S.I. No. 242/1980:

EUROPEAN COMMUNITIES (PROPRIETARY MEDICAL PRODUCTS) (AMENDMENT) REGULATIONS, 1980.

EUROPEAN COMMUNITIES (PROPRIETARY MEDICAL PRODUCTS) (AMENDMENT) REGULATIONS, 1980.

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, 1980.

2. In these Regulations--

"the Principal Regulations" means the European Communities (Proprietary Medicinal Products) Regulations, 1975 ( S.I. No. 301 of 1975 ).

3. There shall be substituted for article 5 of the Principal Regulations the following article:--

"5. (1) Applications for authorisations under these Regulations and the Directives referred to in article 3 thereof 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--£100;

( 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--£50;

( c ) in the case of an application for an authorisation in respect of a proprietary medicinal product which consists of an additional pharmaceutical form or dosage strength of a product for which an authorisation has already been granted--£20;

( d ) in the case of an application for a renewal of any authorisation--£20."

4. These Regulations shall come into effect on the 31st day of July, 1980.

GIVEN under the Official Seal of the Minister for Health this 23rd day of July, 1980.

MICHAEL WOODS,

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.