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Ireland extends falsified medicines deadline for ‘stability’

Ireland is extending the “use and learn” phase of the implementation of the Falsified Medicines Directive to give more time for time for the safety feature system to bed in.

The safety feature requirements – pack-level unique identifiers to allow verification via scanning at the point of dispensing and tamper-evident closures – came into force in the EU on February 9 this year, but countries have been given a transition period to allow pharmacies, hospitals and wholesale distributors to adapt.

Ireland’s Health Products Regulatory Agency (HPRA) says that most supply chain actors are registered and connected to the national system, with unique codes added to 180m medicine packs and more than 11m scans carried out.

That aside, users of the system are still getting used to it and more time is needed to “ensure the continuity of safe supply of medicines to patients” and to make sure that alerts generated by the European medicines verification system (EMVS) are responded to correctly.

It is the second time the use and learn period has been extended in Ireland, coming after an earlier announcement in May.

A key factor behind the delay is the number of alerts being generated by the EMVS, with the HPRA noting that at its height one in five (20 per cent) of scans were generating an alert.

That has now fallen to 3.5 per cent, but is still considered too high to prevent disruption to dispenser workflows, and the system needs time to stabilise so everyone is ready for when it becomes mandatory to investigate and close out all alerts before dispensing packs, according to the regulator.

For the time being, if an alert or any other unexpected message is flagged, dispensers should continue to supply packs to patients in accordance with their existing procedures, unless they have overriding concerns that a falsified medicine may be involved.

“The use and learn period will end on a phased basis, and a detailed plan as to how this will be done, including dates, will be published at the end of September,” notes the HPRA.


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