Freedom of Information request on the Marketing Authorisation application for ONGAVIA (FOI 22/710)
Published 21 December 2023
© Crown copyright 2023
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-20-june-2022/freedom-of-information-request-on-the-marketing-authorisation-application-for-ongavia-foi-22710
FOI 22/710
20th June 2022
Dear
Thank you for your request under the FOI Act 2000. Apologies for the delay, the SmPC and PIL for this product can be located online here: MHRA Products - Search results.
The public assessment report (PAR) is yet to be published, but we expect to publish this document by 15 July 2022.
In terms of “any further information which is not exempt under FOIA” (Q.4), the vast majority of this information will be included in the PAR, and therefore, we suggest awaiting the publication of this document (Section 22 of the FOIA).
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
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