S.I. No. 301/1975 - European Communities (Proprietary Medicinal Products) Regulations, 1975.

S.I. No. 301 of 1975.

EUROPEAN COMMUNITIES (PROPRIETARY MEDICINAL PRODUCTS) REGULATIONS, 1975.

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, 1975 and shall come into operation on 1st April, 1976.

2. In these Regulations words and phrases shall, unless the context otherwise requires, have the same meanings as in the Council Directives referred to in paragraph 3 of these Regulations.

3. With effect from the commencement dates shown in respect of the classes of proprietary medicinal products in the Schedule to these Regulations, such products shall not be placed on the market unless they comply with the provisions of Council Directive 65/65/EEC¹ Council Directive 75/318/EEC² and Council Directive 75/319/EEC.²

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

²Official Journal of the European Communities, 9.6.75, No. L147 (Pages 1-22)

4. The competent authority in the State for the purpose of the Council Directives referred to in these Regulations shall be the Minister for Health.

5. There shall be paid to the Minister for Health a fee of £50 in respect of the grant of an authorisation to place a proprietary medicinal product on the market for the first time. In the case of a product which was on the market prior to the 1st October, 1974 the fee shall be £25. A fee of £10 shall be paid in respect of the renewal of any such authorisation.

6. (1) 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.

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

7. The European Communities (Proprietary Medicinal Products) Regulations, 1974, ( S.I. No. 187 of 1974 ) are hereby revoked.

SCHEDULE

Class of Proprietary Medicinal Product	Commencement Date
1. Products not on the market before 1st October, 1974.	1 April, 1976
2. Products of the following classes on the market before 1st October, 1974:
(a) anti-infectives, hypnotics and sedatives, tranquillisers	(a) 1 April, 1977
(b) antidepressants, analgesics, corticosteroids, diuretics, vaccines	(b) 1 April, 1978
(c) Miscellaneous CNS, autonomic, anti-hypertensives, gonadal, anabolics, hypoglycaemics, other metabolic drugs	(c) 1 April, 1979
(d) anaesthetics, stimulants, cardiovascular, haematinics	(d) 1 April, 1980
(e) coagulation, blood protein and substitutes, vitamins, antiprotozoals, fungicides, anthelminthics, diagnostic agents, drugs acting locally	(e) 1 April, 1983
( f ) miscellaneous not included above	( f ) 1 April, 1983

GIVEN under the Official Seal of the Minister for Health this 15th day of December, 1975.

BRENDAN CORISH,

Minister for Health.

EXPLANATORY NOTE

The effects of these Regulations are

(1) to require that new proprietary medicinal products may not be placed on the market after 1 April, 1976 unless they comply with the provisions of EEC Council Directives 65/65, 75/318 and 75/319,

(2) to require the progressive application of those Directives to proprietary medicinal products already on the market at the date of the initial licensing scheme which was introduced by the European Communities (Proprietary Medicinal Products) Regulations, 1974 with effect from 1 October, 1974, and

(3) to revoke, with effect from 1 April, 1976, the European Communities (Proprietary Medicinal Products) Regulations, 1974.