S.I. No. 187/1974 - European Communities (Proprietary Medicinal Products) Regulations, 1974.

S.I. No. 187 of 1974.


The Minister for Health, in exercise of the powers conferred on him by section 3 of the European Communities Act, 1972 (No. 27 of 1972), hereby makes the following Regulations:

1. These Regulations may be cited as the European Communities (Proprietary Medicinal Products) Regulations, 1974, and shall come into operation on 1st October, 1974.

2. (1) In these Regulations "Council Directive" means Council Directive No. 65/65/EEC1 of 26th January, 1965.

1 Official Journal of the European Communities, 9.2.65., 369/65 (Pages 20-24).

(2) In these Regulations words and phrases shall, unless the context otherwise requires, have the same meanings as in the Council Directive.

3. Proprietary medicinal products which were not on the market in the State on 1st October, 1974, shall not be placed on the market unless they comply with the provisions of Chapters I, II, III and V of the Council Directive and from 1st October, 1975, unless they also comply with the provisions of Chapter IV of the Council Directive.

4. The competent authority in the State for the purpose of the Council Directive shall be the Minister for Health.

5. There shall be paid to the Minister for Health a fee of £50 in respect of the initial grant of an authorisation to place a proprietary medicinal product on the market and a fee of £10 in respect of any renewal of such authorisation.

6. (i) A person who contravenes article 3 of these Regulations shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding £200 and, in the case of a continuing offence, to a further fine not exceeding £20 for each day on which the offence is continued.

(ii) An offence under these Regulations may be prosecuted by or on behalf of the Minister for Health.

GIVEN under the Official Seal of the Minister for Health, this 24th

day of June, 1974.


Minister for Health.


The effect of these Regulations is to require that new proprietary medicinal products may not be placed on the market after 1st October, 1974 unless they comply with the provisions of EEC Directive 65/65, including the requirement of an authorisation by the Minister for Health in respect of each such product. The labelling provisions of the Directive (Chapter IV) will not, however, apply until 1st October, 1975.