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”).
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 e-cigarettes pursuant to the European Union (Manufacture Presentation and Sale of Tobacco and Related Products) Regulations 2016 (S.I. No. 271 of 2016) which transpose the recently revised tobacco legislation at EU level(1) .
DELIVERY DEVICES THAT MAKE MEDICINAL CLAIMS – MEDICAL DEVICES
The Guide further excludes from the definition of a medicinal product delivery devices (such as containers/ tanks, mouthpieces or batteries) that make smoking cessation claims but are intended to be reusable and marketed separately from pre-filled cartridges or nicotine-containing liquid. These products will be regulated as medical devices thus requiring a CE mark to be affixed before placing them on the market in Ireland.
Manufacturers of e-cigarettes that intend to place such products on the Irish market are advised to assess the promotional literature, product labelling and types of claims made in relation to their products to ensure that the correct regulatory regime above is applied to the product.