EU and the FMD
The European regulation is relatively straightforward, requiring manufactures to serialize and report the numbers to the EU hub. There is no requirement to aggregate.
The regulation as it applies to manufacturers requires changes to packaging:
- The printing of a unique serial number on the packaging in 2D data matrix form, as well as various human-readable fields and for that information to be reported to the EU hub.
- The manufacturer must also provide master data information to the EU hub system.
- The format of the serial number can be up to 20 alphanumeric characters: it must be randomized and be unique to a given pack for a defined period of time.
This means that new packaging equipment must be introduced and enterprise IT systems upgraded to manage the provision and use of serial numbers.
The EU regulation is principally a verification system and manufacturers and parallel distributors will be required to send information to the EU hub, managed by the EMVO (European Medicines Verification Organization). The EU hub then distributes information to the national systems, which support “point of sale” verification of the drug’s authenticity when it is sold by the pharmacy to the customer. The EMVO is currently running trials with manufacturers.