Section 4: Functions and powers of Council

4. Functions and powers of Council The functions and powers of the Council shall be to— (a) consider and grant or refuse applications for a trial licence; (Para. (a) came into operation on 24 September 2011.) (b) issue, amend, extend, review, suspend or cancel trial licences; (Para. (b) came into operation on 24 September 2011.) (c) examine and approve the qualifications of every investigator; (Para. (c) came into operation on 24 September 2011.) (d) exercise control over licensees and on sites by inspection, examination of any reports received and such other means as may be appropriate; (Para. (d) came into operation on 24 September 2011.) [Issue 10] C25A – 6 Revised Laws of Mauritius (e) consult regularly with, and consider reports and recommendations from, the Ethics Committee, the Pharmacovigilance Committee and the Trade and Therapeutics Committee; (Para. (e) came into operation on 24 September 2011.) (f) prepare or approve guidelines for the safe and ethical operation of clinical trials; (g) provide for the health, welfare, safety and protection of subjects; (Para. (g) came into operation on 24 September 2011.) (h) keep the Register; (Para. (h) came into operation on 24 September 2011.) (i) keep a record of all published material relating to clinical trials conducted in accordance with this Act; (Para. (i) came into operation on 24 September 2011.) (j) examine and act on any adverse report or complaint received from a sponsor, an investigator, an officer, the Pharmacovigilance Committee or any other person; (Para. (j) came into operation on 24 September 2011.) (k) arrange, where appropriate, for the training or continued training of investigators; (Para. (k) came into operation on 24 September 2011.) continued on page C25A – 7 C25A – 6 (1) [Issue 10] Revised Laws of Mauritius (l) appoint officers whose role includes, but is not limited to, verification of compliance with good clinical practice and pharmacovigilance provisions of this Act through inspections; (Para. (l) came into operation on 24 September 2011.) (m) perform such other duties, not inconsistent with this Act, as may be entrusted to it in writing by the Minister.