Freedom of Information request on the risk management plan for product Tecfidera (FOI 22/781)
Published 21 December 2023
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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-july-2022/freedom-of-information-request-on-the-risk-management-plan-for-product-tecfidera-foi-22781
FOI 22/781
11th July 2022
Dear
Thank you for your email, dated 23rd June 2022, in which you requested:
“specific adverse event follow-up questionnaires approved as part of the risk management plan for the reference product Tecfidera”
We can confirm that the MHRA holds a copy of the requested follow up-questionnaires. Information that has been redacted is exempt under Section 40 (Personal Information) or Section 43 (Commercial Interests) of the Freedom of Information (FOI) Act and is therefore withheld. Section 40 provides that personal information may be exempt from release where to do so would contravene data protection principles. Section 43 provides that information will be exempt from release where to do so would or would be likely to prejudice commercial interests. Furthermore, we do not believe that there is an overriding public interest in disclosing the redacted information in this instance. We hope the information provided is helpful, but 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