Freedom of Information request on Copies of the BMS and Accord Lenalidomide PPP management plans and effectiveness review plans (FOI 21/1253)
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-13-december-2021/freedom-of-information-request-on-copies-of-the-bms-and-accord-lenalidomide-ppp-management-plans-and-effectiveness-review-plans-foi-211253
FOI 21/1253
15th December 2021
Dear,
Thank you for your email, dated 23rd November 2021, in which you requested:
‘Copies of the BMS and Accord Lenalidomide PPP management plans and effectiveness review plans (or equivalents)?’
The Pregnancy Prevention Plan (PPP) for Bristol-Myers Squibb Pharmaceuticals limited Revlimid (Lenalidomide) is publicly available on the electronic medicines compendium (emc), the female and male documents can be viewed within the Risk Management Materials section Revlimid 10 mg Hard Capsules - Risk Management Materials
A copy of the Procedural Documents for Bristol-Myers Squibb Pharmaceuticals limited Revlimid (Lenalidomide), which can be disclosed, is attached.
Information that has been redacted is exempt under Section 40 (Personal Information) of the
Freedom of Information (FOI) Act and is therefore withheld. We have concluded that disclosing this
information would not be appropriate because providing information subject to Section 40 would be an
infringement of personal data. Furthermore, we do not believe that there is an overriding public
interest in disclosing this information in this instance.
The requested information for Accord is exempt under Section 41 (Information provided in confidence): information provided to us in confidence, with the expectation that it will not be released, is exempt from disclosure under the FOI Act.
I 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