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
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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