[membership level=”0,4″][The content continues for paid members only.]
Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership]
In early February, the European Commission (EC) published a new regulation that will require incorporation of safety features on prescription drug packaging by February 2019 for all but three EU member states. Greece, Italy, and Belgium will have an additional six years to implements parts of the requirement as those countries already have similar national regulations in place. The EC regulation introduces two safety features, a unique identifier in the form of a 2-dimension barcode, and an anti-tampering device, to be placed on the packaging of most medicines for human use. An implementation plan was published at the same time by EMA to help guide applicants in meeting the new requirements. The regulation and implementation plan are the latest in a series of efforts supporting the 2011 EU Falsified Medicines Directive. [To see IPQ’s extensive coverage of the falsified medicines directive, click here.]
[/membership]
INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue
