Section 10: Functions of 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.)