System users
At EMVO, we maintain contractual partnerships with both the NMVOs and the On-boarding partners (OBPs). The contractual relationship with the Marketing Authorisation Holder(s), wholesalers, community pharmacies and hospital pharmacies is maintained at national level by the respective NMVOs. In the following sections, we outline the roles and responsibilities of the OBPs and the NMVOs within our system.
Manufacturer
Wholesalers
Pharmacy
Pharmaceutical companies
On-Boarding Partners (OBPs)
In compliance with the Delegated Regulation, Original Pack Manufacturers with marketing authorisation for FMD-affected products and Parallel Distributors must upload unique identifiers and related information to the repositories system prior to the release of their medicinal products for sale or distribution.
An On-boarding Partner (OBP) is a legal entity authorised to upload unique identifiers and other required information (‘OBP Data’) on behalf of Original Pack Manufacturers with marketing authorisation for FMD-affected products and Parallel Distributors, either on its own behalf or in collaboration with them. The OBP initiates this process by concluding a Participation Agreement (PA) with EMVO.
NMVS
National medicines verification system
National Medicines Verification Organisations (NMVOs)
In accordance with Delegated Regulation (EU) 2016/161, Article 32, the European Commission outlines the structure for the repositories system. This system comprises a central information and data router known as the European Hub, connected to repositories serving the territories of one or multiple Member States. Every European country within the European Union (and EEA) is required to establish a National Medicines Verification System (NMVS), overseen by a National Medicines Verification Organisation (NMVO).
Securing medicine: the EMVS workflow
Pharmaceutical Manufacturer
Manufacturers print a unique Data Matrix code with a unique identifier and apply an anti-tampering device to the outer packaging of medicines. The unique code is uploaded to the European Hub allowing validation within National (or supranational) Medicines Verification System(s).
Wholesalers
Conduct risk-based verification upon receiving the product.
Pharmacists
Medicine authenticity is verified during dispensing by the pharmacies (community & hospital) by scanning and matching pack information against a national repository. If a warning is issued, the pack is withheld from the patient, triggering an exceptional event requiring investigation to verify potential falsification.
Patient
Authenticated packs are decommissioned and provided to the patient.
Unique serialisation with random numbers
Risk Based Verification
Verification upon dispense to patient
Upload number
Product code batch expiry S/N