Explanatory note

These Regulations, which replace the Medicines (Fees Relating to Medicinal Products for Animal Use) Regulations 1991, as amended, prescribe fees in connection with applications and inspections relating to licences and certificates granted under the Medicines Act 1968 insofar as they apply to medicinal products for animal use. Most fees are increased by approximately 5%.

The Regulations provide for increased fees to be payable for applications for the grant of product licences, manufacturers' licences, wholesale dealers' licences, animal test certificates and exemption certificates (Part II). Fees will no longer be charged for export certificates and the fees for licences relating to emergency vaccines have not been increased. Provision is made for a lower fee to be payable on application for a licence, renewal of a licence or for an inspection of a site by wholesale dealers who have a low turnover in veterinary medicinal products (Schedule 1, Part II, paragraph 6(2), Schedule 1 Part IV, paragraph 3(2), Schedule 2 paragraph 4(1)(c).

The Regulations also provide for increased fees to be payable for applications for variations of such licences or certificates (Part III) and for renewal thereof (Part IV). A fee is introduced for the variation of a complex application for an animal test certificate (Schedule 1, Part III, paragraph 4). The Regulations provide for increased fees to be payable in respect of inspections of sites carried out in connection with applications for licences or certificates. A fee is introduced in respect of supersite (as defined) inspections (Schedule 2, paragraph 2).

The Regulations provide for increased annual fees for product licences to be payable, calculated on the basis of annual turnover but only where the applicant has sold, supplied or manufactured during the licence year, any medicinal product to which the licence relates (regulation 10(1)).

The fee in respect of any appeal in connection with the grant of a product licence to the Veterinary Products Committee or to the Medicines Commission has been increased (regulation 11).

Administrative provisions (Part VIII) deal with time of payment and waiver or refund of fees in specified circumstances.

Part IX of the Regulations deals with revocations, savings and transitional provisions.