Thông tư 55/2024/TT-BYT sửa đổi gia hạn giấy đăng ký lưu hành thuốc, nguyên liệu làm thuốc tại Thông tư 08/2022/TT-BYT quy định việc đăng ký lưu hành thuốc, nguyên liệu làm thuốc do Bộ trưởng Bộ Y tế ban hành

CIRCULAR

AMENDMENTS TO SOME ARTICLES ON RENEWAL OF MARKETING AUTHORIZATION OF DRUGS AND MEDICINAL MATERIALS OF CIRCULAR NO. 08/2022/TT-BYT DATED SEPTEMBER 05, 2022 OF MINISTER OF HEALTH OF VIETNAM PRESCRIBING MARKETING AUTHORIZATION OF DRUGS AND MEDICINAL 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 Drug Administration of Vietnam;

The Minister of Health of Vietnam promulgates a Circular providing amendments to some articles on renewal of marketing authorization of drugs and medicinal materials of Circular No. 08/2022/TT-BYT dated September 05, 2022 of Minister of Health of Vietnam prescribing marketing authorization of drugs and medicinal materials.

Article 1. Amendments to some articles on renewal of marketing authorization of drugs and medicinal materials of Circular No. 08/2022/TT-BYT dated September 05, 2022 of Minister of Health of Vietnam prescribing marketing authorization of drugs and medicinal materials

1. Some clauses of Article 8 are amended as follows:

a) Heading of Clause 2 is amended as follows:

“2. The validity period of a marketing authorization of the following drugs is 03 (three) years from its issuance or renewal date:”.

b) Clause 2a is added following clause 2 as follows:

“2a. When a marketing authorization of drug or medicinal material expires after the Drug Administration of Vietnam receives an application for renewal thereof, it may be used until it is officially renewed or the Drug Administration of Vietnam issues a notification that the application is rejected or the marketing authorization is suspended in case the drug or medicinal material is found potentially unsafe for users or legal documents are suspected of being forged.”.

2. Clause 3 Article 23 is amended as follows:

“3. Administrative documents of an application for renewal of marketing authorization of chemical medicinal products, vaccines, biologicals, herbal drugs or medicinal materials include:

a) An application form for renewal of marketing authorization of drug or medicinal material which is made using Form 5B/TT enclosed herewith;

b) The unexpired CPP (for imported drug);

c) A report on safety and efficacy of the drug during its marketing which is made using Form 2D/TT enclosed herewith.”.

3. Clause 3 Article 27 is amended as follows:

“3. An application for renewal of a marketing authorization of a chemical medicinal product, vaccine, or biological includes:

The documents specified in Clause 3 Article 23 of this Circular. If there is any change in administrative information about the 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 variations as prescribed in clause 4 of this Article. 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 drug or medicinal material.”.

4. Clause 2 Article 30 is amended as follows:

“2. An application for renewal of a marketing authorization of a herbal drug includes:

The documents specified in Clause 3 Article 23 of this Circular. If there is any change in administrative information about the 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 variations as prescribed in clause 3 of this Article. 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 drug or medicinal material.”.

5. Clause 2 Article 32 is amended as follows:

“2. An application for renewal of a marketing authorization of a medicinal material includes:

The documents specified in Clause 3 Article 23 of this Circular. If there is any change in administrative information about the medicinal 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 variations as prescribed in clause 3 of this Article. If name of the medicinal 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 drug or medicinal material.”.

6. Article 34 is amended as follows:

“1. The Drug Administration of Vietnam and other authorities decided by the Minister of Health of Vietnam (hereinafter referred to as “validating units”) shall organize validation of applications for issuance, renewal and variations to marketing authorization of drugs/medicinal materials, except the cases specified in Point b Clause 2 of this Article.

2. The Drug Administration of Vietnam shall:

a) consider issuing and approving variations to marketing authorization of drugs/medicinal materials, declaration of original brand-name drugs, reference biologicals, and drugs with demonstrated bioequivalence on the basis of application validation and consulting opinions given by the Advisory Board in each specific case or the Advisory Board’s general guidelines for each type of variations, except the case specified in Point d of this Clause;

b) grant approval of renewal of marketing authorization of drugs/medicinal materials on the basis of application validation and consulting opinions given by the Advisory Board in the following cases:

- the drugs specified in Clause 2 Article 8 of this Circular;

- the drugs or medicinal materials subject to decisions on mandatory or voluntary recall due to nonconformance with their specifications during their marketing from the latest issuance or renewal of marketing authorization;

- the drugs involved in serious adverse events which occur during their marketing and are reported using Form 2D/TT enclosed herewith;

c) grant approval of renewal of marketing authorization of drugs/medicinal materials without application validation and consulting opinions given by the Advisory Board in the cases other than those specified in Point b of this Clause;

d) publish on its website the variations to marketing authorization of drugs/medicinal materials without requiring application validation and consulting opinions given by the Advisory Board in respect of the minor variations that only require notification.”.

7. Paragraph 1 Point c Clause 4 Article 35 is amended as follows:

“- Whether to issue or approve renewal of the marketing authorization in the case specified in point b clause 2 Article 34 of this Circular, if legal documents are suspected of being forged; whether to approve variations to the marketing authorization of drugs/medicinal materials;”.

8. Some clauses of Article 37 are amended as follows:

a) Heading of Clause 1 is amended as follows:

“1. Within 03 months from its receipt of an adequate application, the Drug Administration of Vietnam shall consider approving renewal of the marketing authorization of drugs/ medicinal materials in the case specified in point b clause 2 Article 34 of this Circular. If an application is rejected or yet to be approved, the Drug Administration of Vietnam shall give a written response indicating the reasons therefor; processing deadlines are as follows:”.

b) Clause 1a is added following clause 1 as follows:

“1a. Within a maximum duration of 03 months from its receipt of an adequate application, the Drug Administration of Vietnam shall consider approving renewal of the marketing authorization of drugs/ medicinal materials in the case specified in point c clause 2 Article 34 of this Circular. If an application is rejected or yet to be approved, the Drug Administration of Vietnam shall give a written response indicating the reasons therefor; processing deadlines are as follows:

a) Within 07 working days from its receipt of an application, the Drug Administration of Vietnam shall review, classify and transfer it to the validating expert or unit. Within 01 month from its receipt of the application from the Drug Administration of Vietnam, the validating expert or unit shall send a complete validation record to the Drug Administration of Vietnam for consolidating and reaching conclusions as prescribed in clause 4 Article 35 of this Circular;

b) Within 07 working days from its receipt of the validation record, if the application is rejected or yet to be approved, the Drug Administration of Vietnam shall give a written response indicating the reasons therefor;

c) Within 15 days from its receipt of the validation record in which the application is considered satisfactory, the Drug Administration of Vietnam shall issue a decision to renew the marketing authorization.”.

c) Clause 2 is amended as follows:

“2. The applicant is required to provide additional documents within 12 months from the day on which it receives a request from the Drug Administration of Vietnam. Otherwise, its submitted application will be rejected.

During the validation of its submitted application, the applicant shall send written notification to the Drug Administration of Vietnam of updated information about safety and efficacy of the drug, legal documents about the applicant or the manufacturer, or actual marketing of the drug in Vietnam, if different from that provided in the submitted application. The time for consideration of additional documents includes the time spent on notification of updated information by the applicant.

The time limit prescribed in Point c Clause 6 Article 56 of the Law on Pharmacy, as amended in Clause 30 Article 1 of the Law on amendments to the Law on Pharmacy, excludes the period starting from the date on which the Drug Administration of Vietnam sends a request for additional documents to the date on which additional documents are submitted.”.

d) Clause 3 is amended as follows:

“3. Within 03 months from its receipt of adequate additional documents, the Drug Administration of Vietnam shall issue a decision to renew the marketing authorization of drugs/medicinal materials if the application is considered satisfactory; or give a written response and provide explanation if the application is rejected or yet to be approved. Procedures and time limit for consideration of additional documents shall comply with provisions of clauses 1 and 1a of this Article.".

9. Points o and p are added following Point n Clause 1 Article 48 as follows:

“o) Within 03 working days from its receipt of an application for renewal of marketing authorization of drugs/medicinal materials, the Drug 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;

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

10. Form 5B/TT is amended and Form 2D/TT is added in the Appendix enclosed herewith.

11. Point b Clause 2 Article 5 is abrogated.

Article 2. Effect

This Circular comes into force from January 01, 2025.

Article 3. Transition

An application for renewal of marketing authorization of a drug or medicinal 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 drug or medicinal 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. 08/2022/TT-BYT dated September 05, 2022 of the Minister of Health. 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 4. Responsibility for implementation

Chief of the Ministry’s Office, Director of the Drug Administration of Vietnam, the Ministry’s Chief Inspector, heads of departments and affiliates of the Ministry of Health, Directors of Provincial Departments of Health, 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 (via the Drug Administration of Vietnam) for consideration./.

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