S.I. No. 57/1983:

EUROPEAN COMMUNITIES (PROPRIETARY MEDICINAL PRODUCTS) (AMENDMENT) REGULATIONS, 1983.

EUROPEAN COMMUNITIES (PROPRIETARY MEDICINAL PRODUCTS) (AMENDMENT) REGULATIONS, 1983.

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) (Amendment) Regulations, 1983.

2. There shall be substituted for article 5 of the European Communities (Proprietary Medicinal Products) Regulations, 1975 ( S.I. No. 301 of 1975 ) the following article:--

"5. (1) Applications for authorisations under these Regulations and the Directives referred to in article 3 of these Regulations shall be made to the Minister for Health.

(2) A fee as prescribed hereunder shall be paid to the Minister for Health in respect of applications made to him pursuant to sub-article (1) of this article, in the following cases, that is to say--

( a ) in the case of an application for an authorisation to place a proprietary medicinal product on the market -- £200;

( b ) in the case of an application for an authorisation in respect of a proprietary medicinal product which was on the market prior to the 1st day of October, 1974 -- £100;

( c ) in the case of an application for an authorisation in respect of a proprietary medicinal product which consists of an additional dosage strength of a product for which an authorisation has already been granted -- £40;

( d ) in the case of an application for a renewal of any authorisation -- £40."

3. The European Communities (Proprietary Medicinal Products) (Amendment) Regulations, 1980 ( S.I. No. 242 of 1980 ) are hereby revoked.

4. These Regulations shall come into effect on the 1st day of March, 1983.

GIVEN under the Official Seal of the Minister for Health this 28th day

of February, 1983.

BARRY DESMOND,

Minister for Health.

EXPLANATORY NOTE.

These Regulations provide for increases and other changes in connection with the charging of fees in respect of product authorisations under the European Communities (Proprietary Medicinal Products) Regulations, 1975.