Pharma companies must equip their prescription medicine packs with the safety features required by legislation. The safety features consist of the unique identifier (serial number and product code) and an anti tamper device on the package.
The unique identifier is added to the medicine pack in the form of a 2D matrix. In addition to the unique serial number and product code (GTIN), the 2D matrix must include the batch number and expiry date.
Read more about the new medicines packs.
Pharmaceutical companies on-board the European repository
Pharmaceutical companies (manufactures or parallel distributors) on-board the European Medicines Verification System (EMVS) via the European Hub. On-boarding the Hub is a prerequisite for the company to be able to upload information about their medicines into the repository and bring serialized packs to the market. Having on-boarded the Hub is also a pre-requisite for testing and using the system in Finland.
The company entity connecting to the Hub is called an OBP (on-boarding partner). A maximum of two connections/per OBP will be granted (on a European level).
We strongly encourage pharmaceutical companies to start the on-boarding process as soon as possible by contacting the European Medicines Verification Organisation (EMVO) which is the body governing the Hub EMVO. As the on-boarding process will take same time, it’s important to start even if the company is not yet ready to produce serialized packages to the market.
EMVO gives more detailed information about the on-boarding process on its website.
For companies operating on the Finnish market, the on-boarding process will largely take place by the European headquarters. However, if a company's headquarters or similar operations are located in Finland, the engagement is likely to occur here. It’s advisable to check the internal process within the company as soon as possible.
All pharma companies operating with an MAH on the Finnish market must register with FiMVO.