Chapter VI
RULES FOR ORGANIZATION AND OPERATION OF MARKETING AUTHORIZATION ADVISORY BOARD
Article 44. Organization and operation of Marketing Authorization Advisory Board
1. Marketing Authorization Advisory Board is established by the Minister of Health. The Advisory Board consists of experts whose qualifications and experience are appropriate for validating applications, questioning opinions of validating officials and proposals of Drug Administration of Vietnam, provide the Minister of Health with advice regarding about pharmacy laws, safety and efficacy documents of drugs/medicinal ingredients.
2. The Advisory Board has the responsibility to validate applications, provide the Minister of Health with advice on issuance, renewal, revision of marketing authorization; licensing import of drugs without the marketing authorization on the basis of proposals of Drug Administration of Vietnam, and relevant issues at the request of the Minister of Health. The Advisory Board is responsible to the Minister of Health for its advice and comments.
3. Operation of the Advisory Board:
a) The Advisory Board operates according to unanimity, democracy, objectivity and transparency principles. Comments offered by The Advisory Board shall be scientific and lawful with account taken of results given by validating officials, clinical reality and proposals of Drug Administration of Vietnam.
b) Every meeting of The Advisory Board shall be attended by at least 2/3 of its members, including those who send their comments in writing without attending the meeting;
The chairperson or a person authorized by the chairperson to preside over the meeting shall announce the verdict 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 verdict of The Advisory Board shall be written in the meeting minutes, including dissenting opinions.
c) If a meeting is not held, the chairperson shall obtain written comments from the members;
After the deadline for sending comments, the chairperson or a person authorized by the chairperson shall announce a verdict when at least 2/3 of the members have sent their comments.
The verdict shall be based upon consenting opinions of at least 2/3 of the commenting members, the consolidated report and proposal of Drug Administration of Vietnam;
d) Where necessary, the chairperson may seek opinions from independent experts other than Advisory Board members before announcing the verdict. These experts may participate in the Advisory Board meeting or send their comments, have the same responsibilities and interests as those of the members;
dd) Conflict of interest rules are not violated.
4. Drug Administration of Vietnam shall propose to the Minister of Health the regulations on organization and operation of the Advisory Board, the mechanism for cooperation between the Advisory Board and validating officials 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. Standing Committee of Marketing Authorization Advisory Board shall be situated within Drug Administration of Vietnam.
Article 45. Organization and operation of validating official of marketing applications and import license applications
1. Drug Administration of Vietnam shall established validation teams to validate marketing applications and import license applications. The composition of each validation team shall be suitable for the proposed products, registration form or licensing form.
2. The validating officials’ comments shall be lawful and scientific, and written in the validation record. Validating officials are responsible to the Director of Drug Administration of Vietnam for their validation works and proposals.
3. Drug Administration of Vietnam shall introduce regulations on organization and operation of validation teams; sign contracts with validating officials or validating units; provide training courses for validating officials; organize assessment of the validating officials’ knowledge and conformity, which is the basis for replacement or employment of validating officials.
4. Provision of funding for validation shall comply with regulations of law.
Tìm kiếm
Thông tư 32/2018/TT-BYT (Bản Pdf)
Thông tư 32/2018/TT-BYT (Bản Word)