FOI release

Freedom of Information request on the Environmental Risk Assessment for Feldene 0.5% w/w Gel (FOI 22/473)

Published 31 May 2022

FOI 22/473

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 0.5% w/w Gel, PL 00057/0284, approved 17/04/1989 (last renewal 20/03/2009).  The ERA is usually placed in module 1.6 of the marketing authorisation dossier”

As the date of authorisation of the licence in the request pre-dates when the legislation requiring ERAs to be submitted came into force, no ERA was submitted with this application.

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