EU FMD: Challenges and Opportunities
Falsified medicines represent a major public health threat, appearing in the market as legitimate product that can reach patients across the EU and around the world. In response to an increased risk of counterfeiting, in 2013 the EU Commission enacted Directive 2011/62/EU—also referred to as the EU Falsified Medicines Directive (EU FMD). This legislation introduces track and trace regulations that enable harmonized, European-wide measures to rigorously control the safety and supply of medicines for human use.
All supply chain businesses with requirements under the law—pharma companies, parallel importers, wholesalers, and pharmacies—have until February 2019 to comply. This singular deadline for all impacted companies will create resource constraints around hardware, solution providers, and trade partner bandwidth. With so many interdependencies, companies that want to ensure readiness and uninterrupted product supply need to start preparing at least a year in advance.
EU FMD includes serialization, verification, and compliance reporting requirements:
- Serialization - Manufacturers must mark packages with four data elements—a product identifier, serial number, lot or batch number, and an expiry date. A fifth data element, such as a national reimbursement number, may also be required for some markets.
- Verification - Serialization must happen at the secondary or saleable-unit level to enable product verification at one or more stops along the supply chain. By law, pharmacy dispensers must verify drug product identity prior to dispensation. Safety features such as anti-tampering devices also need to be verified.
- Compliance reporting - Information such as product code, lot or batch number, expiry date, doses per pack, target markets, and serial number information must be reported to the European Medicines Verification System (EMVS) to verify the identity of medicines for sale in EU markets. In some cases, such as for parallel importation, reporting is also required by supply chain partners.
Achieve compliance and create business opportunities
TraceLink can help solve today's compliance challenges: 406 companies in Europe have already chosen us as their partner. Beyond compliance, TraceLink is working with the pharmaceutical and healthcare industries to prepare for the analog-to-digital transformation taking place. With the TraceLink network platform, companies will be ready to leverage the power of serialization to extract long-term business and brand value, anticipate drug shortages, initiate rapid drug recalls, and improve the quality of medicines delivered to patients.