United Kingdom Statutory Instruments

" (c) in relation to an application for a variation with extras insofar as it falls within regulation 9 of the 1994 Regulations,".

(i) for "Regulation (EC) No 541/95," substitute " Regulation (EC) 1084/2003";

(ii) for "a marketing authorisation, or" substitute "a marketing authorisation, animal test certificate, export certificate or request for a certified copy of an export certificate, or"; and

(iii) for "Directive 81/851/EEC" substitute "Directive 2001/82/EC".

(b) after paragraph (5), insert:

(i) in its heading by substituting for "and Animal Test Certificates" the phrase "Animal Test Certificates and Export Certificates";

(ii) in paragraphs 2 and 3, by substituting for the phrase "Article 15.2 marketing authorisation" wherever it appears, the phrase "Article 26.3 marketing authorisation";

(iii) by substituting the following for the text in paragraph (8) (animal test certificates):

" The fee for an Animal Test Certificate - Type A application is £290, and the fee for an Animal Test Certificate - Type B application is £700." and

(i) in paragraph 3 (mutually recognised marketing authorisations), Table F, by substituting for Column (1) of that Table, Column (1) of the Table set out in Schedule 3 to these Regulations, and by substituting for the fees set out in Table F, the new fees set out in Columns (2) and (3) of the Table set out in Schedule 3 to these Regulations;

(ii) by substituting for paragraph 4 the following:

(a) the same data is relied on for both the connected variation and the proposed variation, and

(b) the same applicant applies for the connected variation and the proposed variation."

(d) for Part V, paragraph 4 (Article 15.2 marketing authorisations) substitute the following - 

(i) delete the definition "the Homoeopathics Directive";

(ii) in the definition "homoeopathic stock", for "the Homoeopathics Directive" substitute "Article 1.8 of Directive 2001/82/EC;" and

(b) in Part II (Fees Relating to Applications for Registration), paragraph 2(b), for "Article 6 of the Homoeopathics Directive" substitute "Article 16 of Directive 2001/82/EC".

(a) marketing authorisations under the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994 (S.I. 1994/3142);

(b) licences and certificates granted under the Medicines Act 1968 in so far as they apply to medicinal products for animal use; and

(c) the registration of homoeopathic veterinary medicinal products under the Registration of Homeopathic Veterinary Medicinal Products Regulations 1997 (S.I. 1997/322).

Regulations 2 and 3 and Schedules 3 and 4 prescribe new fees in relation to the provisions specified there, with the previous fee shown as a comparison. Most fees payable under these Regulations are increased by 3 per cent (rounded up or down to the nearest £5) in comparison with the 1998 Regulations as last amended.

New charges are introduced and fees set for applications for export certificates (issued under the Medicines Act 1968) and for requests to the licensing authority to carry out specific batch control (regulation 2(2) and (3) and 3(2)(b)(iv)). Charging for referrals of variations with extras falling under regulation 9 of the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994 is brought into line with other variations with extras referred to the Veterinary Products Committee (regulation 3(5)). Amendment is also made to reflect changes in the category of Animal Test Certificate applications (regulation 3(2)(a) and (b)(iii)).

The Regulations also introduce new fees to reflect amendments to the arrangements for processing of applications for variations to mutually recognised marketing authorisations required by recent changes in EC law (see Commission Regulation (EC) No 1084/2003) (regulation 2(2), 3(2)(a) and (c)). References to EC legislation have where appropriate been updated throughout.

Regulation 4 (transitional arrangements) provides that the Regulations, subject to the exceptions in paragraphs (2) and (3) of that regulation, apply to applications made after the Regulations come into force and that, for fees relating to turnover, the first relevant year is 2002.

A Regulatory Impact Assessment has been prepared and a copy has been placed in the library of each House of Parliament. Copies may be obtained from the Veterinary Medicines Directorate, Woodham Lane, Addlestone, Surrey, KT15 3LS.