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.
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Yours sincerely
MHRA Customer Experience Centre