Medicines Act 1968

99 New editions of British Pharmacopoeia, and other compendia. U.K.

(1) The appropriate body shall, at any such time as may be determined in accordance with subsection (5) of this section, prepare or cause to be prepared a new edition of the British Pharmacopoeia, containing such relevant information relating to substances and articles to which this subsection applies as may be so determined.

(2) The substances and articles to which the preceding subsection applies are—

(a) substances and articles (whether medicinal products or not) which are or may be used in the practice of medicine (other than veterinary medicine), surgery (other than veterinary surgery), dentistry or midwifery, and

(b) substances and articles used in the manufacture of substances or articles falling within the preceding paragraph.

(3) Without prejudice to subsection (1) of this section, the appropriate body may, at any such time as may be determined in accordance with subsection (5) of this section, prepare or cause to be prepared any such compendium or edition as is mentioned in either of the following paragraphs, that is to say—

(a) a compendium (other than the British Pharmacopoeia) containing such relevant information relating to substances and articles to which subsection (1) of this section applies, or any class of such substances and articles, as may be so determined, or, where such a compendium has been published under this section, a new edition of that compendium;

(b) a compendium containing such relevant information relating to substances and articles to which this paragraph applies, or any class of such substances and articles, as may be so determined, or, where such a compendium has been published under this section, a new edition of that compendium.

(4) The substances and articles to which subsection (3)(b) of this section applies are—

(a) substances and articles (whether [F1 veterinary medicinal products] or not) which are or may be used in the practice of veterinary medicine or veterinary surgery, and

(b) substances and articles used in the manufacture of substances and articles falling within the preceding paragraph.

(5) Anything falling to be determined for the purposes of subsection (1) or subsection (3) of this section—

(a) except where the appropriate body is the Commission, shall be determined in accordance with directions given by the Commission, or

(b) where the appropriate body is the Commission, shall be determined by the Commission.

(6) Where the appropriate body has prepared or caused to be prepared a new edition of the British Pharmacopoeia or any such compendium or new edition of a compendium as is mentioned in [F2 subsection (3)] of this section, then, on the recommendation of the Commission, the F3 ... Ministers shall cause it to be publishedF4 ...

F5 ...

(7) In this Part of this Act[F6 —]

“the appropriate body”, in relation to any work falling to be prepared under this Part of this Act, means the committee (if any) established under section 4 of this Act whose functions consist of or include the preparation of that work or, if for the time being there is no such committee, means the Commission[F7 ;

“relevant] information”, in relation to any substances or articles, means any information consisting of descriptions of, standards for, or notes or other matter relating to, those substances or articles; and

[F8 “veterinary medicinal product” has the same meaning as in the Veterinary Medicines Regulations 2006].

Textual Amendments

F1 Words in s. 99(4)(a) substituted (1.10.2006) by The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 50(a) (with regs. 2(4), 3)

F2 Words in s. 99(6) substituted (1.10.2006) by The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 50(b)(i) (with regs. 2(4), 3)

F3 Word in s. 99(6) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 50(b)(ii) (with regs. 2(4), 3)

F4 Words in s. 99(6) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 50(b)(iii) (with regs. 2(4), 3)

F5 S. 99(6) proviso repealed (22.7.2004) by Statute Law (Repeals) Act 2004 (c. 14), Sch. 1 Pt. 17 Group 7

F6 Word in s. 99(7) inserted (1.10.2006) by The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 50(c)(i) (with regs. 2(4), 3)

F7 Word in s. 99(7) substituted (1.10.2006) by The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 50(c)(ii) (with regs. 2(4), 3)

F8 Words in s. 99(7) inserted (1.10.2006) by The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 50(c)(iii) (with regs. 2(4), 3)