Freedom of Information request (FOI 22/866)
Published 17 January 2024
© Crown copyright 2024
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-17-october-2022/freedom-of-information-request-foi-22866
18th October 2022
FOI 22/866
Dear
In response to your request detailed below:
“Please may I request the following in respect of Brilique (INN: Ticagrelor), PLGB 17901/0310”
We are pleased to be able to provide you with the requested information, redactions have been made under Section 40 of the FOI act to remove personal information (staff details, and some patient identifiable info). Redactions have also been made under S.43(2) of the FOI act to remove some information related to the marketing status of a list of products, which we believe could give competitors a commercial advantage with respect to market intelligence, we also have been unable to identify a public interest in relation to the very limited amount of material redacted on pages 102-105 of the clinical overview (addendum). For full details of the redactions made please see below.
| Non-Clinical Documents | Comments & justification for proposed redaction |
|---|---|
| nonclinical-overview | In Page 1: Author name - redacted (Personal data protection) |
| nonclinical-overview-addendum | In Page 1: Author name redacted (Personal data protection) |
| nonclinical-overview-justification | No redaction proposed |
| Clinical Documents | Comments & justification for proposed redaction |
|---|---|
| Clinical Overview addendum | In Page 2: Author name - redacted (Personal data protection) |
| In Page 397: Author name – redacted (Personal data protection) | |
| (Personal data protection) |
In Page 35: patient details – redacted
In Page 40: patient details – redacted
In Page 43: patient details – redacted
| In Page 66: patient details – redacted | |
| (Commercial information protection) |
| In Page 102-105: a column on commercial information – redacted | ||
| Clinical Overview | No redaction proposed |
We are using a file transfer service to send this message because the attachments are too large to send by email. However, we have encountered some issues recently when using the service, so please confirm receipt.
In case the file transfer package is not received, this message will also be sent via email without the attachments. In the event of any issues, we can divide the pdfs into smaller files across a number of emails.
We apologise for the delay in responding to this request, it has been a particularly busy period for the MHRA.
If you disagree with how we have interpreted the Freedom of Information Act 2000 in answering your request, you can ask for an internal review. Please reply to this email, within two months of this reply, specifying that you would like an Internal Review to be carried out.
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