According to the delegated act (EU) 2016/161, as of February 9th 2019, prescription drugs will be only permitted to be distributed in the EU if the packaging holds a unique identifier serial number as well as an anti-tampering device.
This delegate act in many regards offers clarity for the pharmaceutical industry. Successful best practices or references upon which Contract Manufacturing Organizations (CMO) and Manufacturing Authorization Holders (MAH) could guide themselves have been almost non-existent until now. Specific questions for individual companies still remain unanswered.
You can find the agenda and the opportunity to register here.
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