Decision 242/QD-BYT 2025 Plan for implementation of Law 44/2024/QH15 Amending the Law on Pharmacy

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ATTRIBUTE

Decision No. 242/QD-BYT dated January 21, 2025 of the Ministry of Health promulgating the Plan for the implementation of the Law No. 44/2024/QH15 Amending and Supplementing a Number of Articles of the Law on Pharmacy
Issuing body: Ministry of HealthEffective date:
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Official number:242/QD-BYTSigner:Do Xuan Tuyen
Type:DecisionExpiry date:Updating
Issuing date:21/01/2025Effect status:
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Fields:Food and drug , Health
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Effect status: Known

THE MINISTRY OF HEALTH
_______

No. 242/QD-BYT

THE SOCIALIST REPUBLIC OF VIETNAM

Independence - Freedom - Happiness
_______________________

Hanoi, January 21, 2025

DECISION

   Promulgating the Plan for the implementation of the Law No. 44/2024/QH15 Amending and Supplementing a Number of Articles of the Law on Pharmacy

____________

THE MINISTER

Pursuant to the Law No. 44/2024/QH15 Amending and Supplementing a Number of Articles of the Law on Pharmacy;

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

Pursuant to the Prime Minister’s Decision No.1610/QD-TTg of December 19, 2024 promulgating the List and agencies assigned to assume the prime responsibility for drafting subordinate legal documents for the implementation of laws and resolutions adopted by the XVth National Assembly at the 8th session;

At the proposal of the Director General of the Drug Administration of Vietnam and the Director General of the Traditional Medicine Administration,

DECIDES:

Article 1. To promulgate, together with this Decision, the “Plan for the implementation of the Law No. 44/2024/QH15 Amending and Supplementing a Number of Articles of the Law on Pharmacy”.

Article 2. This Decision shall take effect from the date of its signing and promulgation.

Article 3. The Chief of the Ministry Office; the Director General of the Drug Administration of Vietnam; the Chief Inspector of the Ministry of Health; Directors General and Directors of Departments under the Ministry of Health; Heads of units directly under the Ministry of Health; Directors of Departments of Health of provinces and centrally-run cities; and Heads of relevant agencies and units shall implement this Decision./.

 

FOR THE MINISTER
DEPUTY MINISTER


Do Xuan Tuyen

THE MINISTRY OF HEALTH
_______

THE SOCIALIST REPUBLIC OF VIETNAM

Independence - Freedom - Happiness
_______________________

   

PLAN

For the implementation of the Law No. 44/2024/QH15
Amending and Supplementing a Number of Articles of the Law on Pharmacy

(Enclosed with the Minister of Health’s Decision No.242/QD-BYT

of January 21, 2025)

_____________

 

I. PURPOSES AND REQUIREMENTS

1. Purposes

To promptly implement the Law No. 44/2024/QH15 Amending and Supplementing a Number of Articles of the Law on Pharmacy (below referred to as the “Law”) immediately upon its effective date, ensuring enforcement with validity and effectiveness.

2. Requirements

- Dissemination and communication of the Law to pharmaceutical business establishments, practitioners, and the public in order to ensure strict compliance with the provisions of the Law;

- Determination of work contents in association with responsibilities, while promoting the proactive and active role of agencies and organizations assigned under the Law, ensuring both quality and timeliness in the completion of tasks;

- Assurance of regular and effective coordination among relevant agencies and organizations in the implementation and enforcement of the Law.

- Detailed and specific implementation plans are developed by each agency and organization to ensure that the Law is carried out fully, uniformly, and consistently nationwide.

- Regularly and timely inspecting, supervising, and providing guidance to address and resolve obstacles and difficulties arising during the implementation process, thereby ensuring the progress and effectiveness of the enforcement of the Law.

II. DISSEMINATION AND IMPLEMENTATION OF THE LAW

1. Drug Administration of Vietnam:

   To organize the thorough implementation of the Law; to disseminate and communicate the contents of the Law and the subordinate legal documents providing detailed provisions and guidance for the implementation of the Law nationwide.

2. Departments, Administrations under the Ministry of Health, the Ministry Office, the Ministry Inspectorate:

   To organize the thorough implementation of the Law; to disseminate and communicate the contents of the Law and the subordinate legal documents providing detailed provisions and guidance for the enforcement of the Law within the scope of their assigned functions and duties.

3. Departments of Health of provinces and centrally-run cities:

To assume the prime responsibility for and coordinate with relevant agencies and organizations in organizing the thorough implementation of the Law; to disseminate and communicate the contents of the Law and the subordinate legal documents providing detailed provisions and enforcement guidance at the local level.

4. Hospitals, Research institutes and Universities:

To organize the dissemination and communication of the contents of the Law and the subordinate legal documents providing detailed provisions and enforcement guidance to relevant entities and organizations.

III. DRAFTING OF DOCUMENTS DETAILING THE IMPLEMENTATION OF THE LAW

1. Documents detailing the implementation of the Law under the authority of the Government

No

Title of Document

Contents to be guided

Lead agency

Coordinating agencies

Completion time

1

Decree detailing a number of articles and measures for the implementation of the Law on Pharmacy

Clauses and Points in Article 1, including:

- Clause 4;

- Clause 5;

- Clause 9;

- Point a Clause 18;

- Point c Clause 18;

- Point d Clause 32;

- Point dd Clause 32;

- Clause 33;

- Clause 39;

- Clause 43.

Drug Administration of Vietnam

- The Traditional Medicine Administration.

- The Department of Science, Technology and Training.

- The Department of Legal Affairs.

- Relevant Departments and Administrations

April 2025

2. Documents under the authority of the Minister of Health

No

Title of document

Contents to be guided

Lead agency

Coordinating agencies

Completion time

1

Circular amending and supplementing a number of articles on extension of marketing authorization certificates for drugs and medicinal ingredients of the Minister of Health’s Circular No. 08/2022/TT-BYT of September 5, 2022, on marketing authorization of drugs and medicinal ingredients

Clause 30 Article 1

Drug Administration of Vietnam

- The Traditional Medicine Administration.

- The Department of Science, Technology and Training.

- The Department of Legal Affairs.

- Relevant Departments and Administrations

December 2024 (completed)

2

Circular amending and supplementing a number of articles on extension of marketing authorization certificates for traditional medicines, traditional herbal medicines and herbal ingredients of the Minister of Health’s Circular No. 21/2018/TT-BYT of September 12, 2018 prescribing the marketing authorization of traditional medicines and herbal ingredients

Clauses and Points in Article 1, including:

- Point d Clause 1;

- Clause 30.

The Traditional Medicine Administration.

- The Drug Administration of Vietnam.

- The Department of Science, Technology and Training.

- The Department of Legal Affairs.

- Relevant Departments and Administrations

December 2024 (completed)

3

Circular replacing the Minister of Health’s Circular No. 35/2018/TT-BYT of November 22, 2018

prescribing good manufacturing practice for drugs and medicinal ingredients

Point dd Clause 1 Article 1

Drug Administration of Vietnam

- The Traditional Medicine Administration.

- The Department of Science, Technology and Training.

- The Department of Legal Affairs.

- Relevant Departments and Administrations

April 2025

4

Circular amending and supplementing a number of articles of the Minister of Health’s Circular No. 02/2018/TT-BYT of January 22, 2018 prescribing on good pharmacy practices,

the Minister of Health’s Circular No. 03/2018/TT-BYT of February 09, 2018 prescribing good distribution practice for drugs and medicinal ingredients,

the Minister of Health’s Circular No. 36/2018/TT-BYT of November 22, 2018 prescribing good storage practice for drugs and medicinal ingredients

Clauses and Points in Article 1, including:

- Point c Clause 18;

- Clause 36.

Drug Administration of Vietnam

- The Traditional Medicine Administration.

- The Department of Science, Technology and Training.

- The Department of Legal Affairs.

- Relevant Departments and Administrations

April 2025

5

Circular replacing the Minister of Health’s Circular No. 07/2018/TT-BYT of April 12, 2018 detailing a number of articles on pharmaceutical business under the Law on Pharmacy and the Government’s Decree No.54/2017/ND-CP of May 8, 2017  detailing a number of articles and measures for the implementation of the Law on Pharmacy

Clauses and Points in Article 1, including:

- Clause 23;

- Point d Clause 37;

- Clause 38;

Drug Administration of Vietnam

- The Traditional Medicine Administration.

- The Department of Science, Technology and Training.

- The Department of Legal Affairs.

- Relevant Departments and Administrations

April 2025

6

Circular replacing the Minister of Health’s Circular No. 11/2018/TT-BYT of May 4, 2018 prescribing the quality of drugs and medicinal ingredients

Clauses in Article 1, including:

- Clause 35;

- Clause 42.

Drug Administration of Vietnam

- The Traditional Medicine Administration.

- The Department of Science, Technology and Training.

- The Department of Legal Affairs.

- Relevant Departments and Administrations

April 2025

7

Circular replacing the Minister of Health’s Circular No. 08/2022/TT-BYT of September 5, 2022, on marketing authorization of drugs and medicinal ingredients

Clauses and Points in Article 1, including:

- Point d Clause 1;

- Clause 30.

Drug Administration of Vietnam

- The Traditional Medicine Administration.

- The Department of Science, Technology and Training.

- The Department of Legal Affairs.

- Relevant Departments and Administrations

April 2025

8

Circular amending and supplementing a number of articles of the Minister of Health’s Circular No. 27/2021/TT-BYT of December 20, 2021 prescribing the electronic prescription of drugs

Clause 36 Article 1

Department of Medical Service Administration

- The Department of Science, Technology and Training.

- Drug Administration of Vietnam.

- The Traditional Medicine Administration.

- The Department of Legal Affairs.

- Relevant Departments and Administrations

April 2025

9

Circular replacing the Minister of Health’s Circular No. 38/2021/TT-BYT of December 31, 2021 prescribing the quality of herbal ingredients, traditional herbal medicines and traditional medicines.

Clauses and Points in Article 1, including:

- Clause 35;

- Clause 42.

The Traditional Medicine Administration.

- The Drug Administration of Vietnam.

- The Department of Science, Technology and Training.

- The Department of Legal Affairs.

- Relevant Departments and Administrations

April 2025

10

Circular replacing the Minister of Health’s Circular No. 21/2018/TT-BYT of September 12, 2018 prescribing the marketing authorization of traditional medicines and herbal ingredients and the Minister of Health’s Circular No. 39/2021/TT-BYT of December 31, 2021 amending and supplementing a number of Articles of Circular No. 21/2018/TT-BYT of September 12, 2018

Clauses and Points in Article 1, including:

- Point d Clause 1;

- Clause 30.

The Traditional Medicine Administration.

- The Drug Administration of Vietnam.

- The Department of Science, Technology and Training.

- The Department of Legal Affairs.

- Relevant Departments and Administrations

April 2025

IV. ORGANIZATION OF IMPLEMENTATION

1. Departments, Administrations, Directorates, the Ministry Inspectorate, the Ministry Office and units under the Ministry of Health:

- To take initiative and act proactively in implementing this Plan according to the assigned tasks, ensuring adherence to schedule, quality, efficiency, cost-effectiveness and avoidance of formality or wastefulness;

- To promulgate the implementation plan of the Law within their respective agencies and units.

2. Departments of Health of provinces and centrally-run cities:

- To perform the tasks assigned under this Plan;

- To advise the People’s Committees of provinces and centrally-run cities on the promulgation of plans to organize the implementation of the Law in localities;

- To direct, guide, urge and inspect the organization of implementation of the Law by organizations and individuals within their scope of management.

3. Drug Administration of Vietnam:

- To act as the focal point assisting the Ministry of Health in organizing the implementation of the Law and monitoring, urging departments, administrations, units directly under the Ministry, provinces and centrally-run cities’ Departments of Health, as well as relevant organizations and individuals, in organizing the implementation of the tasks specified in this Plan in accordance with the assigned contents and timelines;

- To periodically report to the Ministry of Health on the results of implementation.

4. Funding for implementation:

- The funding for the implementation of this Plan shall be allocated within the annual recurrent expenditure estimates of agencies and units, in accordance with the provisions on decentralization of the current state budget, supplemented by the financial resources of such agencies and units and other lawful funding sources;

- Agencies and units assigned to assume the prime responsibility for carrying out specific contents and tasks under this Plan shall prepare their annual state budget estimates, report to the competent authorities for approval, and mobilize other supporting funding sources as prescribed by laws to organize the implementation;

- The Department of Planning and Finance shall advise, submit to the Ministry of Health for decision, and organize the allocation of funds to effectively implement the assigned tasks of agencies and units under the Ministry of Health./.

 

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