FOI release

Request for 1.6 Environmental Risk Assessment reports

Some or all of the information requested was not provided because we didn't hold it.

Case reference FOI2025/01064

Received 3 October 2025

Published 5 November 2025

Request

We are currently working on an ERA for the active substance Baclofen to be submitted in a procedure for a medicinal product indicated for multiple sclerosis, spinal lesions, (e.g. tumours of the spinal cord), syringomyelia, motor neurone disease, transverse myelitis, and traumatic partial section of the cord. In accordance with Article 7 of Regulation (EC) No 1049/2001 regarding public access to European Parliament, Council and Commission documents and in view of the EMA updated Guideline on the environmental risk assessment of medicinal products (EMEA/CHMP/SWP/4447/00 Rev. 1-Corr), we would like to request for all document 1.6 Environmental Risk Assessment reports submitted for the medicinal product Lioresal(r) Tablets & Liquids. This request is made with the intention of avoiding unnecessary duplication of environmental studies/environmental exposures, in accordance with the principles of animal welfare under the provision of FOI.

Response

See attached

Documents

• FOI2025_01064 (redacted).pdf (773.9 KB)

This is Medicines and Healthcare products Regulatory Agency's response to a freedom of information (FOI) or environmental information regulations (EIR) request.

You can browse our other responses or make a new FOI request.