Freedom of Information request (FOI 22/737)
Published 17 January 2024
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8th November 2022
FOI 22/737
Dear
Thank you for your request under FOIA 2000. We have annotated your questions as below:
- How many submission have been made under/through the ECDRP since it was initiated?
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A. 161 applications have been made
- What was the mean and range of the time from submission to MHRA’s determination (approval) on these applications?
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A. Average time (clock on to determination) 62 days, Range: 1 to 244 days.
- How many of these application received major objections by Day 46 that meant it defaulted to the MHRA’s standard review timelines for a full National application?
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.
In order to process your request, we would need to check 161 applications, and we have calculated it will take 10 minutes to open the case folder and check multiple ARs (as these are often separated) and record the information on a spreadsheet, that would equate to 26 hours.
Unfortunately, we cannot offer much in the way of refinement here, as completing the exercise for only a portion of the applications probably wouldn’t deliver any valuable insights to you.
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.
Please note we appreciate that this response was considerably delayed, this was an oversight for which we apologise.
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