HPRA Revisits E-Cigarette Guidance

Author:Mr Colin Kavanagh and Ciara Farrell
Profession:Arthur Cox
 
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The Health Products Regulatory Authority ("HPRA") has updated its Guide to the Definition of a Human Medicine ("Guide") by revisiting Section 6.12 of the Guide on electronic cigarettes ("e-cigarettes").

NEW DEFINITION

In the Guide, the HPRA includes a new definition for e-cigarettes which, unlike the previous version of the Guide, further elaborates on the type of chambers in these products and removes the reference to an LED. E-cigarettes are defined in the Guide as:

"battery powered devices designed to be used in the same way as real cigarettes. They contain either a refill chamber, tank or a disposable cartridge chamber designed to hold a nicotine-containing liquid. The liquid feeds to an atomiser and a sensor activates a heating element within the atomiser causing the nicotine to be vaporised so that it is available for inhalation via a mouthpiece".

E-CIGARETTES THAT MAKE MEDICINAL CLAIMS - MEDICINAL PRODUCTS

The Guide confirms that e-cigarettes that make medicinal claims (such as smoking cessation clams) are medicinal products and, as such, require a marketing authorisation before being placed on the market in Ireland. The HPRA likens these products to nicotine replacement therapies.

E-CIGARETTES THAT DO NOT MAKE MEDICINAL CLAIMS - TOBACCO PRODUCTS

A key change to the Guide is the confirmation that e-cigarettes that are not promoted for medicinal purposes such as smoking cessation but only as alternatives to cigarettes where smoking is not permitted are subject to tobacco legislation. The Health Service Executive is responsible for regulating these...

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