Thông tư 54/2024/TT-BYT sửa đổi về gia hạn giấy đăng ký lưu hành thuốc cổ truyền, vị thuốc cổ truyền, dược liệu tại Thông tư 21/2018/TT-BYT quy định việc đăng ký lưu hành thuốc cổ truyền, dược liệu do Bộ trưởng Bộ Y tế ban hành

CIRCULAR

AMENDMENTS TO SOME ARTICLES ON RENEWAL OF MARKETING AUTHORIZATION OF TRADITIONAL DRUGS, TRADITIONAL MEDICINAL MATERIALS AND HERBAL MATERIALS OF CIRCULAR NO. 21/2018/TT-BYT DATED SEPTEMBER 12, 2018 OF MINISTER OF HEALTH OF VIETNAM PRESCRIBING MARKETING AUTHORIZATION OF TRADITIONAL DRUGS AND HERBAL MATERIALS

Pursuant to the Law on Pharmacy dated April 06, 2016;

Pursuant to the Law on amendments to the Law on Pharmacy dated November 21, 2024;

Pursuant to the Government’s Decree No. 54/2017/ND-CP dated May 08, 2017 elaborating and providing guidelines for implementation of the Law on Pharmacy;

Pursuant to the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 providing amendments to some articles related to business conditions under state management of the Ministry of Health of Vietnam;

Pursuant to the Government’s Decree No. 88/2023/ND-CP dated December 11, 2023 providing amendments to the Government’s Decree No. 54/2017/ND-CP dated May 08, 2017 elaborating and providing guidelines for implementation of the Law on Pharmacy and the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 providing amendments to some articles related to business conditions under state management of the Ministry of Health of Vietnam;

Pursuant to the Government’s Decree No. 95/2022/ND-CP dated November 15, 2022 defining functions, tasks, powers and organizational structure of the Ministry of Health of Vietnam;

At the request of the Director of the Traditional Medicine Administration of Vietnam;

The Minister of Health of Vietnam promulgates a Circular providing amendments to some articles on renewal of marketing authorization of traditional drugs, traditional medicinal materials and herbal materials of Circular No. 21/2018/TT-BYT dated September 12, 2018 of Minister of Health of Vietnam prescribing marketing authorization of traditional drugs and herbal materials.

Article 1. Amendments to some articles on renewal of marketing authorization of traditional drugs, traditional medicinal materials and herbal materials of Circular No. 21/2018/TT-BYT dated September 12, 2018 of Minister of Health of Vietnam prescribing marketing authorization of traditional drugs and herbal materials

1. Article 18 is amended as follows:

“Article 18. Application for renewal of marketing authorization of traditional drugs

An application for renewal of marketing authorization of a traditional drug includes:

1. An application form which is made using Form No. 04A enclosed herewith. If there is any change in administrative information about the traditional drug of which an application for renewal of marketing authorization is submitted, including name or address of the applicant or of the manufacturer, the applicant shall submit an application for approval of variations as prescribed in Article 19 of this Circular. If name of the drug is changed, the applicant may apply for approval of such change in its application for renewal and must clearly specify such change in the application form for renewal of marketing authorization of the traditional drug.

2. The unexpired CPP (for imported traditional drug).

3. A report on safety and efficacy of the traditional drug during its marketing which is made using Form No. 08C enclosed herewith.”.

2. Article 21 is amended as follows:

“Article 21. Procedures for renewal of marketing authorization of traditional drugs

1. Within 12 months before the marketing authorization expires, the applicant shall submit 01 package of application documents for renewal of marketing authorization of the traditional drug (renewal application) as prescribed in Article 18 hereof to the Traditional Medicine Administration of Vietnam affiliated to the Ministry of Health of Vietnam directly, by post or online via the online public service system of the Ministry of Health of Vietnam. Over the above-mentioned time limit, if the applicant fails to submit a renewal application, it shall be required to follow procedures for issuance of a new marketing authorization as prescribed in Article 20 hereof.

2. Upon its receipt of a renewal application containing adequate documents as required, the Traditional Medicine Administration of Vietnam shall give a receipt note which is made using Form No. 02A enclosed herewith. If the application is inadequate, the Traditional Medicine Administration of Vietnam shall request the applicant in writing or directly (in case of direct submission of the renewal application) to submit additional documents as prescribed.

3. Where the marketing authorization of a traditional drug expires after the Traditional Medicine Administration of Vietnam receives an application for renewal thereof, it may be used until it is officially renewed or the Traditional Medicine Administration of Vietnam issues a notification that the application is rejected or the marketing authorization is suspended in case the traditional drug is found potentially unsafe for users or legal documents are suspected of being forged.

4. Approval of renewal of marketing authorization of traditional drugs on the basis of application validation and consulting opinions given by the Advisory Board may be granted in the following cases:

a) The traditional drugs specified in Clauses 1, 2 Article 12 hereof;

b) The traditional drug involved in a first- or second-degree quality-related violation as prescribed in the Circular No. 38/2021/TT-BYT dated December 31, 2021 of the Minister of Health prescribing quality of herbal materials, traditional medicinal materials and traditional drugs;

c) The traditional drug involved in serious adverse events which occur during their marketing and are reported using Form No. 08C enclosed herewith.

5. Within a maximum duration of 03 months from its receipt of adequate application, the Traditional Medicine Administration of Vietnam receiving the application shall give a written response indicating its approval or refusal to give approval of renewal of the marketing authorization of the traditional drug in the cases specified in clause 4 of this Article or in case legal documents of the traditional drug are suspected of being forged. To be specific:

a) Within 07 working days from its receipt of an adequate application, the Traditional Medicine Administration of Vietnam shall review, classify and transfer it to the validating expert or unit. Within 30 days from its receipt of the application from the Traditional Medicine Administration of Vietnam, the validating expert or unit shall send a complete validation record to the Traditional Medicine Administration of Vietnam for consolidating and reaching conclusions;

b) Within 12 days from its receipt of the validation record, the Traditional Medicine Administration of Vietnam shall:

- give a written notice of validation results of the application which needs to be modified or is unsatisfactory, in which reasons therefor must be indicated;

- transfer the application which is considered satisfactory or requires opinions to the Office of the Advisory Board in charge of issuance of marketing authorization of drugs and medicinal materials (hereinafter referred to as “Advisory Board”) for holding a meeting to consider the application;

c) Within 06 working days from its receipt of the documents from the Traditional Medicine Administration of Vietnam, the Office of the Advisory Board shall hold a meeting to consider the application and send its meeting minutes to the Traditional Medicine Administration of Vietnam;

d) Within 18 days from its receipt of the meeting minutes from the Advisory Board, the Traditional Medicine Administration of Vietnam shall give a written approval of renewal of the marketing authorization of the traditional drug or request modification of the application or refuse to give approval at the request of the Advisory Board;

dd) Number of modifications that the applicant may make to its application and the time limit for making such modifications shall be subject to provisions of clause Article 9 Article 4 hereof.

6. Approval of renewal of marketing authorization of traditional drugs is granted without application validation and consulting opinions given by the Advisory Board in the cases other than those specified in Clause 5 of this Article.

Within 03 months from its receipt of adequate application, the Traditional Medicine Administration of Vietnam receiving the application shall give a written response indicating its approval or refusal to give approval of renewal of the marketing authorization of the traditional drug. To be specific:

a) Within 07 working days from its receipt of an adequate application, the Traditional Medicine Administration of Vietnam shall transfer the received application to the validating expert or unit. Within 30 days from its receipt of the application from the Traditional Medicine Administration of Vietnam, the validating expert or unit shall send a complete validation record to the Traditional Medicine Administration of Vietnam for consolidating and reaching conclusions;

b) Within 12 days from its receipt of the validation record, the Traditional Medicine Administration of Vietnam shall:

- give a written notice of validation results of the application which needs to be modified or is unsatisfactory, in which reasons therefor must be indicated;

- grant approval of renewal of the marketing authorization of the traditional drug if the application is satisfactory.

c) Number of modifications that the applicant may make to its application and the time limit for making such modifications shall be subject to provisions of clause Article9 Article 4 hereof.”.

3. Article 27 is amended as follows:

“Article 27. Application for renewal of marketing authorization of traditional medicinal materials and herbal materials

An application form for renewal of marketing authorization of a traditional medicinal material which is made using Form No. 04B or application form for renewal of marketing authorization of a herbal material which is made using Form No. 04C enclosed herewith. If there is any change in administrative information about the traditional medicinal material or herbal material of which an application for renewal of marketing authorization is submitted, including name or address of the applicant or of the manufacturer, the applicant shall submit an application for approval of variations as prescribed in Article 28 of this Circular. If name of the traditional medicinal material or herbal material is changed, the applicant may apply for approval of such change in its application for renewal and must clearly specify such change in the application form for renewal of marketing authorization of the traditional medicinal material or herbal material.”.

4. Article 30 is amended as follows:

“Article 30. Procedures for renewal of marketing authorization of traditional medicinal materials and herbal materials

1. Within 12 months before the marketing authorization expires, the applicant shall submit 01 package of application documents for renewal of marketing authorization of the traditional medicinal material or herbal material (renewal application) as prescribed in Article 27 hereof to the Traditional Medicine Administration of Vietnam affiliated to the Ministry of Health of Vietnam directly or online via the online public service system. Over the above-mentioned time limit, if the applicant fails to submit a renewal application, it shall be required to follow procedures for issuance of a new marketing authorization as prescribed in Article 29 hereof.

2. Upon its receipt of a renewal application containing adequate documents as required, the Traditional Medicine Administration of Vietnam shall give a receipt note which is made using Form No. 02A enclosed herewith. If the application is inadequate, the Traditional Medicine Administration of Vietnam shall request the applicant in writing or directly (in case of direct submission of the renewal application) to submit additional documents as prescribed.

3. Where the marketing authorization of a traditional medicinal material or herbal material expires after the Traditional Medicine Administration of Vietnam receives an application for renewal thereof, it may be used until it is officially renewed or the Traditional Medicine Administration of Vietnam issues a notification that the application is rejected or the marketing authorization is suspended in case the traditional medicinal material or herbal material is found potentially unsafe for users or legal documents are suspected of being forged.

4. Approval of renewal of the marketing authorization of traditional medicinal material or herbal material shall be granted on the basis of the application validation and consulting opinions given by the Advisory Board in case the traditional medicinal material or herbal material is involved in the first-degree quality-related violation as prescribed in the Circular No. 38/2021/TT-BYT dated December 31, 2021 of the Minister of Health prescribing quality of herbal materials, traditional medicinal materials and traditional drugs.

5. Within a maximum duration of 03 months from its receipt of an adequate application, the Traditional Medicine Administration of Vietnam shall give a written response indicating its approval or refusal to give approval of renewal of the marketing authorization of the traditional drug in the cases specified in clause 4 of this Article or in case the legal documents of the traditional medicinal material or herbal material are suspected of being forged. Procedures for renewal of marketing authorization of traditional medicinal materials and herbal materials shall be subject to clause 5 Article 21 hereof.

6. Approval of renewal of marketing authorization of traditional medicinal materials and herbal materials is granted without application validation and consulting opinions given by the Advisory Board in the cases other than those specified in Clause 4 of this Article.

Within 03 months from its receipt of an adequate application, the Traditional Medicine Administration of Vietnam shall give a written response indicating its approval or refusal to give approval of renewal of the marketing authorization of the traditional medicinal material or herbal material. Procedures for renewal of marketing authorization of traditional medicinal materials and herbal materials shall be subject to clause 6 Article 21 hereof.”.

5. Points c, d are added to Clause 1 Article 41 as follows:

“c) Within 03 working days from its receipt of an application for renewal of marketing authorization, the Traditional Medicine Administration of Vietnam shall publish information on the received application on the web portal of the Ministry of Health of Vietnam and on its website;

d) Within 03 working days from the date on which the Traditional Medicine Administration of Vietnam gives a notification that the application for renewal is rejected or the marketing authorization is suspended in case the traditional drug, traditional medicinal material or herbal material is found potentially unsafe for users or legal documents are suspected of being forged, the Traditional Medicine Administration of Vietnam shall publish information thereon on the web portal of the Ministry of Health of Vietnam and on its website.”.

6. Clause 4 is added to Article 41 as follows:

“The National Centre of Drug Information and Adverse Drug Reactions Monitoring (National DI & ADR Centre) shall submit consolidated reports to the Traditional Medicine Administration of Vietnam on the periodical basis of every 06 months.”.

Article 2. Effect

1. This Circular comes into force from January 01, 2025.

2. Clause 20 and clause 27 Article 1 of the Circular No. 39/2021/TT-BYT dated December 31, 2021 of the Minister of Health of Vietnam providing amendments to the Circular No. 21/2018/TT-BYT dated September 12, 2018 of Minister of Health of Vietnam prescribing marketing authorization of traditional drugs and herbal materials cease to have effect from the effective date of this Circular.

Article 3. Terms of reference

If legislative documents referred to herein are superseded or amended, the new ones shall prevail.

Article 4. Transition

An application for renewal of marketing authorization of a traditional drug, traditional medicinal material or herbal material which has been submitted before the effective date of this Circular but is yet to be processed shall be subject to the following provisions:

1. The current marketing authorization of the traditional drug, traditional medicinal material or herbal material may still be used according to point c clause 8 Article 56 of the Law on Pharmacy, as amended in clause 30 Article 1 of the Law on amendments to the Law on Pharmacy.

2. The validation of the application and grant of renewal of the marketing authorization shall comply with provisions of the Circular No. 21/2018/TT-BYT dated September 12, 2018 of Minister of Health of Vietnam prescribing marketing authorization of traditional drugs and herbal materials and the Circular No. 39/2021/TT-BYT dated December 31, 2021 of the Minister of Health of Vietnam providing amendments to the Circular No. 21/2018/TT-BYT dated September 12, 2018 of Minister of Health of Vietnam prescribing marketing authorization of traditional drugs and herbal materials. If the applicant requests processing of its application according to provisions of this Circular, it shall submit a complete application as prescribed for consideration and grant of marketing authorization.

Article 5. Responsibility for implementation

Chief of the Ministry’s Office, Director of the Traditional Medicine Administration of Vietnam, the Ministry’s Chief Inspector, heads of departments and affiliates of the Ministry of Health, Directors of Provincial Departments of Health, pharmacy business establishments, and relevant authorities, organizations and individuals are responsible for the implementation of this Circular.

Difficulties that arise during the implementation of this Circular should be promptly reported to the Ministry of Health of Vietnam (via the Traditional Medicine Administration of Vietnam) for consideration./.

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