The Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2003

Amendment of the Schedules to the Medicines (Products for Animal Use—Fees) Regulations 1998

3.—(1) The Schedules to the principal Regulations shall be amended as specified in this regulation.

(2) In Schedule 1—

(a) Part I (interpretation of Schedule 1) shall be amended in accordance with Schedule 2 to these Regulations;

(b) Part II (Fees Relating to Applications for the Grant of Marketing Authorisations, Product Licences, Manufacturer’s Licences, Wholesale Dealer’s Licences and Animal Test Certificates) shall be amended—

(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

(iv) after paragraph 9 by adding the following new paragraph:

“Export Certificates

10.   The fee for an application for an export certificate is £25 and, for the supply of a certified copy of the original certificate, £10.”;

(c) Part IV shall be amended—

(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:

“4.— (1) The fee for an application for a connected variation shall, in respect of each connected variation to which the application relates, be £1,515 per individual variation where the United Kingdom is acting as the Reference Member State and £230 per individual variation where the United Kingdom is not acting as Reference Member State.

(2) In this paragraph a connected variation means a variation of a kind described in an entry in column (1) of Table F of a mutually recognised marketing authorisation which is connected to a proposed variation of another such authorisation for which a fee is paid in pursuance of paragraph 3, and where—

(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—

“Article 26.3 marketing authorisations

4.   Where an Article 26.3 marketing authorisation is renewed, no fee is payable in respect of the first such renewal.”.

(3) In Schedule 3 in Part II (Calculation of Annual Fees), in paragraph 1, for “£280”, substitute “£290”.

(4) In Schedule 5 (Fees Relating to Applications for Registration of Homoeopathic Veterinary Medicinal Products)—

(a) in Part I (Interpretation)—

(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”.

(5) In Schedule 6 (“Marketing Authorisations, Product Licences and Animal Test Certificates: Fees for references to the Veterinary Products Committee or to the Medicines Commission”), after paragraph 2, add the following new paragraph—

“2A.   The fee payable under regulation 15(c) for a reference to the Veterinary Products Committee in connection with an application for a variation with extras insofar as it falls within regulation 9 of the 1994 Regulations shall be £960.”.

(6) In Schedule 7, paragraph 4(1)(c) for “Article 9 of Directive 81/851/EEC” substitute “Article 23 of Directive 2001/82/EC”.

(7) The provisions of the principal Regulations as to fees which are set out in column (1) of Schedule 4 to these Regulations shall be amended by substituting for the corresponding old fee, set out in column (3), the new fee set out alongside it in column (4) of that Schedule.