Drug safety and the EU’s falsified medicine directive in the spotlight
Central and Eastern Europe’s leading networking event for service providers and decision makers of the pharmaceutical and biotechnology industry: the PHARM Connect Congress took place once again on the 22nd and 23rd of February. From the perspective of pharmaceutical corporations, establishing strong and efficient business relations, gaining industry specific knowledge and ensuring a stable professional growth are all essential. This is especially true when one considers the unique and uncommon challenges that the industry is constantly facing: for instance the European Union’s regulation which is coming into effect in 2019.
More than 400 decision makers and professionals attended the congress from over 25 countries with the same purpose: sharing their experiences, building new partnerships, finding the best solutions for their company and preparing for the challenges of the new regulations.
Medicine falsification is an escalating problem both on European and global level. The increasing market of fake and uncontrolled medicines not only harms the pharmaceutical manufacturers, but the end users of these products can suffer tragic consequences as well. Due to the European Union’s new directives, the pharmaceutical industry in Hungary and the rest of Europe is facing tremendous investment pressure. In fact, serialization – ensuring the traceability of all prescription drug packages – will become mandatory across all EU countries in 2019.
What EU Falsified Medicines Directive will bring?
In order to avoid any interruption or temporary downtime in the manufacturing process, factories are urged to implement the serialization solutions in the production process which was addressed by Neil Lawrence, the Global Serialization Champion of GlaxoSmithKline and during the following panel discussion together with Grzegorz Brzoskowski, the Regional Security Director CEE/Baltic of Sanofi and Réka Balogh, Serialization Project Coordinator, QA Expert of Gedeon Richter.
“In the future, the requirement for serialization and authentication can apply to any pharmaceutical product and products made for children. This is to prevent toxic foodstuffs and forged parts from entering the markets and prevent abuse of such substances” – added Stefan Rowinski the project director of Atlantic Zeiser, one of the leading providers of track & trace, coding and serialization solutions.
Atlantic Zeiser provides sophisticated individualization, serialization and track & trace solutions to monitor product movements, verify authenticity and reliably protect against counterfeiters. Especially for the pharmaceutical industry, the German company offers tailored solutions that bring together the latest machine and printing technologies with intelligent software architecture to ensure compliant, fast and efficient processes. The software easily interfaces with common Enterprise Resource Planning (ERP) systems and is also compatible with production management platforms.
Pharmaceutical companies will be required to mark the packages they produce with a traceable barcode in the future. Wholesalers and distributors can save these codes in their systems for the purpose of ensuring authenticity and investigating any possible drug thefts. This enables pharmacies and hospitals at the end of the distribution chain to check the origin of the medicine based on the given barcode.
Where to find the best solutions?
The implementation of serialization solutions will result in some inevitable extra costs for the pharmaceutical manufacturers. A substantial portion of the expenditure will come from installing new technology in packaging lines. Some production lines will need to be fully remodelled and automated. Many factories are postponing the investment decision therefore; the issue will become increasingly urgent for everybody at the same time. Only those that launched the serialization project fast enough will be able to comply with the regulations in time.
Representatives of the leading specialists in trademark protection were already present at the PHARM Connect Congress in 2017. At the event, the companies instructed pharmaceutical manufacturers on how to initiate and launch serialization projects and they will be present again at PHARM Connect 2018.
For more information please visit: www.pharmconnect.eu
