Medicines Act 1968

[F1 3 Functions of the Commission U.K.

(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) [F2 relating to the execution of the Marketing Authorization Regulations, the Homoeopathic Regulations, the Herbal 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, [F3 the Marketing Authorization Regulations, the Homoeopathic Regulations, the Herbal 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 [F4 the Marketing Authorization Regulations, the Homoeopathic Regulations, the Herbal Regulations or the Clinical Trials 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.]

Textual Amendments

F1 S. 3 substituted (30.10.2005) by Medicines (Advisory Bodies) Regulations 2005 (S.I. 2005/1094), regs. 1(1), 4

F2 S. 3(1)(c) substituted (30.10.2005) by Medicines (Advisory Bodies) (No.2) Regulations 2005 (S.I. 2005/2754), reg. 1(2)(a), Sch. 1 para. 1(2)

F3 Words in s. 3(2) substituted (30.10.2005) by Medicines (Advisory Bodies) (No.2) Regulations 2005 (S.I. 2005/2754), reg. 1(2)(a), Sch. 1 para. 1(3)(a)

F4 Words in s. 3(2)(b)(i) substituted (30.10.2005) by Medicines (Advisory Bodies) (No.2) Regulations 2005 (S.I. 2005/2754), reg. 1(2)(a), Sch. 1 para. 1(3)(b)

Modifications etc. (not altering text)

C1 Pt. I(ss. 1–5) extended by S.I. 1984/187, art. 2

C2 S. 3 applied (1.1.1995) by S.I. 1994/3142, reg. 18(3)

S. 3 modified (1.1.1995) by S.I. 1994/3144, reg.9(1)

C3 S. 3 amendment to earlier affecting provision SI 1994/3144 reg. 9 (30.10.2005) by Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005 (S.I. 2005/2759), regs. 1(a), 2(12)