MHRA request for vigilance information – how to respond

Yellow Card Scheme: Reporting incidents with e-cigarettes and e-liquids

At the end of September 2019, the MHRA wrote to e-liquid producers regarding submitting vigilance information for e-liquid containing electronic cigarette refill containers. The letter was sent on behalf of the MHRA’s Yellow Card Scheme – https://yellowcard.mhra.gov.uk. The Yellow Card scheme is the UK’s system for collecting and monitoring information on suspected safety concerns or incidents involving medicines and medical devices, as well as e-cigarettes and their refill containers (e-liquids).

By law, ‘A producer of electronic cigarettes or refill containers must establish and maintain a system for collecting information about all of the suspected adverse effects on human health of the product.’ (Regulation 39 of the Tobacco and Related Product Regulations 2016 (TRPR))

In the letter, the MHRA requested information relating to all reports of suspected respiratory related adverse reactions. Information provided should be anonymised, including age, gender and details of the suspected product.

A response is required from all recipients, even if to confirm they have not received any relevant reports. Producers are required to email responses and their submitter ID to TPDenforcement@mhra.gov.uk by 15 October 2019.

Having a Quality Management System (QMS) for dealing with concerns or complaints raised by the public is a principle part of a company’s responsibilities as a producer of e-liquids. A QMS should include the following:

  • Staff training on the UK/EU laws and the QMS.
  • Standard Operating Procedure (SOPs) for how to deal with and manage customer concerns and complaints.
  • A staff guide on how to report all public incidents via the MHRA yellow card system.

Download the Yellow Card app to report side effects, receive news and updates. It’s available from the Apple App Store or Google Play Store.

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