A new coordinated approach for preparing and evaluating multilingual packaging for drugs assessed under the EU’s mutual-recognition and decentralized (MR/DC) procedures has now been established as standard practice by regulators, after it proved successful in a four-year pilot.
Multilingual packaging involves the use of two or more EU languages on at least one component of the packaging material for a medicinal product (eg, immediate and/or outer packaging and/or...
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