DECISION OF THE MINISTER OF HEALTH

Regarding the issuance of the Regulation on the construction, issuance, and organization of implementation of legal normative documents in the field of health

 and organization of implementation

 

THE MINISTER OF HEALTH

Pursuant to Decree No. 49/2003/ND-CP dated 15/5/2003 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

Pursuant to the Law on Legal Normative Documents dated November 12, 1996, and the Law Amending and Supplementing Certain Articles of the Law on Legal Normative Documents dated December 16, 2002;

Pursuant to Decree No. 101/CP dated 23/9/1997 of the Government detailing the implementation of certain articles of the Law on Legal Normative Documents;

At the proposal of the Director of the Department of Legal Affairs - Ministry of Health,

 

DECISION:

Article 1. Issued together with this Decision "Regulation on the Construction, Issuance, and Organization of Implementation of Legal Normative Documents in the Field of Health"

Article 2. This Decision shall take effect fifteen days from the date of publication in the Official Gazette

Article 3. The Heads of the Office, Inspectorate, Department of Legal Affairs, Departments, and Bureaus under the Ministry of Health are responsible for implementing this Decision./.

 

REGULATIONS

Construction, issuance, and organization of implementation of legal normative documents in the field of health

(Issued together with Decision No. 4278/2004/QD-BYT dated December 1, 2004 of the Minister of Health)

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation and Applicability

Article 1. This Regulation governs the following matters:

a) Formulating programs for the construction and issuance of legal normative documents in the field of health;

b) Drafting legal normative documents in the field of health;

c) Reviewing, submitting, and issuing legal normative documents in the field of health;

d) Organizing the implementation and evaluation of the enforcement of legal normative documents in the field of health after their issuance;

e) Participating in providing opinions on draft legal normative documents requested by the National Assembly, Standing Committee of the National Assembly, Government, Prime Minister, or other Ministries and sectors;

f) Budget for the construction, organization of implementation, and evaluation of the enforcement of legal normative documents in the field of health.

Article 2. Scope of Application The construction and issuance of legal normative documents in the field of health include:.

1. Drafting for the Minister to submit to competent authorities (National Assembly, Standing Committee of the National Assembly, Government, Prime Minister) for approval

projects of laws, ordinances, resolutions, decrees, decisions, directives

concerning the field of health that have been delegated or assigned by the Government or Prime Minister to the Ministry of Health as the main drafting entity. 2. Drafting for submission to the Minister for approval: Decisions

of the Minister of Health regarding the organization and operation of units under its management; regulations on working conditions,

a) policies for health sector officials and civil servants; standards, technical procedures; measures to implement state management functions in the field of health and other issues entrusted by the Government. Directives

of the Minister of Health regarding measures to guide, urge, inspect, and organize the implementation of tasks related to the care and protection of public health and the enforcement of legal normative documents issued by higher-level state agencies and the health sector.

b) Circulars of the Minister of Health issued to guide the implementation of provisions in Laws, Resolutions of the National Assembly, Ordinances, Resolutions of the Standing Committee of the National Assembly; Orders, Decisions of the President, Resolutions, Decrees of the Government, Decisions, Directives of the Prime Minister, and other issues related to the field of health or within the management functions of the health sector.

c) Joint Resolutions, Circulars between the Ministry of Health and relevant Ministries, sectors, or political-social organizations to guide the implementation of provisions in Laws, Resolutions of the National Assembly, Ordinances, Resolutions of the Standing Committee of the National Assembly; Orders, Decisions of the President, Resolutions, Decrees of the Government, Decisions, Directives of the Prime Minister, and other issues related to the field of health within the inter-sectoral management functions.

d) Individual documents issued by the leadership of the Ministry such as salary increase decisions, commendations, disciplinary actions, appointments, transfers; decisions recognizing inspection and audit results, project approval decisions, directives to launch campaigns, commendations for good deeds, other individual documents, and common administrative documents that are not legal normative documents

3. are not within the scope of application of this Regulation. shall be issued by the Ministry's leadership as decisions on salary increases, awards, disciplinary actions, appointments of officials, transfers of duties; decisions recognizing inspection and audit results, approving projects, directives to launch competitions, commending good people and deeds, individual documents that are not legislative instruments, and other routine administrative documents; are not within the scope of application of this Regulation;.

Article 3. Conditions for legal normative documents on health

1. The legal normative documents prescribed in Clause 1 and 2, Article 2 of this Regulation must meet the following conditions:

a) Have a name form as provided for in Article 1 of the Law amending and supplementing certain Articles of the Law on promulgating legal normative documents;

b) Be issued in accordance with the procedures and authority as prescribed by law;

c) Contain general rules of conduct applicable repeatedly to all subjects or a group of subjects, effective throughout the country or in specific localities;

d) Be ensured by the State for implementation through measures such as propaganda, dissemination, education, persuasion, organizational, administrative, and economic measures; in cases of necessity, the State shall apply coercive enforcement measures and stipulate sanctions against violators.

2. It is not allowed to issue circulars, telegrams, or other administrative documents containing mandatory legal norms.

Article 4. Requirements for legal normative documents on health.

1. Ensure constitutionality, legality; consistency, synchronization; stability, appropriateness, and feasibility.

2. Ensure the format and technical presentation of legal normative documents: Title (national emblem, slogan); issuing agency's name; number, code (year of issuance between number and code); place, date of issuance; type of document, summary; language in the document must be accurate, common, easy to understand, correct spelling and grammar of Vietnamese, appropriate legal style; structure and form of the document must be scientific; at the end of the document, there should be recipient, signature, seal places.

3. Fully comply with the provisions on procedures for drafting, issuing, and publishing in the Official Gazette as prescribed by the Law on Promulgating Legal Normative Documents.

Article 5. Procedures, steps, and authority for drafting and issuing legal normative documents on health

1. The procedures, steps, and authority for drafting and issuing legal normative documents on health must follow the provisions of the Law on Promulgating Legal Normative Documents, the Law amending and supplementing certain Articles of the Law on Promulgating Legal Normative Documents, guiding legal normative documents of the Government, the Ministry of Justice, and the provisions of this Regulation.

2. The legal normative documents on health prescribed in Clause 2, Article 2 of this Regulation shall be signed and issued by the Ministry's leadership.

Article 6. Assignment of responsibility for drafting legal normative documents on health or participating in opinions on legal normative documents

1. The assignment of drafting or participating in opinions on legal normative documents is based on the content of the document related to the functions, tasks, and powers of which Department, it shall be assigned to that Department to take the lead. If the legal normative document relates to the functions, tasks, and powers of several Departments, the Ministry's leadership will consider and decide to assign one Department to take the lead.

2. Within their functions, tasks, and powers, the Legal Affairs Department has the responsibility to assist the Minister of Health:

a) To review legal normative documents on health before submitting them to the Minister of Health for signing and issuing or for submission to the Government, Prime Minister;

b) To directly draft or participate in drafting legal normative documents on health.

PART II

ESTABLISH A PROGRAM FOR THE DEVELOPMENT AND ISSUANCE OF LEGAL NORMATIVE DOCUMENTS ON HEALTH.

Article 7. Proposal for the Program on Drafting and Issuing Legal Normative Documents on Health.

1. The proposal for the Program on Drafting and Issuing Legal Normative Documents on Health must be based on the following grounds:

a) The Party's guidelines, policies, and state laws on protecting, caring for, and improving people's health;

b) The Program on Drafting Laws and Ordinances of the National Assembly and the Standing Committee of the National Assembly throughout the term of the National Assembly;

c) The Program on Drafting Laws of the Government and the Prime Minister;

d) The functions, tasks, and authorities assigned to the Ministry of Health by the Government;

đ) Practical needs in the work of protecting, caring for, and improving people's health.

2. Based on these grounds, each department under the Ministry of Health must annually forecast and develop a program on drafting legal normative documents related to their areas of responsibility and submit it to the Department of Legal Affairs. The Department of Legal Affairs will consolidate and report to the Minister of Health for consideration and submission to competent state agencies to include in the Program on Drafting Laws of the National Assembly, the Standing Committee of the National Assembly, the Government, the Prime Minister, or in the Program on Drafting Legal Normative Documents within the authority of the Minister of Health, jointly with other Ministries, agencies at the ministerial level, or with political-social organizations.

Article 8. Contents of the Program on Drafting Legal Normative Documents on Health.

1. The Program on Drafting Legal Normative Documents on Health includes:

a) A list of proposed laws, ordinances, and resolutions of the National Assembly or the Standing Committee of the National Assembly to be reported to the Government for submission to the National Assembly or the Standing Committee of the National Assembly;

b) A list of proposed decrees and resolutions of the Government or Decisions and Directives of the Prime Minister to be submitted by the Minister of Health to the Government or the Prime Minister for issuance;

c) A list of proposed Decisions and Directives of the Minister;

d) A list of proposed Joint Resolutions and Joint Circulars co-signed and issued by the Minister of Health.

2. Each list must clearly specify the name of the document, the main agency and cooperating agencies responsible for drafting, the time for drafting, the time for submitting to the Minister, the time for completing and submitting to the Government, the Standing Committee of the National Assembly, or the National Assembly, guiding legal normative documents (if any), and the budget for drafting each document. Accompanying the list should be a document explaining the necessity, basic contents, and economic and social impacts of the legal normative document to be drafted.

Article 9. Time limit for considering proposals for drafting legal normative documents on health.

1. Proposals for drafting laws and ordinances annually must be sent to the Ministry of Justice and the Office of the Government no later than July 15 of the previous year. If proposing the program for drafting laws and ordinances for the entire term of the National Assembly, such proposals must be sent to the Ministry of Justice and the Office of the Government no later than July 15 of the last year of the previous term of the National Assembly.

2. Proposals for drafting resolutions and decrees of the Government and decisions and directives of the Prime Minister annually must be sent to the Office of the Government and the Ministry of Justice no later than October 15 of the previous year.

3. Proposals for drafting legal normative documents of the Ministry of Health must be sent to the Department of Legal Affairs and the Office of the Ministry no later than October 15 of the previous year.

4. In cases of emergency arising from practical needs, the time limit for considering proposals for drafting legal normative documents on health will be reconsidered after obtaining the approval of the Minister of Health.

Article 10. Competence to Examine and Approve Drafts for the Construction of Legal Normative Documents on Health

1. The Minister of Health shall examine and decide to submit to the Government the program of the Ministry of Health on the construction of legal normative documents on health within the competence of the Government or the Prime Minister, or report and propose to the Government to submit to the Standing Committee of the National Assembly or the National Assembly for inclusion in the program of legal normative document construction within the competence of the National Assembly or the Standing Committee of the National Assembly.

2. The Minister of Health shall decide on the program for constructing legal normative documents within the competence of the Ministry of Health.

3. In cases where draft legal normative documents on health are proposed for submission beyond the prescribed time limit, the main drafting unit must send a letter to the Department of Legal Affairs detailing the reasons, which will be submitted by the Department of Legal Affairs to the Minister of Health for consideration and adjustment of the submission deadline.

Article 11. Responsibilities in Establishing Programs for the Construction and Issuance of Legal Normative Documents on Health

1. The Department of Legal Affairs shall be responsible for compiling and establishing long-term or annual programs for the construction of legal normative documents on health of the Ministry of Health to report to the Minister of Health for examination and decision.

2. For legal normative documents within the competence of issuance of the National Assembly, the Standing Committee of the National Assembly, the Government, or the Prime Minister, the main drafting department must prepare a Report in accordance with Article 16 of this Regulation and submit it to the Department of Legal Affairs for compilation and submission to the Minister of Health for signature and submission to the Government for inclusion in the national legal construction program according to the deadlines set out in Clauses 1 and 2, Article 9 of this Regulation.

3. For legal normative documents within the competence of issuance of the Minister of Health, the proposing department must prepare a Report along with a list of draft legal normative documents on health planned for issuance and submit it to the Department of Legal Affairs for compilation and submission to the Minister of Health for approval according to the deadline set out in Clause 3, Article 9 of this Regulation.

CHAPTER III

DRAFTING LEGAL NORMATIVE DOCUMENTS ON HEALTH

 Article 12. Establishment of Drafting Committees and Editorial Teams for Legal Normative Documents on Health

1. When authorized or assigned to lead the drafting of draft laws and ordinances to be submitted by the Government to the National Assembly or the Standing Committee of the National Assembly for promulgation, or draft resolutions and decrees to be submitted by the Government for promulgation, the Minister of Health shall establish a Drafting Committee and an Editorial Team (except in cases where establishment is necessary by the Government).

2. The establishment of Drafting Committees and Editorial Teams shall be decided by the Minister of Health and must comply with the following provisions:

a) Drafting drafts of laws and ordinances shall be led by the Chairperson of the Drafting Committee.

b) The Drafting Committee shall consist of a Chairperson, one to two Deputy Chairpersons, and members. Members of the Drafting Committee include Deputy Ministers of Health responsible for relevant fields, leaders of Departments representing related Departments, and the Department of Legal Affairs. If the draft law or ordinance involves other Ministries or sectors, representatives with authority from those Ministries or sectors must participate.

c) Supporting the Drafting Committee is an Editorial Team designated by the Chairperson of the Drafting Committee, consisting of Department leaders, legal experts, professionals, and technical staff knowledgeable about the content covered by the draft document.

d) The Department of Legal Affairs shall coordinate with the Department of Organization and Cadres and the main drafting department to propose personnel to assist the leadership of the Ministry in establishing Drafting Committees for legal normative documents as stipulated in Clauses 1 and 2 of this Article.

3. For decisions, circulars, directives, joint resolutions, and joint circulars within the competence of issuance of the Minister of Health or the Ministry of Health with related Ministries, sectors, and political-social organizations, if they fall under the functions, tasks, and powers of a specific Department, that Department shall lead the drafting process with the participation of the Department of Legal Affairs and representatives of related Departments.

 

Article 13. Responsibilities of the Drafting Board and the Editing Team

1. The Drafting Board or the agency, unit assigned to lead the drafting shall be responsible for determining the purpose, requirements, content, scope, and regulated subjects of the draft regulatory document, while directing, assigning, and managing the work of the Drafting Board members and the Editing Team during the drafting process, reporting on the progress and results of the drafting to the Ministry's leadership or higher state authority with the right to issue such documents.

2. The Drafting Board shall fully implement the provisions of Articles 26, 61, 65, and 66 of the Law on Issuing Regulatory Documents and the regulations of this Charter.

3. The Editing Team shall assist the Drafting Board in performing the tasks stipulated in Clause 2 of this Article and other specific tasks assigned by the Head of the Drafting Board.

Article 14. Requirements during the drafting of health-related regulatory documents

During the drafting of regulatory documents, the Drafting Board or the leading agency, unit shall fulfill the following requirements:

1. Study the Party's policies and the State's laws and regulations concerning the issues addressed in the document's content;

2. Determine the purpose, requirements, scope of regulation, applicable subjects, and contents that need to be specified in the document to concretize through specific provisions in the draft;

3. Conduct surveys and studies on practical aspects related to the content and issues being drafted for laws, ordinances, and other important documents. Specifically, for drafts aimed at amending, supplementing, or replacing currently effective regulatory documents, an assessment of the implementation of those documents must be organized.

4. Collect and study relevant information and materials. Systematize, summarize, and evaluate current documents in the field and content being drafted.

5. Develop a draft outline, determine the content, chapters, titles, and structure of the document;

6. Draft in detail to ensure quality, content, and progress. The draft must be numbered according to its draft version;

7. Depending on the nature, content, form, and type of document, the Drafting Board must send the draft to relevant agencies, organizations, and individuals for comments through appropriate methods; if necessary, organize meetings or seminars. The draft document must be sent to individuals or units requiring comments five working days before the meeting or seminar (if participating in a meeting or seminar) or ten working days before (if participating via a letter);

8. Prepare the submission report and related documents as prescribed in Articles 16 and 17 of this Charter. For documents requiring guidance documents, the Drafting Board or the assigned leading agency must draft the guidance document as prescribed in Article 18 of this Charter to submit along with the draft document.

Article 15. Soliciting Opinions on Draft Health-Related Regulatory Documents

Soliciting opinions on drafts must follow the following procedures:

1. Drafts must necessarily solicit opinions from relevant units within the industry. Depending on the nature, scope of regulation, applicable subjects, and scope of application of the draft, opinions from relevant agencies, units outside the industry, and subjects implementing the document should be solicited.

a) After receiving opinions, the Editing Team must revise the draft. When the draft is relatively complete, the Editing Team must report to the Drafting Board and the Ministry's leadership on the progress of the drafting content and complex issues still having differing opinions to seek guidance. Reporting to seek guidance from the collective leadership of the Ministry (the Minister and Deputy Ministers) is mandatory for draft Laws, Ordinances, Resolutions, Decrees, Decisions, and Directives of the Prime Minister; for drafts such as Decisions, Directives, Circulars under the authority of the Minister, reports must be made to the Deputy Minister directly responsible.

b) After receiving guidance from the Ministry's leadership, the Drafting Board may revise the document if deemed necessary and depending on the nature and scope, may solicit final opinions from relevant units before submitting. If the document is submitted to the Government, the Standing Committee of the National Assembly, or the National Assembly, it is mandatory to solicit opinions from Ministries, sectors according to the Law on Issuing Regulatory Documents, the Law Amending and Supplementing Certain Provisions of the Law on Issuing Regulatory Documents, and the Decree guiding implementation.

2. Soliciting opinions can be done through letters or organizing meetings or seminars. If soliciting opinions through letters, the leading agency's leadership must sign the letter soliciting opinions; if there is no submission report attached to the draft, the key issues needing opinions must be summarized in the letter. Draft documents sent to solicit opinions from Ministries, sectors, political-social organizations, and occupational social organizations must be signed by the Ministry's leadership.

Article 16. Content and format of the Report to the Government and the Prime Minister and authority to sign

1. The report must clearly state the necessity for issuing the document, purpose, requirements, scope, regulated subjects, drafting process, main contents, issues with differing opinions that require guidance from the Government and the Prime Minister; in cases where there are differing opinions, the report must select major issues and propose viewpoints and directions for resolving those issues by the Drafting Board to seek guidance.

2. Reports to the Government and the Prime Minister must be signed by a Minister or Deputy Minister authorized by the Minister and stamped according to their respective authorities.

Article 17. Documents for reviewing health regulatory legal texts

1. Documents for reviewing draft laws, ordinances, resolutions, decrees, decisions, directives of the Prime Minister must include:

a) A report in accordance with the provisions of Article 16 of this Regulation;

b) A letter requesting the Ministry of Justice to review. After the Ministry of Justice has reviewed, the drafting unit or agency must study and perfect the draft, and simultaneously send a letter from the Ministry of Health adopting and explaining the review opinions of the Ministry of Justice;

c) The main draft text and the draft guiding text. The contents of these drafts must be clear and specific so that when the text is issued, it can be implemented immediately;

d) Written opinions from relevant Ministries, sectors, political-social organizations, occupational social organizations, or explanations regarding inquiries made within the prescribed time limit but without responses from related agencies;

đ) Implementation plan upon issuance of the text;

e) Other necessary documents.

2. Documents for reviewing draft decisions, circulars, directives of the Minister of Health, joint resolutions, joint circulars must include:

a) A report from the Minister or Deputy Minister;

b) The draft text with the signature stamp of the representative leader of the drafting unit, the Office of the Ministry, and the Legal Department. For joint resolutions and joint circulars, the signature stamp of the representative leader of the drafting unit and the Legal Department of each participating party signing the text is required;

c) Written opinions from relevant Departments.

3. The submitted documents must be sent to the Legal Department for preliminary review before the Minister signs to issue or reports to the higher authority for issuance.

Article 18. Preparation of health regulatory legal texts guiding the implementation of draft laws, ordinances, resolutions, decrees, decisions, directives of the Prime Minister

1. When submitting draft laws, ordinances, resolutions, decrees, decisions, directives of the Prime Minister, accompanying regulatory legal texts guiding their implementation must also be submitted;

2. The Drafting Board must prepare the drafting of regulatory legal texts guiding implementation once the above drafts are relatively complete. These texts must be determined in terms of form and content needed to guide.

PART IV

REVIEWING AND ISSUING HEALTH REGULATORY LEGAL TEXTS

Article 19. Authority and time limit for reviewing health regulatory legal texts

1. All health regulatory legal texts stipulated in Clause 1 and 2, Article 2 of this Regulation must be sent to the Legal Department for review within 10 working days for draft laws, ordinances, resolutions, decrees, decisions, directives of the Prime Minister, and 5 working days for draft decisions, circulars, directives of the Minister of Health before submitting to the Minister of Health for signature to issue or for submission to the Government and the Prime Minister.

2. For specialized technical texts issued in the form of regulatory legal texts, prior to sending them to the Legal Department for review as stipulated in Clause 1 of this Article, the assigned drafting department must organize consultations with relevant technical experts.

3. Submitted documents and materials for review, and the content of the review must comply with the provisions of Article 17 of this Regulation. During the review, if there are issues requiring discussion, the Legal Department may invite representatives of the leading department responsible for drafting to jointly meet and discuss and reach consensus. If there are unresolved issues, they should be reported to the Ministry leadership for consideration and decision.

Article 20. Contents to be reviewed for health-related regulatory legal documents

The Legal Affairs Department shall review health-related regulatory legal documents based on the following contents:

1. The necessity for issuing health-related regulatory legal documents; the scope of regulation and the subjects to which they apply;

2. The basis and legal grounds for issuing health-related regulatory legal documents;

3. The consistency of the draft content with the Party's guidelines, policies, and state laws;

4. The constitutionality, legality, and consistency of the document with the legal system; the feasibility of health-related regulatory legal documents;

5. Compliance with drafting procedures and formalities; language and technical aspects of the document;

6. The dossier submitted for approval according to Article 17 of this Regulation.

Article 21. Procedures for reviewing health-related regulatory legal documents

1. For health-related regulatory legal documents within the authority of the Minister of Health and joint documents: The Head of the Legal Affairs Department is responsible for organizing the review of all submitted documents and signing off before presenting them to the Ministry’s leadership for signature. The Ministry’s leadership will only approve and sign the document when there is a review opinion from the Legal Affairs Department’s leadership.

2. For health-related regulatory legal documents within the authority of the National Assembly, Standing Committee of the National Assembly, Government, Prime Minister: After submitting to the Government, Prime Minister, the department assigned the main responsibility for drafting the document must send 10 sets of files to the Ministry of Justice for review.

In cases of refusal, the State Bank will issue a document refusing approval to use foreign currency within the territory and clearly state the reasons.

a) Letter requesting review;

b) A report to the Government on the draft law, ordinance, decree, resolution or a report to the Prime Minister on the draft decision, directive;

c) The final draft presented to the Government, Prime Minister for consideration;

d) Copies of comments letters and summaries of opinions from ministries and sectors on the draft (if any);

đ) Draft regulatory legal documents guiding implementation.

Article 22. Tasks and powers of the Legal Affairs Department in reviewing health-related regulatory legal documents

1. The Legal Affairs Department is responsible for reviewing the entire legal aspect of the drafted document's content and form according to Article 20 of this Regulation and must bear responsibility for its review opinion.

2. The review opinion must be expressed in writing or signed directly by the Legal Affairs Department’s leadership on the document.

3. If the document is deemed not ready for the Ministry’s leadership to sign and issue, the Legal Affairs Department must clearly state the reasons and propose that the drafting department revise, supplement, and complete it.

4. The review process must be conducted promptly and accurately, not exceeding 10 working days for draft laws, ordinances, decrees, resolutions, decisions, directives of the Prime Minister and 5 working days for draft decisions, circulars, directives of the Minister of Health or draft joint circulars, joint resolutions from the date of receipt.

Article 23. Submitting health-related regulatory legal documents

1. After the health-related regulatory legal document has been reviewed by the Legal Affairs Department, the drafting agency or unit is responsible for coordinating with the Legal Affairs Department to submit to the Ministry’s leadership.

2. The dossier for the Minister to sign and issue must comply with the provisions of Clause 2, Article 17 of this Regulation.

Article 24. Numbering and Identification of Health Law Regulatory Documents

1. Regulatory documents must be numbered in sequential order starting from the first number (01) according to the year of issuance and have a specific code for each type of document. Documents within the authority of the Government, Standing Committee of the National Assembly, and the National Assembly shall be numbered at the issuing authority. Regulatory documents signed and issued by the Minister must be numbered at the Ministry of Health's Office, simultaneously sent for record-keeping at the Ministry of Health's Office, Legal Department, and the main drafting agency. 

2. The identification code of each type of document consists of abbreviated letters of the document, for example:

a) Decree No. 103 dated 12/9/2003 of the Government must be numbered as: number: 103/2003/NĐ-CP;

b) Decision No. 4021 dated 30/7/2003 of the Minister of Health must be numbered as: number: 4021/2003/QĐ-BYT;

c) Circular No. 09 Jointly Issued by Health-Finance-Civil Service Administration dated 29/9/2003 must be numbered as: number: 09/2003/TTLT-BYT-BTC-BNV;

d) The identification code of other regulatory documents shall also be regulated as above.

Article 25. Publication, Dissemination, and Sending Copies of Health Law Regulatory Documents

1. Health law regulatory documents signed and issued by the Ministry Leader must be published, disseminated, and copies sent to relevant sectors, units, and the Government Office (Publications Division) for publication in the Official Gazette, and sent to the Ministry of Justice (Legal Review Division) for review in accordance with the law.

2. The main drafting department is responsible for making copies of health law regulatory documents and transferring them to the Ministry of Health's Office to send to related agencies, units, localities, and enforcement entities according to the address noted in the document's recipient section, no later than three working days from the date of signing and issuance.

The Ministry Office is responsible for paying the costs for making copies of health law regulatory documents in accordance with Article 37 of this Regulation.

Article 26. Translation of Health Law Regulatory Documents into English

1. Laws, ordinances, resolutions, decrees; other health law regulatory documents with significant content related to foreign factors may be translated into English after issuance.

2. For health law regulatory documents with significant content related to foreign factors that the Publications Division of the Government Office has not or does not translate into English, the International Cooperation Department of the Ministry of Health is responsible for organizing the translation of these health law regulatory documents into English according to the requirements of the Ministry of Health leadership.

CHAPTER V

IMPLEMENTATION AND EVALUATION OF HEALTH LAW REGULATORY DOCUMENTS AFTER ISSUANCE

AND ASSESSMENT OF IMPLEMENTATION

Article 27. Allocation of Responsibilities for Organizing Implementation of Health Law Regulatory Documents

1. The department assigned to draft health law regulatory documents is responsible for organizing their implementation immediately after issuance.

2. In cases where the content of health law regulatory documents relates to the functions, tasks, and authorities of multiple departments, the department assigned to draft the document is responsible for leading and coordinating with related departments to organize implementation immediately after issuance.

3. Related departments are responsible for cooperating with the department assigned to lead the drafting to organize implementation in accordance with Clause 2 of this Article.

Article 28. Implementation of Legal Instruments on Health

1. All legal instruments on health must be copied and sent to relevant agencies, units, localities, and enforcement entities within three working days from the date of signing or issuance, in accordance with Clause 2, Article 25 of this Regulation.

2. For important and sensitive legal instruments on health issued by the National Assembly, Standing Committee of the National Assembly, Government, Prime Minister, or by the Minister of Health or jointly with other Ministries and sectors, the Department responsible for drafting such instruments shall coordinate with the Ministry's Office and related Departments to organize implementation meetings to disseminate plans and explain the contents of the instruments to the enforcement entities.

Article 29. Evaluation of the Implementation of Legal Instruments on Health

1. Laws, ordinances, resolutions, decrees, decisions, or directives of the Prime Minister, and certain legal instruments on health issued by the Minister of Health, depending on their nature, level, and scale, must be evaluated after a period of implementation (one year, two years, three years, or longer).

2. The evaluation focuses on the legal effectiveness, practical effectiveness, feasibility of each provision, advantages and difficulties in implementing the instrument, practical issues arising that the current instrument does not address or has conflicting provisions, and proposals for amendments and supplements.

3. Before amending or supplementing existing legal instruments on health, it is necessary to evaluate the implementation of those instruments.

4. The Department responsible for drafting the instrument shall coordinate with related Departments (if any) to evaluate legal instruments on health according to Clauses 1 and 2 of this Article.

Chapter VI

PARTICIPATION IN THE REVIEW OF LEGAL INSTRUMENTS DRAFTED BY THE NATIONAL ASSEMBLY, STANDING COMMITTEE OF THE NATIONAL ASSEMBLY,

GOVERNMENT, PRIME MINISTER, OR OTHER MINISTRIES AND SECTORS REQUESTING

Article 30. Assignment of Responsibility for Participation in Review

1. Upon receipt of draft legal instruments from the National Assembly, Standing Committee of the National Assembly, Government, Prime Minister, or other ministries and sectors (hereinafter referred to as the drafting agency), 2. In cases where the draft legal instruments from the drafting agency request the Ministry of Health to participate in review and the scope of regulation involves multiple Departments' functions, tasks, and authorities, the Director of the Office will send them to the Legal Affairs Department to lead the participation in review. shall send requests to the Ministry of Health for comments, depending on the scope of adjustment of the draft, the Director of the Office shall send to relevant Departments according to their assigned functions, tasks, and authorities to take the lead in providing comments;

3. Specifically, for draft laws and ordinances that the Office of the Government leads meetings to introduce for ministries and sectors to participate in review, the Director of the Office will send them to the Legal Affairs Department to lead the participation in review.

3. As for draft laws and ordinances which the Government Office takes the lead in convening meetings to introduce to Ministries and sectors for comments, the Director of the Office shall send to the Legal Department to take the lead in providing comments.

Article 31. Procedures for Soliciting Participation Opinions

Within two working days of receiving drafts from the National Assembly, Government, and other sectors requesting the Ministry of Health to participate in review, the Legal Affairs Department or the Department assigned by the leadership of the Ministry shall be responsible for copying and sending the drafts to relevant Departments and units under the Ministry of Health for study and participation in review.

Article 32. Obligation to Provide Comments

Upon receiving draft documents, the Departments requested for comments shall be responsible for organizing research and providing comments; such comments must ensure content and timeframes and bear responsibility for their own Department's comments.

Article 33. Handling Issues with Different Opinions in Commenting

For major issues or those related to the functions and tasks of the sector that still have differing opinions, the Department assigned to lead the commenting process must compile and prepare reports along with the comments from other Departments to submit for consideration and decision by the Ministry’s leadership.

Article 34. Authority to Sign Comment Letters

1. When drafting comment letters in response, the Department assigned to lead the commenting process must submit the document for signature by the Ministry’s leadership or the Department according to the following authority principles:

a) Comment letters submitted to the National Assembly, Standing Committee of the National Assembly, Government, Prime Minister must be signed by the Minister or Deputy Ministers authorized by the Minister.

b) If the relevant Ministries' or sectors' documents are sent for comments by the Minister or Deputy Minister, then the reply comment letters to these Ministries or sectors must be signed by the Minister or Deputy Minister.

c) If the relevant Ministries' or sectors' documents are sent for comments by the General Department, Department, or Bureau level, then the reply comment letters to these Ministries or sectors must be signed by the Department leadership.

2. All comment letters must be concurrently sent to the Legal Affairs Department of the Ministry of Health for monitoring and consolidation.

Article 35. Legal Value of Participatory Opinions

1. Comment letters signed by the Minister, Deputy Minister, or Department-level leadership on behalf are considered the official participatory opinion of the Ministry of Health.

2. Opinions from Department-level leadership and staff during the drafting process are only for reference and not considered the official participatory opinion of the Ministry of Health.

Chapter VII

FINANCIAL RESOURCES FOR THE CONSTRUCTION, ORGANIZATION OF IMPLEMENTATION AND EVALUATION OF THE IMPLEMENTATION OF HEALTH LEGISLATIVE DOCUMENTS

LEGAL FRAMEWORK ON HEALTH

Article 36. Sources of Financial Resources for the Construction, Organization of Implementation and Evaluation of the Implementation of Health Legislative Documents

1. Financial resources for the construction of laws, ordinances, resolutions of the National Assembly, Standing Committee of the National Assembly shall be provided by the State according to guidelines of the Ministry of Justice and the Ministry of Finance. In cases where State-provided financial resources are insufficient to support the drafting process, the Department serving as the permanent body of the Drafting Board shall be responsible for coordinating with the Planning and Finance Department to report to the Ministry’s leadership for additional support through Ministry funds or from Programs, projects, or requesting international organization assistance, while preparing budgets, using, and settling accounts for allocated funds in accordance with legal regulations.

2. Financial resources for the construction of resolutions, decrees of the Government; decisions, directives of the Prime Minister; decisions, circulars, directives of the Minister of Health or joint directives within the Government’s legislative document construction program and the Ministry of Health’s program; financial resources for organizing implementation meetings of health legislative documents as stipulated in Articles 27 and 28 of this Regulation and for organizing evaluations of the implementation of health legislative documents as stipulated in Article 29 of this Regulation shall be sourced from the Ministry of Health’s budget.

Article 37. Budget Estimation

1. Annually, the Legal Department shall be responsible for coordinating with the leading unit to compile the budget estimate for drafting legal regulatory documents prepared by the Ministry, unify with the Planning and Finance Department to report to the Ministry's leadership for consideration and decision. This budget is established as a separate item managed by the Ministry's Office.

2. The budget estimation must include funds for organizing the implementation and enforcement of health-related regulatory documents after their issuance, as well as for evaluating the implementation and translating the documents into English.

Article 38. Use and Settlement of Funds

1. The use and settlement of funds for drafting, organizing the implementation and enforcement, and evaluating the implementation of health-related regulatory documents must comply with the provisions of the law.

2. The Planning and Finance Department shall be responsible for guiding and inspecting the use and settlement of funds for drafting health-related regulatory documents in accordance with the prescribed regulations.     

Chapter VIII

IMPLEMENTING PROVISIONS

Article 39. Transitional Provisions

For documents issued previously without proper authority, format, type, and not meeting the conditions stipulated in Article 3 of this Regulation such as letters, telegrams, and notifications containing legal norms, the Departments primarily responsible for drafting these documents must organize reviews and studies to amend and supplement them in accordance with the Law on Issuing Regulatory Documents, the Law Amending and Supplementing Certain Articles of the Law on Issuing Regulatory Documents, the Decree guiding its implementation, and this Regulation./.