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

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.