[Emergo, UL] MHRA Publishes the Consultation Outcome on Statutory Fees

From August 29, 2024, to October 24, 2024, the Medicines & Healthcare products Regulatory Agency (MHRA) held a public consultation on its proposed amendments to the statutory fees. The consultation reflected fees for services related to medicines, medical devices and blood components for transfusion in the UK.

 

The statutory fees for services are intended to recover the costs involved with the work that comes with these services. Statutory fees need to be aligned with the UK treasury guidance. The height of the fees will reflect the costs of necessary overheads, system investments, costs and complexity of the service the MHRA provides.

 

The consultation covered 5 proposals

1. Increase the statutory fees.
2. Amend the Medical Device Registration fee to include the medical device post-market work.
3. Create a new service providing regulatory advice meetings or medical devices.
4. Amend and increase the fee model for scientific advice meetings, control testing and unlicensed medicines importation.
5. Update and clarify the legal definition of a “standard variation” application for homeopathic products.

 

MHRA publishes the consultation outcome on statutory fees | Emergo by UL

MHRA Publishes the Consultation Outcome on Statutory Fees