Aegate Welcomes the Publication of EU FMD

12 February 2016
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Aegate has welcomed the publication of the Delegated Regulation which sets in motion the Europe wide implementation of the Falsified Medicines Directive (FMD) legislation. This new regulation introduces both digital and physical safety features to the packaging of medicinal products for human use.

This is the most significant change to the pharmaceutical industry in relation to patient safety in decades. The publication of the Delegated Regulation means that each Member State will have 3 years to implement the necessary changes and protocols.

Aegate CEO Mark De Simone commented: ‘This is a very important step in the process of protecting patients across Europe from the dangers of falsified, expired or recalled medicines. Aegate has been investing in our authentication service for many years to ensure that we are ready for this moment. This investment has not just been in financial terms but also in relationships with stakeholders, not least our ongoing, tried and tested service delivery in Belgium, Italy and Greece.’

De Simone continued, ‘The publication of the Regulation is of course just the beginning. The real work starts now to ensure that the investment that manufacturers have already made in packaging, serialisation and tamper proofing is not wasted, or worse dwarfed by the costs of an authentication service that does not work.’

‘For example the huge potential cost of dealing with an issue like false positives within authentication. This could mean not only additional resources being required for investigation but more fundamentally the cost to the reputation of the organisation and its brands because of errors. It is therefore important that manufacturers are fully aware of the issues and are fully involved in the choice of authentication service provider in their country’, he warned.

‘Of course this is a positive day for all of us concerned with patient safety and we look forward to taking on the hard work of the next three years to deliver the full requirements of the Delegated Regulation in partnership with National Medicine Verification Organisations and other stakeholders’, he added.

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