Freedom of Information request on the marketing authorisation applications for Ronapreve and Veklury (FOI 21/1113)
Published 27 April 2022
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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-11-october-2021/freedom-of-information-request-on-the-marketing-authorisation-applications-for-ronapreve-and-veklury-foi-211113
11th October 2021
FOI 21/1113
Dear
Thank you for your information request, dated 7th October.
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 consider that this request would take longer than 24 working hours to complete.
We advise that you narrow your request by, for example, to a single product.
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.
The assessment reports for these products are exempt under Section 21 (information available by other means) and Section 22 (information intended for future publication). This is because all the non-confidential information is either already published in the SmPC/PIL or will be published in the Public Assessment Reports being prepared by the EMA and MHRA for Ronapreve. For Veklury, the Public Assessment Report is published by the EMA and provided via the below link:
https://www.ema.europa.eu/en/medicines/human/EPAR/veklury
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