All manufacturers must appoint a vendor who has a contract in place with the national medicines verification system provider (NMVO) who in turn must have a contract in place with the European FMD Hub (EMVO).
Many of the early adopters of these requirements in leading countries are already uploading data to their national databases, running pilots and testing their new systems.
There are a few choices of providers and these providers should be qualified as with any other provider to assess the suitability for your business needs.
Consideration should be given to the providers your customers and suppliers such as CMO’s may be using. If you use different providers there may be charges to share data which if your product is not very expensive or have a low margin then all these extra costs need to be considered.
Create a change plan to look at all the actions required from a regulatory and quality perspective. Consider the new packaging layout and where the 2D matrix will be located for ease of scanning.
Consider if you need to build up some stock in case you are not ready for the deadline. Many CMO’s have had to increase their lead times to cope with additional demands made on them by their clients and MA holders.
Consider the markets you trade in now and may wish to in the future and check out their readiness.
Suppliers, customers, storage site and distribution hubs will require additional audit visits and quality technical agreements will need to be amended.
Do not let your competition take your market share if you are not ready.