The EU Delegated Act has Landed

Feb 3, 2015, by Christoph Krähenbühl - Category: Pharma

3C Integrity LogoFormer AstraZeneca serialisation expert and member of the EFPIA-led European Stakeholder Model (ESM) technical experts working group, Christoph Krähenbühl, examines the latest update on the 'Safety Features' Delegated Act, currently being examined by Member States' expert teams and gives his personal view on how some of the proposed provisions could have a significant impact on all stakeholders, in particular pharmaceutical manufacturers supplying products to the European Market.


European Falsified Medicines Delegated Act

3CI Delegated Act Paper The publication of the Delegated Act will put paid to the argument that it is not possible to take preparatory action because there is still too much uncertainty about the EU-FMD requirements. Not that the 'wait and see' attitude stands up to scrutiny even today because the provisions of the Delegated Act will not appear out of the blue; on the contrary, they will have been arrived at through extensive consultation and years of engagement with all stakeholders. The trajectory of the Delegated Act has been clear for all to see and, in fact, been set right at the start of the EU-FMD process; what we are now observing are simply the final course corrections that will ensure that the Delegated Act and its provisions land in the right place and do not hit a rock-strewn crater.

Where the Act should land is, of course, circumscribed clearly in the Directive that became EU law in 2011. The legislation sets out: the primacy of patient safety objectives, EU‐wide verification systems architecture and a process based on a machine‐readable Unique Identifier used in combination with anti‐tampering devices. The European Commission has been clear about the ambition to achieve a solution that is cost-effective and acceptable to all stakeholders and has to that effect been holding regular consultations over the course of the last three years, which would have enabled all interested stakeholders to form a good understanding of the likely provisions of the Delegated Act.

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Tags: Pharma, Serialisation, Regulation