EMVO Admits, ‘Insufficient Randomisation’ Warnings Can Be Ignored

The EU Delegated Regulation (EUDR) of the Falsified Medicines Directive (FMD) mandates that all serial numbers placed on non-exempt drugs entering the EU supply chain after February 9, 2019 must be ‘sufficiently randomised’.  What is sufficient randomisation?  The regulation says one thing, and the European Medicines Verification Organization (EMVO), the operator of the EU Hub,

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One thought on “EMVO Admits, ‘Insufficient Randomisation’ Warnings Can Be Ignored”

  1. The question about the delay is valid and pressing. I am not a lawyer, so I am somewhat unsure about this but the original EU FMD (Directive 2011/62/EU) says:

    “However, the Member States shall apply:

    (b) the provisions necessary to comply with points 8, 9, 11 and
    12 of Article 1 of this Directive from 3 years after the date
    of publication of the delegated acts referred to in point 12
    of Article 1 of this Directive.”

    Thus, the deadline is mentioned in the directive. I would think this means that any delay would need to be done by amending the directive, which is quite a process to go through (I wouldn’t think 6 months would suffice).



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