Procedures for extension of Certificate of registration for drug and pharmaceutical ingredients in Vietnam from January 1, 2025

Procedures for extension of Certificate of registration for drug and pharmaceutical ingredients in Vietnam from January 1, 2025

- Within 03 months from the date of full dossier receipt, the Drug Administration shall renew the Certificate of registration for drug and pharmaceutical ingredients for cases specified in point b, clause 2, Article 34 of Circular 08/2022/TT-BYT. In cases of non-renewal or pending renewal, the Drug Administration shall issue a written response stating the reasons.

- Within a maximum of 03 months from the date of full dossier receipt, the Drug Administration shall renew the Certificate of registration for drug and pharmaceutical ingredients for cases specified in point c, clause 2, Article 34 of Circular 08/2022/TT-BYT. In such cases of non-renewal or pending renewal, the Drug Administration shall issue a written response stating the reasons.

- A period of 12 months is allowed for the submission of supplementary documents, starting from the date of notification by the Drug Administration. During this period, the registration establishment must submit the required additional documents. After this period, if the registration establishment fails to submit the supplementary documents, the submitted dossier will no longer be valid.

The registration establishment shall notify in writing to the Drug Administration regarding the dossiers submitted and under review in cases of updating information related to the safety and efficacy of the drugs; the legal documents of the registration establishment, drug manufacturing facility, drug materials; the actual market circulation status of the drugs in Vietnam compared to the submitted dossiers. The time for the establishment to notify updates in writing will be included in the processing time for supplementary dossiers.

The time from the issuance of the notification by the Drug Administration to the submission of supplementary documents by the registration establishment is not counted in the time limit stipulated at point c, clause 6, Article 56 of the Law on Pharmacy, as amended at clause 30, Article 1 of the Law Amending and Supplementing a Number of Articles of the Law on Pharmacy.

- Within 03 months from the date of full supplementary document receipt, the Drug Administration shall issue a decision to renew the Certificate of registration for drug and pharmaceutical ingredients for dossiers that meet the requirements; and shall issue a written response for dossiers that do not meet the assessment requirements, stating the reasons. The procedure, time for reviewing supplementary documents shall be performed as per the above regulations.

Refer to detailed content at Circular 55/2024/TT-BYT which takes effect from January 1, 2025.

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