# The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025, Note: Explanatory note


(This note is not part of the Regulations)
These Regulations make amendments to the Medicines (Products for Human Use) (Fees) Regulations 2016 (S.I. 2016/190).
The Medicines (Products for Human Use) (Fees) Regulations 2016 make provision for the fees payable in relation to authorisations, licences, certificates and registrations in respect of medicinal products for human use, including those under the Human Medicines Regulations 2012 and the Medicines for Human Use (Clinical Trials) Regulations 2004.
The fee amounts specified in these Regulations represent increases in the majority of existing fees of between 9% and 22%, with around 10% of fees rising by more than this, the highest rises being for scientific advice meetings and inspections, and are set in line with a consultation document issued by the Medicines and Healthcare products Regulatory Agency (“MHRA”) on 29 August 2024 . A summary of the consultation responses and the Government’s response to the consultation are published on the MHRA’s website (www.mhra.gov.uk).
Regulation 3 introduces an amended fee structure for the optional service provided by the licensing authority in relation to scientific, regulatory, pharmacovigilance, or advertising advice, based on the complexity of the matter on which advice is given. Regulations 4, 6, 7, 9, and 10 omit the fees which are replaced by the amended fee structure. Regulation 27(30) introduces an amended fee structure for batch testing, so that it would be based on the time taken. Regulation 29(7) increases the number of payment bands for fees in connection with notices for imported special medicinal products. Regulations 25 and 27(2) amend the definition of “standard variation” in relation to homoeopathic medicinal products to explicitly include changes to outer packaging, inner packaging, and package leaflets.
A full impact assessment of the effect that this instrument will have on the cost of business and the voluntary sector is available from the Medicines and Healthcare products Regulatory Agency, 10 South Colonnade, Canary Wharf, London, E14 4PU and is published with the Explanatory Memorandum alongside the instrument on www.legislation.gov.uk.

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Source: https://www.legislation.gov.uk/uksi/2025/317/note (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-amendment-regulations-2025/note
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.