The agreement with EMVO is signed!
The Norwegian NMVO (NoMVO) and NMVS (Nomvec) har signed the agreement with EMVO. This cleares the way for connecting the Norwegian system to the European HUB.
– At the NoMVO board meeting February 15th, the board members, representing pharmacies, wholesalers, parallel importers and the pharmaceutical industry, agreed that we are now ready to connect to the EU HUB. The signing took place at the office of Per Lund, the Managing Director of the Pharmacy Association at February 23rd, Kai Mjaanes the General Manager of Nomvec says.
More than 10 billion packs of prescriptive drugs are sold annually in Europe. All of these packs need to be marked with the 2D matrix code no later than February 9th 2019 and the serialised data uploaded to the European HUB before the products are allowed to be sold. This is all driven by the EU Falsified Medicines Directive (2011762/EU) and the corresponding Delegated Regulation (EU 2016/161)
The European HUB will be connected to a national repository in every member state. This is how the individual pack can be verified as genuine before it is served to a patient at the counter of a pharmacy or at a hospital bed. This way we can prevent falsified or unsafe drugs to enter the supply chain. The verification system is implemented by the industry, but jointly governed by the users of the system: The pharmacies, the pharmaceutical industry, the parallel importers and the wholesalers. For Europe the organisation European Medicines Verification Organisation (EMVO) has been established. In Norway the national database is governed by NoMVO, where all the stakeholders, together with the Norwegian NCA, are represented.
The NMVS is ran by Nomvec, where Kai Mjaanes is the only employee, and Nomvec is responsible for the development, implementation and operation of the Norwegian database. Nomvec is also responsible for the financing and invoicing to the industry. Nomvec is owned by the Pharmaceutical Industry Organisation.
– Signing the agreement with EMVO is a milestone, and an important step on the way to connecting our national repository to the European HUB. This allows us to start testing, correcting and prepare to open the system to real data. We expect the system to be ready to receive real data and transactions by mid June. From that date the MAHs can start to upload serialised data to the system, says Mjaanes.
The IT-supplier for the Norwegian database is Arvato, and it will be an EMVO-approved blueprint solution.