The Medicines (Products for Animal Use—Fees) Regulations 1997

PART I INTERPRETATION

In this Schedule—

“application for a type A marketing authorisation” means an application for a marketing authorisation to which regulation 5(a) of the 1994 Regulations applies and “type A marketing authorisation” shall be construed accordingly;

“application for a type B marketing authorisation” means an application for a marketing authorisation to which regulation 5(b) of the 1994 Regulations applies and “type B marketing authorisation” shall be construed accordingly;

“Article 15.2 marketing authorisation” means a marketing authorisation of the type specified in Article 15.2 of Directive 81/851/EEC;

“category I application” means an application for assistance in connection with a mutual recognition application other than a category II or III application;

“category II application” means an application, other than a category III application, for assistance in connection with a mutual recognition application relating to a marketing authorisation granted in respect of a Veterinary Medicinal Product only intended for administration to animals whose flesh or products are not intended for human consumption;

“category III application” means an application for assistance in connection with a mutual recognition application relating to a marketing authorisation granted in respect of an immunological Veterinary Medicinal Product;

“food-producing animals” means animals whose flesh or products are intended for human consumption;

“type I variation—Administrative” means a variation of the type listed in paragraphs 2 and 3 of Annex I to Regulation (EC) No. 541/95(1);

“type I variation—Scientific” means a variation of the type listed in paragraphs 1 and 4 to 33 of Annex 1 to Regulation (EC) No. 51/95; and

“type II variation” means a variation of the type referred to in Article 3.1(b) of Regulation (EC) No. 541/95.

(1)

OJ No. L55, 11.3.95, p.7.