Freedom of Information request on prescription only menopause medications (FOI 21/718)
Published 29 December 2021
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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-5-july-2021/freedom-of-information-request-on-prescription-only-menopause-medications-foi-21718
6th July 2021
FOI 21/718
Dear
Thank you for your email dated 25th June 2021, where you asked whether there are any pending switch applications from POM to P for vaginal hormonal pessaries, cream or gels indicated for use in menopause.
Details of product licence submissions form part of the information which is considered confidential to marketing authorisation holders (MAHs) and is covered by Section 43 (confidential information) of the Freedom of Information (FOI) Act 2000. Therefore, we are unable to confirm or deny if any such applications have been made to the MHRA to date. I have considered the public interest and do not consider that the reasons for disclosing product licence submissions outweigh those for non-disclosure. Please be aware that details of any such applications that have either been approved or rejected will be made available on our website.
I hope the information provided and explanation regarding the exemption is helpful. If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision.
If you have a query about the information provided, please reply to this email.
Yours sincerely,
FOI Team
Vigilance and Risk Management of Medicines Division