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

Amendment of regulations 2, 3, 12 to 17 and 19 of the Medicines (Products for Animal Use—Fees) Regulations 1998

2.—(1) Regulations 2, 3, 12 to 17 and 19 of the principal Regulations shall be amended as specified in this regulation.

(2) In regulation 2 (Interpretation)—

(a) paragraph (1) shall be amended in accordance with Schedule 1 to these Regulations.

(b) for paragraph (2) substitute:

“(2) Other expressions used in these Regulations have the same meaning as in the Act and the 1971 Act, and, in the case of variations to marketing authorisations other than mutually recognised marketing authorisations, as in Directive 851/81/EEC(1) and Regulation (EC) No 541/95,(2) but in all other cases, as in Directive 2001/82/EC(3) and Regulation (EC) No 1084/2003(4).”.

(3) For regulation 3, substitute:

“Applications for the grant of marketing authorisations, product licences, manufacturer’s licences, wholesale dealer’s licences, animal test certificates and export certificates

3.— (1) Where a person applies for the grant of a marketing authorisation, a product licence, a manufacturer’s licence, a wholesale dealer’s licence, an animal test certificate or an export certificate, he shall pay the relevant fee prescribed in Part II of Schedule 1.

(2) Where a person requests from the licensing authority a certified copy of an export certificate which he has been or is to be granted, he shall pay the fee prescribed in Part II of Schedule 1, paragraph 10.

(3) Paragraph (1) shall not be taken to impose any obligation on an applicant for a new marketing authorisation or product licence falling within regulation 11(2) or on an applicant for a variation with extras.

Specific batch control

3A.   Where the holder of a marketing authorisation (other than a mutually recognised marketing authorisation) or of an animal test certificate requests the licensing authority to undertake specific batch control in respect of a batch of a veterinary medicinal product, he shall pay a fee of £475.”

(4) In regulation 12 (manufacturer’s licences: annual fees), for “an annual fee of £215”, substitute “an annual fee of £220”.

(5) In regulation 13 (wholesale dealer’s licences: annual fees),

(a) in paragraph (1), for “£430”, substitute “£445”; and

(b) in paragraph (2), for “£215”, substitute “£220”.

(6) In regulation 14 (registration of homoeopathic veterinary medicinal products),

(a) in paragraph (2), for “£80”, substitute “£85”; and

(b) in paragraph (3), for “£95”, substitute “£100”.

(7) In regulation 15 (marketing authorisations, product licences and animal test certificates: fees for references to the Veterinary Products Committee or to the Medicines Commission),

(a) in paragraph (a), after “renewal of an animal test certificate”, delete “or” ,

(b) in paragraph (b) after “renewal of a marketing authorisation,”, insert “or”, and

(c) insert a new paragraph as follows:

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

(8) Regulation 16 (payment of fees) shall be amended as follows:

(a) in paragraph (1) for “the Minister of Agriculture, Fisheries and Food”, substitute “the Secretary of State for Environment, Food and Rural Affairs”;

(b) in paragraph (2) delete “or the Minister of Agriculture, Fisheries and Food as may be indicated on the written notice requiring payment referred to in regulation 17(2)”.

(9) In regulation 17 (time for payment of fees)—

(a) in paragraph (4)—

(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:

“(5A) the licensing authority need not undertake specific batch control if the person who requests it has not paid or caused to be paid the fee required under these Regulations.

(5B) Nothing in paragraph (5A) shall be construed as preventing the licensing authority from fulfilling its obligations to observe the duties imposed on member States under Articles 81 or 83 of Directive 2001/82/EC.”.

(10) In regulation 19(2), for “Directive 81/851/EEC” substitute “Directive 2001/82/EC”.

(1)

OJ No. L317, 6.11.1981, p. 1.

(2)

OJ No. L55, 11.3.1995, p. 7.

(3)

OJ No. L311, 28.11.2001, p. 1.

(4)

OJ No. L159, 27.6.2003, p. 1.