Question reference: S6W-18294
- Asked by: Alexander Burnett, MSP for Aberdeenshire West, Scottish Conservative and Unionist Party
- Date lodged: 1 June 2023
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Current status: Answered by Jenni Minto on 14 June 2023
Question
To ask the Scottish Government what its position is on whether the medication, Androfeme, should be made available for treatment of menopause for women in Scotland, and what discussions it has had with the UK Government in relation to this matter.
Answer
The regulations for the licensing, safety and efficacy of medicines are currently reserved to the UK Government and are the responsibility of the UK Medicines and Healthcare products Regulatory Agency (MHRA). For a medicine to be routinely prescribed, it firstly needs to receive a licence from the MHRA. It is the responsibility of individual companies to apply to the MHRA for a marketing authorisation (licence). The application process requires a company to provide data demonstrating the quality, safety and efficacy of the medicine.
The Scottish Government has not had any discussions with the UK Government on the licensing of testosterone for women in perimenopause or menopause. AndroFeme ® is not licensed for the treatment of symptoms of menopause in the UK. The prescribing of an unlicensed medicine is a clinical decision by prescribers directly responsible for individual patients. Both its use and the oversight of the patient’s care are the responsibility of the prescribing clinician.