According to the latest rumours and speculations popping up in relation to the EU-FMD Safety Features provision, we should be “surprised if true serialization/authentication ever got off the ground…” – so stop your implementation pilots, freeze your investment proposals, put your projects on hold. And sleep easy…
Good news at last? – Or just the latest rumour that needs challenging?
To those of us who have been working in this area for a while, it has always been clear that there is a great deal of complexity in the EU-FMD and particularly the Safety Features provisions. Everyone in the pharmaceutical industry who is affected by these provisions – and that is just about everyone! – must surely be glad that the impact assessment and consultation with Member States is carried out with great care and attention to detail.
However, once that process is complete, and the Delegated Act is passed then the clock starts ticking straight away, and because this is a DA, there will be no more scrutiny of its provisions: They will come into force according to the defined timeline, i.e. for most Member States (= those without pre-existing equivalent features) this is 3 years following the adoption of the act. So that means that if the DA was published in the Official Journal before the end of 2014, the mandatory date for compliance is 1st January 2017, and even if the DA is published into 2015, that gives pharma companies only one more year for implementation of the full serialisation capability on all of their manufacturing lines that supply Medicines to Europe.
Speaking at conferences on behalf of EFPIA, I like to show a generic Implementation Plan that spells out just how long it takes to see such projects through to success. The message that I have to give to manufacturers is stark: If you have not started your implementation programme by now, end of Q1 2014, then you’re probably too late for 1st January 2017…
So the message to manufacturers is: If the publication of the DA should slip into 2015, just be grateful that you have been granted more time and are now in with a fighting chance to be ready for the EU FMD after all!
That’s why I would urge all manufacturers to continue or make a start on their Readiness Programme. And how better than signing up for 3C Integrity’s intensive 2-day Serialisation Training on 2nd and 3rd April 2014.
(But then, I would say that, wouldn’t I?)