# The Medicines (Fees Relating to Medicinal Products for Human Use) Regulations 1989, Note: Explanatory note


(This note is not part of the Regulations)
These Regulations, which replace the Medicines (Fees) Regulations 1978 (as amended), 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 human use only.
These Regulations provide for fees to be payable for applications for the grant of product licences, manufacturers' licences, wholesale dealers' licences, clinical trial certificates and export certificates (Part II).
The Regulations also provide for fees to be payable for applications for variations of such licences or certificates (Part III) and for renewal thereof (Part IV). In addition the Regulations provide for 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).
Administrative provisions (Part VI) deal with time of payment and waiver or refund of fees in specified circumstances.
Part VII of the Regulations deals with revocations, savings and transitional provisions.

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Source: https://www.legislation.gov.uk/uksi/1989/418/note (the official version)
Page: https://openlegislation.uk/medicines-fees-relating-to-medicinal-products-for-human-use-regulations-1989/note
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.