Chapter VI
RULES FOR ORGANIZATION AND OPERATION OF ADVISORY BOARD, VALIDATING UNITS AND VALIDATORS
Article 42. Organization and operation of Advisory Board
1. The Advisory Board is established by the Minister of Health of Vietnam. The Advisory Board is composed of experts whose qualifications and experience are appropriate for validating applications, questioning opinions of validators and proposals of the Drug Administration of Vietnam, and provide the Minister of Health with advice about pharmacy laws, safety and efficacy documents of drugs/medicinal materials.
2. The Advisory Board has the responsibility to provide the Minister of Health of Vietnam with advice on issuance, renewal, revision of marketing authorization; issuance of license to import unapproved drugs on the basis of validation conclusions given by validators and proposals of the Drug Administration of Vietnam, and relevant issues at the request of the Minister of Health of Vietnam. The Advisory Board shall assume responsibility before the Minister of Health of Vietnam for its advice and opinions.
3. Operation of the Advisory Board:
a) The Advisory Board operates following the rule of unanimity, democracy, objectivity and transparency. The Advisory Board shall give opinions on a scientific and lawful basis while taking account of validation conclusions given by validators, clinical reality and proposals of the Drug Administration of Vietnam;
b) Every meeting of the Advisory Board shall be attended by at least 2/3 of its qualified members (according to the regulations on organization and operation of the Advisory Board announced by the Ministry of Health of Vietnam), including those who send their opinions in writing without attending the meeting;
The chairperson or a person authorized by the chairperson to chair the meeting shall draw the conclusion when it is approved of by at least 2/3 of the participants. Dissenting opinions shall be reserved.
Opinions, including dissenting opinions, of the members and the conclusions drawn by the Advisory Board shall be written in the meeting minutes.
c) If a meeting is not held, the chairperson shall obtain written opinions from its members;
After the deadline for sending opinions, the chairperson or a person authorized by the chairperson shall reach conclusions when at least 2/3 of the members have sent their opinions.
The conclusions of the Advisory Board shall be reached based on consenting opinions of at least 2/3 of its members, the consolidated report and proposal of the Drug Administration of Vietnam;
The conclusions of the Advisory Board shall be written in the statement of conclusions of its chairperson or the person authorized by the chairperson.
d) Where necessary, members of the Advisory Board are entitled to consider and validate the application, and the chairperson may seek opinions from independent experts other than its members reaching final conclusions. These experts may participate in the meeting of the Advisory Board or send their written opinions, have the same responsibilities and rights as those of the members of the Advisory Board;
dd) Conflict of interest rules must be complied.
4. The Drug Administration of Vietnam shall propose to the Minister of Health of Vietnam regulations on organization and operation of the Advisory Board, the mechanism for cooperation between the Advisory Board and validators regarding issuance, renewal and revision of marketing authorizations and licenses for import of unapproved drugs.
5. Operating budget of the Advisory Council shall comply with regulations of law.
6. The Standing Committee of the Advisory Board shall be situated within the Drug Administration of Vietnam.
Article 43. Organization ad operation of validating units, validators of applications for issuance, renewal and revision of marketing authorization and applications for license to import unapproved drugs
1. The Drug Administration of Vietnam and validating units shall establish validating teams in charge of validating legal documents, specifications, pharmacology, clinical data, dosage form, stability, bioequivalence and list of experts of validating teams in charge of validating marketing applications and applications for license to import unapproved drugs. The composition of each validating team shall be suitable for the proposed products, registration form or licensing form.
2. Validators’ opinions shall be given on a lawful and scientific basis, and written in the validation record. Validators shall assume responsibility before the Director of the Drug Administration of Vietnam and validating units for their validation works and opinions about applications for issuance, renewal and revision of marketing authorization or applications for license to import unapproved drugs.
3. The Drug Administration of Vietnam shall, within the ambit of its assigned functions and tasks, formulate and issue regulations on organization and operation of teams of validators (including experts of validating units) in charge of validating applications for issuance, renewal and revision of marketing authorization and applications for license to import unapproved drugs; sign contracts with validators or validating units;
The Drug Administration of Vietnam and validating units shall provide training courses for validators; organize assessment of the validators’ knowledge and compliance with regulations of law, which is the basis for replacement or employment of validators.
4. Funding for validation shall be allocated in accordance with regulations of law.
Tìm kiếm
Thông tư 08/2022/TT-BYT (Bản Word)
Thông tư 08/2022/TT-BYT (Bản Pdf)