Change in the UK notification system
There is an important change in terms of TPD regulations, as a result of Brexit. There is a division within the UK into Great Britain (England + Wales + Scotland) and NI (Northern Ireland). For GB territories, a new separate English TPD system is created for reporting new products from the new year, that is, from the end of the so-called transition period after Brexit (i.e. from 1 January 2021).
Products on the Northern Ireland market are to be notified in the same way with the current system, as for the entire EU. The authorities have updated the EU system before the end of 2020 so that it is no longer possible to select the UK as the target market. In return, it is possible to select only the Northern Ireland market.
What is important, notifications existing before Brexit are still valid after Brexit. Such notifications are automatically transferred from the EU system to the new system for GB countries. After the migration is completed, you will be able to update them in the new system, add new brands, add annual reports, etc.
How will Brexit affect notification payments?
New rules concerning the UK notification system are important when submitting new products. From the start of 2021 it is possible to indicate in the new English system which markets the product is intended for (whether only GB or GB + NI) and for easier identification, ensuring that products submitted simultaneously to the GB and NI market have the same EC-ID number for easier verification.
This will determine the registration fee to remain at the same level, which is £ 150 per application. The fee will be charged when the product is entered in the GB market only (£ 150) or as soon as the NI market (£ 150), and also only £ 150 (a type of rebate) when reported to both markets through two separate systems.
MHRA (Medicines & Healthcare products Regulatory Agency) is to verify the notification statuses in both systems in order to correctly identify the product, so as not to double the fee. For example: if we want to register a new product throughout the UK, it will require the submission of one product through two different systems, however, we’ll pay £ 150 for only one product. If we are not fancy for the entire UK (only NI or only GB countries), then, depending on the area, you can apply only through one system, but the fee will also be £ 150.
New Great Britain system for e-liquid notifications
The New GB system for e-liquid notifications is a portal that MHRA previously created for the so-called ‘No-deal’ of Brexit. If anyone has set up such an account before, the password and login should still be active and work. Read the step-by-step instructions on how to create an account on this new system. The possibility of reporting new products through the new system is available from January 1, 2021. As for the existing registrations, authorities have migrated current notifications at the end of 2020.