Why validate
the serialisation process?

€10 billion every year

Falsified medication costs the EU pharmaceutical sector €10.18 billion every year.

In addition to this, they are also a serious health risk as they have not passed any safety controls and may contain harmful substances.

The dangers posed by this black market in medication have led the authorities to seriously consider how to stop the fake medication.

Serialisation has proved to be a good solution in the pharmaceutical industry. In this respect, the pharmaceutical sector must not only comply with the European regulations but also be up to date with the compliance challenges.

Why do you need to regularly validate the serialisation process?

Let’s take it one step at a time.

You can find online advertisements for the sale of medication to treat cancer, diabetes or hypertension. All without a prescription and cheaper, of course. A black market is a succulent business for traffickers, but a time bomb for patients.

Falsified medication may:

  • contain ingredients of low quality or the wrong doses;
  • be deliberately and fraudulently mislabelled concerning their identity or source;
  • have fake packaging, the wrong ingredients, or low levels of active ingredients.


For the pharmaceutical sector to avoid the health and economic consequences of this fraud, the European Union has drawn up a directive that is binding for all those involved in the manufacture, distribution and dispensing of medicines.

This directive introduces harmonised European measures to fight medicine falsifications and ensure that medicines are safe and that the trade of medicines is rigorously controlled. 

All stakeholders must be ready to meet their obligations on 9 February 2019. As of that date, manufacturers must mark packages with four data elements: product identifier, serial number, lot, and expiry date.

TraceLink is the most common network platform companies choose to work with. As with any software programme, it is constantly updated and improved.

This is the main reason why companies that want to ensure an uninterrupted product supply must efficiently manage their TraceLink alerts.

How to be up to date with TraceLink?

The ProjectBinder TraceLink team is always up to date with TraceLink compliance. We do all the administration services and support.


At the ProjectBinder operational centre, we monitor real-time alerts of different applications. All alerts triggered by applications for which we provide support are tickets in our ticketing system.

This means we can proactively troubleshoot the problems. We provide support to customers by email, telephone and tickets in our ticketing system, which means customers can contact us any time via their preferred means of contact. 


ProjectBinder resolves all tickets within 24 hours, in accordance with the service level agreement.

Our service desk is an incorporated part of our quality system, which ensures a standard and traceable way of monitoring and responding.

We assist with questions and troubleshooting when our customers are working with the system for which we provide support. You will receive monthly reports of all work performed, which ensures complete transparency and traceability.

We tailor training to what is specifically appropriate for our customers’ operators, supervisors and administrators working with different applications. The delivery of this service is via our own ProjectBinder Academy, which is an online platform where you can find regular TraceLink user training.

These are the advantages your company could obtain:

  • 24/7 support
  • Standard ticketing system
  • Transparency about work carried out
  • Monthly reports with all the work carried out
  • TraceLink-certified engineer teams
  • Service desk support
  • Operational centre
Supply chain security is not a luxury, it’s a requirement.

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