Best Practices for Complying with European Union Serialization Requirements

Counterfeit medicines are an enormous problem in many parts of the world. The World Health Organization (WHO) estimates the problem accounts for between seven and 15% of all medicines circulated in developed countries. It is far worse in developing countries, where up to 25% of all medicines are likely to be falsified (1).

In response, regulatory bodies across the world are introducing new requirements to give patients more confidence in the authenticity of their medicines. The worldwide pharmaceutical industry has a complicated regulatory structure. With variations in the degrees of regulation, legislation and financial resources from country to country, the introduction of a standard approach is almost unique. Pack serialization is one of the first wholesale attempts to make the pharmaceutical industry universally responsible for its supply chain activities.
 
The EU approach

The European Union has approached the concept of serialization with the introduction of the Falsified Medicines Directive (FMD), and serialization requirements come into effect in most EU countries beginning in 2017 (2). The Directive will affect all branches of the pharmaceutical industry, from manufacturer and generics producer to wholesaler and distributor.

After years of debate, what once seemed a distant challenge is now a looming inevitability. The Directive stipulates the need for more rigorous inspections of the manufacturers of active pharmaceutical ingredients. It also places obligations on manufacturers and distributors to report any suspicion of falsified medicines. The implications of the Directive are widespread, ranging from the marketing office that will have to amend packaging designs, to the packing hall that will have to deal with implementing enhanced outer-pack features, all the way through the supply chain to the dispensary.

The ticking clock

Although there is enough information available about the requirements of the Directive for preparations to begin before the delegated acts are announced, manufacturers in the relevant EU member states now realise that compliance by the deadline of Jan. 2, 2017 will not be as straightforward as hoped. Despite having three years to successfully implement serialization, the European Stakeholder Model (ESM) suggests that four to five years is actually more realistic. The repercussions of this discrepancy are therefore potentially huge: any company that doesn’t comply will no longer be able to sell its products within the European Union, and potentially worldwide. The race against time is on.

Although larger manufacturers have the resources to deal with the financial demands of serialization, smaller and mid-sized companies, including generic-drug producers who make a much smaller profit per pack, are faced with a greater challenge.  For them, as with any organisation undertaking serialization or aggregation projects, wholesale upgrade of their coding kit will need to be accompanied by a robust plan that touches on almost every department in the company and which has buy-in from senior management. The time is now to get that plan set in stone.

With the focus at this stage on putting in place the hardware and software infrastructure for compliance, however, less attention is being paid to the anticipated impact of serialization on efficiency. Anecdotal evidence from early adopters of serialization schemes suggests that the reject or rework level in the early stages can be as much as 10%, far in excess of acceptable limits. Over time, the reject rate can fall to less than one percent, but it takes time, commitment and the engineering know-how to achieve preserialization reject levels.

Addressing this challenge is an unenviable task for production teams and regulatory compliance teams alike and requires an examination of packaging line performance from every angle. At its heart is the choice of coding equipment. Beyond the obvious need for high-speed serialization capability, coders must also be able to produce clear, high-resolution codes with a good degree of contrast to facilitate reliable reading at the points of manufacture dispense and beyond. It is anticipated that the code carrier will be a 2D matrix code because this code format can hold a significant amount of data, is robust and legible for vision systems, and does not take up too much room on a pack.  

Beyond that, early serialization pilots have shown just how disruptive unplanned stoppages are, creating issues with both assigning physical and digital identities and handling and accounting for rejects. Addressing poor machine performance in advance is therefore highly recommended.

Making a plan now and considering the impact of serialization on operational efficiency is crucial for successfully meeting serialization requirements by the deadline. 

References
1. World Health Organization, “Substandard and counterfeit medicines,” Fact Sheet 275 (Nov. 2003), http://www.who.int/mediacentre/factsheets/2003/fs275/en/, accessed Feb. 14, 2014.
2. EC Directive 2011/62/EU, Falsified Medicines Directive (Strasbourg, June 2011).

Craig Stobie is Global Life Sciences sector manager at Domino Printing Sciences.