September 01, 2019

According to Circular No. 32/2018/TT-BYT of the Ministry of Health of Vietnam, procedures for renewal of applications for the marketing authorization of drug/medicinal ingredient (hereinafter referred to as “marketing application”) include the following steps:

Illustration (Internet)

Step 1: Within 03 months from the receipt of adequate documents, the Drug Administration of Vietnam shall renew the marketing authorization if the application is satisfactory. If the renewal application is rejected or yet to be granted, the Drug Administration of Vietnam shall respond in writing and provide explanation. Deadlines:

- Within 10 working days from the receipt of adequate documents, the Drug Administration of Vietnam shall classify the applications and send them to validating units. Within 01 month from the receipt of the application from Drug Administration of Vietnam, the validating unit shall send a validation record to Drug Administration of Vietnam in accordance with Clause 4 Article 37 of this Circular;

- Within 15 working days 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. If the application is satisfactory or comments of the Advisory Board are necessary, Drug Administration of Vietnam shall present them in the nearest meeting;

- Within 15 working days from the meeting, the Drug Administration of Vietnam shall issue the decision to renew the marketing authorization if the application is satisfactory; Drug Administration of Vietnam shall send a written response and provide explanation for rejected applications according to comments of the Advisory Board.

Step 2: The authorization holder shall provide additional documents within 12 months from the day on which a request is issued by the Drug Administration of Vietnam. Otherwise, the application will be rejected.

The authorization holder 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 authorization holder 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 03 months from the receipt of additional documents, the Drug Administration of Vietnam shall issue the decision to renew the marketing authorization if the application is satisfactory; Drug Administration of Vietnam shall send a written response and provide explanation for rejected applications according to comments of the Advisory Board.

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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