Circular No. 29/2019/TT-BYT stipulates the construction, issuance, and implementation of legal documents on health.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

1. This Circular stipulates on the preparation of proposals for the program to establish legal normative documents on health; drafting, reviewing, submitting for issuance, organizing implementation, monitoring enforcement of legal normative documents, updating the national database on legal normative documents, and funding for establishing legal normative documents on health.

2. The drafting and issuance of Circulars on national technical standards in the field of health shall be carried out in accordance with the provisions of the law on technical standards and the provisions of this Circular.

Article 2. Applicability

This Circular applies to the General Department, Bureaus, Departments, Office of the Ministry, the Ministry Inspectorate (hereinafter referred to as units under the Ministry), organizations, and individuals related to the work of establishing and issuing legal normative documents within the scope of management of the Ministry of Health.

Article 3. Directing the work of establishing and issuing legal normative documents

1. The Minister directs comprehensively the work of establishing, reviewing, and issuing legal normative documents of the Ministry of Health.

2. Deputy Ministers implement the direction of establishing, reviewing, and issuing legal normative documents according to the assigned fields and report to the Minister before signing for issuance.

Article 4. Format and technical presentation of regulatory legal documents

1. The format and presentation techniques of legal normative documents of the National Assembly, Standing Committee of the National Assembly, President of the State shall be implemented in accordance with the Resolution No. 351/2017/UBTVQH14 dated March 14, 2017 of the Standing Committee of the National Assembly on the format and presentation techniques of legal normative documents of the National Assembly, Standing Committee of the National Assembly, President of the State.

2. The format and presentation techniques of legal normative documents not falling under the cases prescribed in Clause 1 of this Article shall be implemented in accordance with Chapter V of Decree No. 34/2016/NĐ-CP dated May 14, 2016 of the Government detailing some articles and measures to implement the Law on Issuing Legal Normative Documents (hereinafter referred to as Decree No. 34/2016/NĐ-CP).

Article 5. Impact assessment of administrative procedures in the establishment and issuance of legal normative documents containing administrative procedures

1. During the process of preparing proposals for establishment, drafting, and issuance of documents, units under the Ministry shall be responsible for organizing the impact assessment of administrative procedures and building reports on the impact assessment of administrative procedures in accordance with 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 relevant decrees concerning administrative procedure control; Decree No. 92/2017/NĐ-CP dated August 7, 2017 of the Government amending and supplementing certain articles of relevant decrees concerning administrative procedure control, and other legal normative documents related to administrative procedure control.

2. Reports on the impact assessment of administrative procedures must be sent to the Administrative Procedure Control Bureau of the Government Office, the Ministry Office for comments and sent to the Legal Affairs Department for internal review together with the proposal dossier for establishing legal normative documents on health.

3. When summarizing and concluding the monitoring and evaluation of the enforcement of legal normative documents after issuance, the leading agency must assess the impact of administrative procedures to review and consider amending and supplementing administrative procedures.

Article 6. Industry and profession supervisionconditional investment and business and conditions for investment and business

1. For proposals to establish laws, ordinances, decrees that contain business conditions, the leading unit shall be responsible for organizing the review of business conditions and clearly stating these contents in the proposal for establishing legal documents in accordance with Clause 2 of Article 14 of Decree No. 118/2015/NĐ-CP dated November 12, 2015 of the Government detailing and guiding the implementation of certain articles of the Investment Law (hereinafter referred to as Decree No. 118/2015/NĐ-CP).

2. The leading unit shall be responsible for reporting to the Ministry's leadership to sign a document seeking opinions from the Ministry of Planning and Investment, the Ministry of Justice, and relevant ministries and sectors on the contents that have been established in accordance with Clause 1 of this Article.

3. The dossier for proposing to draft legal documents submitted to the Legal Affairs Department for review and internal review must include a report on the results of the review and assessment of business conditions attached or incorporated into the explanatory report and submission.

4. Annually and upon the management requirements of the Ministry, units shall be responsible for reviewing and assessing the implementation of regulations on industries and professions subject to conditions and business conditions within their management scope in accordance with Article 15 of Decree No. 118/2015/NĐ-CP and submit a review report to the Legal Affairs Department before November 15 each year to propose the establishment and issuance of legal normative documents to amend and supplement industries and professions subject to conditions or business conditions.

Article 7. Research and propose the development of legal normative documents on health

1. Units under and directly affiliated with the Ministry of Health shall be responsible for researching and assessing the need to develop legal normative documents, and proposing to the Ministry's leadership for consideration to include in the annual plan for developing legal normative documents on health.

2. The Legal Department shall be responsible for organizing independent research and assessment of the need to develop legal normative documents on health by the Ministry of Health, and reviewing proposals for developing legal normative documents from units, reporting to the Ministry's leadership for consideration to include in the annual plan for developing legal normative documents on health.

Chapter II

SETTING PROPOSAL TO DRAFT REGULATORY LEGAL DOCUMENTS

Section 1

PROPOSAL TO DRAFT REGULATORY LEGAL DOCUMENTS OF THE NATIONAL ASSEMBLY AND THE STANDING COMMITTEE OF THE NATIONAL ASSEMBLY SUBMITTED BY THE GOVERNMENT

Article 8. 3. Amend Clause 3 Article 2 as follows:Request to develop laws, ordinances, resolutions

1. The process of establishing requests to develop legal normative documents as stipulated in Articles 9, 10, 11, 12, and 13 of this Circular applies to:

a) Laws of the National Assembly;

b) Resolutions of the National Assembly as provided for in point b and point c, Clause 2, Article 15 of the Law on Enacting Legal Normative Documents (hereinafter referred to as the Law).

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

d) Resolutions of the Standing Committee of the National Assembly as provided in point b, Clause 2, Article 16 of the Law.

2. Prior to implementing the establishment of requests to develop laws, ordinances, and resolutions as stipulated in Clause 1 of this Article, the leading unit under the Ministry must prepare a Plan for Establishing Requests to Develop Laws, Ordinances, and Resolutions according to the Model prescribed in Appendix 1 issued together with this Circular, and submit it to the Legal Department for comments before reporting to the Ministry's leadership for consideration and approval.

Article 9. File for requesting to develop laws, ordinances, and resolutions

1. The unit requesting to develop laws, ordinances, and resolutions shall be responsible for preparing the file for requesting to develop laws, ordinances, and resolutions, including the documents prescribed in Clause 1, Article 37 of the Law.

In cases where the request to develop a document includes content on administrative procedures, the file for establishing the request must include a report on the impact assessment of administrative procedures as prescribed in Article 5 of this Circular.

In cases where the request to develop a document includes industries or business sectors subject to conditional investment and business conditions, the file for establishing the request must include the documents prescribed in Article 6 of this Circular.

2. The process of formulating policy content and assessing the impact of policies in proposals to draft laws, ordinances, and resolutions shall be carried out in accordance with the provisions of Section 1 Chapter II of Decree No. 34/2016/NĐ-CP.

Article 10. Solicit opinions on requests to develop laws, ordinances, and resolutions

The unit requesting to develop laws, ordinances, and resolutions shall be responsible for organizing the solicitation of opinions from entities directly affected by the policies proposed in the request to develop laws, ordinances, and resolutions, and soliciting opinions from relevant agencies, organizations, and individuals through the forms prescribed in Article 36 of the Law and Article 10, Article 11 of Decree No. 34/2016/NĐ-CP.

Article 11. Internal review by a) Providing testimonies and expert opinions for the case for which they have been summoned; the Legal Department proposal to draft laws, ordinances, resolutions

1. The Legal Department shall be responsible for conducting internal reviews of requests to develop laws, ordinances, and resolutions prepared by units under the Ministry before submitting them to the Ministry of Justice for review. For documents related to citizens' rights and legitimate interests or businesses, or in other necessary cases, to ensure proactivity and improve the quality of the review, the Legal Department shall organize independent evaluations, studies, surveys, and solicitations of opinions on the files for requesting to develop laws, ordinances, and resolutions.

The file submitted for internal review by the Legal Department shall include the documents prescribed in Clause 1, Article 9 of this Circular.

By no later than October 1st each year, the unit requesting to develop laws, ordinances, and resolutions must submit the file for requesting to develop to the Legal Department for internal review.

2. The Legal Department shall organize an internal review board meeting on the files for requesting to develop laws, ordinances, and resolutions within 15 days from the date of receipt of complete files sent by the requesting unit.

3. The review shall focus on the issues prescribed in Clause 3, Article 39 of the Law.

4. The review report must clearly reflect the Legal Department's opinion on the content reviewed as stipulated in Clause 3 of this Article and on whether the request to develop laws, ordinances, and resolutions meets the conditions to be submitted to the Ministry of Justice for review before being submitted to the Government for consideration and approval according to the Model prescribed in Appendix 2 issued together with this Circular.

Article 12. Incorporate and explain opinions oninternal review by the Legal Department and submit for leadership signature to send for review The unit requesting to develop laws, ordinances, and resolutions shall be responsible for studying, incorporating, and explaining the Legal Department's review opinions to refine and perfect the file for requesting to develop laws, ordinances, and resolutions, and submitting the signed letter from the Ministry's leadership to the Ministry of Justice for review according to Clause 2, Article 39 of the Law. proposal to draft laws, ordinances, resolutions

of the Ministry of Justice and submit for the Government's consideration and approval of the request to develop laws, ordinances, and resolutions

Article 13. Incorporate and explain opinions oninternal 1. The unit requesting to develop laws, ordinances, and resolutions shall be responsible for studying, explaining, and incorporating the Ministry of Justice's review opinions to refine and perfect the request to develop laws, ordinances, and resolutions; simultaneously sending the refined request to develop laws, ordinances, and resolutions along with the explanation report to the Legal Department for written comments before submitting to the Ministry of Justice according to Clause 3 of this Article.Within five days from the date of receiving the request for comments from the unit, the Legal Department must provide a written response to the unit, which must clearly reflect the opinion on the incorporated content and explanations and on whether the request to develop laws, ordinances, and resolutions meets the conditions to be submitted to the Ministry of Justice before being submitted to the Government.

2. After receiving the Ministry of Justice's review opinions, the requesting unit shall be responsible for incorporating and explaining the review opinions and submitting them to the Legal Department for written comments before submitting to the Government.

Within five days from the date of receiving the request for comments from the unit, the Legal Department must provide a written response to the unit, which must clearly reflect the opinion on the incorporated content and explanations and on whether the request to develop laws, ordinances, and resolutions meets the conditions to be submitted to the Government.

3. The unit requesting to develop laws, ordinances, and resolutions shall be responsible for coordinating with the Legal Department to report to the Ministry's leadership for submission to the Government for consideration and approval of the request to develop laws, ordinances, and resolutions at least 20 days before the Government convenes its session. The file submitted to the Government shall include the documents prescribed in Clause 2, Article 40 of the Law.

Within five days from the date of receipt of the request letter for comments, the Department of Legal Affairs must issue a response document to the requesting unit, which must clearly express the opinion on the content to be adopted, explanations, and whether the proposal for the enactment of laws, ordinances, and resolutions meets the conditions for submission to the Government or not.

3. The unit proposing the enactment of laws, ordinances, and resolutions shall be responsible for coordinating with the Department of Legal Affairs to report to the Ministry's leadership for submission to the Government for consideration and approval of the proposal for the enactment of laws, ordinances, and resolutions no later than twenty days before the date of the Government's session. The dossier submitted to the Government shall include the documents specified in Clause 2 of Article 40 of the Law.

4. On the basis of the Government's resolution approving the proposal to draft laws, ordinances, and resolutions, the proposing unit shall be responsible for taking the lead and coordinating with the Legal Department to complete the proposal dossier for drafting laws, ordinances, and resolutions to submit to the Ministry's leadership for approval no later than December 15th each year, in accordance with Clause 5 of this Article, to send to the Ministry of Justice as stipulated.

5. No later than December 31st each year, the proposal dossier for drafting laws, ordinances, and resolutions that have been approved by the Ministry's leadership in accordance with Clause 4 of this Article must be sent to the Ministry of Justice to establish the Government's proposal on the legislative program for the following year.

For example, no later than December 31, 2016, the proposal dossier for drafting laws and ordinances must be sent to the Ministry of Justice to establish the Government's proposal on the legislative program for 2018.

Section 2

SETTING PROPOSAL TO DRAFT REGULATORY LEGAL DOCUMENTS

OF THE GOVERNMENT, THE PRIME MINISTER

Article 14. Proposal to draft decrees provided for in Clause 2 and Clause 3 of Article 19 of the Law

1. The proposing units for decrees under the provisions of Clauses 2 and 3 of Article 19 of the Law shall be responsible for preparing the proposal dossier for drafting decrees comprising the documents prescribed in Article 87 of the Law. In cases where the proposal involves administrative procedures, the proposing unit shall supplement the documents as prescribed in Article 5 of this Circular. In cases where the proposal involves industries and trades subject to conditional business operations and business conditions, the proposing unit shall supplement the documents as prescribed in Article 6 of this Circular.

The construction of policy content and impact assessment in the proposal to draft a decree shall be carried out in accordance with the provisions of Clause 2 of Article 9 of this Circular.

2. The proposing units for decrees shall be responsible for soliciting opinions from entities directly affected by the policies proposed in the decree proposals; soliciting opinions from relevant agencies and organizations through the methods prescribed in Article 86 of the Law and Articles 10 and 11 of Decree No. 34/2016/NĐ-CP.

3. The Legal Department shall be responsible for internal review of the proposal dossiers for drafting decrees submitted by units under the Ministry before sending them to the Ministry of Justice for review. When necessary, to ensure proactivity and enhance the quality of the review, the Legal Department may organize evaluations, studies, surveys, and independent opinion solicitation regarding the proposal dossiers for drafting decrees.

The dossier submitted for internal review by the Legal Department includes the documents prescribed in Clause 1 of this Article.

4. The Legal Department shall conduct internal review of the proposal dossiers for drafting decrees within fifteen days from the date of receipt of the complete dossier submitted by the proposing units.

The review focuses on the issues prescribed in Clause 3 of Article 88 of the Law. The review report must clearly reflect the Legal Department's opinion on whether the proposal dossier for drafting the decree meets the conditions, needs further refinement, or does not meet the conditions for submission to the Ministry of Justice for review prior to submission to the Government for consideration and approval in accordance with the Model prescribed in Appendix 2 issued together with this Circular.

5. The proposing units shall be responsible for studying and incorporating the Legal Department's review opinions to refine and perfect the proposal dossier for drafting the decree and submit it to the Ministry's leadership for approval before submitting it to the Ministry of Justice for review in accordance with Clause 2 of Article 88 of the Law.

6. Based on research, explanations, and incorporation of the Ministry of Justice's review opinions, the proposing units for decrees shall be responsible for taking the lead and coordinating with the Legal Department to refine and perfect the proposal dossier for drafting the decree to submit to the Ministry's leadership for approval before submitting it to the Government for consideration and approval in accordance with Clause 2 of Article 89 of the Law.

Article 15. Proposal to draft decrees provided for in Clause 1 of Article 19 of the Law, decision of the Prime Minister

1. For decrees provided for in Clause 1 of Article 19 of the Law, the proposal dossier shall include:

a) An explanation of the proposal to draft the decree, specifying the name of the document; the necessity and legal basis for issuing the document; the basic policy and main content of the document; proposals for amending, supplementing, or replacing industries and trades subject to conditional business operations and business conditions as prescribed in Article 6 of this Circular;

b) A draft outline of the decree and information about the leading agency drafting the document, resources ensuring the work of drafting the document, and the expected time to submit to the Government (specific to the month);

c) An assessment of administrative procedures (if there are administrative procedures);

d) Opinions of relevant agencies and units as prescribed in Clause 3 of this Article.

2. For decisions of the Prime Minister, the proposal dossier shall include:

a) An explanation of the proposal to draft the decision, specifying the name of the document; the necessity and legal basis for issuing the document; the main content of the document;

b) A draft outline of the decision and information about the leading agency drafting the document, resources ensuring the work of drafting the document, and the expected time to submit to the Prime Minister (specific to the month);

c) An assessment of the proposed administrative procedures (if applicable);

d) Opinions of relevant agencies and units as prescribed in Clause 3 of this Article.

3. Before submitting to the Legal Department for internal review, the proposing units for regulatory legal documents prescribed in Clauses 1 and 2 of this Article shall be responsible for sending the dossier to relevant agencies and units as prescribed in Article 5 of this Circular to solicit opinions if the content is related to administrative procedures; sending the dossier to solicit opinions if the content is related to industries and trades subject to conditional business operations and business conditions as prescribed in Article 6 of this Circular.

4. The Legal Department shall be responsible for conducting internal review of the proposal dossiers for drafting decrees and decisions of the Prime Minister submitted by units under the Ministry before sending them to the Ministry of Justice for review. When necessary, to ensure proactivity and enhance the quality of the review, the Legal Department may organize evaluations, studies, surveys, and independent opinion solicitation regarding the proposal dossiers for drafting decrees and decisions of the Prime Minister.

The dossier submitted for internal review by the Legal Department includes the documents prescribed in Clauses 1 and 2 of this Article.

5. The Legal Department shall conduct internal review of the proposal dossiers for drafting decrees and decisions of the Prime Minister within ten days from the date of receipt of the complete dossier submitted by the proposing units.

The content of the review focuses on the issues stipulated in Clause 3, Article 88 of the Law. The review report must clearly reflect the opinion of the Legal Department regarding whether the dossier for proposing to establish decrees and decisions of the Prime Minister meets the conditions, needs further improvement, or does not meet the conditions, before being submitted to the Ministry of Justice for review prior to submission to the Government for consideration and approval according to the Model prescribed in Appendix 2 issued together with this Circular.

6. The unit proposing to establish has the responsibility to study and incorporate the Legal Department's review opinions to revise and perfect the dossier for proposing to establish decrees and decisions of the Prime Minister, and submit it to the Ministry's leadership for submission to the Ministry of Justice for review in accordance with Clause 2, Article 88 of the Law.

7. Based on research, explanation, and incorporation of the Ministry of Justice's review opinions, the unit proposing to establish decrees shall be responsible for leading and coordinating with the Legal Department to revise and perfect the dossier for proposing to establish decrees and decisions of the Prime Minister, and submit it to the Ministry's leadership for approval before submitting to the Government for consideration and approval in accordance with Clause 2, Article 89 of the Law.

Chapter III

ESTABLISHING THE PROGRAM TO BUILD

LEGAL DOCUMENTS ON HEALTH

Article 16. Program and plan to build legal documents on health

1. The program to build laws, ordinances, and resolutions on health of the National Assembly and the Standing Committee of the National Assembly.

2. The program to build legal documents on health of the Government annually.

3. The annual plan to build legal documents on health of the Ministry of Health including the Official Plan and the Preparation Plan.

Article 17. Program to build laws and ordinances on health of the National Assembly and the Standing Committee of the National Assembly annually

1. The unit proposing to build laws, ordinances, and resolutions has the responsibility to prepare the dossier for proposing to build laws and ordinances, including the documents prescribed in Clause 1, Article 37 of the Law.

2. The process of formulating policy content and assessing the impact of policies in proposals to draft laws, ordinances, and resolutions shall be carried out in accordance with the provisions of Section 1 Chapter II of Decree No. 34/2016/NĐ-CP.

3. The deadline for submitting the dossier for proposing to build laws and ordinances on health annually to the Legal Department is no later than October 1st of the year preceding the year in which they are expected to be submitted to the National Assembly and the Standing Committee of the National Assembly.

4. The agency proposing to build the document has the responsibility to seek the opinion of the Ministry's leadership through a meeting or via the Request for Opinion Form according to the Model prescribed in Appendix 3 issued together with this Circular.

5. Based on the proposal of the agency proposing to build the document, the Legal Department has the responsibility to:

a) Organize the review on the necessity of issuing laws and ordinances on health;

b) Coordinate with the agency proposing to build the document to seek the opinion of the Ministry's leadership;

c) Compile the dossier and guide the agencies proposing to build the document to complete the dossier to be submitted to the Ministry of Justice after receiving the opinion of the Ministry's leadership;

d) Submit to the Minister for consideration and signature of a letter to the Ministry of Justice requesting inclusion in the annual program to build laws and ordinances of the National Assembly;

đ) In cases where necessary, to ensure proactivity and improve the quality of the review, the Legal Department organizes evaluation, research, surveys, and independent opinions on the dossier for proposing to build laws and ordinances annually of the National Assembly.

Article 18. Annual Work Program of the Government

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

a) Laws and resolutions of the National Assembly; ordinances and resolutions of the Standing Committee of the National Assembly that provide for the Government to issue guiding documents;

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

c) Results of reviewing, systematizing, codifying, and monitoring the implementation of health-related laws;

d) Necessary measures of the Government to implement the Law.

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

a) For laws and ordinances proposed to be submitted to the Government: The dossier is implemented in accordance with Clause 1, Article 37 of the Law;

b) For decrees prescribed in Clause 2 and Clause 3, Article 19 of the Law: The dossier is implemented in accordance with Article 14 of this Circular;

c) For decrees prescribed in Clause 1, Article 19 of the Law, and decisions of the Prime Minister: The dossier is implemented in accordance with Article 15 of this Circular.

3. By no later than October 1st each year, the agencies proposing to build the document have the responsibility to submit the dossier for proposing to include legal documents on health in the annual Work Program of the Government to the Legal Department.

4. The agency proposing to build the document has the responsibility to seek the opinion of the Ministry's leadership through a meeting or via the Request for Opinion Form according to the Model prescribed in Appendix 3 issued together with this Circular.

5. Based on the proposals of the agencies proposing to build the document, the Legal Department has the responsibility to:

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

b) Coordinate with the main drafting agency to seek the opinion of the Ministry's leadership;

c) Compile the dossier and guide the agencies proposing to build the document to complete the dossier after receiving the opinion of the Ministry's leadership for the Legal Department to compile;

d) Submit to the Minister for signing a letter on the annual program to build legal documents of the Government;

đ) In cases where necessary, to ensure proactivity and improve the quality of the review, the Legal Department organizes evaluation, research, surveys, and independent opinions on the dossier for the annual program to build legal documents of the Government.

Article 19. Drafting Plan for Legislative Acts on Health ON HEALTH Annually of the Ministry of Health

1. Basis for drafting the annual Plan for Legislative Acts on Health of the Ministry of Health:

a) Laws and resolutions of the National Assembly; ordinances and resolutions of the Standing Committee of the National Assembly; decisions of the President; decrees of the Government; decisions of the Prime Minister that stipulate the assignment to the Minister of Health to provide guidance on implementation;

b) The annual program of work of the Government;

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

d) Necessary measures to implement the State management functions of the Ministry of Health.

2. By no later than November 1st each year, agencies proposing to draft legislative acts must submit the proposal dossier for the next year's legislative acts on health to the Legal Department. The dossier includes:

a) List of documents according to the Model prescribed in Appendix 4 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 5 issued together with this Circular;

c) Proposed plan for organizing the drafting of documents according to the Model prescribed in Appendix 6 issued together with this Circular;

d) Estimated budget for drafting the documents;

đ) In cases where it is proposed to draft legislative acts to amend or supplement previously issued legislative acts, the dossier must include a report summarizing and evaluating the enforcement of the legislative act to be amended or supplemented (except in cases of immediate amendment or supplementation upon issuance due to errors discovered);

3. Based on the proposals of agencies proposing to draft documents, the Legal Department is responsible for reviewing and drafting the annual Plan for Legislative Acts on Health of the Ministry of Health, including the Official Plan according to the Model prescribed in Appendix 7 issued together with this Circular and the Preparation Plan according to the Model prescribed in Appendix 8 issued together with this Circular to be submitted to the Minister for signature before December 31st each year.

When necessary, to ensure proactivity, improve quality, and feasibility of the Plan, the Legal Department organizes evaluations, studies, surveys, and independent opinions on the Plan dossier for legislative acts on health annually of units.

Article 20. Monitoring and Adjusting the Plan for Drafting Legislative Acts ANNUAL REPORT ON HEALTH OF THE MINISTRY OF HEALTH

Annually of the Ministry of Health

1. Completion of drafting documents within the Official Plan and the Preparation Plan serves as the basis for assessing competition, rewarding, and internal administrative reform scoring of units under the Ministry. The Official Plan is the basis sent to the Ministry of Home Affairs for scoring the administrative reform of the Ministry of Health and serves as the basis for evaluating the completion of tasks by civil servants.

2. Based on the annual Plan for Drafting Legislative Acts on Health of the Ministry of Health approved by the Minister of Health, agencies primarily responsible for drafting documents are responsible for completing the plan for organizing the drafting of documents according to the Model prescribed in Appendix 6 issued together with this Circular and submitting it to the Legal Department before January 20th of the year implementing the Plan.

3. Regularly once a month (on the 15th of the reporting month), units are responsible for reporting the progress of their own organization's drafting plan to the Legal Department. After receiving reports from units, the Legal Department is responsible for compiling the progress of drafting of documents to report to the Minister of Health.

4. Adjustments to the annual Plan for Drafting Legislative Acts on Health of the Ministry of Health are carried out regularly in October each year.

5. When there is a need to adjust the Plan for Drafting Documents, the primary drafting unit sends the proposed adjustment to the Legal Department:

a) In cases where it is proposed to adjust the time for submitting documents or removing them from the Official Plan or transferring them from the Official Plan to the Preparation Plan: The adjustment proposal document must clearly state the reasons for the adjustment accompanied by the agreement of the Deputy Minister in charge of the field;

b) In cases where it is proposed to transfer documents from the Preparation Plan to the Official Plan: The adjustment proposal document accompanied by the dossier prescribed in Article 32 of this Circular;

c) In cases where it is proposed to add documents to the Plan: The adjustment proposal document accompanied by the dossier prescribed in Clause 2 of Article 19 of this Circular.

Based on the proposals of the agency primarily responsible for drafting documents, the Legal Department is responsible for reviewing and submitting to the Minister for consideration and decision.

Article 21. Preliminary review, summary, and evaluation of the implementation of laws related to drafting health regulatory documents

1. The summary and evaluation of the implementation of legal documents shall be carried out three years after the date the document takes effect.

2. Cases requiring the implementation of the summary and evaluation of the implementation of laws:

a) Before proposing to draft a Law, Ordinance, or Decree as stipulated in Clause 3, Article 19 of the Law;

b) Before proposing to draft a document to amend, supplement, or replace health regulatory documents, except for cases where a new document is issued but must be amended or supplemented due to errors discovered;

c) After inspecting, reviewing, and systematizing documents that contain content contrary to the law, failing to ensure constitutional and legal validity, consistency, and feasibility of the document.

3. The leading agency drafting regulatory documents shall implement the preliminary review, summary, and evaluation of the implementation of laws.

4. Procedures for implementing the summary and evaluation of 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) Survey and evaluate the practical activities of state management concerning the content planned for drafting health regulatory documents to provide evidence to support findings from 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.

In cases of drafting laws, ordinances, or decrees on health, it is necessary to include a section referencing international law in the report on the summary and evaluation of the implementation of laws.

Chapter IV

DRAFTING HEALTH REGULATORY DOCUMENTS

Article 22. Establishment of the Drafting Board

1. Regulatory documents that must establish a Drafting Board:

a) Laws, resolutions of the National Assembly, Ordinances, and resolutions of the Standing Committee of the National Assembly submitted by the Government, except for cases stipulated in Clause 1, Article 52 of the Law;

b) Decrees of the Government.

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

3. The composition of the Drafting Board shall be implemented according to the provisions of Article 53 and Point b, Clause 2, Article 90 of the Law.

4. The organization and operation of the Drafting Board shall be carried out according to the provisions of Articles 54 and 55 of the Law and Article 26 of Decree No. 34/2016/NĐ-CP.

5. The Decision to establish the Drafting Board shall follow the Model prescribed in Appendix 9 attached to this Circular.

Article 23. Establishment of the Editorial Team

1. The Editorial Team has the responsibility to assist the Drafting Board.

2. Members of the Editorial Team shall be appointed by agencies or organizations represented as members of the Drafting Board; experts and scientists shall be invited by the leading drafting agency and shall not exceed one-third of the members being experts from the leading drafting agency. In cases where the document includes administrative procedures, the Editorial Team must have a representative from the Administrative Procedure Control Department of the Ministry's Office.

The head of the Editorial Team shall be a member of the Drafting Board, designated by the Head of the Drafting Board, responsible for reporting to the Head of the Drafting Board about assigned tasks. Members of the Editorial Team shall participate fully in the activities of the Editorial Team and be subject to the assignment of the head of the Editorial Team.

3. In cases where a Drafting Board is not established, the leading drafting agency may establish an Editorial Team with a composition as stipulated in Clause 2 of this Article.

4. The Model for the Decision to establish the Editorial Team is prescribed in Appendix 10 attached to this Circular.

Article 24. Drafting the preliminary outline of the draft legal normative document on health

1. The preliminary outline of the draft legal normative document must clearly reflect the basic contents regarding structure, scope of regulation, and names of main articles in the draft legal normative document, while also 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 main policy and legal orientation 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 the Decree of the Government or Decision of the Prime Minister detailing the implementation of Laws or Ordinances: The outline must reflect the consistency in policy and legal orientation with the Laws or Ordinances being guided, while also clearly reflecting the management viewpoint on the issues intended to be guided.

For the Decree of the Government or Decision of the Prime Minister not detailing the implementation of Laws or Ordinances: The outline must clearly reflect the policy and legal orientation for the content that the draft Decree or Decision intends to regulate.

c) For the preliminary outline of the draft Circular or Joint Circular: The outline must reflect the consistency in policy orientation suitable with the document being guided, while also clearly reflecting the management viewpoint on the issues intended to be guided, and the content of the draft document intended to regulate.

Article 25. Soliciting Opinions on the Preliminary Outline of the Draft Legal Normative Document on Health

1. Depending on the nature of the draft legal normative document on health, the drafting agency decides on the form and object of soliciting opinions according to the provisions of Article 27 of this Circular.

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 Team must organize a meeting of the Drafting Board to unify the preliminary outline before drafting the detailed draft of the Law, Ordinance, or Decree.

Article 26. Drafting the Detailed Draft of the Draft Legal Normative 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) In cases where administrative procedures are prescribed, it must ensure the requirements stipulated in Decree No. 63/2010/NĐ-CP dated June 8, 2010 of the Government on controlling administrative procedures;

d) In cases where the draft legal normative document on health prescribes conditions, responsibilities, obligations, or resources for implementing healthcare services or activities but cannot be immediately applied at the time the legal normative document on health comes into effect or has a phased implementation plan, there must be transitional provisions, clearly specifying how these provisions will be applied.

Article 27. 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) Publishing the full text of the draft document on the Government Portal, the Ministry of Health Portal, or the drafting agency's website (if available) at least 60 days before requesting pre-filing review prior to requesting the Ministry of Justice to examine the provisions under Clause 1, Article 31 of this Circular or requesting examination of the provisions under Clause 2, Article 31 of this Circular;

c) Organizing seminars, conferences, meetings.

2. The entities requested to participate in providing opinions are agencies, organizations, individuals within the scope regulated by the regulatory legal document, related fields, and citizens, specifically as follows:

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

b) Provincial Health Departments (hereinafter referred to as Health Departments);

c) Vietnam Medical Association, social occupational organizations, associations, unions;

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, ministerial-level agencies, government agencies, and provincial People's Committees for draft laws, ordinances, resolutions, decrees, and decisions of the Prime Minister;

l) Other entities depending on the scope of regulation of the draft regulatory legal document.

3. The number of times opinions are solicited shall be decided by the drafting agency based on the nature and complexity of the document but must meet 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, joint circulars: Entities specified in Points a, b, l, and k of Clause 2 of this Article; entities specified in Point k of Clause 2 of this Article for documents that require consensus before issuance.

4. In cases where new policies are added during the drafting process of regulatory legal documents, comprehensive opinions from relevant entities must be sought regarding the new policy content.

5. The entities solicited to provide opinions on regulatory legal documents as stipulated in this Article are responsible for replying within the prescribed time frame, being accountable for the content of their opinions, and submitting their opinions to the leading drafting agency according to the deadline set in the document requesting opinions.

Article 28. Soliciting Opinions on Administrative Procedures

1. Before submitting to the Legal Affairs Department for internal review or at least 60 days of review or at least 20 days of review for administrative procedures issued under the expedited procedure, the agency responsible for drafting must send for opinions from the administrative procedure control agency according to the following provisions:

a) The Administrative Procedure Control Bureau of the Government Office for administrative procedures stipulated in draft normative legal documents submitted to the National Assembly by the Government, the Standing Committee of the National Assembly, draft normative legal documents within the authority of the Government to issue, and draft normative legal documents of the Prime Minister;

b) The Ministry's Office for administrative procedures stipulated in draft normative legal documents within the authority of the Minister of Health to issue, and draft joint circulars between the Minister of Health and the President of the Supreme People's Court, the Procurator General of the Supreme People's Procuracy.

2. Within ten working days, the Ministry's Office shall be responsible for providing comments on the regulations concerning administrative procedures in draft normative legal documents.

3. The dossier for soliciting opinions on the regulations concerning administrative procedures in draft normative legal documents within the authority of the Minister of Health to issue shall be implemented in accordance with Clause 2, Article 9 of Decree No. 63/2010/NĐ-CP.

Article 29. Consolidating, adopting opinions, and revising draft normative legal documents

1. The main drafting unit shall be responsible for consolidating, studying, adopting, and explaining opinions of agencies, organizations, and individuals according to the Model prescribed in Appendix 11 attached to this Circular. In cases where there are sufficient reasons to not adopt the opinions, the main drafting unit must provide detailed explanations accompanied by relevant data and documents (if available).

2. After revising the draft normative legal document according to the provisions of Clause 1 of this Article, the main drafting unit shall report and seek guidance from the Ministry Leader in charge regarding the progress, content, complex issues, and differing opinions on the draft normative legal document according to the Model prescribed in Appendix 12 attached to this Circular.

After receiving guidance from the Ministry Leader in charge, the main drafting unit shall be responsible for revising the draft normative legal document. If necessary, the main drafting unit may continue to solicit opinions from related agencies, units, organizations, and individuals both inside and outside the Ministry.

3. The main drafting unit shall be responsible for sending the consolidated version of adopted opinions and explanations of opinions of agencies, organizations, and individuals along with the draft document for soliciting opinions to be published on the Ministry of Health's website, the main drafting agency's website, and the Legal Affairs Department's website, and updating it according to each round of solicitation.

Article 30. Drafting Normative Legal Documents According to Expedited Procedures

Laws, resolutions of the National Assembly; ordinances, resolutions of the Standing Committee of the National Assembly; decrees of the Government, decisions of the Prime Minister in cases of emergency or to suspend the entire or part of the effectiveness of normative legal documents for a certain period or to immediately amend them to comply with newly issued normative legal documents shall be drafted and issued according to the expedited procedures prescribed in Articles 146, 147, 148, and 149 of the Law.

Article 31. Submitting Dossier of Draft Normative Legal Documents for the Legal Affairs Department to ReviewInternal Review

1. The main drafting unit shall be responsible for submitting the dossier of draft normative legal documents within the authority of the National Assembly, the Standing Committee of the National Assembly, the Government, and the Prime Minister to the Legal Affairs Department for internal review before submitting to the Ministry Leader for consideration and submission to the Ministry of Justice for review in accordance with the Law.

2. The main drafting unit shall be responsible for submitting the dossier of draft circulars to the Legal Affairs Department for review before submitting to the Ministry Leader for consideration and signing for issuance.

3. Time limit for submitting the dossier for review:

a) The dossier of draft normative legal documents within the authority of the National Assembly, the Standing Committee of the National Assembly, the Government, and the Prime Minister shall be submitted to the Legal Affairs Department for internal review at least 75 days before the Government meeting, and submitted to the Ministry of Justice for review at least 45 days before presenting to the Government;

b) The dossier of draft normative legal documents within the authority of the Minister of Health shall be submitted to the Legal Affairs Department for review at least 30 days before registering to submit to the Ministry Leader for signing and issuing the document in the annual plan for drafting normative legal documents on health.

Article 32. Documents for Requesting Review and Internal Review of Health Regulatory Legal Instruments

1. The leading unit shall submit the documents in paper form or electronic form to the Department of Legal Affairs for review.

2. For draft laws, ordinances, and draft resolutions, the documents for requesting review shall include:

a) Draft proposal to the Government on the project or draft;

b) Draft document;

c) Report on policy impact assessment in cases where new policies are generated;

d) Administrative procedure evaluation report in the project or draft document, along with explanations regarding the adoption of comments from the Administrative Procedure Control Agency (Government Office) or the Ministry's Administrative Procedure Control Department if the project or draft document contains administrative procedures;

đ) Report on integrating gender equality issues in the project or draft, if the project or draft includes provisions related to gender equality;

e) Summary, explanation, and adoption of comments; copies of comments from ministries, agencies at the same level, and other relevant entities. For regulatory legal instruments that amend or supplement industries or professions subject to conditional business investment or business investment conditions, there must be copies of comments from the Ministry of Planning and Investment on the contents stipulated in Clause 1, Article 6 of this Circular and explanations and adoption by the leading unit;

g) Draft document detailing the law, resolution of the National Assembly, ordinance, or resolution of the Standing Committee of the National Assembly;

h) Other documents (if any).

3. For draft decrees, the documents for requesting review shall include:

a) Draft proposal to the Government on the draft decree;

b) Draft decree;

c) Report on policy impact assessment as provided for in Clause 2 and Clause 3, Article 19 of the Law;

d) Report summarizing, explaining, and adopting comments from agencies, organizations, individuals, and directly affected parties; copies of comments from ministries, agencies at the same level, and government agencies. For regulatory legal instruments involving industries or professions subject to conditional business investment or business investment conditions, there must be copies of comments from the Ministry of Planning and Investment on the contents stipulated in Clause 1, Article 6 of this Circular and explanations and adoption by the leading unit;

đ) Administrative procedure evaluation report, along with explanations regarding the adoption of comments from the Administrative Procedure Control Agency (Government Office), if the draft includes administrative procedures;

e) Report on integrating gender equality issues, if the draft includes provisions related to gender equality;

g) Draft document detailing the decree;

h) Other documents (if any).

4. For draft decisions of the Prime Minister, the documents for requesting review shall include:

a) Draft proposal to the Prime Minister on the draft decision;

b) The draft decision;

c) Report summarizing, explaining, and adopting comments from agencies, organizations, individuals, and directly affected parties; copies of comments from ministries, agencies at the same level, and government agencies. For regulatory legal instruments involving industries or professions subject to conditional business investment or business investment conditions, there must be copies of comments from the Ministry of Planning and Investment on the contents stipulated in Clause 1, Article 6 of this Circular and explanations and adoption by the leading unit;

d) Administrative procedure evaluation report, along with explanations regarding the adoption of comments from the Administrative Procedure Control Agency (Government Office), if the draft includes administrative procedures;

đ) Report on integrating gender equality issues, if the draft includes provisions related to gender equality;

e) Other documents (if any).

5. For draft circulars or joint circulars, the documents for requesting review shall include:

a) Draft proposal to the Minister on the draft circular or joint circular;

b) Draft circular or joint circular;

c) Summary, explanation, and adoption of comments from agencies, organizations, individuals, and directly affected parties; copies of comments;

d) Impact assessment report; administrative procedure evaluation report, along with explanations regarding the adoption of comments from the Ministry's Office on administrative procedures, if the draft includes administrative procedures;

đ) Report on integrating gender equality issues (if applicable);

e) Draft decision on publicizing administrative procedures specified in the draft (if applicable);

g) Draft consolidated document for cases where the draft amends or supplements certain articles;

h) Other documents (if any).

Article 33. Receiving dossiers for reviewInternal Review

1. The Department of Legal Affairs is responsible for receiving and checking the documents of draft regulatory legal instruments submitted by units for review.

2. If the submitted documents for review do not meet the requirements set forth in Article 32 of this Circular, within two days from the date of receipt of the documents, the Department of Legal Affairs shall request the leading unit to supplement the documents.

3. In cases where the deadline for supplementing documents as requested by the Department of Legal Affairs has expired and the leading unit does not supplement the documents in accordance with regulations, the Department of Legal Affairs shall return the documents to the leading unit.

Article 34. Organization of ReviewInternal Review

1. The Department of Legal Affairs shall organize the review and issue a review report on the project or draft document.

2. For draft circulars or joint circulars that have direct impacts on the rights, obligations, and interests of citizens and businesses, involve multiple sectors or fields, or are drafted by the Department of Legal Affairs, the Department of Legal Affairs shall propose the establishment of an advisory council for review in accordance with Article 48 of Decree No. 34/2016/NĐ-CP.

3. Time limit for organizing the review:

a) Not exceeding ten days from the date the Department of Legal Affairs receives complete internal review request documents for draft laws, ordinances, or government decrees, or prime ministerial decisions;

b) Not exceeding seven days from the date the Department of Legal Affairs receives complete review request documents for draft circulars or joint circulars;

c) Not exceeding five days from the date the Department of Legal Affairs receives complete review request documents for draft regulatory legal instruments developed and issued through simplified procedures;

4. When necessary, the Department of Legal Affairs may request the leading unit to provide explanations on the draft regulatory legal instrument to facilitate the review process.

5. For draft regulatory legal documents that still have differing opinions on certain issues, the Legal Affairs Department shall coordinate with the main drafting unit to handle them. In necessary cases, the Legal Affairs Department may request the Ministry's leadership to convene meetings with relevant units to discuss these issues.

Article 35. Advisory Review Council

1. The Ministry of Health's leadership shall establish the Advisory Review Council. The Advisory Review Council consists of the Chairperson, Secretary, and members who are representatives from related agencies and organizations, experts, and scientists.

The total number of members of the Advisory Review Council shall be decided by the Minister.

2. The Advisory Review Council ceases operations and dissolves itself after completing its tasks.

3. Meeting materials for the Advisory Review Council must be sent by the main reviewing unit to the Council members at least three working days before the meeting date.

Article 36. Content of review

1. Constitutionality, legality, and consistency of the draft document with the legal system; compatibility with international treaties to which the Socialist Republic of Vietnam is a party.

2. Necessity for promulgation of the document, subject matter, and scope of regulation of the document for decisions of the Prime Minister, circulars, joint circulars.

3. Consistency of the content of the draft law, ordinance with the purpose, requirements, scope of regulation, and policies in the proposal to build the law, ordinance that has been approved.

Consistency of the content of the draft decree with the detailed regulations provided for in Clause 1 of Article 19 of the Law; consistency of the content of the draft decree with the policies already approved in the proposal to build the decree for decrees provided for in Clauses 2 and 3 of Article 19 of the Law.

4. Consistency of the content of the draft document with the Party's guidelines and State policies.

5. Compliance with the principles and requirements for stipulating administrative procedures if the draft document contains provisions on administrative procedures; necessity and legality of industries or trades with conditions for investment and business, if the draft document contains provisions on industries or trades with conditions for investment and business; incorporation of gender equality issues in the draft document, if the draft document contains provisions related to gender equality issues.

6. Conditions ensuring human resources and financial resources to ensure implementation of the document.

7. Language, technical aspects, and procedures and processes for drafting the document.

Article 37. Review MeetingInternal Review

1. The Legal Affairs Department is responsible for organizing the review meeting. For draft regulatory legal documents containing content related to administrative procedures or specialized technical factors, or where there are many differing opinions, the Legal Affairs Department shall invite representatives from the Ministry's Office, the main drafting unit, experts, technicians, and other relevant units to participate in the review meeting.

2. The review meeting shall proceed in the following sequence:

a) The Chairperson of the Advisory Review Council announces the reasons for the meeting; discussion topics and requests for opinions;

b) Representatives of the agency in charge of drafting the project or draft regulatory legal document present the content of the draft, issues with differing opinions, and the agency's views on these issues;

c) Representatives of Legal Affairs Department staff assigned to oversee the review provide a preliminary report on opinions regarding the project or draft regulatory legal document;

d) Participants in the meeting discuss and express their opinions, focusing on issues within the scope of review as specified in Article 36 of this Circular;

đ) The Chairperson of the Advisory Review Council summarizes opinions and concludes.

3. The Secretary of the Advisory Review Council is responsible for recording the minutes of the review meeting, including all opinions expressed during the meeting, to serve as the basis for drafting the review report. The minutes must be signed and stamped by the Chairperson of the Advisory Review Council according to the legal regulations on archival work.

Article 38. Review ReportInternal Review

1. Based on the minutes of the review meeting, the Legal Affairs Department shall complete the review report and send it to the main drafting unit no later than three days from the end of the review meeting, or not more than five days for complex documents with many differing opinions.

2. The main drafting unit is responsible for studying, explaining, and incorporating the Advisory Review Council's review opinions to revise and perfect the draft document before reporting to the Ministry's leadership for signature and submission to the Ministry of Justice for review or for approval by the Ministry's leadership.

Chapter V

SUBMISSION AND PROMULGATION OF REGULATORY LEGAL DOCUMENTS

Article 39Soliciting Opinions from the Ministry's Leadership on Draft Regulatory Legal Documents

1. Draft regulatory legal documents, prior to being submitted to the Ministry's leadership for signing and issuance or for submission to the competent authority for signing and issuance, must be solicited for opinions from the Deputy Minister responsible for the content related to the scope of regulation of the document and the Deputy Minister responsible for the main drafting unit.

2. Within at least ten days from the date of receipt of the review report on the project or draft regulatory legal document, the main drafting unit shall be responsible for sending the revised project or draft regulatory legal document according to the Ministry of Justice's review opinions (for projects or draft regulatory legal documents within the jurisdiction of the National Assembly, Standing Committee of the National Assembly, Government, or Prime Minister) or the Legal Affairs Department's review opinions (for circulars and joint circulars) to solicit opinions from the Ministry's leadership as stipulated in Clause 1 of this Article according to the Model Opinion Solicitation Form for Ministry's Leadership attached as Appendix 12 of this Circular.

3. Within five days from the date of receipt of the project or draft regulatory legal document, the solicited Ministry's leaders shall provide their opinions on the Opinion Solicitation Form for Ministry's Leadership.

4. The leading drafting agency is responsible for consolidating the opinions of the Ministry's leaders, explaining and adopting comments, revising, and perfecting the draft regulatory legal document to be submitted to the Government, the Prime Minister, or signed by the Ministry's leadership.

Article 40. Completing the dossier and submitting the draft regulatory legal document to the Government, the Prime Minister

1. Based on the review letter of the draft Law, Ordinance, Decree, or Decision of the Prime Minister from the Ministry of Justice, the leading drafting agency shall decide its responsibility:

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

b) To complete the draft Memorandum to the Government, the draft Law, Ordinance, Decree, or Decision of the Prime Minister, and other documents in the dossier to be submitted to the Government based on the review opinions of the Ministry of Justice and the guidance of the Ministry's leadership.

2. After completing the report on adopting and explaining the review opinions of the Ministry of Justice, the draft Memorandum to the Government, and the draft Decision, the leading drafting agency shall be responsible for:

a) Completing the dossier to submit the draft regulatory legal document to the Prime Minister;

b) Sending the dossier to the Legal Department for verification and co-signing the Memorandum to the Government and the Prime Minister before submitting it to the Ministry's leadership for signing.

3. Within five working days from the date of receiving the complete project dossier, the Legal Department shall be responsible for verifying the dossier to be submitted to the Government and the Prime Minister regarding the draft Decision:

a) In case the dossier meets the requirements, the Legal Department will co-sign the Memorandum to the Prime Minister and the Memorandum to the Minister requesting the signing of the Memorandum to the Government and the Prime Minister regarding the draft regulatory legal document;

b) In case the dossier does not meet the requirements, the Legal Department shall guide the leading drafting agency to complete the dossier.

4. After submitting the draft regulatory legal document to the Government and the Prime Minister, the leading drafting agency shall coordinate with the Legal Department and the Government Office in revising the draft before officially submitting it to the Prime Minister for signing.

5. The dossier for the draft Law or Ordinance to be submitted to the Government includes:

a) A form for issuing the document according to the Model prescribed in Appendix 14 issued together with this Circular;

b) The Memorandum to the Government on the draft, with the signature of the leading drafting agency and the Legal Department's leadership;

c) The revised draft document after receiving the review opinion of the Ministry of Justice;

d) The review report of the Ministry of Justice; the report on explaining and adopting the review opinion of the Ministry of Justice;

đ) An assessment of administrative procedures in the draft if there are provisions on administrative procedures;

e) A report on integrating gender equality issues in the draft if there are provisions related to gender equality issues;

g) A summary, explanation, and adoption of comments;

h) Other documents (if any).

The documents specified in points a, b, and c of this Clause shall be sent in paper form, while the remaining documents shall be sent electronically.

6. The dossier for the draft Decree to be submitted to the Government includes:

a) A form for issuing the document according to the Model prescribed in Appendix 14 issued together with this Circular;

b) The Memorandum to the Government on the draft Decree with the signature of the leading drafting agency and the Legal Department's leadership;

c) The revised draft Decree after receiving the review opinion of the Ministry of Justice;

d) The review report of the Ministry of Justice; the report on explaining and adopting the review opinion of the Ministry of Justice;

đ) A summary, explanation, and adoption of comments from agencies, organizations, individuals, and directly affected entities;

e) An assessment of administrative procedures in the draft if there are provisions on administrative procedures; a report on integrating gender equality issues in the draft if there are provisions related to gender equality issues;

g) The Resolution of the Government approving policies in the proposal to establish the Decree as stipulated in Clause 2 and Clause 3 of Article 19 of the Law;

h) Other documents (if any).

The documents specified in points a, b, and c of this Clause shall be sent in paper form, while the remaining documents shall be sent electronically.

7. The dossier for the draft Decision to be submitted to the Prime Minister includes:

a) A form for issuing the document according to the Model prescribed in Appendix 14 issued together with this Circular;

b) The Memorandum to the Prime Minister on the draft Decision with the signature of the leading drafting agency and the Legal Department's leadership;

c) The revised draft Decision after receiving the review opinion of the Ministry of Justice;

d) The review report of the Ministry of Justice; the report on explaining and adopting the review opinion of the Ministry of Justice;

đ) A report on assessing the impact of policies in the draft Decision;

e) A summary, explanation, and adoption of comments from agencies, organizations, and individuals;

g) Other documents (if any).

The documents specified in points a, b, and c of this Clause shall be sent in paper form, while the remaining documents shall be sent electronically.

8. The report on explaining and adopting the review opinion of the Ministry of Justice accompanying the revised draft document must be simultaneously sent to the Ministry of Justice when submitting the draft regulatory legal document to the Government and the Prime Minister as stipulated in Clause 1, 2, and 3 of this Article.

9. After submitting to the Government and the Prime Minister, the leading drafting agency shall coordinate with the Legal Department and functional units of the Government Office assigned to verify the draft and project during the verification process of the draft and project of regulatory legal documents.

Article 41. Submitting draft laws and ordinances to the National Assembly and the Standing Committee of the National Assembly

1. After the Government approves the draft laws and ordinances, the leading agency responsible for drafting shall be responsible for:

a) Incorporating and revising the report to the National Assembly and the Standing Committee of the National Assembly on the draft laws and ordinances;

b) Completing the dossier for submission to the National Assembly and the Standing Committee of the National Assembly in accordance with the provisions of Article 64 of the Law;

c) Sending the dossier for submission to the National Assembly and the Standing Committee of the National Assembly to the Legal Department for review and co-signing on the report to the National Assembly and the Standing Committee of the National Assembly and the proposal form for the Minister's signature to promulgate the draft laws and ordinances.

2. Within five working days from the date of receipt of the dossier meeting the requirements, the Legal Department shall be responsible for reviewing the dossier for submission to the National Assembly and the Standing Committee of the National Assembly:

a) In case the dossier for submission to the National Assembly and the Standing Committee of the National Assembly meets the requirements, the Legal Department shall co-sign on the report to the National Assembly and the Standing Committee of the National Assembly and the proposal form for the Minister's signature to promulgate the laws and ordinances;

b) In case the dossier for submission to the National Assembly and the Standing Committee of the National Assembly does not meet the requirements, the Legal Department shall be responsible for guiding the leading agency responsible for drafting to complete the dossier.

3. After submitting to the National Assembly and the Standing Committee of the National Assembly, the leading agency responsible for drafting shall coordinate with relevant agencies of 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.

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

Article 42. Submitting circulars and joint circulars issued by the Minister of 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.

In cases where the Deputy Minister is requested to sign and issue the document, the dossier for submission to issue the circulars and joint circulars must include an authorization document from the Minister allowing the Deputy Minister to sign and issue the document.

2. The dossier for submission to the Ministry's leadership to issue circulars and joint circulars includes:

a) A form for issuing the document according to the Model prescribed in Appendix 14 issued together with this Circular;

b) The revised draft circulars and joint circulars after receiving comments from the Legal Department;

c) Legal review report of the Legal Department; report explaining and adopting review comments;

d) A summary and explanation of opinions from agencies, organizations, individuals, and directly affected entities;

đ) An assessment of administrative procedures when assigned by law or government decrees to establish administrative procedures; a report on gender equality issues (if applicable);

e) Draft decision on publicizing administrative procedures specified in the draft (if applicable);

g) The draft consolidated document for amendments and supplements to certain articles;

h) A summary and explanation of opinions from Ministry leaders (if applicable);

i) Other documents (if applicable).

3. The draft circulars and joint circulars submitted for the Minister's signature must include all documents specified in Clause 2 of this Article, the initials of the heads of the leading drafting unit and the Legal Department at the bottom right corner of each page of the document and the initials at the end of the draft document in the section for the Minister's signature.

- Prime Minister;43. Issuance and publication circulars and joint circulars drafted by the Ministry of Health

1. Issuing circulars and joint circulars:

a) After the document is signed by the Ministry's leadership, the leading drafting unit shall be responsible for sending two copies of the signed document along with the electronic version to the Ministry's Office and shall be responsible for the accuracy of the electronic version compared to the original circulars and joint circulars;

b) The Ministry's Office shall be responsible for numbering, stamping, archiving, reproducing, distributing the circulars and joint circulars to the agencies, organizations, and individuals listed in the "Distribution" section of the circulars and joint circulars, and returning the dossier for signing to the leading drafting unit.

2. Publishing in the Official Gazette and disseminating:

a) Within three days from the date of issuance, the Ministry's Office shall be responsible for sending the circulars and joint circulars (paper and electronic versions) to the Government's Office for publication in the Official Gazette and dissemination on the Government's website and the Ministry of Health's website, except for documents containing state secrets as stipulated by the law on state secrets;

b) Within three days from the date of issuance, the Ministry's Office shall be responsible for sending the circulars and joint circulars to the Legal Normative Documents Inspection Department (Ministry of Justice) and the Legal Department for inspection according to regulations.

3. The Legal Department shall be responsible for publishing the full text of the circulars and joint circulars on the national legal database no later than ten days from the date of issuance.

Article 44. Handling errors and amending legal documentsunder the authority of the Minister after promulgation 1. Circulars and joint circulars that have been issued but contain errors in content must be corrected or replaced through the form of circulars and joint circulars.

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.

ORGANIZING IMPLEMENTATION AND MONITORING OF LEGAL REGULATIONS ON HEALTH AFTER PROMULGATION

Chapter VI

IMPLEMENTATION AND MONITORING OF CONSOLIDATED DOCUMENTS

HEALTH LEGISLATIVE PROVISIONS AFTER ENACTMENT

Article 45. Allocation of Responsibilities for Implementation, Supervision, and Enforcement of Legal Normative Documents on Health organizing the implementation, monitoring, and enforcement of legal normative documents on health

1. The agency assigned to primarily draft legal normative documents on health shall be responsible for organizing the implementation and monitoring the enforcement of such documents after they are promulgated.

2. In cases where laws, ordinances, decrees are primarily drafted by the Legal Affairs Department, the agency responsible for organizing the implementation of the legal normative document after it is promulgated shall be the agency tasked with overseeing the relevant field regulated by that law, ordinance, or decree.

3. Where the content of legal normative documents on health pertains to the functions, tasks, and authorities of multiple agencies, the agency assigned to primarily draft the document shall have the responsibility to lead and coordinate with related agencies to organize its implementation immediately after promulgation.

4. Agencies involved have the responsibility to cooperate with the agency assigned to primarily draft the document to organize implementation and monitor enforcement according to the provisions of Clause 2 of this Article.

Article 46. Dissemination of Legal Normative Documents on Health After Promulgation

1. Forms of dissemination:

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

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

c) Press conferences;

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

đ) Summarizing and publishing the content of the document on the Ministry of Health's electronic portal, the drafting agency’s electronic portal, and the Health and Life newspaper within three working days from the date of signing and promulgating the document;

e) Organizing dissemination meetings (mandatory for laws, ordinances, and decrees);

g) Training sessions for entities responsible for enforcing the document;

h) Publishing the full text and introduction articles in other health sector newspapers and magazines;

i) Other appropriate forms of dissemination based on the nature and scope of regulation of the document.

2. Legal normative documents on health must be disseminated through at least three of the forms specified in Clause 1 of this Article and the mandatory forms for documents specified in points d and e of Clause 1 of this Article after promulgation.

3. Within fifteen working days from the date the National Assembly or the Standing Committee of the National Assembly approves a law or ordinance, the drafting agency is responsible for developing a plan to implement the law or ordinance to submit to the Minister for review and approval or to the Prime Minister for approval of the plan, directive, or issuance of a directive to implement the law or ordinance related to the responsibility of multiple Ministries and sectors for implementation. If a plan for implementing the law or ordinance is issued, the plan must include at least the following contents:

a) Disseminating the law or ordinance;

b) Drafting legal normative documents guiding the implementation of the law or ordinance, specifying the name of the document, the drafting agency, and the deadline for completing the draft guidance document.

Article 47. Updating the National Database on Law

1. Within two working days from the date of publication or signing of the promulgation of legal normative documents primarily drafted by the Ministry of Health or from the date of signing verification for consolidated documents, the drafting unit must send the electronic version of the document in ".doc" format to the Legal Affairs Department to update the National Database on Law.

2. The following legal normative documents must be sent immediately in ".doc" format to the Legal Affairs Department for updating on the day of publication or signing of promulgation:

a) Documents prescribing measures for emergency situations, documents issued to promptly address requirements for disaster prevention and control, and disease prevention and control as stipulated by the Law;

b) Documents effective from the date of publication or signing of promulgation.

3. Time limit for posting

a) Within ten working days from the date of receipt of the document specified in Clause 1 of this Article, the Legal Affairs Department shall post the document on the National Database on Law.

b) Within two working days from the date of receipt of the document specified in Clause 2 of this Article, the Legal Affairs Department shall post the document on the National Database on Law.

4. Heads of units under the Ministry are responsible for ensuring the deadlines, accuracy, and completeness of providing legal normative documents and consolidated documents drafted by their units to the Legal Affairs Department for updating on the National Database on Law as stipulated in Clauses 1 and 2 of this Article.

Article 48. CSupplying Information for Building a Press Release on Legal Normative Documents

1. Within three days from the date of signing and promulgation of a government decree or prime minister decision, the drafting unit is responsible for sending the Legal Affairs Department information to build a press release according to the Model for Providing Information to Build a Press Release attached as Appendix 16 to this Circular. The provision of information for building a press release is carried out in the form of a letter and email.

2. Within two days from the date of receipt of the information sent by units according to Clause 1 of this Article, the Legal Affairs Department is responsible for compiling and supplying information to the Ministry of Justice about legal normative documents of the Government and the Prime Minister drafted by the Ministry of Health to serve the construction of a press release.

Article 49Consolidation of Legal Normative Documents ON HEALTH

1. The agency primarily drafting the amended document shall carry out consolidation in accordance with Articles 6 and 7 of the Ordinance on Consolidation of Legal Normative Documents.

2. The draft consolidated document must be submitted along with the proposal for the Legal Affairs Department to review and sign the circular or joint circular before submitting to the Ministry Leader for signing and promulgation.

3. The consolidated document must be signed and verified by the Ministry Leader in accordance with the time limits set forth in Clause 3 of Article 6 and Clause 5 of Article 7 of the Ordinance on Consolidation of Legal Normative Documents.

4. The draft consolidated document must be submitted for comments to the Legal Department, relevant ministries, and equivalent agencies (if applicable) and must be reviewed for content and consolidation accuracy in writing by the Legal Department before being signed off by the Ministry's leadership to authenticate the consolidated document.

5. After completing the consolidation of regulatory legal documents, the main drafting unit shall be responsible for sending the electronic format ".doc" version and the "PDF" version to the Legal Department to update on the National Legal Database in accordance with Article 47 of this Circular; at the same time, the consolidated document shall be published on the Government Gazette, the Government Portal, and the Ministry of Health Portal as follows:

a) For the consolidated document of Decrees and Prime Minister's Decisions within two working days from the date of signing off the consolidated document, the main drafting agency shall send the consolidated document to the Government Gazette and the Government Portal;

b) For the consolidated document of Circulars and joint Circulars within two working days from the date of signing off the consolidated document, the main drafting agency shall send the consolidated document to the Government Gazette and the Ministry's Office to publish on the Ministry of Health Portal.

Article 50. Codification Account on the eCoSys System 1. The Legal Affairs Department shall take the lead and coordinate with relevant units to advise and assist the Minister in inspecting and handling regulatory legal documents within the responsibility and inspection authority of the Minister, urging and directing the inspection and handling of regulatory legal documents at the Ministry of Industry and Trade; urging, coordinating, guiding, and compiling the results of reviewing and systematizing common regulatory legal documents of the Ministry of Industry and Trade. ON HEALTH

1. The Legal Department shall report to the Ministry's leadership to issue a plan assigning units under the Ministry to carry out codification for items within the Ministry of Health's codification authority according to the Prime Minister's Decision and regulatory legal documents drafted by the Ministry of Health under the codification items of ministries and equivalent agencies.

2. Codification according to items shall be carried out in accordance with Articles 9, 11, 12, and 14 of the Codification Law of the System of Regulatory Legal Documents (hereinafter referred to as the Codification Law); Decree No. 63/2013/ND-CP dated June 27, 2013 of the Government detailing the implementation of the Codification Law of the System of Regulatory Legal Documents (hereinafter referred to as Decree No. 63/2013/ND-CP); Circular No. 13/2014/TT-BTP dated April 29, 2014 of the Minister of Justice guiding the implementation of codification of the system of regulatory legal documents (hereinafter referred to as Circular No. 13/2014/TT-BTP).

3. After the codification item has been approved by the Government, units under the Ministry responsible for drafting new regulatory legal documents shall be responsible for updating new regulatory legal provisions into the Code in accordance with Article 13 of the Codification Law, Articles 16, 17, 18, and 19 of Decree No. 63/2013/ND-CP, and Article 11 of Circular No. 13/2014/TT-BTP.

4. In cases where new regulatory legal provisions are issued in accordance with Clause 2 of Article 13 of the Codification Law, within five days from the date of issuance of the new document, the unit responsible for drafting the new regulatory legal document shall coordinate with the Legal Department to propose the establishment of a new item to be sent to the Ministry of Justice for review and submission to the Prime Minister for decision on the assignment of the agency to carry out codification of the new item. The codification of the new item shall be carried out in accordance with Article 21 of Decree No. 63/2013/ND-CP.

Article 51. Supervision and Implementation legal documents  June 22, 2015;  ON HEALTH

1. Departments, Bureaus, General Bureaus, the Ministry's Office, and the Ministry's Inspectorate shall be responsible for supervising and implementing health-related regulatory legal documents issued by their own units and related regulatory legal documents, supervising the implementation of laws on administrative violations in their assigned areas, and submitting periodic reports on the supervision and implementation of laws every six months to the Legal Department for monitoring and summarizing.

2. The Legal Department shall act as the focal point for summarizing the work of supervising and implementing health-related regulatory legal documents, supervising the implementation of laws and administrative penalties on health matters annually, conducting summaries, and reporting on the supervision and implementation of health laws.

In cases where it is necessary to serve the completion of the legal system, the Legal Department may independently supervise the implementation of health-related regulatory legal documents, supervise the implementation of laws on administrative violations by topic or supervise the implementation of regulatory legal documents related to multiple fields.

Article 52. Inspection of the Implementation of Health Laws

1. Departments, Bureaus, General Departments, the Ministry's Office, and the Inspectorate shall be responsible for developing annual inspection plans on the implementation of laws according to their assigned fields, submit these plans for the Minister's signature and issuance, and organize their implementation.

2. The Legal Department shall be responsible for coordinating with other specialized health sectors to ensure efficient collaboration, cost savings, time reduction, enhanced inspection effectiveness, and avoidance of overlapping inspection content and subjects, upon the leadership's approval.

3. In cases where necessary or involving multiple departments, bureaus, general departments, the Ministry's Office, and the Inspectorate, the Legal Department shall take the lead in drafting and organizing inspections on the implementation of laws according to specific topics following the Minister's approval.

Chapter VII

EXPENSES FOR THE DEVELOPMENT AND ORGANIZATION OF IMPLEMENTATION OF HEALTH LEGAL DOCUMENTS

Article 53. Bảo đảm human resources and material infrastructure for the work of developing and issuing legal documents

The Ministry's leadership and heads of units under the Ministry within their functional, task, and authority scope shall be responsible for allocating civil servants, supporting funds, working tools, information, and other necessary conditions for preparing, drafting, participating in opinions, reviewing, and issuing legal documents.

Article 54. Expenses and Budget Preparation

1. Expenses for drafting, issuing, consolidating, codifying health legal documents, disseminating and educating the law, inspecting, reviewing, systematizing, monitoring the enforcement of laws, and administrative procedure control in accordance with this Circular shall be funded from the Ministry of Health’s budget.

2. Annually, based on the approved plan for developing, consolidating, codifying health legal documents, disseminating and educating the law, inspecting, reviewing, systematizing, monitoring the enforcement of laws, and administrative procedure control by the Minister, the Legal Department shall coordinate with the Planning and Finance Department to prepare budgets for each activity, submit them for the leadership's review and decision.

3. The Planning and Finance Department shall only allocate funds for legal documents included in the Ministry of Health's annual legal document development program after obtaining the Legal Department's agreement. These funds shall be established as a separate item managed by the Ministry's Office.

4. Budget preparation must include expenses for organizing the implementation of health legal documents after issuance, evaluating implementation, and translating documents into English.

5. The Legal Department shall cooperate with the Ministry's Office to base on legal provisions regarding allocation standards and expenditure limits for activities such as drafting, issuing, consolidating, codifying, inspecting, reviewing, systematizing, monitoring, disseminating, and educating the law, and organizing evaluations of legal document implementation to develop expenditure items and budgets for the Minister's signature and issuance.

Article 55. Expenses for Research and Evaluation of the Need to Develop Health Legal Documents

1. The Legal Department shall lead and coordinate with the Institute of Strategy and Health Policy to research, compile, and evaluate the need to develop legal documents to report to the leadership for assignment of units to implement and allocate funds; organize scientific research and evaluation of the need to develop health legal documents.

2. The Planning and Finance Department shall report to the leadership and allocate funds for scientific research and evaluation of the need to develop health legal documents as stipulated in Clause 1 of this Article from the Ministry of Health’s budget based on the Legal Department's and the Institute of Strategy and Health Policy's proposals.

Article 56. Use and settlement of funds

1. The use and settlement of funds for the construction, consolidation, codification of legal normative documents on health, dissemination, education of laws, inspection, review, systematization, monitoring the implementation of laws, and administrative procedure control in the field of health must comply with the provisions of the law.

2. The Department of Planning and Finance shall be responsible for guiding and inspecting the use and settlement of funds for the construction, consolidation, codification of legal normative documents on health, dissemination, education of laws, inspection, review, systematization, monitoring the implementation of laws, and administrative procedure control in the field of health according to the prescribed regulations.

Chapter VIII

IMPLEMENTING PROVISIONS

Article 57. Evaluation, urging work on drafting and promulgating legal normative documents

The Legal Affairs Department shall be responsible for summarizing, concluding, evaluating, urging, and quarterly reporting to the Minister about the work on drafting and promulgating legal normative documents of the Ministry.

Article 58Rewards

1. The progress in drafting and the quality of constructing legal normative documents are among the bases for assessing and considering annual competitions and rewards for individuals and units under the Ministry according to the Minister of Health's regulations on competition and reward work.

2. Based on the results of constructing legal documents from units with outstanding achievements, the Legal Affairs Department shall take the lead and coordinate with the Ministry Office and related units to consider recommending the Leadership of the Ministry for exceptional rewards.

3. Units assigned to lead and draft legal normative documents will be prioritized for achievement awards when they successfully complete the construction of legal normative documents within the deadline for two consecutive years.

Article 59. Evaluation of completion of tasks,1. The Minister shall examine and handle collective and individual responsibility of the head of the unit assigned to draft regulatory legal documents in accordance with Article 68 of the Law. in promulgating legal normative documents on health

1. Units assigned to lead the drafting of legal normative documents shall not be considered for competition and rewards in the year when more than 50% of the documents in the Plan are delayed by three months or more without valid reasons.

2. The Legal Affairs Department shall not be considered for competition and rewards in the year when more than 50% of the reviewed documents are not completed within the prescribed time without valid reasons or when there are legal normative documents issued by the Minister of Health beyond their authority.

3. Heads and Leaders of units assigned to lead the drafting of legal normative documents shall not be considered for competition and rewards in the year, and shall be criticized at the Ministry's meeting when the unit has documents in the Plan delayed by three months or more without valid reasons and fails to complete the construction and issuance of documents in the Plan.

4. Individuals assigned to lead the drafting of legal normative documents shall not be considered for competition and rewards in the year, and shall be criticized within the unit when the assigned documents in the Plan are delayed by three months or more without valid reasons, fail to complete the construction and issuance of documents in the Plan, issue documents contrary to the law; fail to timely propose the issuance of legal normative documents within their area of responsibility to provide detailed regulations and enforcement measures for higher-level state agencies' legal normative documents.

5. Individuals, leaders of units, Departments, Bureaus, General Departments, the Ministry Office, and the Inspectorate shall not be rated as having satisfactorily completed their tasks when they do not ensure the quality and progress of issuing documents according to the plan for issuing legal normative documents on health.

6. The Cadre and Civil Service Organization Department shall be responsible for organizing and evaluating the degree of completion of tasks by the Leaders of Departments, Bureaus, General Departments, the Ministry Office, and the Inspectorate, and reporting to the Minister of Health based on the plan for constructing legal normative documents on health and the plan for constructing legal normative documents based on reports from the Legal Affairs Department.

Article 60. Reference 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 61. Effective Date

1. This Circular takes effect from February 1, 2020.

2. Circular No. 22/2014/TT-BYT dated June 30, 2014 of the Ministry of Health on the drafting, issuance, and implementation of health-related regulatory documents shall cease to be effective from the date this Circular takes effect.

Article 62. Responsibility for Implementation

1. The Legal Affairs Department shall organize the implementation, interim review, final assessment, and supervision of the enforcement of this Circular. Departments, Bureaus, General Departments, the Ministry's Office, and the Ministry's Inspectorate shall be responsible for implementing, interim reviewing, final assessing, and supervising the enforcement of this Circular within their respective areas of responsibility.

2. The Heads of the Legal Affairs Department, the Director of the Ministry's Office, the Director of the Ministry's Inspectorate, the Heads of Departments, Bureau Chiefs, and General Department Directors under the Ministry of Health, and related organizations and individuals shall be 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./.