In previous blogs in this series, we’ve walked you through the Tobacco Products Directive (TPD) and Tobacco and Related Products Regulation (TRPR) requirements and testing , as well as taking an in-depth look at safety assessments and stability testing. Here, we look at the TPD/TRPR submission process, the costs, and the differences between the GB/EU systems.

For notifications of e-cigarettes and e-liquids in Great Britain (England, Scotland and Wales) and EU (European Union and Northern Ireland), secure online portals are used. Great Britain uses the MHRA portal, whereas, for EU and Northern Ireland notifications, the EU-CEG portal is used. Both portals require the same information in order to make a successful notification, although there are slightly different layouts due to Great Britain having their own regulatory requirements.

The TPD/TRPR process requires a lot of information to be submitted, therefore great attention to detail is needed to ensure the smallest parts are not missed out.

XML (Extensible Markup Language) creator software is needed in order to create your submission in the XML file format. This part of the submission requires you to upload the following information and attachments:

These are necessary as they form the information that will be reviewed before your product is placed on the market.

As TPD is adapted by the individual Member States of the European Union, there are different variations and requirements between the countries. An example of this is that Germany requires a notification and the full TPD process to be followed for 0mg/ml nicotine products, whilst 0mg/ml nicotine products remain unregulated under the TPD in countries such as Bulgaria, Ireland, Portugal, Spain and Greece. and therefore do not require notification.

An additional country-specific requirement is the regulatory fees. Each Member State has set their own fees which can range from 0 Euro to several thousands of Euros. Therefore, it is important that you know which countries you want to submit your products in and how much you will have to pay to do this.

There is a wide variety of laws and regulations which need to be precisely followed in order to be successful and get your product on the market. The creation and gathering of information prior to the notification may take some time, but with the relevant experience behind us, we can make the submission process straightforward for our clients. Contact us to hear how you can benefit from our expertise in TPD/TRPR submission and get your products on the UK and EU markets.

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