The role of the competent authority for e-cigarette regulation

The role of the competent authority for e-cigarette regulation Beryl Keeley

Summary • Tobacco Products Directive • Role of MHRA • Regulation of e-cigarettes • Medicinal products 2

Tobacco Products Directive (2014/40/EU) (TPD) • Department of Health are the competent authority for the whole of the TPD and led a public consultation • Article 20 establishes new rules for e-cigarettes • Applies to consumer products, not those subject to medicines licensing • National implementation – 20 May 2016 3

Purpose The regulatory framework introduced by the TPD is intended to provide: • minimum standards for safety and quality of all e-cigarettes and e-liquids • information to consumers so that they can make informed choices • an environment that protects children from beginning to use these products 4

Limits for e-cigarettes • Maximum cartridge / tank size 2 ml • Maximum refill container volume 10 ml • Maximum concentration 20 mg/ml nicotine 5

MHRA role • TPD requires manufacturers and importers of e-cigarettes to submit a notification to the competent authority • MHRA will be the competent authority for e-cigarettes in the UK • Light-touch regulation • Focus on safety in use 6

Our vision We protect and improve the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research 7

Notification scheme • Proportionate scheme – minimise regulatory burden • Notify MHRA 6 months before place on market • Existing products on the market must notify by 20 November 2016 • Data will be published (except confidential information) 8

Notification scheme Must submit: • Ingredients • Toxicological data regarding the product’s ingredients and emissions • Nicotine dose • Description of components • Description of production process 9

Packaging requirements • Containers must have child-resistant closures • Must be tamper-evident • Refill mechanism to ensure no leaking • Labelling with health warning • Accompanying leaflet 10

Notification scheme Reliance on: • Declaration of conformity with Article 20 requirements • Declaration that manufacturer and importer bear full responsibility for the quality and safety of the product when placed on the market and used under normal or reasonably foreseeable conditions 11

Safety concerns • Responsibility of manufacturer to investigate and report actions taken to MHRA • MHRA Yellow Card portal • Work with Trading Standards bodies across UK • Provisional action and European co-ordination 12

Partnership with Trading Standards Trading Standards bodies across the UK are responsible for TPD enforcement around e-cigarettes We are working together to agree a framework for this and training for TS staff Data sharing across our organisations to ensure effective handling and support for each other 13

Medicines - key differences Licensed Nicotine Replacement Therapies: • Can make smoking cessation and harm reduction claims • Can contain higher concentration of nicotine • Subject to stricter regulation to obtain marketing authorisation 14

Indication for use - medicine [Product] relieves and/or prevents craving and nicotine withdrawal symptoms associated with tobacco dependence. It is indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them. [Product] is indicated in pregnant and lactating women making a quit attempt. 15

Any questions? To register as an interested party and be kept informed of any developments in our implementation of the TPD regulations, please send your contact details to [email protected] 16