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The withdrawal of the United Kingdom from the European Union had many concerns. One of them being Regulatory Submissions. To smoothen the submissions process, the EU and the UK have set up a clear set of rules. Many of them are related to the existing and new marketing authorisation applications (MAAs) for CAPs, DCP and MRP, Batch testing, QP Certification, etc. Let us have a look at what Brexit means for the EU and the UK Regulatory Submissions. Here is a clear-cut Brexit impact summary that has recently been published by a consulting firm.
EU | UK |
New Marketing Authorization Applications for Centrally Authorized Products (CAPs) |
- MAH must be present in the EU
| - MAH must apply for a separate authorization
|
New Marketing Authorizations for Mutual Recognition Procedure (MRP)/Decentralized Procedure (DCP) |
- The same process applies to the EU
| - MAH must have a separate application
|
Existing Marketing Authorizations |
- MAH must be located in the EU/EEA
- CAPs must have an MAH in the EU
- UK (Co-)rapporteurs must be assigned to other EU/EEA member states
- In case of MRP/DCP, RMS/CMS cannot be in the UK. If UK is the RMS, it must be transferred to RMS in the EU
| - MAH must be located in the UK by the end of 2022
- CAPs are automatically granted authorization for one (01) year to share the baseline data with MHRA
- Contact is needed in the UK from Feb 1, 2021
|
Batch Testing and QP Certification |
- Batch testing must be within the EU/EEA or with a mutual recognition agreement (MRA) country.
- QP certification must be within the EU/EEA. From 1 Jan 2022, products exported to Northern Ireland must have re-testing and QP certification in Northern Ireland.
| - Batch testing must be within the EU/EEA/MRA country.
- QP certification is not if certified by a QP in the EU/EEA
- Wholesalers importing from EU/EEA must name an RPi on WDA by 1 Jan 2023.
|
Batch Testing for Products Manufactured in the EU/EEA |
- Batch testing must be performed within the EU/EEA
| - No additional batch testing is required for imports until 1 Jan 2023
|
Batch Testing for Products Manufactured in a Third Country with no MRA with the EU |
- Batch testing must be performed within the EU/EEA
| - Batch testing must be performed within the EU/EEA or the UK
- No additional batch testing is required for imports until 1 Jan 2023
|
Access to Eudravigilance |
- EU can continue reporting to Eudravigilance
| - UK will no longer have access to Eudravigilance. With UK’s new systems, ADRs must be reported to MHRA
|
GMP and GDP |
- EU’s GMP and GDP guidance applies
| - The UK will follow EU’s GDP and GMP guidance until 1 Jan 2023
|
Ref: https://www.nsf.org/consulting/health
With a lot of changes expected to be developed in the UK and the EU post-Brexit, it is essential to keep a tab on the upcoming Regulations. You can also reach out to a partner with high-level Regulatory and operational expertise to navigate the changes in the Regulatory landscape. Stay informed. Stay updated.
