Submitting regulatory information on medical products if there’s no Brexit deal
MHRA stakeholders are being informed of what they’ll need to do to continue to submit regulatory information to us in the unlikely event of a no-deal scenario.
25th September 2018
UK is currently a part of the EU regulatory networks for medicines and medical devices. These regulatory networks have shared processes and systems.
You can submit information into one place for it to be shared around all EU and EEA countries.
The shared systems, in the case of human medicinal products, include, but are not limited to:
- CESP (common European submission portal)
- EMA (European Medicines Agency) gateway
- Common repository
- PSUR (periodic safety update report) repository
- PedRA (paediatric record application)
- EudraCT and the new CTR (clinical trial regulation) portal
- Article 57 database
- EudraLink and EudraMail
For medical devices, shared systems include, but are not limited to, the European Databank for medical devices (EUDAMED).
Shared systems also exist for other products, such as the EU common entry gate (EU-CEG) for tobacco products, e-cigarettes and refill containers.
After 29 March 2019 if there’s no deal
If there’s no deal, the UK would no longer be part of the EU medicines and medical devices regulatory networks. The sharing of these common systems, and the associated exchanges of data, between the UK and EU/EEA countries would end.
UK would have its own processes and systems to manage UK human medicines and devices regulatory activities. To do this, some new systems are being developed for March 2019 and MHRA stakeholders would need to submit regulatory information relating to human medicines and devices directly using these national portals.
This information is correct on 14 September 2018 and may be updated over time. For more detailed information please refer the full text here.