The Medicines Act 1968 (Amendment) (No. 2) Regulations 1992

Explanatory Note

(This note is not part of the Regulations)

These Regulations amend the Medicines Act 1968 (“the Act”) for the purpose of implementing Council Directive 92/26/EEC (OJ No. L113, 30.4.92, p. 5) (“the classification of human medicines directive” ) and Council Directive 90/676/EEC (OJ No. L373, 31.12.90, p. 15) which amends Council Directive 81/851/EEC (OJ No. L317, 6.11.81, p. 1) “the veterinary medicines directive”).

The classification of human medicines directive lays down the criteria to be applied by member States in specifying which medicinal products for human use are to be supplied only upon medical prescription. These Regulations insert a new section 58A of the Medicines Act 1968 (“the 1968 Act”) which specifies the relevant criteria according to which powers under section 58 of that Act must be exercised.

Similarly, these Regulations insert a new section 58B of the 1968 Act implementing the requirement of the veterinary medicines directive that certain veterinary medicinal products shall be supplied on prescription only (article 1.4 Directive 90/676/EEC which introduces a new article 4.3 into the veterinary medicines directive).

There are associated amendments to section 132 (interpretation) of the 1968 Act (regulation 3).