If the revised TPD is voted through in its current form on the 8th of October, electronic cigarettes will from 2016 need to be marketed as a medicinal product authorised under the Medical Products Directive regime. This we and countless others have argued will constitute a ban because electronic cigarettes are not medicines and are not capable of reclassification as medicines.
Lawyers representing an electronic cigarette manufacturer in the UK sought clarity from the Medicines and Healthcare Products Regulatory Agency (MHRA), whose lead the EU is following, as to whether or not their product range were medicinal. The MHRA confirmed in writing that, under the Medicinal Products Directive 2001/83/EC, none of the products sold by this company as of the 22nd of August 2013 were considered medicinal, nor were they considered medical devices under the Medical Devices Directive 1993 (Directive 93/42/EEC). Furthermore they confirmed that the TPD as it currently stands would not alter this fact.
As a result of this confirmation, the MHRA has confirmed that this company is not required to seek marketing authorisations or any other form of license for its products. However, in its reply, the MHRA stated that if the draft TPD passes into law in its current form, this company, in order to legally sell its current product range, would be required to seek marketing authorisations from the MHRA under the Medicinal Products Directive. In other words, this company would have to seek medicines licences for products the MHRA has confirmed are not medicines.
As a direct result of a freedom of information request by the E-Cigarette Consumer Association (ECCA), the MHRA confirmed in writing that if a product is not medicine the MHRA cannot use medicines regulation to regulate it.
Having established that none of this company’s product range qualifies as a medicinal product, it would be impossible for them to obtain authorisations and as a result they would be prohibited in law from selling any of their existing products. This is the clearest statement yet that currently available electronic cigarette products will be banned from 2016 if the TPD passes into law in its current form.
As this company’s product range is broadly similar to that distributed by other electronic cigarette vendors in the EU, the logical conclusion to draw from the above is that if the draft TPD passes as proposed, there will be a shutdown of the general sale of currently available electronic cigarette products from 2016 throughout the EU.