EU-FMD: Post-deadline challenges do not mean the end of new sales
February 18, 2019
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February 26, 2019

India Pack Coding: the challenge for EU pharma

We are nearing the deadline of the EU-FMD and – unsurprisingly, given the scope of the regulations and the complexity of the European medicines supply chain – many challenges remain.

One of these is presented by packs of medicines, particularly of over-the-counter medicines that are commonly seen in many markets. These packs are coded under regulations governing the export of medicines from India and present with a 4-element 2D DataMatrix code that to the naked eye and – crucially – to any scanner looks like a pack of medicines carrying the Unique Identifier that must be applied to all medicines in scope of the EU-FMD from February 9th 2019.

Challenge one: Unknown pack – Alert!

When the 2D DataMatrix of one of these India Export packs is scanned at a point-of-verification in Europe, a search of the European Database will be carried out and will almost certainly create an alert because many of these Indian packs are out of scope for the EU-FMD and their identifiers are therefore not known to the European System.

Looking at this issue in more detail, there are a couple of additional considerations that add complexity for manufacturers but also hold the key to a pragmatic way of dealing with the Unknown Pack Alert caused by Indian serialised packs, at least in the short term.

How to deal with this challenge

Download our full report, via our knowledgebase, written by Senior Director, Christoph Krähenbühl to find out the answers to these challenges.

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