The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department with responsibility for ensuring medicines meet appropriate standards of quality, efficacy, and safety.

The MHRA has plans to gather the currently available evidence on mental health and related risks for licensed migraine prophylaxis medications, as referenced in a response to HL1488. Prescribing safety will be considered as part of this review within the scope of the MHRA’s remit. This will include, for example, assessing how prescribing conditions are described in the product information of relevant migraine medicines. However, clinical practice, national or regional clinical guidelines, and a healthcare professional’s decision to prescribe a particular medicine are outside the MHRA’s direct scope of work.