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November 18, 2014

The practical challenges of serialisation

We recently tweeted the following:

Christoph ‘virtually’ presented to the GS1 Global Healthcare Conference in Copenhagen and on the same day gave a talk to the IPSE seminar on ‘serialization – practical considerations for implementation’ on the related topics of the specific challenge of pharma serialisation and EFPIA’s European Stakeholder Model.

Serialisation is a challenge for everyone within the European, and worldwide, pharma market. However, as Christoph explored in his talk, it isn’t just the challenge of implementing serialisation- there is also a challenge in recognising the impact this will have for the industry.

In 2013 there were 408 incidents of counterfeiting in Europe alone (according to the Pharmaceutical Security Institute PSI) – an area where we probably feel safe from such issues. However, this was the second largest incident rate in the World after Asia.

It is the recognition that falsified medicines are a rising threat also in markets that are seen as having a strong legal and regulatory framework in place that has led to the issue of the EU Falsified Medicines Directive (EU-FMD) which was passed on the 1st July 2011 and prescribes a number of measures to increase the security of the medicinal supply chain in Europe,  which will be spelled out in more details in the the Safety Features Delegated Act whose publication is anticipated before the end of this year.

Whilst the exact outcome of the Delegated Act is not yet 100 per cent clear (although Christoph has previously spoken about the ‘spoilers’ within the Act), Christoph highlighted in his talks that it is however evident that participation in a systems-based Europe-wide Medicines Verification process will be mandatory.

At 3C Integrity, we fear that many manufacturers will be caught out by this unless they start their readiness programme now. Otherwise a typical manufacturer based in Europe risks losing a significant share of their sales, in many cases up to 80%.

The message is clear: The EU-FMD response (let alone response to other serialisation / traceability requirements) needs to be priorisited now. Delaying is not an option.

3C Integrity can help

We’ll be holding our next serialisation workshop on the 27th-28th January 2015 in Uppsala, Sweden where we will provide you with the knowledge to start your own tailored serialisation programme. Places are limited to ensure delegates gain maximum benefit from their attendance.

Register online at Eventbrite to ensure your place on this packed two-day programme that will see the world’s foremost pharma experts on serialisation communicate their real world experience of the practicalities of traceability.

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