Europe's Readiness for the Falsified Medicines Directive is Lagging


GS1 Ireland and Enterprise System Partners (ESP) just published an interesting Serialization Industry Readiness Report 2017.  The report is based on their survey of drug manufacturers, CMOs, virtual manufacturers and others who will fall under the European Union Falsified Medicines Directive (FMD) when it goes into effect on February 9, 2019.  The readiness survey was conducted between May and July 2017.

The FMD and its companion, the Delegated Regulation, requires drug Market Authorization Holders (MAH) serving the larger European market to apply two safety features to every drug package introduced into the supply chain by that date.  The safety features are an anti-tampering device, and a unique identifier (UID) encoded into a 2D Datamatrix barcode and human readable text.  The UID includes the product code, a random serial number, the lot number, expiration date, and in some cases a reimbursement code.  In addition, these companies must upload the data about these serialized units to the EU Hub, a repository operated by the non-profit, European Medicines Verification Organization (EMVO).

The survey results reveal that the industry is lagging on the road to FMD readiness.  There are less than 18 months left to prepare, yet the survey found that more than one quarter of the respondents do not have a single packaging line converted to meet the FMD safety feature requirements.  While 7% are “Ready” and 63% say their programs are “In Progress”, 15% say there are “Some Issues” and fully 15% have not even started preparing for the FMD.

Clearly, some of these companies are going to be late, and others are going to have to rush to get ready from this point onward.  Fortunately, Systech offers a cost-effective way to get compliant with the serialization requirement in under 90 days.  We specialize in rapid deployment and onboarding.  Our solutions take care of managing your product codes for each EU Member State, serial number randomization and assignment, application of the Unique Identifier on each package and uploading the data to the EU Hub repository.  For those who want to go beyond the minimum requirements we can also take care of capturing aggregation data (see “WHAT IS AGGREGATION?”), and we can add non-additive anti-counterfeiting capabilities to your packaging line.

Learn more about the FMD at our comprehensive EU FMD Resource page.