Top 15 Questions on EU FMD Safety Features and Verification

Now set for early 2019, the Delegated Act on safety features for the European Union (EU) Falsified Medicines Directive (FMD) has pharmaceutical companies, parallel importers, wholesalers, and pharmacies facing a tight timeline to address extensive serialization, compliance reporting, and verification requirements. The Delegated Act includes several unexpected rules that add complexity to FMD planning and preparation.

Many supply chain companies have raised questions related to the impending Delegated Act requirements. We have compiled a list of common queries, plus answers from TraceLink experts.

Q: What is the likelihood that all supply-chain organizations will be prepared by the February 9, 2019, deadline? What is the sense of readiness within the pharmaceutical industry?

A: There is a lot to do for the hundreds of thousands of supply chain members serving the EU market in order to be ready within the next three years. Each company faces considerable work both internally and across their supply network to prepare, and the decisions that you make will be dependent on the decisions that others in your supply network make. But there are clear ways of reducing time, cost, and risk during this period. Many companies are already in the process of developing a clear strategy for surveying product lines, internal packaging sites, and external supply partners to determine the data management and network connectivity scope they need to master.

Three years may seem like a lot of preparation time. But if you wait to create a full serialization and compliance plan with resource requirements and realistic timelines, you introduce significant risk.

Use the lead time you have to your advantage in order to determine the full scale and scope of your business requirements and the key solution capabilities and resources that you’ll need for success.

To read more questions and answers about safety features and verification, compliance reporting, countries that are covered, decommissioning, and more, download the full Q&A eBook.