Recommendations on a harmonised implementation of the EU Falsified Medicines Directive using GS1 standards
The EU Falsified Medicines Directive 2011/62/EU (FMD) and the supplementing Commission Delegated Regulation 2016/161 require the interoperability of product verification repositories across Europe. A harmonised coding structure across countries is the key to achieve this goal.
In order to comply with the requirements of the Directive, GS1 Healthcare strongly recommends the use of a GTIN as the product code for both supply chain and reimbursement purposes (Option 1), and where this is not possible, that Option 2 is implemented, if a national number is to be kept, to solely encode the GTIN in the GS1 DataMatrix.
These two options are recommended as they provide the most efficient ways for all stakeholders to identify products and enable flexibility when working with multi-market packs. However, GS1 also acknowledges that in some member states the national number must appear on the packaging. In those cases, Option 3 can be used.
GS1 Healthcare and its global members invite the respective national authorities to liaise with local stakeholders to establish clear and explicit guidance on the identifier to be used to implement the Directive.