Director QMC / Senior Consultant, PharmaLex
The UK’s departure from the European Union is having significant implications for the pharmaceutical industry. Charley Maxwell, Senior Consultant at PharmaLex explains more about the impact of Brexit and hurdles facing pharmaceutical companies.
Prior to Brexit, the EU including the UK, was one single trading block. However, shipment of medicines from Britain to the EU now requires customs declarations, additional testing and import checks before being re-released in the EU.
Similarly, suppliers to the UK can no longer sell directly from the EU. Stock must be transferred to a UK warehouse, where a UK Responsible Person for Import (RPi) conducts import checks before releasing stock. Thus impacting the just in time supply chain model previously enjoyed.
Goods flowing from GB to NI are treated similarly to goods coming into the EU from a third country.
Complex rules around Northern Ireland
Supply to Northern Ireland is also complicated as different rules apply depending on the flow of goods.
GB to NI requires completion of customs declarations, sanitary and phytosanitary inspections meaning that goods flowing from GB to NI are treated similarly to goods coming into the EU from a third country.
In the other direction, manufacturers/wholesalers benefit from the Unfettered Access Procedure (UAP), introduced via the Northern Ireland Protocol, which guarantees free trade from NI to GB.
Medicine verification systems
Divergence in standards is leading to internal trade issues as demonstrated with Serialisation through the European Medicines Verification System (EMVS). Securemed – the UK-NI National Medicines Verification System (NMVS), now only allows for serialisation of packs destined for Northern Ireland, so manufacturers can no longer serialise packs for the GB market.
Similarly, there are different Adverse Drug Reaction reporting requirements and so suppliers to the UK as a whole now require two distinct stock-keeping units (SKUs) for supply to GB and NI.
The EMVS system makes medicines very difficult to counterfeit and with the UK only partially connected, there is a risk counterfeiters may target the UK. Thus, leaving it vulnerable to falsified medications entering the supply chain. The UK government has taken steps to counter this however, it may take several years to implement a UK only system to duplicate the EMVS.