EU Extends Provisions For Ensuring Post-Brexit Flow Of Medicines
‘Bridging Measures’ Needed After End Of Grace Period
Proposals for averting medicines supply disruptions caused by Brexit in Northern Ireland and three EU markets are about to be discussed by EU legislators.
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The UK regulator explains the new requirements for batch testing and release in Great Britain and Northern Ireland, what's involved in importing clinical trial drugs to Northern Ireland, and what factors determine the location of the Qualified Person.
National pricing and reimbursement systems remain a key barrier to medicines access, and requiring companies to market their products in all EU countries and to notify regulators of their launch intentions is not the answer, according to EuropaBio, which represents a wide range of biotech firms operating in Europe.
The latest proposals for solving regulatory and trade issues caused by Brexit and the Northern Ireland Protocol have been welcomed by EU and UK pharmaceutical industry bodies.