Freedom of Information request on the Risk Management Plan for Flolan (FOI 21/1073)
Published 27 April 2022
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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-11-october-2021/freedom-of-information-request-on-the-risk-management-plan-for-flolan-foi-211073
14th October 2021
FOI 21/1073
Dear
Thank you for your emails, dated 22nd and 24th September 2021, in which you requested the Risk Management Plan for Flolan.
A copy of the information, 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. These redactions have been marked “PPD” to signify Protection of Personal Data. 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.
Please note due to the age of the EU-RMP (6 years), the SPC and PIL included in Annex 2 (p146) are not current as they reflect the labelling at the time of the EU-RMP approval and that this should, therefore, not be considered to reflect the current registered details in the EU and GB. Up to date versions of the UK SPC and the PIL can be accessed at the emc: Home - electronic medicines compendium (emc).
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