Freedom of Information request on actions against companies breaching regs on hand sanitiser products (FOI 20-542)
Published 24 March 2021
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Thank you for your email of 7 December.
Please see below the number of complaint cases investigated and closed involving hand sanitiser products making Coronavirus/Covid 19 claims. We’ve also included the total number of products, associated with those cases, we determined to be medicines and took action against. Please note that we were previously advised by lawyers that the names of specific companies and products are deemed commercially sensitive information and that we are only permitted to specifically name products and the identity of companies where we have been through the full statutory determination procedure (issued a Final Determination Notice under reg 164 of HMR) or where we have successfully prosecuted. This is why that information has been omitted.
To clarify, action was taken by issuing Urgent Notices under reg 165 of the HMR, determining the products to be medicinal products due to the claims made in their promotional material. Companies were instructed to either amend their promotional material to remove all medicinal claims or immediately remove the products from the UK market.
In regard to guidance, please see the link to MHRA’s Guidance Note 8: A guide to what is a medicinal product which provides detailed information on how we classify products as well as specific guidance on topical products for: anti-bacterial, antiseptic, antimicrobial, general disinfection and cleansing, and preoperative preparation of the skin, found in Appendix 5.
| No of complaint cases | No of products determined to be medicinal products | Reason for determination | Period |
|---|---|---|---|
| 69 | 341 | Products presented with claims for the prevention of infections associated with the specifically named pathogen coronavirus/COVID-19 | Jan 2020 to 22nd Dec 2020 |
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Yours sincerely
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU Telephone 020 3080 6000