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 an increase in the existing fees of 10% or more and are set in line with a consultation response issued by the Medicines and Healthcare products Regulatory Agency (“MHRA”) on 31 January 2023. 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).

A full impact assessment of the effect that this instrument will have on the costs 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.