Freedom of Information request on the clinical and non-clinical overviews (FOI 22/524)
Published 1 June 2022
© Crown copyright 2022
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.
Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.
This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-7-march-2022/freedom-of-information-request-on-the-clinical-and-non-clinical-overviews-foi-22524
FOI 22/524
11th March 2022
Dear
Thank you for your email.
Please find enclosed the clinical and non-clinical overviews for these products. Redactions have been made 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.
Section 43 is a qualified exemption and a consideration of the public interest is required. We have considered the public interest and cannot see any public interest arguments that outweigh the commercial harm in providing information that can aid a competitor in their product development and help them overcome regulatory hurdles to get their product onto the marketing quicker.
If you have a query about the information provided, please reply to this email.
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 Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000FOI 22/524
11th March 2022
Dear
Thank you for your email.
Please find enclosed the clinical and non-clinical overviews for these products. Redactions have been made 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.
Section 43 is a qualified exemption and a consideration of the public interest is required. We have considered the public interest and cannot see any public interest arguments that outweigh the commercial harm in providing information that can aid a competitor in their product development and help them overcome regulatory hurdles to get their product onto the marketing quicker.
If you have a query about the information provided, please reply to this email.
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 Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000