S.I. No. 242/1980 - European Communities (Proprietary Medical Products) (Amendment) Regulations, 1980.
S.I. No. 242 of 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. |