Circular No. 22/2014/TT-BYT on the drafting, issuance, and implementation of legal instruments concerning health

CIRCULAR

Regulations on drafting, promulgating, and organizing the implementation of health-related regulatory legal documents

_____________________________

 

Pursuant to the Law on Legislative Acts of 03 June 2008;

Based on the Ordinance on Consolidation of Regulatory Legal Documents dated December 22 of the Government detailing the Law on Foreign Trade Management; Pursuant to the Ordinance on Consolidating Normative Legal Documents dated March 22

Based on Decree No. 24/2009/NĐ-CP dated March 5 March 2009 of the Government detailing and providing measures for the enforcement of the Law on Issuing Regulatory Legal Documents;

Based on Decree No. 63/2010/NĐ-CP dated June 8, 2010 of the Government on administrative procedure control; Decree No. 48/2013/NĐ-CP dated May 14, 2013 of the Government amending and supplementing certain articles of related decrees concerning administrative procedure control;

This Circular prescribes procedures for receiving, providing health care for domestic violence victims and statistical reports on domestic violence victims at medical facilities.

At the proposal of the Director of the Legal Department;

The Minister of Health issues this Circular regulating the drafting, promulgating, and organizing the implementation of health-related regulatory legal documents.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates the establishment of programs, procedures for drafting, organizing the implementation of health-related regulatory legal documents, and the budget for developing health-related regulatory legal documents.

Article 2. Scope of Application

Article 1. This Circular applies to the drafting, promulgating, and organizing the implementation of health-related regulatory legal documents, including the following forms of documents:

a) Laws of the National Assembly;

b) Ordinances of the Standing Committee of the National Assembly;

c) Resolutions of the National Assembly, the Standing Committee of the National Assembly;

Point d) Decrees of the Government;

d) Decisions of the Prime Minister as specified in Article 15 of the Law on Issuing Regulatory Legal Documents;

e) Circulars of the Minister of Health;

g) Joint Circulars between the Minister of Health and the Ministers or Heads of Ministries at the same level.

Article 2. This Circular does not apply to the drafting, promulgating, and organizing the implementation of administrative documents on health, including the following forms of documents:

a) Resolutions of the Government;

b) Decisions of the Prime Minister not falling under the cases specified in Point d Clause 1 of this Article;

c) Decisions of the Minister of Health;

d) Directives;

e) Other administrative documents as specified in Circular No. 01/2011/TT-BNV dated January 19, 2011 guiding the format and technical presentation of administrative documents.

Article 3. Application of laws on technical construction of health-related regulatory legal documents

Clause 1. The validity of health-related regulatory legal documents shall be implemented according to Articles 78, 79, 80, 81, and 82 of the Law on Issuing Regulatory Legal Documents.

Clause 2. The format and technical drafting of health-related regulatory legal documents shall be carried out in accordance with Circular No. 25/2011/TT-BTP dated December 27, 2011 of the Minister of Justice on the format and technical presentation of regulatory legal documents of the Government, the Prime Minister, Ministers, and Heads of Ministries at the same level, and joint regulatory legal documents, and Decision No. 1857/QĐ-BTP dated June 26, 2012 of the Minister of Justice regarding the correction of Circular No. 25/2011/TT-BTP dated December 27, 2011 of the Minister of Justice on the format and technical presentation of regulatory legal documents of the Government, the Prime Minister, Ministers, and Heads of Ministries at the same level, and joint regulatory legal documents issued by the Minister of Justice.

Chapter II

ESTABLISHING THE PROGRAM FOR DEVELOPING HEALTH-RELATED REGULATORY LEGAL DOCUMENTS

Article 4. Classification of Programs for Developing Health-Related Regulatory Legal Documents

Clause 1. The Program for Drafting Laws and Ordinances on Health of the National Assembly.

Clause 2. The Annual Work Program of the Government.

Clause 3. The Annual Program for Developing Health-Related Regulatory Legal Documents of the Ministry of Health, including the formal program and preparatory program.

Article 5. Building the Program on Law and Ordinance Construction in the Field of Health for the National Assembly

1. Before preparing the dossier to propose the construction of laws and ordinances, the agency proposing the construction of laws and ordinances must carry out the following tasks:

a) Summarize and evaluate the practical implementation of laws in the field intended for the proposed construction of laws and ordinances in accordance with Article 9 of this Circular;

b) Draft an explanatory memorandum on the necessity of promulgating laws and ordinances based on the summary and evaluation report of the practical implementation of laws.

The explanatory memorandum must comply with the provisions at Point a Clause 1 Article 4 of Decree No. 24/2009/NĐ-CP dated March 5, 2009 of the Government detailing and providing measures to implement the Law on Legal Documents (hereinafter referred to as Decree No. 24/2009/NĐ-CP) and the requirements for administrative procedure control in the health sector as prescribed by the Minister of Health;

c) Conduct a preliminary impact assessment of laws and ordinances in accordance with Appendix 5 issued together with this Circular.

2. Dossier for Proposing the Construction of Laws and Ordinances in the Field of Health:

a) Dossier for Proposing the Construction of Laws and Ordinances in the Field of Health during the term of the National Assembly shall be carried out in accordance with Clause 1 Article 4 of Decree No. 24/2009/NĐ-CP;

b) Annual Dossier for Proposing the Construction of Laws and Ordinances in the Field of Health:

- For projects of laws and ordinances already included in the Program on Law and Ordinance Construction during the term of the National Assembly: The dossier shall be carried out in accordance with Clause 2 Article 4 of Decree No. 24/2009/NĐ-CP;

- For projects of laws and ordinances not yet included in the Program on Law and Ordinance Construction during the term of the National Assembly: The dossier shall be carried out in accordance with Clause 3 Article 4 of Decree No. 24/2009/NĐ-CP.

3. Time for Submitting the Dossier for Proposing the Construction of Laws and Ordinances in the Field of Health to the Legal Affairs Department:

a) Dossier for Proposing the Construction of Laws and Ordinances in the Field of Health during the term of the National Assembly: At the latest by February 1 of the first year of the term of the National Assembly;

b) Annual Dossier for Proposing the Construction of Laws and Ordinances in the Field of Health: At the latest by November 1 of the preceding year to the year in which it is planned to submit to the National Assembly, the Standing Committee of the National Assembly.

4. Based on the proposal of the agency proposing the construction of legal documents, the Legal Affairs Department shall have the responsibility:

a) For proposals to construct laws and ordinances during the term of the National Assembly:

- Organizing the review on the necessity of promulgating laws and ordinances in the field of health;

- Compiling the dossier and seeking opinions from the Ministry's leadership through meetings or through Opinion Request Forms according to the model prescribed in Appendix 1 issued together with this Circular;

- Guiding agencies proposing the construction of legal documents to complete the dossier to be sent to the Ministry of Justice after receiving the opinion of the Ministry's leadership;

- Submitting to the Minister for consideration and approval of the letter to the Ministry of Justice requesting inclusion in the Program on Law and Ordinance Construction during the term of the National Assembly.

b) For proposals to construct annual laws and ordinances in the field of health:

- Guiding agencies proposing the construction of legal documents to complete the dossier to be sent to the Ministry of Justice;

- Submitting to the Minister for consideration and approval of the letter to the Ministry of Justice requesting inclusion in the Annual Program on Law and Ordinance Construction of the National Assembly.

c) In cases where the main agency proposes to include in the Annual Program on Law and Ordinance Construction in the field of health a project of law or ordinance that is not included in the Program on Law and Ordinance Construction during the term of the National Assembly, the Legal Affairs Department shall have the responsibility to implement in accordance with the provisions at Point a Clause of this Article.

Article 6. Annual Program of Government Work

1. Basis for preparing proposals for legal documents on health to be included in the annual Work Program of the Government:

a) Laws, resolutions of the National Assembly; ordinances, resolutions of the Standing Committee of the National Assembly that provide for the Government to develop guiding documents for implementation;

b) Decrees of the Government that provide for the Prime Minister to issue guiding documents;

c) Results of reviewing, systematizing, codifying, and monitoring the enforcement of laws on health care.

2. The dossier for proposing to include legal documents on health in the annual Work Program of the Government includes:

a) For draft laws, ordinances to be submitted to the Government: The dossier shall be implemented according to the provisions of Point b Clause 2 Article 5 of this Circular;

b) For decrees of the Government to guide laws, resolutions of the National Assembly; ordinances, resolutions of the Standing Committee of the National Assembly: A letter clearly stating the scope of regulation, the expected time for submitting the draft decree to the Government, and related contents concerning administrative procedure control in the field of health care as prescribed by the Minister of Health;

c) For decrees of the Government, decisions of the Prime Minister to guide new issues arising in practice:

- A report summarizing and evaluating the practical enforcement of laws in the relevant field, proposing the development of normative legal documents within the authority of the Government to issue, as stipulated in Article 9 of this Circular;

- Preparing a detailed explanation on the necessity of issuing a decree of the Government, a decision of the Prime Minister based on the summary and evaluation report of the practical enforcement of laws;

The explanation must comply with the provisions of Point a Clause 1 Article 4 of Decree No. 24/2009/NĐ-CP and the requirements for administrative procedure control in the field of health care as prescribed by the Minister of Health;

d) For decisions of the Prime Minister to guide laws, resolutions of the National Assembly; ordinances, resolutions of the Standing Committee of the National Assembly; decisions of the President; decrees of the Government: A letter clearly stating the scope of regulation, the expected time for submitting the draft decision to the Prime Minister, and related contents concerning administrative procedure control in the field of health care as prescribed by the Minister of Health;

3. By the latest date of November 1 each year, agencies responsible for proposing the development of normative legal documents shall submit the dossier requesting inclusion of normative legal documents on health care in the Annual Program of Government Work to the Legal Department;

4. Based on the proposals of agencies responsible for proposing the development of normative legal documents, the Legal Department shall have the responsibility:

a) Organize the review on the necessity of issuing the document;

b) To compile the dossier, seek opinions from the Minister and Deputy Ministers through meetings or via Opinion Request Forms according to the model prescribed in Appendix 1 issued together with this Circular for cases stipulated in Point c Clause 2 of this Article;

c) To guide agencies responsible for proposing the development of normative legal documents to complete the dossier to be sent to the Office of the Ministry for compilation after receiving opinions from the Minister and Deputy Ministers;

Article 7. Development of the Plan for Developing Normative Legal Documents ON HEALTH Annually of the Ministry of Health

1. Basis for preparing the annual plan for developing normative legal documents on health care:

a) Laws, resolutions of the National Assembly; ordinances, resolutions of the Standing Committee of the National Assembly; decisions of the President; decrees of the Government; decisions of the Prime Minister that provide for the Minister of Health to guide implementation;

b) The annual program of work of the Government;

c) Results of reviewing, systematizing, codifying, and monitoring the enforcement of laws on health care;

2. By the latest date of November 1 each year, agencies responsible for proposing the development of normative legal documents must submit the dossier proposing the development of normative legal documents on health care for the following year to the Legal Department;

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) List of documents according to the model prescribed in Appendix 2 issued together with this Circular;

b) Detailed explanation about the scope of regulation and structure of each document according to the model prescribed in Appendix 3 issued together with this Circular;

c) Proposed plan for organizing the development of documents according to the model prescribed in Appendix 4 issued together with this Circular;

d) Estimated budget for drafting the documents;

d) In cases where the proposal is to develop normative legal documents to amend and supplement previously issued normative legal documents, the dossier must include a report summarizing and evaluating the enforcement of the normative legal document proposed for amendment and supplementation, as stipulated in Article 9 of this Circular;

3. Based on the proposals of agencies responsible for proposing the development of normative legal documents, the Legal Department shall have the responsibility to review and prepare the annual plan for developing normative legal documents on health care of the Ministry of Health, including the official program and the preparatory program to be submitted to the Minister of Health for approval before December 31 each year.

Article 8. Monitoring and Adjusting the Program for Drafting Legal Normative Documents ANNUAL REPORT ON HEALTH OF THE MINISTRY OF HEALTH

1. Based on the annual Program for Drafting Legal Normative Documents on Health Care approved by the Minister of Health, the agencies responsible for drafting the documents shall complete the plan for organizing the drafting of documents according to the model prescribed in Appendix 4 attached to this Circular and submit it to the Department of Legal Affairs before January 20 of the year in which the Program is implemented.

2. Every two weeks, the agencies responsible shall report the progress of implementing their organizational plans for drafting documents to the Department of Legal Affairs. After receiving the reports from the agencies, the Department of Legal Affairs shall be responsible for compiling and transferring the summary of progress reports on the drafting of the following types of documents: laws, ordinances, resolutions of the National Assembly, decrees of the Government, and decisions of the Prime Minister to the Office of the Ministry for inclusion in the annual progress report on implementing projects submitted to the Government.

3. The adjustment of the annual Program for Drafting Legal Normative Documents on Health Care of the Ministry of Health shall be carried out quarterly.

4. When there is a need to adjust the Program for Drafting Legal Normative Documents, the agency proposing the adjustment shall send the proposed adjustment to the Department of Legal Affairs:

a) In the case of requesting to adjust the time for submitting the document or removing it from the Program or transferring it to the reserve Program: The document proposing the adjustment must clearly state the reasons for the adjustment;

b) In the case of requesting to transfer the document from the reserve Program to the main Program: The document proposing the adjustment shall be accompanied by the Memorandum assessing the draft document issued by the Department of Legal Affairs;

c) In the case of requesting to include a document in the Program: The document proposing the adjustment shall be accompanied by the dossier prescribed in Clause 2, Article 7 of this Circular.

5. Based on the proposal of the agency responsible for drafting the document, the Department of Legal Affairs shall be responsible for reviewing and submitting to the Minister for consideration and decision.

For legal normative documents included in the list of projects submitted to the Government, after obtaining approval from the Minister, the Department of Legal Affairs shall be responsible for sending the document proposing adjustments to the Office of the Ministry to implement the procedures for adjusting the annual work program of the Ministry of Health.

Article 9. Summarizing and Evaluating the Implementation of Laws Related to Drafting Legal Normative Documents on Health Care

1. Situations requiring summarizing and evaluating the implementation of laws:

a) Before proposing to draft laws, ordinances, or decrees under the provisions of Clause 4, Article 14 of the Law on Enacting Legal Normative Documents;

b) Before proposing to draft documents to amend, supplement, or replace legal normative documents on health care;

c) Three years after the date the document becomes effective.

2. Procedures for summarizing and evaluating the implementation of laws:

a) Systematize all regulatory documents related to the content planned for drafting health regulatory documents;

b) Analyze the content of the collected regulatory documents to identify issues that need to be regulated in the draft health regulatory document;

c) Surveying and evaluating the practical activities of state management related to the content planned for drafting legal normative documents on health care to provide evidence to support the conclusions obtained during the analysis of the legal system;

d) Prepare a report on the summary and evaluation of the implementation of laws related to the content planned for drafting health regulatory documents.

3. In cases of drafting laws, ordinances, or decrees on health care, it is necessary to add a section referencing international law in the report summarizing and evaluating the implementation of laws.

Chapter III

DRAFTING HEALTH REGULATORY DOCUMENTS

Article 10. Establishment of the Drafting Board

1. Regulatory documents that must establish a Drafting Board:

a) Laws, resolutions of the National Assembly;

d) Decrees of the Government; joint resolutions between the Government and the Central Steering Committee of the Vietnam Fatherland Front; decisions of the Prime Minister;

c) Government Decree.

2. For forms of regulatory legal documents not covered under Clause 1 of this Article, based on the nature and complexity level of the document, the Minister of Health shall decide on the establishment of the Drafting Board based on the proposal of the main drafting agency.

3. Members of the Drafting Board and the Editorial Group must be individuals directly related to the content of the draft regulatory legal document.

4. The organization and operation of the Drafting Board shall be carried out in accordance with the provisions of Articles 30, 31, and 60 of the Law on Issuing Regulatory Legal Documents and Articles 20, 21, 22, 23, and 24 of Decree No. 24/2009/NĐ-CP.

Article 11. Drafting the Preliminary Outline of the Draft Regulatory Legal Document on Health

1. The preliminary outline must clearly reflect the basic contents of each article in the draft regulatory legal document while meeting specific requirements for each type of document as stipulated in Clause 2 of this Article.

2. Specific requirements for the preliminary outline:

a) For the preliminary outline of the draft law, ordinance, or resolution: The outline must clearly reflect the direction of policy and legal construction for the content that the draft law, ordinance, or resolution intends to regulate;

b) For the preliminary outline of the draft Decree of the Government or Decision of the Prime Minister:

- For Government Decrees and Prime Minister's Decisions detailing the implementation of laws and ordinances: The outline must reflect the consistency of the direction of policy and legal construction with the laws and ordinances being guided, and must clearly express the management viewpoint on the issues intended to be guided;

- For Government Decrees and Prime Minister's Decisions not detailing the implementation of laws and ordinances: The outline must clearly reflect the direction of policy and legal construction for the content that the draft decree intends to regulate.

Article 12. Soliciting Opinions on the Preliminary Outline of the Draft Regulatory Legal Document on Health

1. Depending on the nature of the draft regulatory legal document on health, the main drafting agency shall decide on the form and target audience for soliciting opinions according to the provisions of Article 14 of this Circular but must at least solicit opinions from units under the Ministry of Health.

2. For the preliminary outline of the draft law, ordinance, or decree, in addition to the provisions of Clause 1 of this Article, the Editorial Group must convene a meeting of the Drafting Board to unify and approve the preliminary outline before drafting the detailed draft of the law, ordinance, or decree.

Article 13. Drafting the Detailed Draft of the Draft Regulatory Legal Document ON HEALTH

1. Based on the preliminary outline, the drafting agency proceeds to draft the detailed contents of the articles, clauses, and points of the draft legal normative document on health.

2. The content of the detailed draft of the draft legal normative document on health must meet the following requirements:

a) Ensuring logical and scientific coherence between chapters, articles, clauses, and points within the draft content;

b) Not repeating contents already regulated in other legal normative documents;

c) Only specify the scope of application in cases where the scope has special characteristics;

d) In cases where administrative procedures are prescribed, clearly specify the required documents, timeframes, and methods for implementing such procedures;

đ) In cases where other regulatory legal documents are referenced within the content of the draft regulatory legal document on health, there must be provisions regarding cross-referencing clauses, except for draft regulatory legal documents in the form of laws, ordinances, resolutions, decrees, or decisions of the Prime Minister;

e) In cases where the draft regulatory legal document on health includes provisions on conditions for providing healthcare services or activities but cannot be implemented immediately upon the entry into force of the regulatory legal document on health or includes provisions on phased implementation, there must be transitional provisions specifying the methods for applying these provisions.

Article 14. Soliciting opinions on draft detailed regulatory legal documents ON HEALTH

1. Methods for soliciting opinions:

a) Sending a document requesting participation in providing opinions;

b) Publish the full text of the document on the portal website or electronic news page of the drafting agency at least 60 days before requesting pre-filing review prior to requesting the Ministry of Justice for examination under Clause 1, Article 18 of this Circular or requesting examination under Clause 1, Article 19 of this Circular;

For laws, ordinances, decrees, and decisions of the Prime Minister, in addition to the above, the full text of the draft must be published on the Government’s portal website.

c) Organizing seminars, conferences, meetings.

2. Subjects requested to participate in providing opinions:

a) Departments, Bureaus, Office of the Ministry, Inspectorate of the Ministry, General Departments, and subordinate units of the Ministry of Health;

b) Health Departments of provinces and centrally governed cities (hereinafter referred to as provinces);

c) Vietnam Medical Association;

d) Provincial general hospitals and private hospitals for documents related to professional matters in the field of medical diagnosis and treatment or organization and operation of hospitals;

đ) Provincial focal points on preventive health for documents related to professional matters or organization and operation in the field of preventive health;

e) Vietnam Chamber of Commerce and Industry and enterprises operating in the healthcare sector for contents related to the rights and obligations of enterprises;

g) Ministry of Science and Technology for national technical standards and regulations in the field of health;

h) Ministry of Public Security for contents related to security, public order, and social safety;

i) Drafting Board for draft laws, ordinances, resolutions of the National Assembly and decrees;

k) Ministries, agencies equivalent to ministries, government agencies, and provincial People's Committees for draft laws, ordinances, resolutions, decrees, and decisions of the Prime Minister;

l) Other subjects depending on the scope of regulation of the draft regulatory legal document or upon the request of the Ministry's leadership or the superior agency.

3. The number of times soliciting opinions shall be decided by the drafting agency based on the nature and complexity of the document but must comply with the minimum requirements as follows:

a) For draft laws, ordinances, and decrees:

- Entities specified in Points a and b of Clause 2 of this Article after completing the first draft of the law, ordinance, or decree;

- Drafting Board after finalizing the draft based on the opinions of the entities specified in Points a and b of Clause 2 of this Article;

- Entities specified in Points c and k of Clause 2 of this Article after finalizing the draft based on the Drafting Board's opinions;

- Drafting Board before requesting the Ministry of Justice to examine.

b) For draft decisions of the Prime Minister:

- Entities specified in Points a and b of Clause 2 of this Article after completing the first draft of the decision;

- Entities specified in Points c and k of Clause 2 of this Article before sending for the Ministry of Justice's opinion examination;

c) For draft circulars and joint circulars: the subjects specified in points a, b, and l of Clause 2 of this Article.

Article 15. Soliciting opinions on administrative procedures regulations

1. At least 60 days before sending for examination, the agency assigned to draft the document must send for opinions from the administrative procedure control agency according to the following provisions:

a) The Administrative Procedure Control Department of the Ministry of Justice for administrative procedures stipulated in draft regulatory legal documents submitted by the Government to the National Assembly, the Standing Committee of the National Assembly, and draft regulatory legal documents within the promulgation authority of the Government and the Prime Minister;

b) The Legal Affairs Department for administrative procedures stipulated in draft regulatory legal documents within the promulgation authority of the Minister of Health and draft joint circulars between the Minister of Health and Ministers or heads of agencies equivalent to ministries.

2. Within ten working days, the Legal Affairs Department shall provide opinions on the administrative procedures regulations in draft regulatory legal documents within the promulgation authority of the Minister of Health and draft joint circulars between the Minister of Health and Ministers or heads of agencies equivalent to ministries.

3. The process of soliciting opinions on administrative procedures regulations in draft regulatory legal documents within the promulgation authority of the Minister of Health shall be carried out in accordance with the provisions of Clause 2, Article 9 of Decree No. 63/2010/ND-CP.

Article 16. Impact Assessment of Regulatory Legal Documents

1. Preliminary impact assessment of draft regulatory legal documents on health:

a) A preliminary impact assessment report shall only be conducted when preparing to draft laws, ordinances, and decrees;

b) The process of conducting a preliminary impact assessment of regulatory legal documents on health shall be carried out in accordance with the provisions set forth in Appendix 5 attached to this Circular.

2. Simple impact assessment of draft regulatory legal documents on health:

a) A simple impact assessment report must be conducted before drafting detailed drafts of laws, ordinances, and decrees;

In cases where the drafting agency determines that the content of the assessment falls under one of the circumstances specified in Clause 3 of this Article, a comprehensive impact assessment may be immediately conducted without the need for a simple impact assessment;

b) The process of conducting a simple impact assessment of regulatory legal documents on health shall be carried out in accordance with the provisions set forth in Appendix 6 attached to this Circular.

3. Comprehensive impact assessment of draft regulatory legal documents on health:

a) A comprehensive impact assessment report shall be conducted in the following cases:

- The document may generate annual costs of 15 billion VND or more for the State, agencies, organizations, or enterprises and individuals;

- The document may affect a large number of businesses;

- The document significantly increases consumer prices;

- The document has many differing opinions, is of public concern, and significantly affects common interests.

b) The process of conducting a comprehensive impact assessment of regulatory legal documents on health shall be carried out in accordance with the provisions set forth in Appendix 6 attached to this Circular.

4. The impact assessment of administrative procedures shall be carried out in accordance with the provisions of Decree No. 63/2010/ND-CP dated June 8, 2010 of the Government on administrative procedure control, Decree No. 48/2013/ND-CP dated May 14, 2013 of the Government amending and supplementing certain articles of related decrees concerning administrative procedure control, and Circular No. 07/2014/TT-BTP dated February 24, 2014 of the Minister of Justice guiding the impact assessment of administrative procedures and the review and assessment of administrative procedures.

Article 17. Documents for Requesting the Examination of Health-related Regulatory Legal Instruments

1. Documents for requesting the Ministry of Justice to examine draft laws, ordinances, decrees on health:

a) Draft proposal report to the Government;

b) Draft law, ordinance, decree;

c) Detailed explanatory memorandum on the draft;

d) Report on the impact assessment of the draft instrument;

đ) Report on the summary and evaluation of the implementation of existing laws (Not applicable for decrees guiding newly enacted laws and ordinances);

e) Summary of opinions received, responses, and explanations according to the form prescribed in Appendix 7 issued together with this Circular;

g) Report on the impact assessment of administrative procedures (if applicable);

h) Other documents (if applicable);

2. Documents for requesting the Ministry of Justice to examine draft decisions of the Prime Minister:

a) Draft proposal report to the Prime Minister;

b) Draft decision of the Prime Minister;

c) Report on the summary and evaluation of the implementation of existing laws (Not applicable for decisions guiding newly enacted laws, ordinances, and decrees);

d) Summary of opinions received, responses, and explanations according to the form prescribed in Appendix 7 issued together with this Circular;

đ) Report on the impact assessment of administrative procedures (if applicable);

3. Documents for requesting the Department of Legal Affairs to examine circulars, joint circulars:

a) Proposal report to the Minister;

b) Draft circular or joint circular;

c) Report on the summary and evaluation of the implementation of existing laws (Not applicable for circulars, joint circulars guiding newly enacted laws, ordinances, decrees, and decisions of the Prime Minister);

d) Summary of opinions received, responses, and explanations according to the form prescribed in Appendix 7 issued together with this Circular;

đ) Report on the impact assessment of administrative procedures (if applicable);

e) Draft consolidated document (only applicable for drafts amending or supplementing circulars, joint circulars);

g) Draft decision on publicizing administrative procedures (if applicable).

Article 18. Pre-examination of Documents Before Requesting the Ministry of Justice to Examine Health-related Regulatory Legal Instruments

1. The main drafting agency has the responsibility to send the documents specified in Clauses 1 and 2 of Article 16 of this Circular to the Department of Legal Affairs for pre-examination before submitting them to the Ministry of Justice for examination at specific times as follows:

a) For draft laws:

- Not later than January 31 of the year in which the document is submitted to the National Assembly for consideration during the mid-year session;

- Not later than June 30 of the year in which the document is submitted to the National Assembly for consideration during the end-of-year session;

b) For draft ordinances: Not later than 180 days prior to the date of submission to the Standing Committee of the National Assembly;

c) For draft decrees: Not later than 30 days prior to the first day of the month in which the draft is expected to be submitted to the Government;

d) For draft decisions of the Prime Minister: Not later than 30 days prior to the first day of the month in which the draft is expected to be submitted to the Prime Minister.

2. Within 10 working days, the Department of Legal Affairs shall organize the pre-examination of the documents for examination:

a) In cases where the documents for examination meet the requirements, the Department of Legal Affairs shall be responsible for co-signing the draft proposal report to the Government and the letter sent to the Ministry of Justice requesting examination;

b) In cases where the documents for examination do not meet the requirements, the Department of Legal Affairs shall be responsible for guiding the main drafting agency to complete the documents.

3. The main drafting agency has the responsibility to submit the documents for examination of laws, ordinances, resolutions, and decrees to the Ministry of Justice after the Department Head signs the letter requesting the Ministry of Justice to conduct the examination.

Deadline for submission to the Ministry of Justice for examination: Not later than the first day of the month in which the draft is expected to be submitted to the Government.

Article 19. Review of Circulars and Joint Circulars

1. Not later than twenty days before the first day of the month when Circulars and Joint Circulars are expected to be submitted for signature by the Ministry's leadership, the drafting agency shall send the request for review to the Legal Department.

2. Within ten working days, the Legal Department shall organize the review of Circulars and Joint Circulars:

a) In case the submitted documents meet the requirements, the Legal Department shall co-sign the draft Circulars and Joint Circulars and the Memorandum requesting the Minister’s signature to issue Circulars and Joint Circulars;

b) In case the submitted documents do not meet the requirements, the Legal Department shall guide the drafting agency to complete the documents.

3. In cases where the content of the document is complex and involves multiple fields, the Legal Department shall establish a review board within ten working days from the date of receipt of the documents and request the drafting agency to report on the draft content at the review meeting.

The review board shall have at least seven members, including:

a) The leader of the Legal Department - Chairman of the Board;

b) Legal and health experts related to the content of the document;

c) Legal Department staff responsible for the field - Secretary of the Board.

4. Within five working days from the end of the review meeting, the Legal Department shall send the minutes of the review to the drafting agency.

5. Upon receiving the minutes of the review, the drafting agency shall be responsible for reporting on the adoption and explanation of the review opinions, completing the draft document, and sending it to the Legal Department for consensus.

6. After receiving the report on the adoption and explanation of the review opinions and the completed draft document from the drafting agency, the Legal Department shall implement the provisions of Clause 2 of this Article.

Article 20. Submission of Draft Laws, Ordinances, and Decrees to the Government

1. Based on the Ministry of Justice's review letter on draft laws, ordinances, and decrees, the drafting agency shall be responsible for:

a) To prepare a report on adopting and explaining the review opinions of the Ministry of Justice;

b) Revising the draft Memorandum to the Government, draft laws, ordinances, and decrees, and other documents in the submission package for draft laws and ordinances to the Government based on the Ministry of Justice's review opinions.

2. After completing the report on the adoption and explanation of the Ministry of Justice's review opinions, the draft Memorandum to the Government, and draft laws, ordinances, and decrees, the drafting agency shall be responsible for:

a) Completing the submission package to the Government:

- Draft laws and ordinances according to Article 37 of the Law on Legislative Documents;

- Draft decrees according to Article 64 of Decree No. 24/2009/NĐ-CP;

b) Sending the submission package for draft laws, ordinances, and decrees to the Legal Department for verification and co-signature on the Memorandum to the Government before submitting it for the Minister's signature.

3. Within five working days, the Legal Department shall verify the submission package for draft laws, ordinances, and decrees:

a) In case the submission package meets the requirements, the Legal Department shall co-sign the Memorandum to the Government and the Memorandum requesting the Minister’s signature to issue the Memorandum to the Government for draft laws, ordinances, and decrees;

b) In case the submission package does not meet the requirements, the Legal Department shall guide the drafting agency to complete the documents.

4. After submitting draft laws, ordinances, and decrees to the Government, the drafting agency shall coordinate with the Government Office in:

a) Editing draft laws, ordinances, and decrees before officially submitting them to the Government;

b) Adopting and explaining the opinions of Government members;

c) In case the draft laws and ordinances are approved by the Government: Completing the draft laws and ordinances and the draft Memorandum to the National Assembly and the Standing Committee of the National Assembly.

Article 21. Submitting draft laws and ordinances to the National Assembly, the Standing Committee of the National Assembly

1. After the Government approves the draft laws and ordinances, the drafting agency shall be responsible for completing the procedures for the Minister of Health to sign on behalf of the Prime Minister regarding the report to the National Assembly and the Standing Committee of the National Assembly on the draft laws and ordinances.

2. Completing the dossier for submitting draft laws and ordinances to the National Assembly in accordance with Article 42 of the Law on Enacting Legal Normative Documents.

3. Cooperating with the National Ethnic Council and the Committee assigned by the National Assembly and the Standing Committee of the National Assembly to examine the draft laws and ordinances during the examination process of the draft laws and ordinances.

In case there are significant changes in structure or content, the drafting agency shall be responsible for reporting to the Minister to seek the Prime Minister's opinion.

Article 22. Submitting draft decisions to the Prime Minister

1. Based on the review letter of the draft decision from the Ministry of Justice, the drafting agency of the decision shall be responsible for:

a) To prepare a report on adopting and explaining the review opinions of the Ministry of Justice;

b) Revising the draft report to the Prime Minister, the draft decision, and other documents in the dossier for submitting the draft decision to the Prime Minister based on the review opinions of the Ministry of Justice.

2. After completing the report on adopting and explaining the review opinions of the Ministry of Justice, the draft report to the Prime Minister, and the draft decision, the drafting agency shall be responsible for:

a) Completing the dossier for submitting the draft decision to the Prime Minister in accordance with Article 32 of Decree No. 24/2009/NĐ-CP;

b) Sending the dossier for submitting the draft decision to the Prime Minister to the Department of Legal Affairs for verification and co-signing the report to the Government before the Minister signs it into effect.

3. Within five working days, the Department of Legal Affairs shall be responsible for verifying the dossier for submitting the draft decision to the Prime Minister:

a) If the dossier for submitting the draft decision to the Prime Minister meets the requirements, the Department of Legal Affairs shall co-sign the report to the Prime Minister and the report to the Minister requesting signature to issue the report to the Prime Minister on the draft decision;

b) If the dossier for submitting the draft decision to the Prime Minister does not meet the requirements, the Department of Legal Affairs shall be responsible for guiding the drafting agency to complete the dossier.

4. After submitting the draft decision to the Prime Minister, the drafting agency shall be responsible for coordinating with the Office of the Government to revise the draft decision before officially submitting it to the Prime Minister for signing into effect.

Article 23. Submitting circulars and joint circulars on health

1. Authority to sign and issue circulars and joint circulars:

a) The Minister signs and issues circulars and joint circulars within the authority of the Ministry of Health;

b) The Deputy Minister signs and issues circulars and joint circulars in areas assigned by the Minister after obtaining written consent from the Minister.

2. The dossier for the Minister to sign and promulgate circulars and joint circulars shall be implemented in accordance with Clause 3, Article 17 of this Circular. For draft circulars and joint circulars, they must have the abbreviated signature of the leader of the Department of Legal Affairs.

3. In cases where the Deputy Minister signs and promulgates the document, the dossier for promulgating circulars and joint circulars must include the authorization document of the Minister for the Deputy Minister to sign and promulgate the document.

- Prime Minister;24Issuance and publication circulars and joint circulars drafted by the Ministry of Health

1. Issuing circulars and joint circulars drafted by the Ministry of Health:

a. After the document is signed and issued, the Office of the Ministry shall be responsible for numbering the document; printing, ensuring the accuracy of the printed material compared to the original; stamping; retaining; sending the document to organizations and individuals listed in the "recipients" section, and returning the dossier for signing to the drafting agency.

b. The drafting agency shall be responsible for sending the Office of the Ministry the electronic file of the document and ensuring the accuracy of the electronic file version of the document.

2. Within two working days from the date of signing and issuing the document, the Office of the Ministry shall be responsible for publishing the circulars and joint circulars drafted by the Ministry of Health:

a. Sending the original document along with the electronic file to the Office of the Government for publication in the Official Gazette according to the regulations on publication in the Official Gazette and for publication on the Government's Electronic Information Portal;

b) Publishing the full text of the document on the Ministry of Health's electronic portal;

c. Sending the document to relevant agencies and units listed in the "recipients" section of the document.

Article 25Correcting legal normative documents

2. After publication in the Official Gazette, if errors in format or presentation techniques are discovered during the drafting process, the leading agency responsible for drafting shall be responsible for drafting a Decision to amend according to the Model prescribed in Appendix 15 attached to this Circular and seeking the Legal Department's opinion before submitting it to the Minister for promulgation.

2. After the legal normative document is published in the Official Gazette, if errors in format or presentation techniques are discovered during the drafting process, the drafting agency shall be responsible for drafting a Decision to correct and seeking the opinion of the Department of Legal Affairs before submitting it to the Minister for issuance.

Chapter IV

IMPLEMENTATION OF LEGAL NORMATIVE DOCUMENTS ON HEALTH AFTER ISSUANCE

Article 26. Allocation of Responsibilities for organizing and implementing health-related regulatory documents

1. The agency assigned to draft health-related regulatory documents shall be primarily responsible for organizing and implementing such documents after they are issued.

2. In cases where laws, ordinances, decrees are drafted under the main responsibility of the Legal Affairs Department, the agency primarily responsible for organizing and implementing such regulatory documents after issuance shall be the agency entrusted with the responsibility to oversee the field regulated by those laws, ordinances, or decrees.

3. Where the content of health-related regulatory documents pertains to the functions, tasks, and authorities of multiple agencies, the agency assigned to draft the document shall have the primary responsibility to coordinate and cooperate with related agencies to organize and implement the document immediately after its issuance.

4. Agencies involved shall have the responsibility to cooperate with the agency assigned to draft the document to organize and implement it according to the provisions of Clause 2 of this Article.

Article 27. Dissemination of Health-Related Regulatory Documents After Issuance

1. Forms of dissemination:

a) Sending copies to related agencies, units, localities, and enforcement entities;

b) Posting on the Ministry of Health's electronic portal;

c) Displaying at the headquarters of the agency;

d) Press conference;

d) Press release (applicable only to decrees and decisions of the Prime Minister);

e) Summarizing the content of the document and posting it on the Health and Life newspaper within three working days from the date of signing and issuing the document;

g) Organizing a conference to disseminate the document (mandatory for laws, ordinances, and decrees);

h) Training sessions for entities responsible for implementing the document;

i) Publishing the full text in medical newspapers and journals;

k) Other appropriate dissemination methods suitable for the nature and scope of regulation of the document.

2. Health-related regulatory documents must be disseminated through at least three of the methods specified in Clause 2 of this Article after issuance.

3. Within fifteen working days from the date the National Assembly or the Standing Committee of the National Assembly approves laws or ordinances, the drafting agency shall be responsible for developing a plan to organize and implement the laws or ordinances to submit to the Minister for review and approval or to the Prime Minister for approval of the plan or issuance of a directive to implement the laws or ordinances that involve the implementation responsibilities of multiple ministries and sectors. If a plan to implement the laws or ordinances is issued, the plan must include at least the following contents:

a) Plan for disseminating laws and ordinances;

b) Plan for drafting regulatory documents guiding the implementation of laws and ordinances, specifying the name of the document, the drafting agency, and the deadline for completing the drafting of the guidance document.

Article 28. CSupplying Information for Building a Press Release on Legal Normative Documents

1. For regulatory documents of the National Assembly and the Standing Committee of the National Assembly:

Within fifteen working days from the date the laws or resolutions of the National Assembly, ordinances or resolutions of the Standing Committee of the National Assembly are approved, the drafting agency shall be responsible for providing information to the Office of the President to prepare press releases and hold press conferences announcing the President's decree promulgating the laws, resolutions of the National Assembly, ordinances, or resolutions of the Standing Committee of the National Assembly.

2. For regulatory documents of the Government and the Prime Minister:

Within five working days from the date the regulatory document of the Government or the Prime Minister is signed and issued, the drafting agency shall be responsible for sending information according to the form attached to Circular No. 12/2013/TT-BTP dated August 7, 2013, of the Minister of Justice regarding the process of issuing press releases on regulatory documents issued by the Government or the Prime Minister in the form of a letter and email to the Ministry of Justice.

3. For circulars issued by the Minister of Health or joint circulars drafted under the main responsibility of the Ministry of Health:

a) Within five working days from the date the regulatory document is issued, the drafting agency shall be responsible for sending a letter clearly stating the name of the document, the date of issuance, the issuing agency, the effective date, the necessity and purpose of issuing the regulatory document, and its main content to the Legal Affairs Department for compilation and editing of the content and preparation of a press release;

b) The press release must be posted on the Ministry's electronic portal and the Health and Life newspaper.

Article 29Consolidation of Legal Normative Documents ON HEALTH

1. Consolidation of health-related regulatory documents applies to documents that amend or supplement certain articles of previously issued documents.

2. The consolidation of health-related regulatory documents shall be carried out in accordance with the provisions of the Law on Consolidation of Regulatory Documents and the procedure for consolidating regulatory documents issued by the Minister of Health.

Article 30. Organization to assess the implementation of legal normative documents on health

1. Laws, ordinances, resolutions, decrees must be organized for assessment of implementation according to the provisions of Article 39 of Decree No. 24/2009/NĐ-CP.

2. For forms of documents not specified in Clause 1 of this Article, the provisions on the time limit for assessment set forth in Decree No. 24/2009/NĐ-CP may not be applied, but such documents must still be assessed within a period not exceeding five years from the date they take effect.

3. In addition to complying with the content assessment provisions stipulated in Clause 2 of Article 39 of Decree No. 24/2009/NĐ-CP, the content of the assessment must also include additional information on the effectiveness of the law, practical effectiveness, feasibility of each regulation, advantages and difficulties in implementing the document, practical issues arising that the current document does not regulate or has overlapping regulations, and proposals for amendments and supplements.

4. The agency assigned the main responsibility for drafting the document shall be responsible for coordinating with relevant agencies (if any) to organize the assessment of legal normative documents on health according to the provisions of Clauses 1 and 2 of this Article.

Chapter V

EXPENSES FOR IMPLEMENTATION

 Article 31. Sources of funding and budget preparation

1. Funding for drafting, promulgating, consolidating legal normative documents on health, disseminating and educating the law, and controlling administrative procedures on health as prescribed in this Circular shall be provided from the Ministry of Health's budget.

2. Annually, based on the plan for drafting, consolidating legal normative documents on health, disseminating and educating the law, and controlling administrative procedures on health approved by the Minister, the Legal Department shall be responsible for coordinating with the Planning and Finance Department to prepare a budget for each activity to be submitted for consideration and decision by the leadership of the Ministry.

3. The Planning and Finance Department shall only allocate funds for legal normative documents included in the annual program for drafting legal normative documents on health of the Ministry of Health after obtaining the agreement of the Legal Department. This source of funding shall be established as a separate item managed by the Ministry's Office.

4. Budget preparation must include funding for organizing the implementation of legal normative documents on health after promulgation, organizing the assessment of implementation, and organizing the translation of documents into English.

Article 32. Use and settlement of funds

1. The use, settlement, and finalization of funding for drafting, consolidating legal normative documents on health, disseminating and educating the law, and controlling administrative procedures on health must comply with the provisions of the law.

2. The Planning and Finance Department shall be responsible for guiding and inspecting the use, settlement, and finalization of funding for drafting, consolidating legal normative documents on health, disseminating and educating the law, and controlling administrative procedures on health in accordance with the prescribed regulations.

Chapter VI

IMPLEMENTING PROVISIONS

Article 33. Cross-referencing Provisions

In cases where the referenced documents in this document are replaced or amended, implementation shall be in accordance with the replacement or amended document.

Article 34. Effective Date

1. This Circular takes effect from August 15, 2014.

2. Decision No. 4278/2004/QĐ-BYT dated December 1, 2014 of the Minister of Health on the issuance of the Regulation on drafting, promulgating, and organizing the implementation of legal normative documents on health shall cease to be effective from the date this Circular takes effect.

Article 35. Responsibility for Implementation

The Head of the Legal Department, the Director of the Ministry's Office, Heads of Departments, Directors of Bureaus, and General Directors of the Departments, Bureaus, and General Departments under the Ministry of Health are responsible for enforcing this Circular.

In the course of implementation, if there are difficulties or obstacles, units shall report to the Ministry of Health (Legal Affairs Department) for study and resolution./.