A maximum of two connections/per OBP will be granted (on a European level). We strongly encourage pharmaceutical companies to start the onboarding process as soon as possible by contacting EMVO. This is important even if the company is not yet ready to produce serialized packages for the market.
Pharmaceutical companies should prepare for the new requirement by:
• Making sure that each package has a unique product code (GTIN or NTIN)
• Ensuring technical readiness to create a unique serial number according to the requirements of the Delegated Act.
• Ensuring that production lines are fully equipped to fulfill the requirements of legislation.
• Getting ready for the new legislation by renewing the lay-out of the packages when necessary.
• Ensuring that onboarding the Hub is begun as soon as possible.
• In case packages are equipped with the unique identifier before the Finnish verification system is in place, the company must make sure the information is downloaded to the Hub as soon as the national system is operational.
The national supply chain
National supply chain operators (pharmacies, hospital pharmacies and wholesalers) will connect to the national system. The building of the Finnish system will start in the beginning of 2017.
Financial aspects of the system
The costs of the ramp-up phase and operational phase are currently being investigated. In the first part of the project, shareholders of FiMVO will finance the ramp-up of the system through loans.
Eventually, all costs of the ramp-up phase in addition to regular operational costs will be charged to all marketing authorization holders having their products on the market. The first payments are expected in Q3-Q4/2018.