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

Explanatory Note

(This note is not part of the Regulations)

These Regulations revoke and re-enact with modifications the Medicines (Products for Animal Use—Fees) Regulations 1997. As in the case of the 1997 Regulations, they prescribe fees in connection with applications and inspections relating to:

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

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

(c) the registration of homoeopathic veterinary medicinal products.

In prescribing fees in relation to the 1994 Regulations, these Regulations continue to supplement the 1994 Regulations in implementing Council Directive 93/40/EEC (OJ No. L214, 24.8.93, p.31) which contains amendments to Council Directive 81/851/EEC (OJ No. L317, 6.11.81, p.1).

The average level of fees payable under the Regulations is increased by 10% in comparison with the 1997 Regulations.

The changes in these Regulations include–

(a) the introduction of a separate fee for variations to marketing authorisations which have been mutually recognised and which relate to medicinal products (primarily immunological) falling within the scope of introductory statement A to Annex 1 of Commission Regulation 541/95/EC;

(b) a reduction in the fee payable for a variation which is additional, consequential and in identical terms to the first variation of a mutually recognised marketing authorisation;

(c) a reduction in the fee payable for manufacturers' licences and wholesale dealers' licences.

The Regulations also provide for:

(a) the method and time for payment of fees (regulations 16 to 18);

(b) the suspension of licences and certificates where fees remain unpaid (regulation 19);

(c) the waiver, reduction or refund of fees (regulation 20 and Schedule 7); and

(d) transitional provisions (regulation 22).

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.