FOI release

Freedom of Information request about a copy of the latest UK educational materials associated with Esbriet® (Pirfenidone) Risk Management Plan (FOI 21/253)

Published 7 May 2021

Thank you for your email dated 12th March2021, where you requested: “a copy of the latest UK educational materials associated with Esbriet® (Pirfenidone) Risk Management Plan as follows: •Safety Checklist for Prescribing Physicians” This document is exempt from release under Section 21 of the Freedom of Information Act –information accessible by other means, the information you have requested is already in the public domain.

The safety checklist for prescribing physicians document on eMC is the currently approved version and can be accessed via the following link: https://www.medicines.org.uk/emc/product/3705/rmms

hope the information provided is helpful; however, 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 of this response; and can be addressed to this email address. Please remember to quote the reference number above in any future communications. Yours sincerely,

FOI Team,Vigilance and Risk Management of Medicines Division

The MHRA information supplied in response to your request is subject to Crown copyright. The FOIA only entitles you to access to MHRA information. For information on the reproduction or re-use of MHRA information, please visit

https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information

If you have a query about this email, please contact us. If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please write to the Communications Directorate, 4-T, Medicines and Healthcare products Regulatory Agency, (via this email address). After that, if you remain dissatisfied, you may ask the Information Commissioner at:

The Information Commissioner’s Office

Wycliffe House Water Lane Wilmslow Cheshire SK9 5AF

Copyright notice

The information supplied in response to your request is the copyright of MHRA and/or a third party or parties and has been supplied for your personal use only. You may not sell, resell or otherwise use any information provided without prior agreement from the copyright holder.