Circular 55/2024/TT-BYT amend Circular 08/2022/TT-BYT on marketing authorization of drugs

CIRCULAR

Amending and supplementing a number of articles on renewal of marketing authorization of drugs and medicinal ingredients in
the Minister of Health's Circular No. 08/2022/TT-BYT dated September 05, 2022 on marketing authorization of drugs and medicinal ingredients

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

Pursuant to the Law Amending and Supplementing a Number of Articles of the Law on Pharmacy dated November 21, 2024;

Pursuant to the Government’s Decree No. 54/2017/ND-CP dated May 08, 2017 detailing a number of articles of and providing measures for implementing the Law on Pharmacy;

Pursuant to the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018, amending and supplementing a number of regulations on business investment conditions under the state management of the Ministry of Health;

Pursuant to the Government’s Decree No. 88/2023/ND-CP dated December 11, 2023, on mending and supplementing a number of articles of the Government’s Decree No. 54/2017/ND-CP of May 8, 2017, detailing a number of articles of, and providing measures for implementing, the Law on Pharmacy, and the Government’s Decree No. 155/2018/ND-CP of November 12, 2018, amending and supplementing a number of regulations on business investment conditions under the state management of the Ministry of Health;

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

At the proposal of the Director of Drug Administration of Vietnam;

The Minister of Health promulgates the Circular amending and supplementing a number of articles on renewal of marketing authorization of drugs and medicinal ingredients in the Minister of Health's Circular No. 08/2022/TT-BYT dated September 05, 2022 on marketing authorization of drugs and medicinal ingredients.

Article 1. Amending and supplementing a number of articles on renewal of marketing authorization of drugs and medicinal ingredients in the Minister of Health's Circular No. 08/2022/TT-BYT dated September 05, 2022 on marketing authorization of drugs and medicinal ingredients

1. To amend and supplement a number of clauses of Article 8 as follows:

a) To amend and supplement the title of Clause 2 as follows:

“2. The validity duration of a marketing authorization is 3 (three) years from the date of its grant or renewal for the following drugs:”.

b) To add Clause 2a after Clause 2 as follows:

“2a. In case the marketing authorization of a drug or medicinal ingredient has expired, but the Drug Administration of Vietnam has received a dossier of request for renewal of such marketing authorization in accordance with regulations, it shall continue to be used until it is renewed or until the Drug Administration of Vietnam issues a notice on refusal of renewal or on suspension from use of marketing authorization of a drug or medicinal ingredient upon detection of the drug or medicinal ingredient likely to be unsafe to users or doubt about forged legal documents.”.

2. To amend and supplement Clause 3 Article 23 as follows:

“3. Administrative documents included in an application dossier for renewal of marketing authorization of a pharmaceutical, vaccine, biological product, herbal drug or medicinal ingredient consists of:

a) An application for renewal of marketing authorization of drug or medicinal ingredient, made using the Form 5B/TT issued together with this Circular;

b) The Certificate of Pharmaceutical Product (CPP), for an imported drug, which remains valid;

c) A report of the safety and efficacy of the drug during circulation, made using the Form 2D/TT issued together with this Circular.”.

3. To amend and supplement Clause 3 Article 27 as follows:

“3. An application dossier for renewal of marketing authorization of a pharmaceutical, vaccine or biological product must comprise:

Documents defined in Clause 3, Article 23 of this Circular. In case of change in the administrative information pertaining to the drug of which the renewal of the marketing authorization is requested, including the name and address of the registering establishment; the name and address of the manufacturing establishment, the registering establishment shall submit an application dossier for revision of the marketing authorization in accordance with Clause 4 of this Article. In case of change to the drug name, such change may be requested in the application dossier for renewal and must be explicitly stated in the application for renewal of marketing authorization of drug or medicinal ingredient.”.

4. To amend and supplement Clause 2 Article 30 as follows:

“2. An application dossier for renewal of marketing authorization of a herbal drugs must comprise:

Documents defined in Clause 3, Article 23 of this Circular. In case of change in the administrative information pertaining to the drug of which the renewal of the marketing authorization is requested, including the name and address of the registering establishment; the name and address of the manufacturing establishment, the registering establishment shall submit an application dossier for revision of the marketing authorization in accordance with Clause 3 of this Article. In case of change to the drug name, such change may be requested in the application dossier for renewal and must be explicitly stated in the application for renewal of marketing authorization of drug or medicinal ingredient.”.

5. To amend and supplement Clause 2 Article 32 as follows:

“2. An application dossier for renewal of marketing authorization of medicinal ingredient must comprise:

Documents defined in Clause 3, Article 23 of this Circular. In case of change in the administrative information pertaining to the medicinal ingredient of which the renewal of the marketing authorization is requested, including the name and address of the registering establishment; the name and address of the manufacturing establishment, the registering establishment shall submit an application dossier for revision of the marketing authorization in accordance with Clause 3 of this Article. In case of change to the medicinal ingredient’s name, such change may be requested in the application dossier for renewal and must be explicitly stated in the application for renewal of marketing authorization of drug or medicinal ingredient.”.

6. To amend and supplement Article 34 as follows:

“1. The Drug Administration of Vietnam and units decided by the Minister of Health (hereinafter referred to as appraising units) shall appraise application dossiers for grant of marketing authorization of drugs and medicinal ingredients, renewal and revision thereof, except for cases defined at Point d, Clause 2 of this Article.

2. The Drug Administration of Vietnam shall:

a) Grant the marketing authorization, and approve revision of the marketing authorization of drugs or medicinal ingredients, declaration of proprietary drugs, reference biological products, drugs with demonstrated bioequivalence on the basis of the appraisal of dossiers and advisory opinions given by the Committee in each specific case or general guidelines given by the Committee applied to each type of revision, except the cases specified at Point d of this Clause;

b) Renew the marketing authorization of drugs or medicinal ingredients on the basis of the appraisal of dossiers and advisory opinions of the Committee, in the following cases:

- Drugs defined in Clause 2 Article 8 of this Circular;

- Drugs and medicinal ingredients of which a decision on mandatory recall or voluntary recall has been issued due to failure to meet quality standards during the circulation period since the most recent issuance or renewal of the marketing authorization;

- Drugs with serious adverse events during the circulation that are reported in the Form 2D/TT issued together with this Circular;

c) Renew the marketing authorization of drugs or medicinal ingredients without requesting the appraisal of dossier and advisory opinions of the Committee, for the cases other than those defined at Point b of this Clause;

d) Publish on its website the minor variations to the marketing authorization of drugs or medicinal ingredients that only require notification and not require the appraisal of dossier and advisory opinions of the Committee.”.

7. To amend and supplement item 1 Point c Clause 4 Article 35 as follows:

“- Grant, refusal of grant; renewal, refusal of renewal for the cases defined at Point b Clause 2 Article 34 of this Circular, cases with doubt about forged legal documents; approval, non-approval of revision of marketing authorization of drugs or medicinal ingredients;”.

8. To amend and supplement a number of clauses of Article 37 as follows:

a) To amend and supplement the title of Clause 1 as follows:

“1. Within 3 months from the date of receipt of the complete application dossier, the Drug Administration of Vietnam shall renew the marketing authorization of drug or medicinal ingredient for cases defined at Point b, Clause 2, Article 34 of this Circular. In cases where renewal is refused or has not yet been carried out, the Drug Administration of Vietnam shall issue a written reply, clearly stating the reason. Processing deadlines are specified as follows:”.

b) To add Clause 1a after Clause 1 as follows:

“1a. Within 3 months from the date of receipt of the complete application dossier, the Drug Administration of Vietnam shall renew the marketing authorization of drug or medicinal ingredient for cases defined at Point c Clause 2, Article 34 of this Circular. In cases where renewal is refused or has not yet been carried out, the Drug Administration of Vietnam shall issue a written reply, clearly stating the reason. Processing deadlines are specified as follows:

a) Within 7 working days from the date of receipt of the application dossier, the Drug Administration of Vietnam shall review, classify, and forward the dossier to the evaluators or appraising units. Within 01 month from the date of receiving the dossier from the Drug Administration of Vietnam, the evaluators or appraising units must complete the appraisal minutes and send it to the Drug Administration of Vietnam for synthesis and conclusion of the appraisal record in accordance with Clause 4, Article 35 of this Circular;

b) Within 07 working days from the date of receiving the appraisal minutes, the Drug Administration of Vietnam shall issue a written reply, clearly stating the reason if the dossier is unsatisfactory or unqualified;

c) Within 15 days from the date of receiving the appraisal minutes and the appraised dossier meeting the requirements, the Drug Administration of Vietnam shall issue a decision on renewal of the marketing authorization.”.

c) To amend and supplement Clause 2 as follows:

“2. The marketing authorization applicant shall provide additional documents within 12 months from the date on which it receives a request from the Drug Administration of Vietnam.  In the case where the applicant fails to submit the additional documents after this time limit, the submitted application dossier shall be no longer valid.

During the validation of the submitted application dossier, the marketing authorization applicant shall be allowed to send a written notification to the Drug Administration of Vietnam of updated information about safety and efficacy of the drug; legal papers of the applicant, the drug or medicinal ingredient manufacturer; actual circulation of drugs in Vietnam compared with the submitted dossier. The time of handling of the additional dossier include the time the applicant notify the update in writing.

The time limit prescribed at Point c, Clause 6, Article 56 of the Law on Pharmacy, which was amended in Clause 30 Article 1 of the Law on Amending and Supplementing a Number of Articles of the Law on Pharmacy, shall exclude the period from the date on which the Drug Administration of Vietnam issues the written request for additional documents to the date on which the additional documents are submitted.”.

d) To amend and supplement Clause 3 as follows:

“3. Within 03 months from the date of receiving adequate additional documents, the Drug Administration of Vietnam shall issue a decision to renew the marketing authorization of drug or medicinal ingredient if the application dossier is satisfactory; or give a written reply, clearly stating the reason if the application dossier is unsatisfactory or unqualified. Order and time limits for examining additional documents shall comply with Clause 1 and Clause 1a of this Article.”.

9. To add Point o and Point p after Point n Clause 1 Article 48 as follows:

“o) Within 03 working days from the date of receipt of the application dossier for renewal of marketing authorization of drug or medicinal ingredient, the Drug Administration of Vietnam shall publicize the receipt of the application dossier on the Ministry of Health’s portal and the Drug Administration of Vietnam website;

p) Within 3 working days from the date on which the Drug Administration of Vietnam issues a written notice on refusal of renewal or on suspension from use of marketing authorization of drug or medicinal ingredient upon detection of the drug or medicinal ingredient likely to be unsafe to users or doubt about forged legal documents, the Drug Administration of Vietnam shall publicize such information on the Ministry of Health’s portal and the Drug Administration of Vietnam website.”.

10. To amend the Form 5B/TT and to add Form 2D/TT issued together with this Circular.

11. To repeal Point b Clause 2 Article 5.

Article 2. Effect

This Circular takes effect on January 1, 2025.

Article 3. Transitional provisions

Application dossiers for renewal of marketing authorization of drugs or medicinal ingredients submitted prior to the effective date of this Circular but the relevant marketing authorization has not yet been renewed shall be processed as follows:

1. The relevant marketing authorization of drugs or medicinal ingredients shall continue to be used in accordance with Point c, Clause 8, Article 56 of the Law on Pharmacy, which was amended and supplemented by Clause 30, Article 1 of the Law Amending and Supplementing a Number of Articles of the Law on Pharmacy.

2. The appraisal and renewal of the relevant marketing authorization shall continue to be implemented if the regulations of the Minister of Health's Circular No. 08/2022/TT-BYT dated September 05, 2022 on marketing authorization of drugs and medicinal ingredients are satisfied. In cases where the establishments request to handle the dossiers in accordance with this Circular, they must complete their dossiers according to regulations for the consideration for such renewal.

Article 4. Implementation responsibility

Chief of Ministry Office; Director of the Drug Administration of Vietnam; Chief Inspector of Ministry; Heads of units under the Ministry of Health; Directors of Departments of Health of provinces and centrally-run cities; relevant agencies, organizations and individuals shall implement this Circular.

Any problem arising in the course of implementation shall be promptly reported to the Ministry of Health (Drug Administration of Vietnam) for consideration and settlement./.

* All Appendices are not translated herein.