This version of this provision is prospective.
There are outstanding changes not yet made by the legislation.gov.uk editorial team to The Medicines (Advisory Bodies) Regulations 2005. Any changes that have already been made by the team appear in the content and are referenced with annotations.
Prospective
4. For section 3 of the Act (general functions of the Commission)(1), substitute—
3.—(1) The Commission shall give to any one or more of the Ministers specified in paragraphs (a) and (b) of section 1(1) of this Act advice on matters—
(a)relating to the execution of this Act,
(b)relating to the exercise of any power conferred by this Act,
(c)relating to the execution of the Marketing Authorisation Regulations or the Clinical Trials Regulations,
(d)relating to the exercise of any power conferred by those regulations, or
(e)otherwise relating to medicinal products,
where either the Commission consider it expedient, or they are requested by the Minister or Ministers in question, to do so.
(2) Without prejudice to the preceding subsection, and to any other duties or powers imposed or conferred on the Commission by or under this Act, the Marketing Authorisation Regulations or the Clinical Trials Regulations, it shall be the duty of the Commission—
(a)to—
(i)give advice with respect to safety, quality or efficacy in relation to medicinal products,
(ii)promote the collection and investigation of information relating to adverse reactions, for the purposes of enabling such advice to be given, and
(iii)undertake the functions mentioned in section 4(4) of this Act,
except in so far as those functions are for the time being assigned to a committee established under section 4 of this Act; and
(b)to advise the licensing authority in cases where the authority—
(i)are required by the provisions of Part 2 of this Act, or by the provisions of the Marketing Authorisation Regulations or the Clinical Trial Regulations, to consult the Commission with respect to any matter arising under those provisions, or
(ii)without being required to do so, elect to consult the Commission with respect to any matter arising under any of those provisions.”.
Commencement Information
I1Reg. 4 in force at 30.10.2005, see reg. 1(1)
Section 3 was amended by paragraph 1 of Schedule 10 to S.I. 2004/1031.
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