# The Medicines (Fees Relating to Medicinal Products for Animal Use) Regulations 1991, Note: Explanatory note


(This note is not part of the Regulations)
These Regulations which replace the Medicines (Fees Relating to Medicinal Products for Animal Use) Regulations 1990, prescribe fees in connection with applications and inspections relating to licences and certificates granted under the Medicines Act 1968 in so far as they apply to medicinal products for animal use only.
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 export certificates (Part II). A fee is introduced for the grant or variation of an animal test (confirmation of exemption) certificate (Schedule 1, Part II, paragraph 7 and Part III paragraph 4) and for the grant, variation or renewal of a product licence solely relating to emergency vaccines (Schedule 1, Part II, paragraph 1, Part III, paragraph 2(b) and 5(d) and Part IV paragraph 1).
The Regulations also provide for increased fees to he payable for applications for variations of such licences or certificates (Part III) and for renewal thereof (Part IV). The Regulations provide for increased fees to be payable in respect of inspections of sites carried out in connection with such applications for such licences or certificates. A fee is introduced for quality control inspections relating to biological medicinal products (Schedule 2, paragraph 5). Statutory fees for the testing of biological medicinal products are deleted.
The Regulations provide for increased annual fees for product licences to be payable, calculated on the basis of annual turnover.
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 restructured to take account of the kind of product licence involved. A fee is now introduced in respect of an application for an animal test certificate which is referred, on appeal to the Veterinary Products Committee or to the Medicines Commission (Part VII). The fees are set out in Schedule 6 to the Regulations.
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.

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Source: https://www.legislation.gov.uk/uksi/1991/632/note (the official version)
Page: https://openlegislation.uk/medicines-fees-relating-to-medicinal-products-for-animal-use-regulations-1991/note
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.