Circular No. 10/2018 / TT-BYT dated 04/5/2018 of the Minister of Health stipulates the organization and operation of the Advisory Council to grant business eligibility certificates to business entities.
Chapter I: GENERAL RULES
Article 1: Adjust adjustment
This information defines the position, functions, tasks, powers, organizational structure and operation of the Pharmaceutical Business Conference (hereinafter referred to as the Council) for all types of establishments. Business data must comply with the following:
1. Establishments producing, exporting, importing or providing services for the protection of drugs, psychotropics, drugs, raw materials, pharmaceuticals, drugs and sprays;
2. Construction of compounds containing compounds of the compounds according to the invention.
3. Trading and retailing drugs, psychotropics, medicines, sprays.
Article 2: Application of objects
This Circular applies to members of the Councils, organizations and individuals participating in consultancy on the grant of certificates of eligibility for trading in pharmaceuticals to establishments specified in Article 1 of this Circular.
Chapter II: LOCATION, FUNCTIONALITY, TASKS, RIGHTS, ORGANIZATIONAL STRUCTURE OF THE COUNCIL
Article 3: Position of the Council
1. The Council of the Ministry of Health is established by the Minister of Health.
2. The Health Council of the province or city directly under the Central Government (hereinafter referred to as the Department of Health) is established by the Director of the Health Service.
Article 4: Functions of the Council
1. The Health Ministry's Council has the function of evaluating the establishments dossiers of application for certificates of satisfaction of pharmaceutical business conditions prescribed in Clauses 1 and 2, Article 1 of this Circular for consultation with the Minister. Ministry of Health. It's about allowing drug businesses to have special control.
2. The provincial / municipal Health Services shall have the function of evaluating dossiers of application for certificates of eligibility for trading in pharmaceuticals of establishments defined in Clause 3, Article 1 of this Circular to consult the directors of the provincial / municipal Health Services The permission to trade in drugs is subject to special control.
3. The Council shall be answerable to the Minister of Health or the Director of the Health Service for his / her opinion.
4. The Council's consultancy shall serve as a basis for the Ministry of Health or the Health Service to conduct field evaluations and consider and grant certificates of eligibility for trading in pharmaceuticals.
Article 5: Tasks of the Council
1. The Health Ministry's Council: To consider, evaluate and issue written consultancy on dossiers of application for certificates of eligibility for trading in pharmaceuticals of establishments defined in Clauses 1 and 2, Article 1 of this Circular. This is satisfactory or unsatisfactory. Modifications and / or additions.
2. The Health Service Council shall consider, evaluate and consult in writing dossiers of application for certificates of eligibility for trading in pharmaceuticals of establishments specified in Clause 3, Article 1 of this Circular. This is satisfactory or unsatisfactory, must be modified or added.
The Board will send its comments to the Ministry of Health or the Department of Health within 30 days after receiving the application.
Article 6: Powers of the Council
1. The dossier-receiving agency (the Vietnam Drug Administration, the Health Ministry's Council or the Health Services of the provincial / municipal Health Services) shall supply dossiers and information related to the inspection. Considering the dossiers of application for certificates of eligibility for pharmaceutical business under the provisions of Article 49 of the Government's Decree No. 54 / ND-CP of May 8, 2017, detailing a number of articles and measures to be taken. Pharmaceutical Law.
2. The right to reserve opinions from the standpoint of the independent council.
3. Conditions on material foundations and equipment in service of the evaluation of dossiers and consultancy activities of the Council shall be ensured.
4. The members of the Council shall work part-time and enjoy remunerations according to the current regime.
Article 7: Organizational structure of the Council
1. The Health Ministry Council shall ensure the following members:
a / The Managing Board chairman is the leader of the Vietnam Drug Administration;
b / The Vice Chairman of the Council is the director of a functional section under the Vietnam Pharmacy Management Department;
c / The secretary of the council is a specialist of the Vietnam Pharmacy Management Department;
d / Representatives of the Ministry of Public Security, which are involved in the control of drug-related activities, for cases of grant of certificates of eligibility for trading of pharmaceutical products to production, import or export or security services. Management of narcotic drugs, psychotropic medicines, pre-substances and drug materials being habit-forming drugs, psychotropics and pre-substances for use as drugs;
e / Representatives of the Ministry of Science and Technology on the management of radiation and nuclear safety for cases of grant of certificates of eligibility for trading in pharmaceutical products to production, import or export establishments. providing drug preservation services;
e / A representative of the Inspectorate of the Health Ministry;
g) Other members in case of necessity.
2. The Health Service Council shall have the following composition:
a / The chairman of the council is the head of the Health Service in charge of pharmaceutical work or a functional section of the Health Service;
b) The secretary of the council is an expert of the Health Service;
c / Representatives of the police offices of the provinces or centrally-run cities, which are related to the control of drug-related activities, for cases of granting of certificates of full satisfaction of drug business conditions.
Source: Drug Administration of Vietnam