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Outline

The regulation of Nicotine-Containing Products (NCPs) UK National Smoking Cessation Conference 28 June 2013 Jeremy Mean. Outline. MHRA and the regulation of Nicotine-Containing Products (NCPs) Main features of medicines regulation European proposals for regulating NCPs UK Government action.

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Outline

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  1. The regulation of Nicotine-Containing Products (NCPs)UK National Smoking Cessation Conference 28 June 2013 Jeremy Mean

  2. Outline • MHRA and the regulation of Nicotine-Containing Products (NCPs) • Main features of medicines regulation • European proposals for regulating NCPs • UK Government action

  3. Role of the MHRA • The Medicines and Healthcare products Regulatory Agency (MHRA) is the Government Agency responsible for ensuring medicines and devices work and are acceptably safe – a statutory role • The Agency is part of the Department of Health and supports the Government’s wider public health policies • This includes reducing the impact of smoking on public health and how NCPs are regulated

  4. All of these products contain nicotine

  5. NCPs regulated by MHRA These products are NOT regulated by MHRA All of these products contain nicotine

  6. Public consultation • Growing concerns about safety and quality of products on the UK market • Growing acceptance of harm reduction approach to smoking “..to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them”

  7. Outcome of consultation AgainstMHRA regulationFor MHRA regulation Some importers Medical professional bodies, Users of NCPs NHS, pharmaceutical industry tobacco industry trading standards some importers

  8. Working with stakeholders Public Health Sector NICE, DH, BIS, No. 10 Researchers -UKCTCS Prof Hajek MHRA ECITA Pharma

  9. Research • Investigation of the levels of nicotine • The nature, quality and safety of unlicensed NCPs • The actual use of unlicensed NCPs in the marketplace • The efficacy of unlicensed NCPs in smoking cessation • The potential impact of bringing these products into medicines regulation on public health outcomes

  10. Summary of main findings • Nicotine levels vary from the labelled content and from batch to batch • Variable content and nicotine delivery • Unlicensed NCPs fail to meet standards of safety, quality and efficacy • Most NCP used to support stop smoking or harm reduction • Limited evidence of effectiveness • Current regulation does not serve public health

  11. Main features of medicines regulation • Proportionate licensing regime • Labelling and product information • Sale and Supply • Advertising controls • Safety monitoring • Risk management tools

  12. European proposals on NCPs • Part of wider Tobacco Products Directive • Nicotine threshold approach • Medicines licence required for some products • Warnings for others

  13. UK Government action • Regulation of NCPs as medicines serves the public health • MHRA stands ready to license NCPs now • UK Government will press for EU law to create a Europe wide legal position on NCPs as medicines • This will mean all NCPs will require a medicines licence

  14. The regulation of Nicotine-Containing Products (NCPs)UK National Smoking Cessation Conference 28 June 2013 Jeremy Mean

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