The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) is on course to take charge of new e-cigarette product notifications in England, Scotland and Wales from 1st January, when Britain will officially no longer be a member of the EU following the 12-month transition period.
The agency has already migrated to the new submission portal about 99% of UK notifications made to date via the European Common Entry Gate (EU-CEG).
According to the MHRA, post-Brexit changes to the notification system will be “very minimal”. The agency believes the new procedure to upload data will be faster for submitters.
To ensure an accurate migration, the MHRA asked e-cigarette manufacturers not to submit notifications for the UK market via the EU-CEG after 21st December but to wait until the new UK system is fully operational.
Products notified to EU-CEG between November and December may not appear in the new MHRA system until 4th January.
Northern Ireland still to use Euro portal
The agency warned that delays due to compliance issues with individuals submitters “may still occur”, but the commitment of authorities is to reduce this during 2021.
“We are in touch with submitters where we have identified conflicts and are working with them to resolve conflicts and ensure successful data migration,” an MHRA spokesperson said.
From January, every new e-cigarette notification in the UK will have to name a responsible person acting as legal entity located in Great Britain.
Notifications for Northern Ireland will continue to be submitted through the EU-CEG portal and companies there will be able to use a responsible person based in Europe.
From now on, the UK will publish two separate e-cigarette notification lists, one for Northern Ireland and one for the rest of the UK.
The new MHRA system will generate a country identification (GBID) for each notified e-cigarette product marketed in the country.
What This Means: One of the first consequences of Brexit for the vaping industry will be the new system to notify new products to be marketed in England, Scotland and Wales.
The MHRA has published two reference guides to help manufacturers and importers set up and manage their submission accounts.
– Antonia di Lorenzo ECigIntelligence contributing writer
Photo: Sander Crombach