Freedom of Information request on access to the RMP's for Tukysa, Enhertu, Nerlynx, Tykerb and Margenza (FOI 21/1273)
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-27-december-2021/freedom-of-information-request-on-access-to-the-rmps-for-tukysa-enhertu-nerlynx-tykerb-and-margenza-foi-211273
FOI 21/1273
29th December 2021
Dear
Thank you for your email, dated 1st December 2021, in which you requested:
‘access to the RMPs for the following products:
- tucatinib Tukysa®
- fam-trastuzumab deruxtecan Enhertu®
- neratinib Nerlynx®
- lapatinib Tykerb®
- margetuximab Margenza®’
We can confirm that the MHRA holds copies of the RMPs for Tukysa, Enhertu, Nerlynx and Tykerb. We do not have an RMP for Margenza on our records.
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