Pharmaceutical serialisation: opportunity or perfect storm?

Audit imageThe protection of the public from falsified or counterfeit medicines has never been more relevant or topical, and one of the key weapons in the pharmaceutical industry's arsenal is serialisation, according to a new executive briefing from

Placing a unique numerical identification code on each individual package of medicine is a key tool not only for anti-counterfeiting, but also areas such as supply chain security and control, traceability, diversion control, product recalls and returns management, according to Mark Davison of Blue Sphere Health, the author of the report.

"On balance, the long-term benefits of serialisation are huge, and not just in anti-counterfeiting," says Davison. "Manufacturing quality issues can be dealt with at much higher resolution than at present - partial batch recalls alone could save millions of dollars."

Having greater visibility over product returns - a normal feature of any industry - could also provide cost savings and close off an avenue for the insertion of counterfeits into the supply chain or false claims for returns. "Traceability through serialisation of each pack would help prevent those potentially expensive frauds," according to Davison.

While some larger drugmakers are already well advanced in the adoption of serialisation, many companies both large and small have yet to embark fully on this path. Recent regulatory developments suggest that the time for the 'wait-and-see' approach has now passed.

On February 16, 2011, the European Parliament ratified the long-awaited amendments to Directive 2001/83/EC "as regards the prevention of the entry into the legal supply chain of medicinal products which are falsified in relation to their identity, history or source".

The exact impact of these changes is not clear yet, but some form of Europe-wide serialisation scheme is the only logical outcome. This is widely expected to be in place around 2016. In the US, meanwhile, the California pedigree requirements (whether or not superseded by Federal laws) will mean that 2015-2016 is also a major milestone in the US pharmaceutical supply chain.

"A perfect storm is brewing in pharmaceutical serialisation and it is drawing closer very quickly," says Davison in the report, entitled Pharmaceutical serialisation: opportunity or perfect storm? “Those who are unprepared will have a rough ride.”

"For the report, I interviewed senior executives from key technology vendors.  They stressed that four years is not a long time to implement these complex international projects. They require budget planning, capital equipment purchase, and intensive vendor involvement, as well as manufacturing downtime and revalidation. The potential gains are there to be had, and there is still a window of opportunity for late starters to beat the deadlines, but the time to act is now!"

Pharmaceutical serialisation: opportunity or perfect storm? is a brand new, must-read executive briefing that discusses the latest developments in the field, with a strong focus on practical advice and inside tips which cannot be found in books or gained easily from meetings. The principles discussed will prove a valuable primer for those just entering the field or those seeking to enlighten their peers. More information is available here.

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