vaping regulations 2016

This means that electronic cigarettes that have not been authorised by a Competent Authority (e.g.: in the UK the MHRA Medicines & Healthcare Products Regulatory Agency) are banned from the market.

What happens to products that were already on the market before the 20 May 2016?
What do you have to do if you are an importer of vaping systems?
Do you need assistance in placing your application to the MHRA?

 

What products fall into the scope of application of TPD2?

All devices - disposable or refillable or rechargeable - that can be used for the consumption of nicotine-containing vapour, including devices without cartridge or tank.


My product does not contain nicotine. Does TPD2 apply to it?

No: the TPD2 Directive applies only to electronic cigarettes to be used with nicotine-containing liquids up to a concentration of 20 mg/ml.


I am an importer. What do I have to do?

First of all check if the product has already been registered by the manufacturer or by another importer. The same product can be known under different brands, but in the EU Common Entry Gate (http://ec.europa.eu/health/euceg/) it will be identified by a unique product identification number.

If the product is not registered yet, you have to submit your own notification:

http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32015D2183&from=EN

When submitting information on products with the same composition and design, manufacturers and importers should, as far as possible, use the same product identification number, regardless of brand and subtype or whether they are placed on the market in one or more Member States.
 

My product is already on the market. Can I continue selling it?

Yes, but not for long: you have to submit a notification by 20 November 2016.

Products that are not TPD2 compliant can be produced until 20th November 2016 and can be sold until 20th May 2017.


What should be included in a notification?

The notification should include sufficient information for the Competent Authority to verify that the product satisfies the minimum quality and safety requirements, that the information provided to the final users allows them to make an informed choice and that the due care is applied in order to protect children from starting to use electronic cigarettes.

Detailed information can be found in the Article 20 of the TPD2:
http://ec.europa.eu/health/tobacco/docs/dir_201440_en.pdf


Do you have other questions?

Contact us! We'll be glad to help.

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