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* Medicines & Healthcare products Regulatory Agency FOI release FREEDOM OF INFORMATION REQUEST ON RISK MANAGEMENT PLAN (RMP) APPROVED FOR MELATONIN CONSILIENT HEALTH 1 MG/ML ORAL
SOLUTION (FOI 22/015) 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:
[email protected]. 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-31-january-2022/freedom-of-information-request-on-risk-management-plan-rmp-approved-for-melatonin-consilient-health-1-mgml-oral-solution-foi-22015
FOI 22/015 3rd February 2022 Dear, Thank you for your email, dated 5th January 2022, in which you requested: “Risk Management Plan (RMP) approved for Melatonin Consilient Health 1 mg/ml
oral solution” 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. 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 DivisionFOI
22/015 3rd February 2022 Dear, Thank you for your email, dated 5th January 2022, in which you requested: “Risk Management Plan (RMP) approved for Melatonin Consilient Health 1 mg/ml oral
solution” 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. 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 Back
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