The Falsified Medicines Directive (FMD) 2011/62/EU

Counterfeit drugs entering the European supply chain pose a significant health and safety threat to patients. Furthermore, the European Union Intellectual Property Office (EUIPO) estimates that the legitimate industry loses approximately €10 billion of revenue annually due to the presence of counterfeit medicines6 in the EU marketplace, corresponding to 4.4% of the sector’s sales.

To fight against this scourge, the European Union (EU) has put in place directive 2011/62/EU or Falsified Medicines Directive with which pharmaceutical manufacturers (whether MAH or CMO) as well as their supply chain partners will have to comply by early 2019.

While there are whitelist exemptions, most pharmaceutical prescription drugs are affected by the FMD but most OTC drugs are not concerned. Requirements set out in the Falsified Medicines Directive will have effects throughout the whole supply chain from the manufacturer/CMO via wholesalers, distributors and parallel traders all the way through retail pharmacies and dispensers.

The FMD comes into effect in February 2019 for all members of the European Union including countries like Iceland and Liechtenstein and probably Switzerland. Despite Brexit, Britain is expected to keep in line with the Falsified Medicines Directive as well. Countries which already have some sort of serialization and/or tracking system in place like Belgium, Italy and Greece will have until 2025 to harmonize theirs with the European approach.

In Europe, only saleable units will have to be identified and serialized. For a harmonized serialization ‘language’ understood by all, GS1 standards have been chosen for European serial numbers. GS1 standards are widely used the world over for unique product identification. Information such as GTIN (Global Trade Item Number) product identifier, serial number, lot/batch number and expiry date of the packaged drug need to be provided in a 2D barcode or datamatrix as well as in human readable format.

Serial codes can be generated on site by a CMO/packaging plant through algorithmic, randomized or incremental methods or can be sent by authorities or customers. The serial number contains a maximum of 20 digits and must be unique until one year after product expiry date. This means your serialization solution needs to be able to generate, exchange and store a huge amount of data so make sure you opt for a highly scalable solution. This will also be beneficial if you want to expand production or a looking for new customers in case you are e CMO. When thinking of the huge number of data generated, stored and exchanged, you should bear in mind that there are data protection and storage regulations as well that might differ from country to country. Your solution will need to comply with those as well.

One of the major compliance challenges for Marketing Authorization Holders (MAH) and Contract Manufacturing Organizations (CMO) lies in the relative flexibility of Directive 2011/62/EU which allows for country-specific requirements. Thus, some countries might ask for National Reimbursement Numbers to be printed on packaging, others might expect manufacturing dates and so forth. This means that you need on the one hand printing devices that are able to cope with different printing masks. On the other hand, your serialization solution should also be able to manage those different requirements without too much hassle during changeover. A centrally configurable solution that lets you define requirements at site-level and then simply dispatch those pre-configured parameters to the packaging lines in question comes in handy here.

Furthermore, you should be aware whether your stakeholders and supply chain partners might mandate serialization at additional packaging levels and include aggregation, further adding complexity for the manufacturer. They might not today but a serialization solution that can, at the same time, either natively handle aggregation or easily be upgraded is of importance. Otherwise, winning new customers will be difficult for CMOs that are not aggregation ready. It will also restrict access to new markets that require aggregation for MAHs that cannot aggregate.

Reporting requirements under the FMD

Manufacturers will have to report product master data (product codes, form, dosage, target market(s) for distribution, etc.) and serialization data including product codes, lot, expiry data and serial numbers etc. to a European Hub as well as the National System in the  country of manufacturing. Events like recalls, aggregation, decommissioning, recommissioning will also have to be reported in a secure way in the required formats. More on the European authorities and data exchange in an recent blog post.

As we have seen, it is not about serialization alone. You will also need to be prepared for changing regulations, new regulations as well requirements made by customers and your supply chain partners. That being said, even though the FMD is an attempt at harmonizing serialization legislation in the European Union, there are a few national exceptions remaining.

In addition to a serialization solution that is compliant with current requirements (again not only in terms of serialization but potentially aggregation-, data security-, and data exchange-compliance) you should ensure that your serialization solution is flexible and scalable to be future-proof. And why not opt for a solution that goes beyond compliance? More on turning your serialization solution into business intelligence in an upcoming blog post. But you can already have a look at this video explaining how to make the most of the digital profile of your products.