Freedom of Information request on the documents for ‘Stelara’: Rapporteurs Day 150 Joint CHMP and PRAC Response Assessment Report (FOI 21/1104)
Published 26 May 2022
© Crown copyright 2022
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.
Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.
This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-15-november-2021/freedom-of-information-request-on-the-documents-for-stelara-rapporteurs-day-150-joint-chmp-and-prac-response-assessment-report-foi-211104
FOI 21/1104
15th November 2021
Dear,
Thank you for your information request, dated 5 October 2021, where you asked for the following documents for ‘Stelara’: Rapporteurs Day 150 Joint CHMP and PRAC Response Assessment Report (Clinical - Assessment of the responses to the CHMP/PRAC List of Questions); Rapporteur and Co-rapporteur Day 180 Joint Response Assessment Report (Clinical - Assessment of the responses to the CHMP List of outstanding issues); and the initial submission of CTD module 2.5 from originator
I am pleased to provide you with some of the information requested. The redacted Module 2.5 for Stelara is attached to this email.
Unfortunately, some of the information is exempt from release under section 21 -Information available by other means. The non-confidential parts of the Rapporteurs Day 150 Joint CHMP and PRAC Response Assessment Report Rapporteur and the Co-rapporteur Day 180 Joint Response Assessment Report will be available through the product information and the European Public Assessment Report.
The Freedom of Information Act only entitles you access to information – the information supplied is subject to Crown copyright, and there are some restrictions on its re-use. For information on the reproduction or re-use of MHRA information, please visit https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information.
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 will 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
If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk
Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices
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 Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU