Freedom of Information request on the data covering the period of 11th October 2020- 11th October 2021 on adverse event reports (FOI 21/1138)
Published 26 May 2022
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FOI 21/1138
9th November 2021
Dear,
Thank you for your communication to the MHRA in relation to a Freedom of Information request for:
Please provide the data covering the period of 11th October 2020- 11th October 2021.
“How many adverse event reports have the MHRA received over the past 5 years related to consumer use of products identified as food supplements containing melatonin? Example via the Yellow card scheme.
We would like to inform you that there have been 18 requests from the public regarding melatonin in this time frame.
MHRA have not classified all products containing melatonin as medicinal products. MHRA reaches a determination on whether a product is or is not a medicinal product on a case by case basis, and in light of:
• the definitions of a medicinal product
• following an assessment of all the available evidence for that specific product
• and relevant ECJ and domestic Court precedents
This is a requirement based on case law which means the MHRA cannot simply determine all products containing melatonin as medicinal products.
As mentioned previously, food supplements are outside the remit of the MHRA, as such adverse reports for food supplements are to be reported to the Food Standards Agency.
The Yellow Card scheme run by the MHRA is the UK system for collecting and monitoring information on safety concerns such as suspected side effects or adverse incidents involving medicines and medical devices. The scheme relies on voluntary reporting of suspected side effects or medical device incidents to be reported by health professionals and the public, including patients, carers and parents.
This Interactive Drug Analysis Profile (iDAP) for melatonin displays an overview of all UK spontaneous suspected Adverse Drug Reactions (ADRs) reported through the Yellow Card Scheme for this substance. It is important to note that reported adverse reactions have not been proven to be related to the drug, and should not be interpreted as a list of known side effects. The iDAP also details the different melatonin product brand names captured within these Yellow Card reports. This should enable you to identify whether any of the products you are interested in have been reported.
If you have a query about this letter, please do not hesitate to contact us at IE&SFOI@mhra.gov.uk
If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please email: info@mhra.gov.uk
Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices.
After that, if you remain dissatisfied, you may write to the Information Commissioner at;
The Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
They will make a decision on whether or not we have interpreted the FOIA correctly in handling your request.
Kind regards,
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 0203 080 6000