The Medicines (Products for Animal Use—Fees) Regulations 1997

Explanatory Note

(This note is not part of the Regulations)

These Regulations consolidate with some changes the Regulations revoked. 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.

The principal changes are:

(a) the removal of the 15% low turnover relief for wholesale dealers’ licences;

(b) the introduction of a fee for the assessment of an application for a marketing authorisation for parallel imports;

(c) the introduction of a reduced fee for the renewal of a marketing authorisation or product licence for herbal products; and

(d) a requirement that all fees should be payable within 30 days of demand.

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).

Fees for applications for product licences, marketing authorisations, manufacturer’s and wholesale dealer’s licences, fixed annual fees and fees for the renewal or variation of those licences and authorisations have all been increased by an average of 6%.

A Compliance Cost 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 3NB.