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  • New law strengthens punishment for assaulting health sector workers

    New law strengthens punishment for assaulting health sector workers

    Friday, 27 July 2018 16:08
  • Home Office gives go ahead to allow cannabis-derived medicinal products on prescription

    Home Office gives go ahead to allow cannabis-derived medicinal products on prescription

    Friday, 27 July 2018 15:58
  • Review on prescribed medicines sets out scope and terms of reference

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    Tuesday, 24 July 2018 12:30
  • AMs recommend that pharmacists have access to palliative care data in Wales

    AMs recommend that pharmacists have access to palliative care data in Wales

    Wednesday, 18 July 2018 17:41
  • APTUK questions claims about pharmacy technicians’ desire to supervise medicines supplies

    APTUK questions claims about pharmacy technicians’ desire to supervise medicines supplies

    Wednesday, 18 July 2018 17:17

Umesh Modi is a chartered accountant, and Pamini Jatheeskumar is a chartered certified accountant at Silver Levene...
  Don Lavoie is alcohol programme manager at Public Health England and Gul Root is lead...
Don Lavoie is alcohol programme manager at Public Health England and Gul Root is lead pharmacist, Health and Wellbeing Directorate, Public Health England
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e cigaretteMay 11 2016

Regulations affecting the nicotine content, packaging and selling of e-cigarettes will be introduced next week. The most immediate effect will be for retailers who have cross-border sales of e-cigarettes, for example via online sales, who will be required to register this.

The medicines regulator, the MHRA, has set out the requirements around e-cigarettes which have to comply with the EU Tobacco Products Directive (TPD) 2014. UK legislation is set out in The Tobacco and Related Products Regulations 2016, and allows a six month transition phase for manufacturers to bring stock into line with regulatory requirements and a further six months for any old stock to be sold through.

In addition to banning advertising of e-cigarette products, the regulations say that:

  • nicotine-containing liquids must be no stronger than 20mg/ml of nicotine
  • refill containers must be no more than 10ml and single use containers must not contain more than 2ml
  • nicotine liquids must not contain any additive vitamins, colourings or other stimulant compounds such as caffeine or taurine
  • e-cigarettes must be child-resistant and tamper evident
  • specially designed refill devices must be used to protect against the risk of spillage.

Labelling requirements include:

  • a reference that the product is not recommended for use by young people and non-smokers
  • contra-indications
  • warnings for specific risk groups
  • possible adverse effects
  • addictiveness and toxicity
  • contact details of the producer
  • a batch number
  • a recommendation to keep the product out of reach of children
  • a health warning complying with certain size and type face requirements and to state that “This product contains nicotine which is a highly addictive substance”.

The 12 month transition period for implementing the new regulations means that from May 20 to November 19, the retailing of products can continue as has been happening up to now.

However, from November 20 to May 19 2017, retailers may continue to sell products they already had in stock, but when sourcing new supplies of any e-cigarette or e-liquid product, retailers should ask the supplier whether the product complies with the requirements of the TPD. If the answer is no, the product may only be sold until May 19 2017.

From May 20 2017 onwards, retailers must remove any stock that does not comply with the regulations. Retailers will be asked to check that details that the producer has notified the MHRA and has approval. The MHRA says it will be publishing that information online, in due course.

For businesses selling e-cigarettes cross border, for example via online sales, the business needs to register from May 20 2016 onwards.

This applies to:

  • businesses established in the UK selling e-cigarettes and / or e-liquids to consumers in another European Economic Area (EEA) state– the 28 EU Member States plus Iceland, Liechtenstein and Norway
  • businesses established in the EEA or third country selling to UK consumers.

Business to business sales, that is sales not direct to consumers, do not need to be registered.

A European Union Court of Justice ruling last week said that the requirements as set out in the Directive, which also brings in a number of regulations for tobacco-based products, had not “exceeded the limits of what was appropriate and necessary in order to achieve the objective pursued by the directive.”

Links:

MHRA e-cigarettes guidance

The Tobacco and Related Products Regulations 2016

E-cigarette cross-border sales registration (via Department of Health)

EU Court of Justice

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