Freedom of Information request on Clinical/Non-Clinical Overviews for BUFYL (FOI 21-037)
Published 24 March 2021
© Crown copyright 2021
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-8-february-2021/freedom-of-information-request-on-clinicalnon-clinical-overviews-for-bufyl-foi-21-037
Ref: FOI 21/037
Thank you for your communication, dated 13 January 2021, in which you requested the clinical and non-clinical overviews for BUFYL 1.25mg/ml and 2microgram/ml Solution for Infusion (PL 02848/0237).
Please find copies of the clinical and non-clinical overviews.
Confidential information has been redacted in these documents, according to Section 40 (personal information), Section 41 (Information provided in confidence) and Section 43 (Commercial interests) of the FOI Act.
Please note that Sections 40 and 41 of the FOI Act are an absolute exemption and no consideration of the public interest is required. Section 43 is a conditional exemption, conditional on the public interest in releasing it not outweighing the company’s/commercial enterprise’s right to confidentiality and the probable damage that the company/commercial enterprise could suffer as a result of the information being released. In this case we have not identified any issues which would benefit the public as a whole by being brought to their attention (examples of issues would be a major public health risk or a major procedural failure or irregularity).
I now consider this request closed. If you require any further information, please respond to the FOI Licensing Team at FOILicensing@mhra.gov.uk.
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.
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,
The FOI Licensing Team