Freedom of Information request on the Environmental Risk Assessment for Feldene Melt 20mg, Feldene 10mg Capsules and Feldene 20mg (FOI 22/474)
Published 31 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-21-february-2022/freedom-of-information-request-on-the-environmental-risk-assessment-for-feldene-melt-20mg-feldene-10mg-capsules-and-feldene-20mg-foi-22474
FOI 22/474
25th February 2022
Dear
Thank you for your email of 18th February where you have asked “We would like to make a freedom of information request for a copy of the Environmental Risk Assessment (ERA) for:
-
Feldene Melt 20mg PL 00057/0352, approved 14/09/1992 (last renewal 31/03/2009).
-
Feldene 10mg Capsules PL 00057/0145, approved 20/07/2009
-
Feldene 20mg Capsules PL 00057/0146, approved 20/07/2009
The ERA is usually placed in module 1.6 of the marketing authorisation dossier (if in CTD format)”
As the dates of authorisation of all three product licences in the request pre-date when the legislation requiring ERAs to be submitted came into force, no ERA was submitted with these applications.
If you have a query about the information provided, please reply to this email.
If you disagree with how we have interpreted the Freedom of Information Act 2000 in answering your request, you can ask for an internal review. Please reply to this email, within two months of this reply, specifying that you would like an Internal Review to be carried out.
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