Consultation by the Medicines and Healthcare Product Regulatory Agency (MHRA) on proposals to amend its statutory fees

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Consultation opened on 31 August 2022. Closing date 23 November 2022 at 17:00.

Summary

Generally, wherever the Medicines and Healthcare product Regulatory Agency (MHRA) provides a direct service for medicines, medical devices or blood components for transfusion regulatory work, a fee is charged to recover the cost of the work involved, in line with HM Treasury guidance Managing Public Money. The MHRA has launched a 12 week consultation on proposals for changes to the MHRA’s statutory fees and is seeking views on the proposals.

Consultation description

The MHRA’s statutory fees have not been increased since financial year 2016/17 for medicines, financial year 2017/18 for medical devices, and financial year 2010/11 for blood components for transfusion. Decisions to not adjust fees were made following 2016 and 2017 in order to ensure as much certainty and stability for industry throughout the EU Exit period and while the Agency responded to the unprecedented challenge of COVID-19.

The proposals for fee adjustments are set out in the consultation document and are designed to ensure the MHRA is resourced to provide the high-quality service that patients, the public and industry want and expect, and to achieve full cost recovery in line with HM Treasury’s principles on Managing Public Money. This will ensure the MHRA is financially sustainable in the long-term, enabling the Agency to deliver a responsive, innovative and efficient regulatory service that protects and improves patient and public health by facilitating access to high-quality, safe, effective and innovative medical products.

The consultation, including full details of the proposals are available here.

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