Why validate
the serialization process?

10 billion euros

Falsified medicines cost the EU pharmaceutical sector 10.188 million euros each year.


Not only that 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 medicines have led the authorities to seriously consider how to end with fake medicines.

Serialization has proved to be a good solution in the pharma industry. In this sense, the pharma sector must comply with the European regulation but not only, but they also have to be up to date with the compliance challenges.

Why do you need to regularly validate the serialization process?

Let’s take it one step at a time.

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

Falsified medicines may:

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


To avoid the health and economic consequences of this fraud for the pharmaceutical sector the European Union has drawn up a directive. A document which is binding on 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-in medicines is rigorously controlled. 

All stakeholders must be ready to meet their obligations on 9th February 2019. Since then, manufacturers must mark packages with 4 data elements: product identifier,  serial number, lot, and expiry date.

TraceLink is the most common network platform companies chose to work with. And as any software programme 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 alarms.

How to be up to date with TraceLink?

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


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

This way we are proactive to troubleshoot the problems. We give support to the customers by email, telephone, and tickets in our ticketing system which means the customer can contact us anytime with their preferred way of contacting. 


ProjectBinder resolves all tickets within 24 hours according to 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 in questions and troubleshooting when our customers are working with the system for which we give support. You will receive monthly reports of all work performed which ensures complete transparency and traceability.

We make tailored training for what is exactly appropriate for our customer’s operators, supervisors and administrators working with different applications. The delivery of this service is via our own ProjectBinder Academy. It is an online platform where you can find regular TraceLink user training.

Consider all the advantages that your company could obtain:

  • 24/7 support
  • Standard ticketing system
  • Transparency over work done
  • Monthly reports with all the work done
  • TraceLink Certified engineers teams
  • Service desk support
  • Operational centre

Supply chain security is not a nice-to-have. It’s required.