Freedom of Information request the initial submission of CTD module 2.7.1, 2.7.2, 2.7.3, 2.7.4 from originator for Stelara. (FOI 21/1220)
Published 31 May 2022
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FOI 21/1220
15th December 2021
Dear
Thank you for your information request, dated 17 November 2021, where you asked for the initial submission of CTD module 2.7.1, 2.7.2, 2.7.3, 2.7.4 from originator for Stelara.
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, 53 documents would need to be reviewed which we consider that this would take longer than 24 working hours to complete.
We advise that you narrow your request by, for example, reducing the documents you require.
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.
Kind Regards
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU Telephone 0203 080 6000