- Arvato Systems and Basic Pharma sign a contract on implementing the Falsified Medicines Directive
- Basic Pharma, from the Netherlands, uses the Arvato CSDB IT solution for the serialization of prescription drugs
The European Union adopted the Delegated Regulation to the Falsified Medicines Directive in 2016. Since then, the delegated regulation has been incorporated into the national laws of all E.U. member states. This law is designed to prevent counterfeit medicines from being able to access the European market. Under the new directive, all pharmaceutical packaging must bear a unique identifier (UI). All prescription drug packaging will have to comply with this new requirement starting in February 2019.
The unique identifier for all prescription medicines that are produced in or imported to the European Union are registered in an E.U. database. When a prescription is dispensed from a pharmacy, a system checks whether the unique identifier exists or has not yet been issued. From the generation of the unique identifier to registration at the E.U. level, the entire process takes place at Basic Pharma using Arvato Systems’ Arvato CSDB software solution.
The introduction of the new European system will be monitored in the Netherlands by the Dutch Foundation for the Review of Pharmaceuticals (Stichting Nederlandse Medicijnen Verificatie Organisatie). This organization is implementing the national database, together with Arvato Systems as part of the European system, and will inform all parties about the process.
Basic Pharma has deliberately opted for a solution that ensures smooth integration both with regard to the national and E.U. databases and to (new) production machines.
Arvato CSDB is an integrated and modular IT solution. Communication in the area of serialization can take place at level 3 (control of the production machines), level 4 (own issuing of serialization codes), and level 5 (from national systems to the E.U. Hub as well as to all business partners).
Prepared for the future
Peter Stemerdink, Key Account Manager at Arvato Systems, comments, “We see that too few companies in the Netherlands are actively addressing the importance of the Falsified Medicines Directive, or FMD for short. Implementation requires the adaptation of entire processes, and early implementation is immensely important.”
Harry Relouw, General Manager & CFO of Basic Pharma, is very proud of the fact that his company has taken the lead on the serialization issue: “We are a proactive, process-oriented company that likes to get to the bottom of things and tackle goals. That certainly applies to serialization. We can deal with this drastic change in good time because we have taken sufficient steps to solve this issue ahead of time. By taking this approach, we can assure our clients that there will be no interruptions to the supply of our medicines either today or in the future.”
About Basic Pharma
Basic Pharma is a well-equipped niche player in the pharmaceuticals industry. The company, which is based on the Chemelot campus in Geleen, the Netherlands, is part of the Basic Pharma Group, a group of independent companies that develop, produce, and supply new medicines.