DG Sanco confirms EU-FMD Safety Features DA Timeline

Published by Christoph Krähenbühl at March 13, 2014

How big is the European slice of your business (that you risk losing…)?

The view expressed by Serialisation Guru Christoph Krähenbühl in his recent post Rumours and Chinese Whispers, has today been confirmed by EUROPE DIRECT, the European Union (EU) information service. In response to a request for clarification, the responsible Commission department (DG SANCO / DG Health and Consumers) has issued the following response:

“The Delegated act on the Safety Features will become applicable 3 years (6 years in those Member States having an authentication system in place on 1 July 2011) from its publication in the Official Journal (Article 2(2) of Directive 2011/62/EU*).

The Commission aims at adopting the Delegated Act by the end of 2014. Publication in the OJ [Official Journal of the European Union] will follow in the first half of 2015, due to Parliament, Council and WTO scrutiny rights.

If this timing is respected, the Delegated act will become applicable sometimes in the first half of 2018.”

The clock is ticking – 2018 for all your EU products to be ready

This remains the question that senior decision makers in pharma manufacturers need to ask themselves – or will you now take action to mitigate that risk and make a start on your Readiness Programme, for example by signing up for 3C Integrity’s intensive 2-day Serialisation Training on 2nd and 3rd April 2014?

A fighting chance to be ready?

What are you going to do with this information? 2018 may seem a long way off but given the complexity of these implementation projects, the experience of early adopters and – not to forget – the limited capacity of vendors and solution providers, you would be well advised to press ahead with your implementation and not take your eye off the ball.

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