Medicines Healthcare Products Regulatory Agency
Detail of outcome
The MHRA led on a joint consultation on proposed amendments to the MHRAs statutory fees with the Department of Health in Northern Ireland, in accordance with Section 45(1) of the Medicines and Medical Devices Act 2021.
The consultation ran between 31 August and 23 November 2022 to seek views on proposals to update the statutory fees charged for the MHRAs regulatory services. The fees are set on a cost recovery basis, in accordance with Managing Public Money guidelines, however they have not been updated for several years and are not fully recovering costs.
The above provides our response to the consultation and outlines next steps. We received a total of 99 responses. There was general acceptance of the need to ensure cost recovery for regulatory activities, and that this was important for ensuring a consistent level of service.
Original consultation
Consultation description
The aim of this consultation is to seek the views of stakeholders on proposals to amend statutory fees from the Medicines and Healthcare products Regulatory Agency (MHRA). The proposed adjustments fall into 3 categories:
- A 10% indexation uplift across statutory fees
- A further uplift for 61 significantly under recovering fees to achieve cost recovery
- The introduction of 22 new fees for services that require cost-recovery since the last fee changes in 2016/2017 for medicines and 2017/2018 for medical devices
The fee proposals set out in this consultation 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 Treasurys 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.
