# The Medicines (Fees Relating to Medicinal Products for Animal Use) Regulations 1990, Note: Explanatory note


(This note is not part of the Regulations)
These Regulations, which replace the Medicines (Fees Relating to Medicinal Products Animal Use) Regulations 1989, 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 of certain certificates of exemption (regulation 3 and Schedule 1, Part II, paragraph 7).
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). 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 and during the currency thereof (Part V).
The method of charging for tests of biological medicinal products has been changed. The licensing authority will allocate the product to a category according to specified criteria and the testing fee will be determined by that allocation (Part VI). The Regulations also provide for increased annual fees to be payable, calculated on the basis of annual turnover, in connection with applications for the grant or renewal of any product licence. The value of feedingstuff is now included in the value of intermediate feed when calculating the yearly turnover (Part VII, and Schedule 4 Part I, paragraph 3).
A fee is introduced in respect of any product referred, on appeal, from a decision of the licensing authority to the Veterinary Products Committee or to the Medicines Commission (Part VIII).
Administrative provisions (Part IX) deal with time of payment and waiver or refund of fees in specified circumstances.
Part X of the Regulations deals with revocations, savings and transitional provisions.

---
Source: https://www.legislation.gov.uk/uksi/1990/1205/note (the official version)
Page: https://openlegislation.uk/medicines-fees-relating-to-medicinal-products-for-animal-use-regulations-1990/note
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.