Medicines Act 1968

4 Establishment of committees. U.K.

(1)The MinistersF1...F2... may by order establish one or more committees under this section.

(2)A committee may be so established for any purpose, or combination of purposes, [F3connected with—

(a)the execution of this Act [F4, the Marketing Authorisation Regulations][F5, the Homoeopathic Regulations, the Herbal Regulations]or the Clinical Trials Regulations, or

(b)the exercise of any power conferred by this Act or those regulations,

either generally or in relation to any particular class of substances or articles to which any provision of this Act or those regulations applies.]

(3)Without prejudice to the generality of subsection (2) of this section, in relation to any such class of substances or articles a committee may be established under this section for either or both of the following purposes, that is to say—

(a)giving advice with respect to safety, quality or efficacy, or with respect to all or any two of those matters;

(b)promoting the collection and investigation of information relating to adverse reactions, for the purpose of enabling such advice to be given.

(4)A committee or committees may be established under this section for the purpose of performing any function under Part VII of this Act in relation to the British Pharmacopoeia or in relation to any such compendium or list of names or other publication as is mentioned in that Part of this Act.

[F6(4A)A committee established under this section shall have at least eight members.]

(5)The Ministers F7... shall appoint the members of the committee, and shall appoint one of those members to be chairman of the committee.

F8(5A). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F9(6)In this Act “the appropriate committee”, for the purposes of any provision of this Act under which a function falls to be performed, means—

(a)in a case where—

(i)a committee has been established under this section for purposes which consist of or include any of those specified in subsection (3) of this section, and

(ii)the authority performing that function considers it to be the appropriate committee in the circumstances,

that committee; and

(b)in any other case, the Commission.]

Textual Amendments

F1Words in s. 4(1) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 4(a) (with regs. 2(4), 3)

F2Words in s. 4(1) omitted (30.10.2005) by virtue of Medicines (Advisory Bodies) Regulations 2005 (S.I. 2005/1094), regs. 1(1), 5(2)

F7Words in s. 4(5) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 4(b) (with regs. 2(4), 3)

Modifications etc. (not altering text)

C1Pt. I(ss. 1–5) extended by S.I. 1984/187, art. 2

C2S. 4 applied (1.1.1995) by S.I. 1994/3142, reg. 18(3)

S. 4 modified (1.1.1995) by S.I. 1994/3144, reg. 9(1)

C3S. 4 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)

C4S. 4(1)(5): Certain functions made exercisable (S.) (30.6.1999) by S.I. 1999/1748, art. 3, Sch. 1 para. 3

C5S. 4(2)(3) modified (6.3.2002 for certain purposes and 1.4.2002 otherwise) by 2001 c. 15, s. 63(8) (with ss. 64(9), 65(4)); S.I. 2002/1095, art. 2(1)

C6s. 4(5) amended (S.) (1.7.1999) by S.I. 1999/1750, art. 4, Sch. 3 (with art. 7)