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The Medicines Act 1968 (Amendment) (No. 2) Regulations 1994

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Section 24 of the Act — duration and renewal of licence

5.  In section 24(1) (duration and renewal of licence)—

(a)in subsection (1A) after “obligation” there is inserted “(other than an obligation under the 1992 Directive)”;

(b)in subsection (3)(c) after “this Act” there is inserted “and any Community obligation under the 1965 Directive or the 1992 Directive”; and

(c)after subsection (6) there is inserted—

(7) In this section “the 1992 Directive” means Council Directive 92/27/EEC(2) of 31st March 1992 on the labelling of medicinal products for human use and on package leaflets..

(1)

Section 24 was amended by regulation 4(4) of S.I. 1977/1050 and regulation 5(4) of (N.I.) S.R. 1977 No. 150, and applied by regulation 2 of, and the Schedule to, the Medicines Act 1968 (Application to Radiopharmaceutical-associated Products) Regulations 1992 See also the Medicines Act (Application to Radiopharmaceutical-associated Products) Regulations 1992 (S.I. 1992/605).

(2)

OJ No. L113,30.4.92, p.8.

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