STATUTORY INSTRUMENTS.

S.I. No. 269 of 1981.

EUROPEAN COMMUNITIES (COLOURING OF MEDICINAL PRODUCTS) REGULATIONS, 1981.

S.I. No. 269 of 1981.

EUROPEAN COMMUNITIES (COLOURING OF MEDICINAL PRODUCTS) REGULATIONS, 1981.

The Minister for Health in exercise of the powers conferred on her by section 3 of the European Communities Act, 1972 ( No. 27 of 1972 ), and for the purpose of giving effect to Council Directive 78/25/EEC⁽¹⁾ , hereby makes the following Regulations:--

1. These Regulations may be cited as the European Communities (Colouring of Medicinal Products) Regulations, 1981.

2. These Regulations shall come into operation on the 16th day of December, 1981.

3. In these Regulations words and phrases shall, unless the context otherwise requires, have the same meanings as in Council Directive 78/25/EEC.

4. Any person who manufactures or sells a medicinal product containing a colouring matter other than a colouring matter covered by Annex 1, Sections I and II, of the Council Directive of 23 October, 1962⁽²⁾ (on the approximation of the rules of the Member States concerning the colouring matters authorised for use in foodstuffs intended for human consumption) as subsequently amended and which complies with the requirements of Council Directive 78/25/EEC as amended by Council Directive 81/464/EEC⁽³⁾ , shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding £200.

5. An offence under these Regulations may be prosecuted by the Minister for Health.

6. These Regulations shall not apply as respects the manufacture or sale of a medicinal product for export to a country which is not a Member State of the European Economic Community.

EXPLANATORY NOTE.

(This note is not part of the Instrument and does not purport to be a legal interpretation.)

The purpose of these Regulations is to give effect to Directive 78/25/EEC which restricts the colouring matters which may be added to medicinal products for human and veterinary use. The colouring matters which may be used are set out in Annex 1, Sections I and II of the Council Directive of 23 October 1962 (O.J. No. 115, 11 November 1962) as amended.

(1) O.J. No. L11, 14 January, 1978.

(2) O.J. No. 115, 11 November, 1962.

(3) O.J. No. L183, 4 July, 1981.