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E-cigarettes: an evidence update <br /> <br />20 <br />3. UK policy framework <br />E-cigarette regulations in England: current and proposed <br />Regulations have changed little in England since the previous PHE reports. Currently <br />EC are governed by general product safety regulations (UK and EU) which do not <br />require that the products be tested before being put on the market. However, <br />manufacturers can apply for a medicinal licence through the Medicines and Healthcare <br />products Regulatory Agency (MHRA) [11] and from next year any EC not licensed by <br />the MHRA will be governed by the revised European Union Tobacco Products Directive <br />(TPD)[12]. Both the MHRA licensing and the TPD regulatory routes are described <br />below. The TPD regulations are extensive and will have a significant impact on the EC <br />market. <br /> <br />One change from the previous PHE report, which was introduced by the Advertising <br />Standards Authority in October 2014, is that until the TPD comes into force, advertising <br />of EC is governed by a voluntary agreement. This agreement indicates, inter alia, that <br />advertising must be socially responsible, not promote any design, imagery or logo that <br />might be associated with a tobacco brand or show the use of a tobacco product in a <br />positive light, make clear that the product is an EC and not a tobacco product, not <br />undermine quit tobacco messaging, and must not contain health or medicinal claims <br />unless the product is licensed. These guidelines will be reviewed in October 2015 and <br />when more is known about the application of the TPD the role of the Code will be <br />clarified. <br /> <br />A further recent change is the introduction of measures to protect children from EC: an <br />age of sale lower limit of 18 years of age (in line with tobacco cigarettes) is being <br />introduced and a ban on proxy purchasing of EC. <br /> <br />EU Tobacco Products Directive (TPD) route <br />The revised TPD will introduce new regulations for EC or refill containers (referred to <br />below as products) which are not licensed by the MHRA. We have listed these in detail <br />below because they are wide-ranging and will impose a significant step change for <br />manufacturers, importers and Member State (MS) authorities: <br /> <br /> notification: Manufacturers must inform competent authorities of the MS six months <br />before placing new products on the market. For those already on the market by 20 <br />May 2016, the notification needs to be submitted within six months of this date. Each <br />substantial modification of the product requires a new notification <br /> reporting obligations (for which manufacturers/importers might be charged) <br />include: