10.2. SR 09-08-2015 - Laserfiche WebLink

Home Browse Search

E-cigarettes: an evidence update 23  where a competent authority believes specific products could pose a serious risk to human health it should take appropriate provisional measures, immediately inform Commission and competent authorities of other MS of measures taken and communicate any supporting data. The Commission will determine whether provisional measure is justified informing the MS concerned of its conclusions to enable appropriate follow-up measures to be taken  the Commission can extend any prohibition to other MS if such an extension is justified and proportionate  the Commission is empowered to adapt wording of health warnings and ensure factual  the Commission will give a common format for notification and technical standard for the refill mechanism outlined above The exact date of implementation in England is yet to be specified but full compliance is likely to be necessary by 2017. One UK company, Totally Wicked, has challenged the UK’s intention to transpose the Directive into UK law. The case rests on whether the TPD was properly made and has been referred to the European Court of Justice for a preliminary ruling. This is expected in late 2015/early 2016. During implementation, government will need to undertake an impact assessment for the UK market on the final proposals as set out in the Directive and this will be consulted upon. The TPD certainly raises the barrier for bringing EC products to market or continuing to market existing products, and will undoubtedly constrain the EC market. Understanding any unintended consequences of the EU TPD as well as intended ones will be important. For example, the cap on nicotine concentrations introduced by the TPD will take high nicotine EC and refill liquids off the market, potentially affecting heavier smokers seeking higher nicotine delivery products. Medicines and Healthcare products Regulatory Agency (MHRA) licensing route Following a consultation in 2010, the UK MHRA introduced a mechanism for the licensing of EC and other nicotine containing products as medicines requiring medicinal purity and delivery standards. Such a licence would be required for products to be prescribed on the NHS. As with other licensed nicotine containing products, advertising controls would be applied and VAT of 5% would be imposed. The licensing process has been described by the MHRA [11]. This regulation was described initially as ‘light touch’ recognising a product that delivered nicotine could be effectively used for harm reduction or cessation purposes, thus implying a relatively speedy route to licensing. This was subsequently changed to ‘right touch’ as it was apparent that the process was more lengthy and costly than originally envisaged. We understand that the MHRA estimated costs for a one-off application of between £252K and £390K with an annually recurring cost of between £65K and £249K, for each