Companies who market prescription drugs in any part of Europe should pay close attention to the new requirements spelled out by the Falsified Medicines Directive (FMD) and Delegated Regulation (DR). The FMD/DR spell out new and complex requirements for applying randomized unique identifiers to almost all prescription drug packages marketed in the EU by February 9, 2019. That date is now less than 18 months away. And it’s not just the EU Member States because other European countries have announced that they intend to participate in the solution, even though they are not obligated by European Commission regulations. These include Iceland, Switzerland and Norway, and it also includes the United Kingdom, which will continue to participate even after Brexit is complete.
Fortunately, Systech has scheduled a webinar called “Meeting the Falsified Medicines Directive” on September 13, 2017. This webinar will be conducted by our own Regulatory Strategist and global regulatory expert, Dirk Rodgers. He will provide some background on the FMD/DR and then take a deeper dive into the Delegated Regulation, which is where all the detailed requirements are located. He will then discuss many of the complications that make this regulation more difficult to implement and market under than most people realize.
If you are already familiar with the DSCSA serialization requirement in the United States, but need to start working on meeting the FMD, this is the perfect opportunity to learn the differences between the unique identifier requirements of the two markets. This will jump start your preparations for this deceptively complex regulation.
Don’t miss this opportunity to hear about what makes the FMD unique among global pharma serialization regulations, and what it takes to meet it them.