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Section 10: Functions of Pharmacovigilance Committee

Clinical Trials Act · PART IV: PHARMACOVIGILANCE COMMITTEE

consolidated text (as at 2017, amended since). juris shows the text as it was consolidated; it does not confirm that this is the law in force today.

10. Functions of Pharmacovigilance Committee (1) The functions of the Pharmacovigilance Committee shall be to— (a) collect all available information on adverse events and adverse reactions, in Mauritius or elsewhere, particularly in relation to subjects involved in clinical trials; (b) analyse and classify any such information and communicate it to the health personnel and to the public and, where appropriate, to the relevant division of the World Health Organisation; (c) liaise with the Trade and Therapeutics Committee for the purpose of recommending measures, by means of legislation or otherwise, to minimise the risk of adverse events and adverse reactions; (d) ensure that health personnel are given adequate training in the collection and analysis of adverse events and adverse reactions; (e) depute any of its members, where it deems necessary, to conduct an inspection in accordance with section 26; (f) advise the Council and the Ethics Committee on any matter specified in this section. (2) The Pharmacovigilance Committee shall establish and follow its own standard operating procedures. PART V – TRIAL LICENCE (Part V came into operation on 24 September 2011.)

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