Brexit: New Rules Will Hit Parallel Trade From UK to EU
Traders Disappointed At Asymmetry In IP Regimes
From next year, owners of trademarks and other rights in the European Economic Area will be able to prevent the parallel export of medicines from the UK to the EEA. But those owning similar rights in the UK will not be able to stop parallel imports from EEA countries.
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The trade deal agreed by the EU and the UK may have brought some relief to the life sciences sector in that it averts the chaos that would have followed failure to reach a deal, but it contains little that will have a direct impact on the regulation of medicines.
The pharmaceutical industry has welcomed a decision to allow more time to bring in new medicines regulations in Northern Ireland, but continues to insist that a mutual recognition agreement between the UK and the EU on drug manufacturing is the best way forward.
Regulatory bodies from Australia, Canada and the UK say a new pilot program will reduce the need for multiple inspections of the same site, while an MoU signed by Australia and Canada will cut the amount of documentary evidence required from drug sponsors seeking GMP clearances.