Procedures for extension of the traditional medicine registration certificate in Vietnam

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

On January 7, 2025, the Minister of Health issued Decision 75/QD-BYT regarding the announcement of administrative procedures being amended, supplemented, and repealed in the fields of Traditional Medicine and Pharmacy as stipulated in Circular 54/2024/TT-BYT, which revises the extension of registration certificates for traditional medicine, traditional medicinal herbs, and medicinal materials in Circular 21/2018/TT-BYT prescribing the registration of circulation licenses for traditional medicine and medicinal materials.

Procedures for extension of the traditional medicine registration certificate in Vietnam

* Case 1: Dossiers must be submitted to the Council:

Step 1: Within 12 months before the registration certificate of circulation expires, the registration entity must submit one set of dossiers requesting an extension of the registration certificate of traditional medicine circulation (extension dossier) according to the provisions in Article 18 of Circular 21/2018/TT-BYT to the Department of Traditional Medicine and Pharmacy Management, Ministry of Health via direct submission, postal mail, or online submission on the Ministry of Health's online public service system. In case the submission is delayed beyond this timeframe, the registration entity must perform the procedure for issuing a circulation registration certificate according to the provisions of Article 20 of Circular 21/2018/TT-BYT.

Step 2: Upon receipt of a complete extension dossier as prescribed, the Department of Traditional Medicine and Pharmacy Management issues the registration entity a receipt note for the dossier following form number 02A issued with Circular 21/2018/TT-BYT. In case the dossier is incomplete, the Department of Traditional Medicine and Pharmacy Management provides written communication or a request (in case of direct submission) to the registration entity to supplement the dossier as required.

The traditional medicine circulation registration certificate, once its validity period expires and if the Department of Traditional Medicine and Pharmacy Management has received the extension dossier according to regulations, can continue to be used until it is renewed or until the Department of Traditional Medicine and Pharmacy Management issues a written notice of non-renewal or a suspension notice due to the traditional medicine being found potentially unsafe for users or suspected of having counterfeit legal documentation.

Step 3: Within a maximum of three months from the date of receiving the complete dossier, the Department of Traditional Medicine and Pharmacy Management issues a written agreement or disagreement on the extension of the traditional medicine circulation registration certificate for cases defined in Clause 4 of Article Circular 21/2018/TT-BYT or traditional medicines suspected of having counterfeit legal documents. Specifically:

- Within seven days from receipt of the complete dossier, the Department of Traditional Medicine and Pharmacy Management reviews, categorizes, and forwards the dossier to evaluation experts or evaluation units. Within 30 days of receiving the dossier from the Department of Traditional Medicine and Pharmacy Management, evaluation experts or units must complete an evaluation report and send it to the Department of Traditional Medicine and Pharmacy Management for aggregating and concluding the evaluation report;

- Within 12 days of receiving the Evaluation Report, the Department of Traditional Medicine and Pharmacy Management provides written notification:

+ Notifying the evaluation results for dossiers requiring modifications or supplements or dossiers failing the requirements and specifying reasons;

+ Transferring to the Advisory Council's Office for the issuance of registration certificates for meetings to issue circulation registration certificates for pharmaceuticals and medicinal raw materials for approved evaluations and cases needing advisory opinions;

- Within six working days from receiving documents from the Department of Traditional Medicine and Pharmacy Management, the Advisory Council's Office organizes meetings to issue circulation registration certificates for pharmaceuticals and medicinal raw materials and sends meeting minutes to the Department of Traditional Medicine and Pharmacy Management;

- Within 18 days from receiving the meeting minutes from the Advisory Council, the Department of Traditional Medicine and Pharmacy Management issues written decisions to extend the traditional medicine circulation registration certificate, require amendments or supplements, or deny issuance based on the Advisory Council's recommendation to issue circulation registration certificates for pharmaceutical and medicinal raw materials;

- The time frame and the number of times the registration entity needs to amend or supplement the dossier are stipulated in Clause 9, Article 1 of Circular 39/2021/TT-BYT.

* Case 2: Dossiers not requiring submission to the Council:

Step 1: Within 12 months before the registration certificate of circulation expires, the registration entity must submit one set of dossiers requesting an extension of the registration certificate of traditional medicine circulation (extension dossier) according to the provisions in Article 18 of Circular 21/2018/TT-BYT to the Department of Traditional Medicine and Pharmacy Management, Ministry of Health via direct submission, postal mail, or online submission on the Ministry of Health's online public service system. In case the submission is delayed beyond this timeframe, the registration entity must perform the procedure for issuing a circulation registration certificate according to the provisions of Article 20 of Circular 21/2018/TT-BYT.

Step 2: Upon receipt of a complete extension dossier as prescribed, the Department of Traditional Medicine and Pharmacy Management issues the registration entity a receipt note for the dossier following form number 02A issued with Circular 21/2018/TT-BYT. In case the dossier is incomplete, the Department of Traditional Medicine and Pharmacy Management provides written communication or a request (in case of direct submission) to the registration entity to supplement the dossier as required.

The traditional medicine circulation registration certificate, once its validity period expires and if the Department of Traditional Medicine and Pharmacy Management has received the extension dossier according to regulations, can continue to be used until it is renewed or until the Department of Traditional Medicine and Pharmacy Management issues a written notice of non-renewal or a suspension notice due to the traditional medicine being found potentially unsafe for users or suspected of having counterfeit legal documentation.

Step 3: Extend the registration certificate of traditional medicine circulation without requiring dossier evaluation or Council consultation for cases not part of the regulations in Clause 5, Article 21 of Circular 21/2018/TT-BYT.

Within three months of receiving the complete dossier, the Department of Traditional Medicine and Pharmacy Management issues a written agreement or disagreement on extending the traditional medicine circulation registration certificate. Specifically:

- Within seven working days of receiving the complete dossier, the Department of Traditional Medicine and Pharmacy Management transfers the dossier to evaluation experts or evaluation units. Within 30 days of receiving the dossier from the Department of Traditional Medicine and Pharmacy Management, evaluation experts or units must complete an evaluation report and send it to the Department of Traditional Medicine and Pharmacy Management for aggregating and concluding the evaluation report;

- Within 12 days of receiving the Evaluation Report, the Department of Traditional Medicine and Pharmacy Management provides a written document:

+ Notifying the evaluation results for dossiers requiring modifications or supplements or dossiers failing the requirements and specifying reasons;

+ Granting extensions to the traditional medicine circulation registration certificate for dossiers meeting requirements.

- The time frame and number of times for the registration entity to amend or supplement the dossier are stipulated in Clause 9, Article 1 of Circular 39/2021/TT-BYT.

Refer to the details in Decision 75/QD-BYT effective from January 1, 2025.

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