In light of the fact that the world is facing a persistent and increasing threat from counterfeit medicines, government leaders, politicians and executives from major pharmaceutical providers are driving efforts to develop methods to reliably track and trace medicinal products.
Based on this growing threat, the EU “Falsified Medicines Directive” as well as other globally enhanced legal requirements have defined a strong legal framework for the manufacturing and distribution of medicines. Reliable traceability and compliance with those rules are obligatory for pharmaceutical manufacturers who need to ensure product safety by keeping counterfeit medicines out of the legitimate supply chain.
Most pharmaceutical companies have already put the work in to comply with major regulations in the European Union and United States, but as other countries -including Russia, who recently implemented strict new serialization and aggregation requirements of their own - develop and publish their own serialization regulations it becomes increasingly important to stay up-to-date on the various requirements currently in force and new regulations on the horizon.
We have developed a guide that provides companies, crucial information needed to stay on top of regulations across the globe by outlining:
- Summarizing the minimum requirements of a serialization solution
- Outlining the complexity involved when implementing a serialization solution
- Detailed questions that must be addressed when choosing a production line equipment supplier
- Providing an overview of current and upcoming serialization requirements across the globe.