EMVO Admits, ‘Insufficient Randomisation’ Warnings Can Be Ignored

The EU Delegated Regulation (EUDR) of the Falsified Medicines Directive (FMD) mandates that all seri

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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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