Chương IX Thông tư 03/2012/TT-BYT: Tổ chức thực hiện

Chapter IX

ORGANIZATION OF IMPLEMENTATION

Article 39. Responsibility for implementation

The Department of Science and Training shall preside over and coordinate with the concerned Departments:

1. To receive and examine registration dossiers and guide organizations and individuals with drugs of clinical trial and organizations undertaking clinical drug trial to comply with the provisions of this Circular and other concerned provisions of law.

2. To appraise the conditions for clinical drug trial dossiers, professional capacity, material facilities and legality of the organizations undertaking clinical drug trial, clinical research organization (CRO), the management organization of research sites (SMO) and report to leader of the Ministry for permission to conduct trial.

3. To organize the meetings of the Council of Ethics in biomedical research - Ministry of Health to review for approval of research outlines, evaluation of the contents of ethics in research and specialized science; to assess the results of research of clinical drug trial, synthesize and submit to leader of the Ministry for approval.

4. To organize period or irregular supervision, inspection during the course of research.

5. To disseminate and guide implementation of the contents of this Circular and guide good clinical practice and ethics in biomedical research for the concerned units, organizations and individuals.

Article 40. Transitional provisions

The registration dossiers for clinical drug trial submitted before the effective date of this Circular are reviewed and evaluated according to "Regulation on clinical drug trial" issued together with Decision No.01/2007/QD -BYT dated 11/01/2007 of the Minister of Health.

Article 41. Effect

1. This Circular takes effect from 20/03/2012.

2. To annul the Decision No.01/2007/QD-BYT dated 11/01/2007 of the Minister of Health promulgating the "Regulations on clinical drug trial" from the effective date of this Circular.

3. Heads of agencies, organizations and concerned units are responsible for organizing the propagation, dissemination and implementation of this Circular to the subjects for implementation.

In the implementation process if there are any problems, the concerned organizations, individuals should report them promptly to the Health Ministry for reviewing amendment and supplement accordingly.