Medicines Act 1968

103 Construction of references to specified publications. U.K.

(1) In this section “specified publication” means any of the following, that is to say—

(a) the European Pharmacopoeia;

(b) the British Pharmacopoeia;

(c) the British Pharmaceutical Codex;

[F1 (ca) the International Pharmacopoeia;

(cb) the Cumulative List of Recommended International Nonproprietary Names;]

F2 (d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(e) the British National Formulary;

(f) the Dental Practitioners’ Formulary;

(g) any compendium prepared under subsection (3) and published under subsection (6) of section 99 of this Act; and

(h) any list of names prepared and published under section 100 of this Act.

(2) Where any licence granted or certificate issued under Part II of this Act refers to a specified publication, but not to a particular edition of that publication, then, for the purpose of determining whether anything done, at a time when the licence or certificate is in force, is done in accordance with the licence or certificate, the reference shall, unless the licence or certificate otherwise expressly provides, be construed as a reference to the current edition of that publication as in force at that time.

(3) Where under any enactment [F3 contained in this Act or in any other] Act (whether passed before or after the passing of this Act) there is power to make any regulations, rules, order, list or other instrument which is to have effect by virtue of, or for the purposes of, that enactment, and an instrument made in the exercise of that power—

(a) could be made so as to refer to the current edition of a specified publication as in force at the time when the instrument is made, but

(b) could not, apart from this subsection, be made so as to refer to the current edition of a specified publication as in force at a subsequent time,

the power to make the instrument may (unless, in the case of an enactment passed after this Act, the enactment otherwise expressly provides) be exercised so as to refer to the current edition of a specified publication as in force at such time (whether before, at or after the time when the instrument is made) as may be specified in, or determined in accordance with, the instrument.

(4) Where any such power as is mentioned in subsection (3) of this section (in this subsection referred to as “the primary power”) includes power to vary instruments made in the exercise of the primary power, subsection (3) of this section shall have effect in relation to any exercise of the power to vary any such instrument (whether the instrument was made before, or is made after, the passing of this Act) as it has effect in relation to any exercise of the primary power.

(5) In this section any reference to the current edition of a specified publication as in force at a particular time is a reference to the edition of that publication in force [F4 , under whatever title,] at that time together with any amendments, additions and deletions made to it up to that time; and any reference to making an instrument in the exercise of a power conferred by an enactment shall be construed as including a reference to issuing or approving such an instrument.

Textual Amendments

F1 S. 103(1)(ca)(cb) inserted by Health and Medicines Act 1988 (c.49, SIF 113:2, 84), s. 22(1)

F2 S. 103(1)(d) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 53 (with regs. 2(4), 3)

F3 Words substituted by Health and Medicines Act 1988 (c. 49, SIF 113:2, 84), s. 22(4)

F4 Words inserted by Health and Medicines Act 1988 (c. 49, SIF 113:2, 84), s. 22(6)

Modifications etc. (not altering text)

C1 Pt. VII 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)

C2 S. 103 applied (with modifications) (1.1.1995) by S.I. 1994/3144, reg. 9(8)

C3 S. 103 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)