Medical supplies-MHRA regulations and guidance on e-cigarettes

In April 2017, the Tobacco Products Directive came into force. Since this date the Medicines and Healthcare Regulatory Authority (MHRA) has been responsible for devices used to inhale nicotine solutions – commonly known as ‘vaping’ or ‘e-cigarettes’.

Since these products are now regulated, there are standards to which these products have to conform in order to be safe and these are set out in the directive. This includes both the vaping itself and other risks such as the fire risk from improper charging.

It should be noted that people will still be able to access non-regulated products on the internet and devices from before regulation will still be in use, so it should not be assumed that every device a patient has meets these conditions.

Part of the regulator’s job is to collect data on adverse events with devices. Therefore, any adverse event caused by an electronic nicotine inhalation device should be reported via email to TPDsafety@mhra.gov.uk.

Recently there have been reports of lung disease in users of electronic cigarettes in the USA. The cause of this has been identified as additives in the solutions when they are used to inhale illegal cannabis-derived products. Therefore, the current advice from Public Health England still applies in that these devices are likely to be less harmful than tobacco but are not licensed as medicines.

MHRA guidance:
https://bit.ly/2M74MLj

Yellow Card Scheme:
https://yellowcard.mhra.gov.uk/