The Medicines (Products for Animal Use—Fees) Regulations 1998

PART I INTERPRETATION

In this Schedule–

“application” means an application to register a product;

“formulation” means the formulation of a product but does not include the formulation of a homoeopathic stock contained in such a product;

“the Homoeopathics Directive” means Council Directive 92/74/EEC widening the scope of Directive 81/851/EEC on the approximation of the provisions laid down by law, regulation or administrative action relating to veterinary medicinal products and laying down additional provisions on homoeopathic veterinary medicinal products(1) as adapted by the EEA Agreement;

“homoeopathic stock” has the same meaning as in the Homoeopathics Directive;

“identical” means–

(a)

in relation to the formulation of a product, identical as regards the requirements in respect of the qualitative composition, preparation and testing;

(b)

in relation to a homoeopathic stock, identical as regards the source, composition and preparation of the stock and the tests which it is required to undergo;

“product” includes a series of products which are all dilutions prepared from an identical homoeopathic stock or stocks and each of which has the same pharmaceutical dosage form;

“repeat formulation”, in relation to an application, means–

(a)

the formulation of a product which is identical to the formulation of a registered product–

(i)

which the applicant is responsible for marketing; or

(ii)

to which the applicant has been authorised in writing to make reference for the purposes of his application by the person responsible for marketing that product; or

(b)

the formulation of a product which is identical to another product in respect of which the applicant has made a simultaneous application;

“repeat stock”, in relation to an application, means–

(a)

a homoeopathic stock which is used in the preparation of a product (either on its own or in combination with another homoeopathic stock or stocks), and which is identical to another homoeopathic stock which is used (whether on its own or in combination with any other homoeopathic stock or stocks) in the preparation of a registered product–

(i)

which the applicant is responsible for marketing; or

(ii)

which another person is responsible for marketing and to which the applicant has been authorised in writing to make reference for the purposes of the application by the person (or, if more than one, each of such persons) who supplied information to the Ministers in connection with the application made to register that registered product; or

(b)

a homoeopathic stock which is used in the preparation of a product (either on its own or in combination with another homoeopathic stock or stocks), and which is identical to a homoeopathic stock which is used (whether on its own or in combination with any other homoeopathic stock or stocks) in the preparation of a product in respect of which the applicant has made a simultaneous application; and

“simultaneous application” means an application which is made by an applicant at the same time as making another application or applications, and which is the first of such applications to be considered by the Ministers.

(1)

OJ No. L297, 13.10.92, p.12.