Update on the procedures for renewal of marketing authorization for drugs/medicinal materials in Vietnam

Update on the procedures for renewal of marketing authorization for drugs/medicinal materials in Vietnam

Decision 2898/QD-BYT has revised the procedures for renewing the marketing authorization for drugs/medicinal materials in Vietnam as follows:

- Step 1: The applicant submits one set of registration dossier for the issuance of a marketing authorization (authorization dossier) in accordance with the provisions of Articles 27, 30, 32, 37 of Circular 08/2022/TT-BYT to the Drug Administration of Vietnam - Ministry of Health (receiving agency).

- Step 2: Upon receiving a complete and compliant registration dossier with the adequate fee, the Drug Administration - Ministry of Health issues a Dossier Receipt Note to the applicant.

- Step 3: Within 3 months from the date recorded on the Dossier Receipt Note, the Drug Administration - Ministry of Health is responsible for:

+ Conducting an appraisal of the registration dossier;

+ Presenting to the Advisory Council for marketing authorization issuance for dossiers that meet the requirements; or proposing advice and appraisal from the Council.

+ Issuing the marketing authorization following the conclusions of the appraisal and advisory council.

- Step 4:

+ In case the dossier does not meet the requirements, during the review period, the Drug Administration - Ministry of Health must issue a written response stating the reasons.

+ The time for the applicant to amend and supplement the dossier:

No more than 12 months from the date of the notification letter from the Drug Administration - Ministry of Health.

The time for the applicant to amend and supplement the dossier is not counted in the dossier review period. If this period is exceeded, the registration dossier loses its validity, and the applicant must redo the registration procedure.

- In case of non-approval, the Drug Administration - Ministry of Health must provide a written response stating the reasons.

- Step 5: Supplemental dossiers can be submitted online, via post, or directly to the Drug Administration. The process is then conducted from Step 1.

More details can be found in Decision 2898/QD-BYT, which comes into force in Vietnam from September 30, 2024.

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