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Open consultation: Consultation on proposals for changes to the Medicines and Healthcare products Regulatory Agency’s statutory fees

Medicines Healthcare Products Regulatory Agency

August 31
15:46 2022

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.

Documents

Consultation document

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