Freedom of Information request on the clinical study reports on prothrombin complex concentrate submitted to MHRA (FOI 22/475)
Published 31 May 2022
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FOI 22/475
25th February 2022
Dear
Thank you for your email.
I can confirm that the MHRA does hold some of the information that you have requested. However, we have also determined that the information is exempt under Section 12 of the Freedom of Information Act and we cannot process your request any further.
Section 12 of the Act allows public authorities to refuse requests where the cost of dealing with them would exceed the appropriate limit, which for central government is set at £600. This represents the estimated cost of one person spending 24 working hours in determining whether the department holds the information, locating, retrieving and extracting the information.
We advise you to come back with one particular PL number that you want to see the clinical studies for.
We also advise you that for applications granted before we stored dossier parts on our electronic systems, which would be stored in our archive on paper, due to the current Covid restrictions, we may not be able to obtain some of these records.
If you have a query about the information provided, please reply to this email.
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