Freedom of Information request on the copper chelating agents Cufence and Cuprior (FOI 21/524)
Published 28 June 2021
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27th May 2021 FOI 21/524
Dear
Regarding your request, dated 29 April 2021, for supporting documentation on the analysis of the two copper chelating agents Cufence and Cuprior, this information is exempt 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 consider its disclosure to constitute 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 providing specifications and analysis data from the quality part (Module 3) of the eCTD dossier, that can be used by competitors to gain insight into the development of a current granted medicinal product, and provide know-how in the developing their own product or overcoming regulatory hurdles to get their product onto the market quicker.
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
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
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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 Telephone 0203 080 6000