At the end of September, the MHRA wrote to producers regarding submitting vigilance information for e-liquid containing electronic cigarette refill containers.
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. Email responses and the 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 key 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.
For further information go to gov.uk/mhra.