With the appointment of Boris Johnson as Prime Minister, it is likely that the United Kingdom (UK) may leave the European Union (EU) on the 31st of October 2019 and without a deal (“Hard Brexit”). Pharmaceutical authorities see challenges for pharmaceutical manufacturers in many areas, not only in terms of drug availability and drug testing.
The MHRA have already posted several guidelines for a possible no-deal scenario which concerns the following areas:
- Medical Devices
- Clinical Trials
- Biologicals and ATMPs
- List of approved countries
- Trading in drug precursors
- QPPV and PV Master File
For a comprehensive overview see “MHRA guidance and publications about a possible no-deal Brexit.”
Will clinical trials be impacted by Brexit?
Clinical trial sponsors and associated partners should be prepared for a variety of scenarios arising from Brexit which could impact on the manufacturing, licensing and distribution of health products between Ireland and the UK.
The way clinical trials are conducted will undergo a major change when the new Clinical Trial Regulation comes into application. The Regulation surrounding EU Clinical Trials harmonises the assessment and supervision processes for clinical trials throughout the EU. This will come into force in 2020. As this will be introduced after the UK leaves the EU, the UK will not be in line with EU regulations and UK’s future alignment will be subject to negotiations with the EU.
In the likely case of a no-deal Brexit, issues concerning clinical trials with medicinal products are to be considered.
Shipping of investigational medicinal products (IMPs) from the UK will now constitute an import. This will also apply if only parts of the manufacture take place in the UK. For example, study – specific packaging or labelling of IMPs. The batch release of IMPs must take place in the EU. After Brexit, manufacturers responsible for final batch release who are established in the UK will no longer be able to certify clinical trial batches for the EU.
If you would like to discuss any specific requirements relating to Brexit readiness and how MIAS Pharma can help you, get in touch with us today at firstname.lastname@example.org or call us on +353 (1) 846 3605.