The Tobacco Products Directive 2014/14/EU (TPD) introduces new rules for nicotine-containing e-cigarettes and refill containers (Article 20). MHRA is responsible for implementing the majority of provisions under Article 20 and has been designated as the competent authority for the notification scheme for e-cigarettes and refill containers in the UK.

The TPD introduces new rules which ensure:

Ø  minimum standards for the safety and quality of all e-cigarettes and refill containers (otherwise known as e-liquids)

Ø  that information will be provided to consumers so that they can make informed choices

Ø  an environment that protects children from starting to use these products

Ø  Putting a new product into the UK market

Products already in the UK market

The UK Tobacco and Related Products Regulations 2016, which were laid before Parliament on 22 April 2016, implement the TPD in the UK, and come into force on 20 May 2016. Part 6 of the regulations sets out the requirements for e-cigarettes and refill containers.

From May 2016, the regulations introduce requirements for producers of e-cigarettes and refill containers. A producer is anyone who manufactures or imports these products or who re-brands any product as their own. Producers must submit information about their products to MHRA through a European Common Entry Gate (EU-CEG) notification portal.

Details of when producers need to submit a notification can be found in the document below. E-cigarette transition periods for producers (PDF, 317KB, 1 page)

If the manufacturer has submitted a UK notification for the specific product you import, then you do not need to submit a duplicate notification. Similarly, if the manufacturer has notified details of a product that you have re-branded, and your brand name is listed in the manufacturer’s notification, then you do not need to submit a duplicate notification.

Retailers do not need to submit information for any products they sell unless they also qualify as a producer. Retailers have until 20 May 2017 to sell through stock of products that do not comply with the labelling and product composition requirements of the TPD.

When MHRA is satisfied that a product notification is complete and complies with theTPD, we will publish all non-confidential information. Producers will be able to specify information that they consider to be confidential when they submit a notification.

The TPD does not cover nicotine-containing products that are authorised as medicines.

From 20 May 2016 onwards, producers of new e-cigarette and refill container products will need to submit a notification to MHRA 6 months before they intend to put their product on the UK market.

There are transitional arrangements for the period between 20 May to 19 November 2016. During this period, applications for new products which companies intend to put on the market must be made at least one day before they are sold for the first time.

A product which has been substantially modified will count as a new product and must also follow this process. Further information regarding what qualifies as a substantial modification can be found in the guidance on submission type below.

Producers of all e-cigarettes and refill containers that are covered by the TPD and are on the market before 20 May 2016 will have until 20 November 2016 to submit a notification to MHRA. After that date producers may only sell batches of a product that does not comply with the TPD requirements if the batch was produced before 20 November 2016.

Requirements for e-cigarette producers to report safety concerns

E-cigarette producers must inform MHRA if they have reason to believe that a notifiable product is unsafe, not of good quality or not compliant with TPD regulations and provide details of the risk to human health and safety and any corrective action taken. E-cigarette producers should notify the MHRA by email to This e-mail address is being protected from spambots. You need JavaScript enabled to view it