Stephen Thomson, our regulatory affairs Director, writes about the latest Brexit news.
The UK government has published a series of technical notices that give guidance on how to prepare for Brexit if there’s no deal.
A ‘no deal’ scenario is one where the UK leaves the EU and becomes a third country at 11pm GMT on 29 March 2019 without a Withdrawal Agreement and framework for a future relationship in place between the UK and the EU. In a ‘no deal’ scenario there would therefore be no agreement to apply any of the elements of the Withdrawal Agreement.
For medicinal products, the relevant publications are:
Batch testing medicines
The UK will “continue to
- accept batch testing of human medicines carried out in countries on a list from the Medicines and Healthcare products Regulatory Agency (MHRA)
- require a UK, EU or EEA-based qualified person (QP) to certify batch testing
The approaches to QP certification of licensed medicines will also apply to Investigational Medicinal Products. Full details are available here
How medicines, medical devices and clinical trials would be regulated in the UK
‘The UK’s participation in the European regulatory network would cease. The MHRA would take on the functions currently undertaken by the EU for medicines on the EU market’. As a consequence of no deal:
- All centrally authorised medicinal product marketing authorisations will be automatically converted into UK marketing authorisations on 29 March 2019
- The outcome of ongoing EU MAA procedures, (i.e. centralised, decentralised and mutual recognition procedures) that have not reached the decision phase will not be valid in the UK; however, they will continue to be assessed by MHRA as National Procedures
- New ‘generic’ applications would need to be based on reference products that have been authorised in the UK, as MHRA will not have access to the data provided in support of approved products in other EU member states
- A UK based Marketing Authorisation Holder should be established by the end of 2020. Until then, the MHRA will require a contact in the UK
- UK clinical trial applications will continue to be authorised by the MHRA and ethics committees. Note that the new EU Clinical Trials Regulation (CTR) 536/2014 will not be in force in the EU at the time that the UK exits the EU.
- A Qualified Person for Pharmacovigilance (QPPV) should be established in the UK
- For a limited time, the UK will continue to recognise CE Mark on medical devices.
There are a number of other aspects for which consultation is proposed, including Orphan medicinal products, paediatric medicines, medical devices (after an initial ‘The MHRA is planning a public consultation in early autumn on some of the key proposed legislative changes’. Full details are available here
Submitting regulatory information to MHRA
If there’s no deal, regulatory information relating to human medicines and devices that would typically be submitted via the EU regulatory networks shared processes and systems (e.g. CESP (common European submission portal); EMA (European Medicines Agency) gateway; EudraVigilance) will have to be submitted directly to MHRA. MHRA are developing independent processes and systems for regulatory activities, and further information will be available in due course. Full details are available here
How medicines, medical devices and clinical trials would be regulated in the EU
The European Commission (EC) and EMA’s position continues to be that, as of 00:00h (CET) on 30 March 2019, the UK will become a ‘third country’, and the EU legislation and guidance on medicinal products will no longer apply to the UK. In the Questions and Answers documents published by the EC/EMA and CMD(h), the advice to marketing authorization holders is that all relevant tasks and responsibilities currently conducted in the UK should be transferred to within the EEA by 30 March 2019.
The EU have not yet made any comment as to what mitigation measures they may choose to adopt. Latest updates from EMA available here
EMA Business Continuity Plan
EMA has also recently announced that it expects a staff loss of about 30% as a consequence of the move to the new Amsterdam location in March 2019.
EMA will start to temporarily scale back or suspend additional activities in order to protect EMA’s essential public health activities including
- Collaboration at international level,
- Development and revision of guidelines,
- Holding of non-product-related working parties
- Programmes and projects, where activities in relation to project governance will be reduced in line with the reduction/suspension of projects;
- Organisation and attendance at stakeholder meetings, which will be limited to Brexit-related interactions;
- Clinical data publication