(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.