FiMVO is looking for companie that already can or will soon be able to produce serialised packs on to the market. In addition to the serialized packs, an established connection with the European Hub is a pre-requisite for participating in the pilot.
The piloting will partly take place in a real production environment. Also wholesalers, pharmacies and hospital pharmacies will take part in the pilot. The process starts with pharma companies as there is always a delay in the products actually entering the market and being dispensed to the patients.
We encourage companies to commit to the pilot already in spring 2017. It is however possible to join the pilot also later on. We do encourage companies to onboard the system as soon as the company can produce serialized packs and is connected to the EU Hub.
Connecting to the EU Hub
Pharma companies (manufacturers and parallel traders) connect to the Verification System via the European repository, the EU Hub. The organisation governing the Hub, EMVO has detailed information on its website about how to onboard the Hub. An established connection with the Hub is a pre-requisite for taking part in piloting the system in Finland.
EMVO grants two user credentials/organisation throughout Europe. Even if a company does not yet have the ability to produce serialized packs, we strongly recommend initiating the Hub connection with EMVO. The process will take some time.
Timeframe for building the system
The high level timeframe is pictured below.
Klick on the image to see it full size
In phase 2, the information flow from pharma companies to the Hub and onwards to the Finnish system will be tested in a test environment.
At the end of the phase early bird companies have connected to the Hub and the flow of information has been tested in a test environment. Also early bird wholesalers and pharmacies will be connected to the system.
In phase 3 the system will be piloted in a production environment. The first serialized packs have arrived in the supply chain. Preparations to onboard the remaining supply chain actors will be under way.
In phase 4 all the remaining actors are onboarded. The aim is to be able to use the system in a normal production environment. To ensure a sufficient buffer time before Feburary 2019, the system needs to be fully operational by November 2018.
A check-list for pharma companies
Pharmaceutical companies should prepare for the new requirements 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.
Please contact us for more information! (email@example.com, tel. 040 700 1655).