Joint Circular No. 11/2008/TTLT-BYT-BKHCN guiding the development, examination, publication of the National Standard on Drugs and issuance, publication of the Vietnamese Pharmacopoeia

JOINT CIRCULAR

Guidelines for developing, reviewing, publishing National Standards on Medicines and Issuing, Publishing the Vietnamese Pharmacopoeia

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Pursuant to Decree No. 188/2007/NĐ-CP dated December 27, 2007 of the Government on the functions, tasks, powers, and organizational structure of the Ministry of Health;

Pursuant to Decree No. 28/2008/NĐ-CP dated March 14, 2008 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Science and Technology;

Pursuant to the Medicine Law dated June 14, 2005;

Pursuant to the Law on Standards and Technical Regulations dated June 29, 2006;

Pursuant to Decree No. 79/2006/NĐ-CP dated August 9, 2006 of the Government detailing implementation of certain provisions of the Medicine Law;

Pursuant to Decree No. 127/2007/NĐ-CP dated August 1, 2007 of the Government detailing implementation of certain provisions of the Law on Standards and Technical Regulations;

To ensure that the development of national standards on medicines complies with the provisions of the Medicine Law, the Law on Standards and Technical Regulations, and related documents, aligns with international practices, and meets the specific requirements of national standards on medicines, and to meet the demands of international integration in the pharmaceutical sector, the Ministry of Health and the Ministry of Science and Technology issue guidelines for developing, reviewing, publishing national standards on medicines and issuing, publishing the Vietnamese Pharmacopoeia.

This technical regulation sets out technical requirements, testing methods, sampling procedures; management requirements; responsibilities of organizations and individuals producing, trading, and importing cigarettes.

Thông tư này quy định chi tiết khoản 4 Điều 38 Luật Thủy sản số 18/2017/QH14 đã được sửa đổi, bổ sung tại điểm c khoản 21 Điều 14 Luật số 146/2025/QH15.

These Circulars guide the planning, drafting, development, review, publication of national standards on medicines and the issuance, publication of the Vietnamese Pharmacopoeia.

Thông tư này áp dụng đối với tổ chức, cá nhân có liên quan đến hoạt động kinh doanh đối tượng thủy sản nuôi chủ lực trên lãnh thổ Việt Nam.

These Circulars apply to agencies and organizations involved in the planning, drafting, development, review, publication of national standards on medicines and the issuance, publication of the Vietnamese Pharmacopoeia.

In this technical regulation, the following terms are understood as follows:

3.1. National standard on medicines is a quality standard for medicines, including specifications, technical requirements, testing methods, packaging, labeling, transportation, storage, and other relevant requirements concerning the quality of medicines.

3.2. National standards set on medicines is a collection of national standards on medicines reviewed and published by the Ministry of Science and Technology.

3.3. Vietnamese Pharmacopoeia is a technical document setting quality standards for medicines issued by the Ministry of Health based on the national standards on medicines.

4. Responsibilities of the Ministry of Health

The Ministry of Health is responsible for leading and coordinating with the Ministry of Science and Technology to draft plans for the development of national standards on medicines; organizing the drafting of the draft national standards on medicines; issuing and publishing the Vietnamese Pharmacopoeia; promoting and disseminating the application of the Vietnamese Pharmacopoeia and national standards on medicines.

The Ministry of Health is responsible for the content, scientific nature, and suitability of the national standards on medicines and the Vietnamese Pharmacopoeia.

5. Responsibilities of the Ministry of Science and Technology

The Ministry of Science and Technology is responsible for coordinating with the Ministry of Health to draft plans for the development of national standards on medicines; leading the organization of reviews and publication of national standards on medicines.

II. PROCEDURES FOR DEVELOPING NATIONAL STANDARDS ON MEDICINES

1. Drafting and Approving Planning for Developing National Standards on Medicines

Based on the strategy, planning for the development of the pharmaceutical industry, advancements in science and technology, actual needs in state management of medicine quality, practical needs in the production and business of medicines, harmonization with international standards in the field of medicine quality, and improving the quality of medicines produced and circulated in Vietnam:

1.1. The Ministry of Health is responsible for organizing the drafting of preliminary plans for five-year and annual planning for developing national standards on medicines, widely soliciting opinions from organizations and individuals active in the pharmaceutical sector; compiling and sending these plans to the Ministry of Science and Technology for inclusion in overall planning and five-year and annual plans according to Circular No. 21/2007/TT-BKHCN dated September 28, 2007 of the Ministry of Science and Technology guiding the development and application of standards (hereinafter referred to as Circular No. 21/2007/TT-BKHCN), and organizing their examination and approval.

1.2. Adjustments and supplements to the content of five-year and annual plans for developing national standards on medicines shall be carried out in accordance with relevant regulations stipulated in Circular No. 21/2007/TT-BKHCN.

2. Procedures for Developing, Reviewing, and Publishing National Standards on Medicines

2.1. The Ministry of Health establishes the Vietnamese Pharmacopoeia Council and technical standard committees under the Vietnamese Pharmacopoeia Council to study and develop drafts of national standards on medicines.

2.2. The development of draft national standards on medicines follows the procedures and formalities prescribed in Point 3.1 Clause 3 of Circular No. 21/2007/TT-BKHCN, taking into account the characteristics of national standards on medicines and international practices, specifically as follows:

Step 1: Drafting the national standards on medicines.

- According to the approved plan, the Ministry of Health assigns the Vietnamese Pharmacopoeia Council to organize the development of the draft national standards on medicines.

- The Vietnamese Pharmacopoeia Council organizes the development of the draft national standards on medicines through the technical standard committees. The procedures for drafting and technical verification are carried out according to the regulations of the Vietnamese Pharmacopoeia Council.

Step 2: Soliciting Opinions and Finalizing the Draft National Standards on Medicines

- Department of Drug Management - Ministry of Health:

+ Cooperates with the Vietnamese Pharmacopoeia Council to send the draft national standards on medicines to solicit opinions from relevant agencies, organizations, and experts; announces the solicitation of opinions on the website of the Ministry of Health and the Department of Drug Management. The period for soliciting opinions on the draft must be at least 60 days from the date of sending the draft.

+ Organizes specialized conferences with the participation of relevant parties to discuss and provide feedback on the draft.

- The Vietnamese Pharmacopoeia Council collaborates with the Department of Drug Management to compile and process feedback to finalize the draft national standards on medicines, prepare the draft national standards on medicines dossier according to Clause 1 Article 5 of Decree No. 127/2007/NĐ-CP dated August 1, 2007 of the Government detailing implementation of certain provisions of the Law on Standards and Technical Regulations.

- The Drug Administration Department (in coordination with relevant Departments and Bureaus and experts from the Ministry of Health) organizes the review of the draft National Standard for Medicines to ensure its alignment with scientific and technological progress, technical regulations, legal provisions, international commitments, harmonization with international standards, consistency within the national standard system for medicines, and compliance with professional requirements and procedures for developing national standards for medicines.

- The Drug Administration Department completes the National Standard for Medicines along with the review conclusion and related documents and transfers them to the General Bureau of Standards, Metrology and Quality Control under the Ministry of Science and Technology for examination.

Step 3: Examine the draft National Standard for Medicines.

- The General Bureau of Standards, Metrology and Quality Control establishes and organizes the Examination Committee for the draft National Standard for Medicines based on reviewing the examination conclusions of the Ministry of Health.

- The Examination Committee prepares the examination record with conclusions and recommendations regarding the draft National Standard for Medicines and transfers it back to the General Bureau of Standards, Metrology and Quality Control for consideration and decision-making.

Step 4: Publish the National Standard for Medicines.

The General Bureau of Standards, Metrology and Quality Control organizes the review of the examination results and prepares the draft National Standard for Medicines for approval by the Ministry of Science and Technology.

- In cases where the draft National Standard for Medicines meets the requirements according to the examination content, the General Bureau of Standards, Metrology and Quality Control submits to the Ministry of Science and Technology for issuance of a decision to publish.

- In cases where the draft National Standard for Medicines does not meet the requirements, the General Bureau of Standards, Metrology and Quality Control transfers the draft National Standard for Medicines to the Drug Administration Department for handling and completion.

3. Symbols, Presentation, and Content Expression of the National Standard for Medicines

3.1. Provisions on Symbols:

The standard symbol only applies to the National Standard for Medicines. The symbol of the National Standard for Medicines includes the number, year of publication following the abbreviation TCVN, separated by a colon (:). The number of the standard is represented by Roman numerals. Example: TCVN IV: 2008

3.2. Provisions on Presentation and Content Expression of the National Standard for Medicines:

- The expression of content and structure of the National Standard for Medicines shall be in accordance with the regulations of the Ministry of Health and consistent with international practices.

- Font, font size, spacing in presenting the National Standard for Medicines shall comply with the provisions of TCVN 1-2.

3.3. Drafts of the National Standard for Medicines are stored at the General Bureau of Standards, Metrology and Quality Control in accordance with current regulations on document storage.

4. Periodic Review, Amendment, Supplement, Replacement, and Revocation of the National Standard for Medicines

The periodic review, amendment, supplement, replacement, and revocation of the National Standard for Medicines are carried out in accordance with procedures and formalities stipulated in Clause 5 Part II Circular No. 21/2007/TT-BKHCN, taking into account the specific characteristics of the National Standard for Medicines and international practices, specifically as follows:

4.1. Periodic Review of the National Standard for Medicines:

4.1.1. The Pharmacopoeia Council compiles a list of National Standards for Medicines that need to be periodically reviewed within three years and submits it to the Ministry of Health for inclusion in the annual plan for developing National Standards for Medicines.

4.1.2. The Pharmacopoeia Council takes the lead in organizing the periodic review of the National Standards for Medicines according to the compiled list. The review is conducted in accordance with the operational guidelines of the General Bureau of Standards, Metrology and Quality Control.

4.1.3. The results of the periodic review, along with explanatory notes, are sent to the Ministry of Health (Drug Administration Department) for consolidation and processing, specifically as follows:

- Checking and evaluating the review results, compiling them into an overall review result, and sending them out for comments from relevant organizations and individuals;

- Compiling, processing comments, preparing a review result file as the basis for developing the annual plan for developing the National Standard for Medicines and reporting to the Ministry of Health.

4.2. Amendment and Supplement of the National Standard for Medicines.

4.2.1. The amendment and supplement of the National Standard for Medicines must be included in the annual plan for developing national standards as stipulated in Point 1.2 Clause 1 Section of this Article.

4.2.2. The amendment and supplement of the National Standard for Medicines are carried out in accordance with the procedures and formalities specified in Point 2.2 Clause 2 Section of this Article.

4.2.3. The result of amending and supplementing the National Standard for Medicines is the decision to publish the amended and supplemented National Standard for Medicines issued by the Ministry of Science and Technology.

4.3. Revocation of the National Standard for Medicines.

4.3.1. The revocation of the National Standard for Medicines is based on the results of the periodic review of the National Standard or upon the request for revocation from organizations and individuals, carried out as follows:

- The Pharmacopoeia Council compiles and sends the request for revocation of the National Standard for Medicines to the Drug Administration Department of the Ministry of Health for consideration and organization of examination. The request for revocation of the National Standard for Medicines includes:

+ The standard to be revoked;

+ The request document from the Pharmacopoeia Council;

+ An explanatory note (reasons, legal basis, scientific basis);

+ Opinions of relevant agencies, organizations, and individuals;

+ Other related documents (if any);

- The Drug Administration Department leads and coordinates with the General Bureau of Standards, Metrology and Quality Control to organize the examination of the request for revocation of the National Standard for Medicines. Based on the examination results and the request for revocation, the General Bureau of Standards, Metrology and Quality Control submits to the Minister of Science and Technology for publication of the revocation of the National Standard for Medicines.

4.4. The General Bureau of Standards, Metrology and Quality Control announces the publication of amendments, supplements, or revocations of the National Standard for Medicines.

III. ISSUANCE, AMENDMENT, SUPPLEMENTATION AND PUBLICATION AND DISSEMINATION OF THE VIETNAMESE PHARMACOPOEIA

1. Issuance of the Vietnamese Pharmacopoeia

The Drug Administration Department submits to the Minister of Health for issuance of a decision to issue the Vietnamese Pharmacopoeia including the National Standard for Medicines approved by the Ministry of Science and Technology.

2. Symbols, Presentation and Content Expression of the Vietnamese Pharmacopoeia

2.1. Provisions on Symbols:

The Vietnamese Pharmacopoeia is promulgated according to its edition number and year of publication (DĐVN X:Y, where X represents the edition number and Y represents the year of publication; for example, DĐVN IV:2009 means the fourth edition of the Vietnamese Pharmacopoeia published in 2009).

2.2. Provisions on the Presentation and Content of the Vietnamese Pharmacopoeia:

Font type, font size, spacing shall comply with the national standard for pharmaceuticals as stipulated in TCVN 1-2.

2.3. Structure and Content Presentation of the Vietnamese Pharmacopoeia:

The structure and content of the Vietnamese Pharmacopoeia are consistent with international practices and are presented as follows:

2.3.1. Cover Page: Vietnamese Pharmacopoeia; Edition Number ...; Year ... and bears the National Emblem.

2.3.2. Structure and Content Consist of Four Parts as Follows:

Part I: General Section

- Decision on the Publication of the National Standard for Pharmaceuticals by the Minister of Science and Technology;

- Decision on the Publication of the Vietnamese Pharmacopoeia by the Minister of Health;

- Introduction to the Content of the Vietnamese Pharmacopoeia;

- Preface;

- Introduction to the History and List of the Vietnamese Pharmacopoeia Council;

- General Provisions of the Vietnamese Pharmacopoeia.

Part II: National Standards for Pharmaceuticals: Individual Monographs for Each Drug.

National standards for pharmaceuticals are presented in the following order:

- Raw materials and finished products of modern drugs;

- Herbal medicines and finished products of traditional drugs;

- Vaccines and medical biological products;

Part III: Appendices: National Standards for Pharmaceuticals (General Quality Specifications and Common Testing Methods – Appendices).

Part IV: Indexes for Reference.

2.4. Drafting files of the National Standards for Pharmaceuticals and the Vietnamese Pharmacopoeia are kept at the Office of the Vietnamese Pharmacopoeia Council in accordance with current regulations on document storage.

3. Amending, Supplementing, Replacing, and Abolishing the Vietnamese Pharmacopoeia.

3.1. The Drug Administration of Vietnam submits to the Minister of Health for issuance of decisions on amending, supplementing, and abolishing monographs in the Vietnamese Pharmacopoeia based on decisions to amend, supplement, or abolish the National Standards for Pharmaceuticals by the Ministry of Science and Technology.

3.2. Drafting files for periodic reviews, amendments, supplements, and abolitions of the National Standards are stored at the Vietnamese Pharmacopoeia Council in accordance with current regulations on document storage.

4. Announcing, Publishing, and Disseminating the Vietnamese Pharmacopoeia

4.1. The Ministry of Health announces on its website about the national drug standards that have been issued, amended, supplemented, or abolished, and publishes them in the Ministry's journal and the Drug Administration's journal within thirty days from the date the Ministry of Science and Technology announces the amendment, supplementation, or abolition of the national pharmaceutical standards.

4.2. The Ministry of Health assigns the Vietnamese Pharmacopoeia Council to be responsible for organizing the publication and distribution of the Vietnamese Pharmacopoeia in paper and electronic formats.

4.3. The Drug Administration of Vietnam collaborates with the Vietnamese Pharmacopoeia Council to organize the dissemination of the Vietnamese Pharmacopoeia.

4.4. The dissemination of the Vietnamese Pharmacopoeia is carried out through forms such as conferences, seminars, training, and other forms as prescribed by the Ministry of Health’s program on legal education and dissemination.

IV. IMPLEMENTATION

1. The Ministry of Health assigns the Drug Administration of Vietnam as the lead agency to organize the implementation of this Circular.

2. The Ministry of Science and Technology assigns the General Department of Standardization, Metrology, and Quality Control as the lead agency to organize the implementation of this Circular.

3. Annually in December, the leaders of the two Ministries conduct an evaluation of the results of cooperation between the two Ministries and direct cooperative work for the following year.

4. This Circular takes effect fifteen days after its publication in the Official Gazette.

5. During the implementation of this Circular, if there are difficulties or obstacles, units and localities are requested to report to the Ministry of Health (Drug Administration) or the Ministry of Science and Technology (General Department of Standardization, Metrology, and Quality Control) for prompt coordination and resolution by the inter-ministerial team./.