The European Medicines Verification Organisation (EMVO) recently published an announcement to confirm that only marketing authorisation holders (MAHs) or parallel distributors (MAH with parallel distribution activities) are able to connect to the European Hub for serialization compliance.

The likelihood is that many brand owners will start too late and under-estimate the workload associated with on-boarding.

The European Falsified Medicines Directive (FMD) states that MAHs are the entities that must fund the entire end-to-end verification system and that they are ultimately accountable for the safety of medicines. As a result, there must be an On-boarding Partner (OBP) within the MAH that is responsible for managing the transfer of serialization data into the EU Hub.

Staffan Widengren, Recipharm’s director corporate projects shares his views in inPharmaTechnologist.

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Limited access to the EU Hub could threaten serialization readiness, says CMO