Chương V Thông tư 22/2009/TT-BYT: Tổ chức, hoạt động của chuyên gia thẩm định và hội đồng tư vấn cấp sổ đăng ký lưu hành thuốc

Chapter V

ORGANIZATION AND OPERATION OF APPRAISERS AND THE ADVISORY COUNCIL FOR THE GRANT OF CIRCULATION REGISTRATION NUMBERS FOR DRUGS

Article 36. Organization and operation of the Advisory Council for the Grant of Circulation Registration Numbers for Drugs

1. The Ministry of Health shall set up the Advisory Council for the Grant of Circulation Registration Numbers for Drugs (below referred to as the Advisory Council).

2. The Advisory Council is tasked to advise the Ministry of Health on the grant of registration numbers for drugs to be circulated in Vietnam; policies on harmonization of drug registration regulations with those of regional and world countries; policies on the manufacture, import and circulation of drugs in Vietnam, including the use of drugs on Vietnamese, to evaluate the safety and effects of drugs when necessary.

3. The Advisory Council shall operate on the principle that its advisory opinions must be based on legal and scientific grounds and recorded in minutes of its meetings. The Advisory Council is answerable to the Minister of Health for its advisory opinions relating to drug registration.

4. The Drug Administration of Vietnam shall advise the Minister of Health in promulgating regulations on the organization and operation of the Advisory Council and the mechanism of coordination between the Advisory Council and groups of appraisers in the grant of circulation registration numbers for drugs.

Article 37. Organization and operation of groups of appraisers of drug registration dossiers

1. The Ministry of Health shall assign the Drug Administration of Vietnam to set up groups of appraisers of drug registration dossiers (below referred to as groups of appraisers).

2. Groups of appraisers shall advise the Drug Administration of Vietnam in appraising drug registration dossiers and propose the grant, supplementation of non-grant of registration numbers.

3. Groups of appraisers operate on the principle that appraisers' comments and/or proposals must be based on legal and scientific grounds and written in records of appraisal of drug registration dossiers. Appraisers are answerable to the director of the Drug Administration of Vietnam for their advisory contents/opinions and proposals relating to the appraisal of drug registration dossiers.

4. The Drug Administration of Vietnam shall elaborate and promulgate regulations on criteria for the selection, organization and operation of groups of appraisers; annually sign contracts with appraisers; organize the appraisal and summarize appraisal results for submission to the Advisory Council; organize training courses for appraisers; and evaluate the professional capacity and observance of regulations for replacing or adding appraisers as appropriate.