Freedom of Information request on the Risk Management Plan approved for Oxycodone HCl from Mundipharma/ Napp UK (FOI 22/708)
Published 27 March 2023
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FOI 22/708
16th May 2022
Dear
Thank you for your email, dated 18th May 2022, in which you requested:
“the most recent Risk Management Plan approved for Oxycodone HCl from Mundipharma/ Napp UK”
We can confirm that the MHRA holds a copy of the requested RMP. 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.
Please note that although this RMP is the most recently approved version, it is from 2017 and therefore is due to be updated in line with GVP module V rev2. It should also be brought in line with CMDh list of harmonised safety concerns for prolonged tablets. Hence the only important safety concerns to be included in the RMP are: respiratory depression, drug dependence and withdrawal, abuse, misuse and diversion. There are no important potential risks or missing information.
The applicant should also consider that there are national risk minimisation measures in place to minimise risk of dependence and addiction and improve education. 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