ACCORDING TO THE MHRA, THE EVIDENCE IS CLEAR THAT E-CIGARETTES ARE LESS HARMFUL TO HEALTH THAN SMOKING
over the shelf life of the product. This should be kept in mind when selecting the battery for a battery-operated device
• compliance with the requirements of the European Pharmacopoeia monograph for Preparations for Inhalation
• compliance with the requirements of the British Pharmacopoeia monograph for Nicotine Inhalation Cartridges
Non-clinical (safety) requirements With respect to safety, the toxicological consequences of heating and vaporising the formulation of nicotine and excipients (including flavourings) during the normal use of the product need to be considered. For example, particular concern has been raised in studies about the presence of acrolein and other carbonyls, such as formaldehyde and acetaldehyde that can be produced as a consequence of the thermal decomposition of glycerol and propylene glycol. Analytical chemistry data should be used to confirm the compounds present in the vapour produced by an e-cigarette device under its normal operating conditions. Information on the
potential toxicity of any degradation products at relevant exposure levels and all routes of exposure should be provided.
Clinical (efficacy and safety) requirements The efficacy and safety of an NCP intended for treating tobacco dependence depends in part on the plasma nicotine levels produced by the product. Therefore, as a general principle, an applicant would be required to demonstrate that the plasma nicotine concentration which their product will achieve when used as intended is both effective and safe. To ensure efficacy, plasma nicotine concentrations of the applicant’s product should not be substantially less than for established nicotine replacement therapy (NRT) products. To ensure safety, plasma nicotine concentrations of the applicant’s product should not be more than for a tobacco cigarette.
Non-nicotine containing e-cigarettes If the e-cigarette does not administer or contain nicotine or any other active substance, then it is not considered a medicinal product under the
definitions of Human Medicines Regulation 2012, as amended. Consequently, a marketing authorisation is not required.
E-liquid or nicotine liquid only If a medical claim is made, it would be possible to apply for a marketing authorisation for the nicotine liquid only. However, it would be necessary to demonstrate that the liquid is safe and effective in specified e-cigarettes or other vaporising devices. Furthermore, such e- cigarettes or vaporising devices would need to be registered as medical devices and carry a CE/UKCA marking.
‘The evidence is clear’, said Dr June Raine, Chief Executive of the MHRA, ‘that e-cigarettes are less harmful to health than smoking tobacco and that nicotine-containing e-cigarettes can help people quit smoking for good. The updated guidance on licensing requirements we have published is a strong first step towards availability of safe and effective licensed e-cigarette products.
‘To license e-cigarettes and other inhaled NCPs as medicines, the proposed products should meet standards of quality, safety and efficacy as defined under medicines regulations. The proposed medicinal products should also meet the usual quality and safety standards for consumer e-cigarettes that have been developed by national and international standards organisations, where relevant. Proposed products may also need to comply with the UK medical device regulations, depending on the design of the product.’
UK context and cases It is estimated that 3.6 million people use e- cigarettes in the UK. Nicotine-containing e-cigarettes and e-liquids have been regulated since the introduction of the Tobacco and Related Products Regulations (TRPR) in 2016.
3.6 MILLION PEOPLE USE E-CIGARETTES IN THE UK
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