Circular No. 10/2018/TT-BYT stipulates on the organization and operation of the Advisory Council for issuing certificates of adequate conditions for pharmaceutical business for special control drug retail establishments.

CIRCULAR

Provisions on the organization and operation of Advisory Council

issuing certificates of qualification for pharmaceutical business for

drug business establishments subject to special control

Pursuant to the Decree No. 54/2017/NĐ-CP dated May 8, 2017 of the Government detailing some provisions and measures for implementing the Medicine Law;

Pursuant to Decree No. 75/2017/NĐ-CP dated June 20, 2017 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

At the proposal of the Director of the Drug Administration Department,

The Minister of Health issues this Circular prescribing the organization and operation of Advisory Council for issuing certificates of qualification for pharmaceutical business for drug business establishments subject to special control.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates the position, functions, tasks, powers, organizational structure, and operation of the Advisory Council for issuing certificates of qualification for pharmaceutical business (hereinafter referred to as the Council) for the following drug business establishments subject to special control:

1. Establishments producing, exporting, importing, and providing storage services for narcotic drugs, psychotropic substances, precursor chemicals, raw materials for narcotic drugs, psychotropic substances, precursors used in drug production, radioactive drugs;

2. Establishments producing combined drugs containing narcotic substances, combined drugs containing psychotropic substances, combined drugs containing precursors;

3. Wholesalers and retailers of narcotic drugs, psychotropic substances, precursors, radioactive drugs.

Article 2.Applicability

This Circular applies to members of the Council, organizations, and individuals related to the advisory activities for issuing certificates of qualification for pharmaceutical business for the establishments specified in Article 1 of this Circular.

Chapter II

POSITION, FUNCTIONS, TASKS,

POWERS, ORGANIZATIONAL STRUCTURE OF THE COUNCIL

Article 3. Position of the Council

The Council includes:

1. The Council at the Ministry of Health established by the Minister of Health;

2. The Council at the Provincial Department of Health (referred to as the Department of Health) established by the Director of the Department of Health.

Article 4. Functions of the Board

1. The Council is an organization with the function of advising the head of the establishment authority regarding granting permission for pharmaceutical business to the establishments specified in Article 1 of this Circular in accordance with the authority of issuing certificates of qualification for pharmaceutical business of the establishment authority.

2. The advisory opinion of the Council is one of the bases for the competent authority to consider granting or not granting the Certificate of Qualification for Pharmaceutical Business to the establishments specified in Article 1 of this Circular.

Article 5. Tasks of the Council

1. The Council of the Ministry of Health: Examines, evaluates, and provides written advisory opinions on the application files for certificates of qualification for pharmaceutical business of the establishments specified in Clause 1 and Clause 2, Article 1 of this Circular as meeting requirements or not meeting requirements, requiring amendments or supplements.

2. The Council of the Department of Health: Examines, evaluates, and provides written advisory opinions on the application files for certificates of qualification for pharmaceutical business of the establishments specified in Clause 3, Article 1 of this Circular as meeting requirements or not meeting requirements, requiring amendments or supplements.

3. The Council sends its advisory opinions to the competent authority issuing the Certificate of Qualification for Pharmaceutical Business within thirty days from the date of receipt of the file.

Article 6. Powers of the Council

1. To be provided with complete files and relevant information by the establishment authority for examining the files and providing advisory opinions on the application files for certificates of qualification for pharmaceutical business as meeting requirements or not meeting requirements, requiring amendments or supplements.

2. To have the right to retain advisory opinions according to the independent viewpoint of the Council.

3. To be guaranteed conditions regarding material facilities and equipment serving the research and advisory activities of the Council.

4. Members of the Council operate under a part-time system and receive remuneration according to current regulations.

Article 7. Organizational Structure of the Council

1. The Council of the Ministry of Health shall have at least five members, ensuring the following member structure:

a) The Chairman of the Council shall be a representative of the Ministry of Health;

b) Vice-Chairman of the Council (if necessary);

c) Members of the Council advising on the issuance of business licenses for establishments engaged in production, export, import, and service provision for the storage of narcotic drugs, psychotropic substances, precursor chemicals, and raw materials for drugs that are narcotic drug substances, psychotropic drug substances, and precursors used to make drugs must include a representative of the Ministry of Public Security as stipulated in Point b Clause 1 Article 52 Decree No. 54/2017/ND-CP dated May 8, 2017 of the Government detailing certain provisions and measures to implement the Drug Law (hereinafter referred to as Decree No. 54/2017/ND-CP); Members of the Council advising on the issuance of business licenses for establishments engaged in production, export, import, and service provision for the storage of radioactive drugs must include a representative of the Ministry of Science and Technology as stipulated in Point c Clause 1 Article 52 Decree No. 54/2017/ND-CP;

d) Secretary of the Council;

đ) Other members if necessary.

2. The Council of the Department of Health shall have at least three members, ensuring the following member structure:

a) The Chairman of the Council shall be a representative of the Department of Health;

b) Members of the Council shall be individuals representing relevant agencies, organizations, and units;

c) Secretary of the Council.

Article 8Criteria for Council Members

1. Members of the Council advising on the issuance of business licenses for establishments engaged in production, export, import, service provision for the storage, wholesale, and retail of narcotic drugs, psychotropic substances, precursors, and raw materials for drugs that are narcotic drug substances, psychotropic drug substances, and precursors used to make drugs; establishments producing combined drug formulations containing narcotic drug substances, combined drug formulations containing psychotropic drug substances, and combined drug formulations containing precursors must meet the following criteria simultaneously:

a) Hold a bachelor's degree or higher in one of the fields of medicine, pharmacy, security, or police;

b) Have at least two years of work experience in areas related to the management, research, training, testing, guidance, and use of narcotic drugs, psychotropic substances, precursors, and raw materials for drugs that are narcotic drug substances, psychotropic drug substances, and precursors used to make drugs, combined drug formulations containing narcotic drug substances, combined drug formulations containing psychotropic drug substances, and combined drug formulations containing precursors; and narcotic substances.

2. Members of the Council advising on the issuance of business licenses for establishments engaged in production, export, import, service provision for the storage, wholesale, and retail of radioactive drugs must meet the following criteria simultaneously:

a) Hold a bachelor's degree or higher in one of the fields of medicine, pharmacy, radiochemistry, analytical chemistry, radiopharmaceutical chemistry, or nuclear physics;

b) Have experience in areas related to the management, research, training, testing, guidance, and use of radioactive drugs, radioactive substances, and nuclear substances.

3. In cases where necessary, the Council may include members holding a bachelor's degree or higher in law, with work experience or knowledge of regulations related to specially controlled drugs.

Chapter III

ACTIVITIES OF THE COUNCIL

Article 9. Principles of Operation of the Council

1. The Council operates on the principles of collective, democratic, and independent deliberation when examining, appraising, and advising.

2. The conclusion opinion of the Council is based on the majority opinion of its members (more than 50% of the Council members as decided upon establishment). In cases where the opinions of the Council members are evenly divided (50%/50%), the conclusion shall follow the opinion of the Chairman of the Council.

3. In cases where there are multiple differing opinions and less than 50% of the Council members as decided upon establishment cannot be reached, the final advisory opinion shall be determined by the Chairman of the Council who will bear responsibility for such decision.

Article 10. Methods of Operation of the Council

1. The Council conducts its work through meetings or by sending out consultation opinion forms to Council members within fifteen days from the date recorded on the receipt form. The Secretary of the Council reports to the Chairman of the Council about the application for a business condition certificate within two working days from the date of receiving the file from the receiving agency. The Secretary proposes organizing a meeting or sending out consultation opinion forms to Council members within two working days from the date of receiving the file from the receiving agency.

a) Within fifteen days from the date recorded on the receipt form, the receiving agency must send the file to the Secretary of the Council. The Secretary of the Council reports to the Chairman of the Council about the application for a business condition certificate and proposes organizing a meeting or sending out consultation opinion forms to Council members within two working days from the date of receiving the file from the receiving agency.

b) Within two working days from the date of receiving the report from the Secretary of the Council, the Chairman of the Council must provide comments on the method of operation of the Council.

2. Meeting Method of the Council:

a) Within two working days from the date of receiving the Chairman's comments on organizing a meeting, the Secretary of the Council must send an invitation letter along with the application for a business condition certificate (photocopy) to the Council members.

b) The Council meeting must have at least two-thirds (two-thirds) of the members named in the establishment decision present.

c) The opinions of each member and the Council's advisory opinion are reflected in the Council meeting minutes.

d) The Chairman of the Council concludes the Council's advisory opinion on the meeting minutes and signs the document regarding the Council's advisory opinion sent to the competent authority issuing the business condition certificate within five working days from the end of the meeting.

3. Method of Sending Consultation Opinion Forms to Council Members:

a) Within two working days from the date of receiving the Chairman's comments on organizing the sending of consultation opinion forms, the Secretary of the Council sends the Council members consultation opinion forms along with the application for a business condition certificate (photocopy).

b) Council members study, record their opinions on the consultation opinion forms within five working days from the date of receiving the file.

c) The Secretary of the Council compiles the opinions of the Council members into a summary of the Council members' consultation opinions according to the model prescribed in Appendix No. 02 issued together with this Circular within five working days from the date of receiving the consultation opinion forms of the Council members. The summary only has value when compiled from the opinions of at least two-thirds (two-thirds) of the Council members as decided upon establishment.

d) The Chairman of the Council concludes the Council's advisory opinion on the summary of consultation opinions and signs the document regarding the Council's advisory opinion sent to the competent authority issuing the business condition certificate within five working days from the date of receiving related documents.

4. Within three working days from the date of receiving the approval document from the Chairman of the Council, the Secretary of the Council sends the file along with the document regarding the Council's advisory opinion to the competent authority.

Article 11. Responsibilities of Each Member of the Council

1. Responsibilities of the Chairman of the Council:

a) Chair meetings of the Council, conclude the advisory opinions of the Council in the Minutes of Meeting or Summary of Advisory Opinions, and sign the document on the Council's advisory opinions to be sent to the competent authority issuing the Business Registration Certificate for pharmaceuticals, specifying whether the dossier meets the requirements or not, and the contents that need to be amended and supplemented.

b) Propose to the agency establishing the Council to relieve or supplement members of the Council.

c) Be responsible before the Minister of Health (for the Chairman of the Ministry of Health’s Advisory Council) and the Director of the Department of Health (for the Chairman of the Department of Health’s Advisory Council) for the activities of the Council; be responsible under the law for their concluding opinions.

d) Delegate the Vice-Chairman of the Council to perform the duties and powers of the Chairman of the Council when unable to attend Council meetings or when absent without being able to conclude the Summary of Advisory Opinions of Council members.

đ) Fulfill the responsibilities of Council members as stipulated in Clause 3 of this Article.

2. Responsibilities of the Vice-Chairman of the Council:

a) Perform the duties and powers of the Chairman of the Council when authorized by the Chairman of the Council.

b) Fulfill the responsibilities of Council members as stipulated in Clause 3 of this Article.

3. Responsibilities of Council Members:

a) Attend Council meetings upon receiving meeting invitations from the Chairman, review and assess dossiers, and make statements at Council meetings. In case of absence, they may submit their opinions in writing to the Council Secretary within five working days from the date of receipt of the meeting invitation.

b) Review, assess dossiers, and provide timely and accurate opinions on dossiers when the Council does not convene.

c) Adhere to the operational principles of the Council as prescribed in this Circular.

d) Ensure confidentiality regarding dossiers and advisory opinions according to the provisions of the law.

đ) Be responsible before the decision-making body establishing the Council, the Chairman of the Council, and under the law for their advisory opinions.

e) Provide a written report to the Chairman of the Council about non-participation in advising on dossiers of entities where the member or their spouse, biological or adoptive parents, biological or adoptive children, full siblings, brothers-in-law, sisters-in-law, or sisters-in-law work or invest.

4. Responsibilities of the Council Secretary:

a) Urge, monitor, and coordinate with the administrative support unit for the Council in preparing dossiers and materials for the Council's advisory opinion solicitation work.

b) Report to the Chairman of the Council on matters requiring opinions in cases where there are inconsistent opinions.

c) Prepare and report to the Chairman of the Council the Summary of Advisory Opinions of Council members.

d) In cases where the Council convenes a meeting, the Council Secretary will compile the opinions of the members, record the Minutes of Meeting, present them to the Chairman of the Council for signing at the end of the meeting, and issue a notification of the Council's advisory opinion.

đ) Carry out procedures for settling accounts related to the Council's activities according to the provisions of the law.

e) Archive materials related to Council meetings, Summaries of Advisory Opinions of Council members, Opinion Recording Sheets of Council members, and other relevant materials.

g) Fulfill the responsibilities of Council members as stipulated in Clause 3 of this Article.

Article 12. Administrative Support Unit for the Council

1. The person issuing the decision to establish the Council assigns an appropriate organization or unit under their management as the administrative support unit for the Council.

2. The support unit has the duty to arrange working conditions and means, provide complete documents and information related to advisory work on issuing certificates of qualification for pharmaceutical business operations for the Council to carry out its activities.

Chapter IV

IMPLEMENTING PROVISIONS

Article 13. Effective Date

This Circular takes effect from the date of      month      year 2018.

1. The Minister, Heads of Ministries equivalent to ministries, Heads of government agencies, Chairmen of provincial People's Committees under the central government, and related agencies, units, and individuals are responsible for implementing this Circular.

1. The Director of the Drug Administration Department, the Head of the Ministry's Office, the Inspector General of the Ministry, the Heads of Departments, Directors of Bureaus and General Directors of Bureaus, Departments, and General Departments under the Ministry of Health, the Heads of units directly under the Ministry of Health, the Directors of Provincial Health Services under central cities and provinces, and organizations and individuals concerned shall be responsible for implementing this Circular.

2. The Director of the Drug Administration Department shall organize the implementation of this Circular nationwide.

During the implementation process, if there are difficulties or obstacles, agencies, organizations, and individuals shall promptly reflect them to the Ministry of Health (Drug Administration Department) for consideration and resolution./.