Freedom of Information request on clinical trial documents for Xolair (Omalizumab) (FOI 21/985)
Published 17 January 2022
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17th September 2021
FOI 21/985
Dear
Thank you for your information request, dated 25th August.
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 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 consider that this request would take longer than 24 working hours to complete.
We advise that you narrow your request by, for example, reducing the documents required to a single document.
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.
Some of the information you have requested may already be in the public domain, through the EMA clinical database (https://clinicaldata.ema.europa.eu/web/cdp/home) and the clinical trials databases that are linked below:
https://www.clinicaltrialsregister.eu/
https://clinicaltrials.gov/ct2/home
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