After Brexit: Consequences for GMP and Supply Chain - Online Training Recording

The decision of the United Kingdom to leave the EU has caused a high uncertainty throughout industry in general and in the pharmaceutical industry more specifically. Since January 1st the UK has become “third country” from an EU perspective. Currently no MRA exist between UK and EU.

Up to now, there are many questions about the exact procedure and consequences. However, pharmaceutical companies must prepare to ensure supply continuity of critical medicines in UK and EU. The procedures and regulations applicable to medicinal products and APIs coming from or going to UK since 1st of January are no longer the same. Further, third countries outside the EU are impacted as well. MHRA has performed many inspections on behalf the EU outside the EU, and has issued GMP certificates.

Delays in delivery, challenges in the supply chain and even drug shortages are scenarios that are very likely to happen. Companies in EU importing medicines from UK must have provisions in place for to the QP certification of all batches received from UK. Additional questions are: How will companies approve the UK sites? Who is going to audit these sites? How do companies get their GMP certificates etc.? And finally: How do companies cope with the Northern Ireland Protocol?

The ECA and EQPA have therefore designed this online meeting to provide the latest updates from EU Commission and MHRA. Two presentations will cover the challenges: Delivery from EU to the UK and Delivery from UK to the EU. In addition plenty of time will be granted for discussion whiles our presenters will answer delegates' questions.