Freedom of Information request (FOI 22/809)
Published 17 January 2024
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4th August 2022
FOI 22/809
Dear,
Thank you for your email.
We are grateful if you could let us know if the enquiry relates to medicines or devices? Please note that the broad scope of the questions you have asked is very likely in excess of the Section 12 threshold. 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 would suggest that your company considers asking about a specific area e.g. GMP, GDP, GVP etc, and for a limited period such as one calendar year.
Please note that substantially similar requests made within 60 working days of an original request can be aggregated into one for the purposes of calculating a cost limit, meaning that section 12 could still apply.
If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review would be carried out by a senior member of the Agency who was not involved with the original decision.
If you have a query about the information provided, please reply to this email.
Yours sincerely
MHRA Customer Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency