FOI release

Freedom of Information request on the qualitative composition of Alimemazine Tartrate (FOI 21-595)

Published 13 August 2021

21st June 2021 FOI 21/595

Dear

Thank you for your email.

The qualitative composition is available in the SmPC that is published on the MHRA website. https://mhraproducts4853.blob.core.windows.net/docs/6538ec4ab6c3e73ff6862a8e6aaca8dca2c33077

The quantitative composition is withheld under Section 41 (information provided in confidence) and Section 43 (commercial interests) of the Freedom of Information (FOI) Act. Section 41 is an absolute exemption and no consideration of the public interest is required, except to state that we would consider the release of this information to be an actionable breach of confidence. Section 43 is a qualified exemption and a consideration of the public interest should be made. We have considered the public interest and cannot see any public interest argument that outweighs the commercial harm in releasing the quantitative composition of a medicinal product to competitors, which can be used in the development of a rival product or to overcome regulatory hurdles to get their product to market quicker.

If you have a query about the information provided, please reply to this email

If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk

Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office Wycliffe House Water Lane Wilmslow Cheshire SK9 5AF

Yours sincerely

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU