Guest Post by 'Evaporate' - UKV member
This is a guest post by Evaporate, a member of the UK Vapers Forum, who explains why Article 18 is the same as medical regulation of e-cigs - a defeat, as if amendment 170 never happened.
Don't be fooled, article 18 of the Tobacco Products Directive, which can be read on Clive Bate's website is the same as medicinal regulation for electronic cigarettes.
Vendors must inform the competent authority within 6 months of marketing
- The competent authority is the MHRA.
The information required is toxicity, emissions on heating, inhaled
health effects and inter alia (meaning amongst other things) addictive
effects, Also required is nicotine dosing and uptake under foreseeable
- This data can only be obtained from lab experiments and
This is effectively market authorisation data.
data plus manufacturing process data, also required, is normally
provided on a product dossier for each product.
If the MHRA find fault, they could say the data is inadequate and does
not comply with the directive, stopping marketing or removing from sale.
Section 8 requires market surveillance data and adverse reaction reporting, this is called pharmacovigilance in medicinal regulations.
Section 9 gives (Medical) authorities power to ban a device
Section 5 limits free speech
Unless MEPs realise that these are medicinal regulation they will not see they are being fooled.