Procedures for the extension of traditional medicine registration certificate in 2025 in Vietnam

Procedures for the extension of traditional medicine registration certificate in 2025 in Vietnam​ (Image from the internet)

On December 31, 2024, the Minister of Health of Vietnam promulgated Circular 54/TT-BYT amending and supplementing certain articles concerning the renewal of registration certificates for traditional medicines, traditional medicinal substances, and pharmaceuticals as specified in Circular 21/2018/TT-BYT.

Procedures for the extension of traditional medicine registration certificate in 2025 in Vietnam

Clause 2 of Article 1 in Circular 54/TT-BYT has amended and supplemented Article 21 of Circular 21/2018/TT-BYT prescribing procedures for renewing the registration certificate for traditional medicines in Vietnam as follows:

(1) Within 12 months before the expiration of the circulation registration certificate, the registration facility shall submit one set of application documents requesting the renewal of the traditional medicine circulation registration certificate (renewal application) in accordance with Article 18 of Circular 21/2018/TT-BYT to the Department of Traditional Medicine and Pharmacy Management, Ministry of Health, in a direct form, via postal service, or online through the Ministry's online public service system. In cases where the registration facility fails to submit the renewal application within the specified period, it shall perform procedures for the issuance of a circulation registration certificate in accordance with Article 20 of Circular 21/2018/TT-BYT.

(2) Upon receipt of a renewal application with all required components, the Department of Traditional Medicine and Pharmacy Management shall issue a Receipt of Application Certificate to the registration facility according to Form 02A issued with Circular 21/2018/TT-BYT. In cases where the required components are incomplete, the Department shall issue a written request or suggest (in the case of direct submissions) the registration facility to complete the application as stipulated.

(3) When the traditional medicine circulation registration certificate expires and its renewal application has been accepted by the Department of Traditional Medicine and Pharmacy Management as stipulated, it shall remain valid until it is renewed or the Department issues a written notification of non-renewal or a suspension due to safety concerns or suspicion of forged legal documents.

(4) Renewal of the circulation registration certificate for traditional medicines based on dossier assessment and advisory council consultation for cases including:

- Traditional medicines as specified in Clause 1 and Clause 2 of Article 12 of Circular 21/2018/TT-BYT;

- Traditional medicines with level 1 or level 2 quality violations as per Circular 38/2021/TT-BYT;

- Traditional medicines with severe adverse events reported in Form 08C annexed to Circular 21/2018/TT-BYT.

(5) Within a maximum of 03 months from the receipt of a complete file, the Department of Traditional Medicine and Pharmacy Management shall have a written agreement or disagreement on renewing the circulation registration certificate for traditional medicines for the cases specified in Clause (4) or traditional medicines suspected of forged legal documents. Specifically:

- Within 07 days from receiving the complete file, the Department shall review, categorize, and submit the file to assessment experts or assessment units. Within 30 days from receiving the file from the Department, the experts or assessment units shall complete the assessment record and notify the Department for consolidation and conclusion of the assessment record;

- Within 12 days from receiving the assessment record, the Department shall issue:

+ A notification on the assessment results for the applications requiring amendments or supplementation or those that do not meet requirements, stating clearly the reasons;

+ Transfer the file to the Advisory Council office for the issuance of circulation registration certificates for medicines and raw materials for medicines to organize an Advisory Council meeting to make decisions on assessment files and those needing advice.

- Within 06 working days from receiving documents from the Department, the Advisory Council office for the issuance of circulation registration certificates shall organize a meeting and send minutes of the meeting to the Department;

- Within 18 days from receiving the minutes of the Advisory Council meeting, the Department shall issue a renewal of the traditional medicine circulation registration certificate or request amendments or supplementation or reject as per the Advisory Council's recommendations;

- The timeframe and number of times for the registration facility to amend or supplement the application as stated in Clause 9, Article 4 of Circular 21/2018/TT-BYT.

(6) Renewal of the circulation registration certificate for traditional medicines without requiring dossier assessment, advisory council consultation for cases not covered under Clause (5).

Within 03 months from the receipt of a complete file, the Department shall issue a written agreement or disagreement on renewing the circulation registration certificate. Specifically:

- Within 07 working days from the receipt of a complete file, the Department shall transfer the file to assessment experts or units. Within 30 days from receipt, the experts or units shall complete the assessment record and notify the Department for consolidation and conclusion.

- Within 12 days from receiving the assessment record, the Department shall issue:

+ A notification on the assessment results for applications requiring amendments or supplementation or those that do not meet requirements, stating clearly the reasons;

+ Issue the renewal of the traditional medicine circulation registration certificate for qualified applications.

- The timeframe and number of times for the registration facility to amend or supplement the application as stated in Clause 9, Article 4 of Circular 21/2018/TT-BYT.

Refer to more details in Circular 54/TT-BYT effective from January 1, 2025.

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