Freedom of Information request on the full email exchange for CSC 23485 and the original version of the Public Assessment Report linked to CSC 23485 (FOI 22/705)
Published 21 December 2023
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FOI 22/705
15th July 2022
Dear
Thank you for your email of 13 May where you have asked “ Please can you give the full email exchange for reference number CSC 23485 and the original version of the Public Assessment Report linked to in the emails and any later versions?”
We are exempting your request under Section 38 - Health and Safety and Section 40 – Personal information of the Freedom of Information Act.
Section 38 - Information is exempt information if its disclosure under this Act would, or would be likely to endanger the physical or mental health, or the safety, of any individual. To release our discussions into the public domain could misinform members of the public and also would inhibit the free discussion of how we deal with enquiries, which would be detrimental to patient health and safety in general.
Section 40 protects personal data, the disclosure of which would breach one or more of the data protection principles. The Agency is satisfied that disclosure here would breach the first data protection principle, in particular the requirement of fairness on the basis that disclosure would not be reasonably expected by the people mentioned in the information.
Regarding the Public Assessment Reports (PARs), the PAR for the initial grant of each of the vaccines is available on the MHRA website. Our working practice is that these are unaltered and any changes to the authorisation of the medicinal product are added as annexes to the original granted PAR, rather than changing the text of the original published PAR itself.
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
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