FOI release

Freedom of Information request on statutory determination procedures and information (FOI 21-033)

Published 24 March 2021

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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-18-january-2021/freedom-of-information-request-on-statutory-determination-procedures-and-information-foi-21-033

Thank you for your communication to the MHRA in relation to a Freedom of Information request for:

  • The details of any products and companies that have been through the full statutory determination procedure (if any)
  • A note of the different stages of enforcement actions and the related status of the companies covered by your table below against those stages (if such information is held) – in other words, what other stages are there and how many companies / products have progressed to which stages
  • The prevalence of alcohol versus non-alcohol based products in your enforcement action, if that information is held
  • What actions companies have or have not taken in response to your direction

Please, see our response below:

  • No Final Determination Notices were issued between Jan 2020 to 22nd Dec 2020 and therefore no product has gone through the full statutory determination procedure. Compliance has been achieved through either voluntary compliance or compliance with notices issued under regulation 165 of HMR. This not only applies to hand sanitiser products, but to all products investigated by the Medicines Borderline Section during the period specified.

  • Guidance for both the statutory determination procedure and the steps in which the MHRA takes in classifying products can be found on MHRA website.

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/872742/GN8FINAL_10_03_2020__combined.pdf

  • When determining the status of the products referred to in our previous response, MHRA did not differentiate between alcohol or non-alcohol based products, nor did we specifically log this information. The status of the products as medicines were determined based on the claims made within the products’ promotional material. The section takes into account everything and anything that may come to the general public’s attention. This includes labelling, leaflets, packaging, use of graphics, advertisements, internet promotions, editorials, broadcasts and consumer reviews.

  • In response to the Urgent Notices issued by MHRA, companies have either removed all references to treatment or prevention of Coronavirus/COVID-19 and all other specifically named pathogens from their promotional material with immediate effect or, alternatively, completely removed the product from the UK market. Companies that did not comply with the requests of the Urgent Notices were referred to the Enforcement Section for further action.

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.

Yours sincerely

IE&S FOI Team MHRA Inspection, Enforcement and Standards cc FOI_Policy

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