National Medicines Verification Organisations

Structure & Objective

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). The primary objective of the NMVS is to function as a verification platform utilised by pharmacies and other registered entities, including wholesalers, self-dispensing doctors, or hospital pharmacies, to authenticate the legitimacy of a product. 

Pharmaceutical Manufacturer

European Hub

Parallel Distributor

National System

National Blueprint System

Pharmacy

Wholesaler

Pharmacy

Wholesaler

Pharmaceutical Manufacturer

European Hub

Parallel Distributor

National
System
National Blueprint
System

Pharmacy

Wholesaler

 European Hub (operated by   EMVO): 

  • The main place for storage of master data 
  • A gateway for the transmission of manufacturer data to the national systems 
  • Data reconciliation on repackaging activities, i.e., maintaining a link between original and repackaged product batches, is exclusively performed on the European Hub.   
  • A single entity from which national systems can obtain revised/new product serialisation data. 
  • Information on product recalls. 

National Systems (operated by the NMVOs): 

  • Verification platforms that pharmacies or other parties can use to check a product’s ‘authenticity’   
  • Uses the interface to the Hub   
  • Contain the relevant product serialisation data   
  • Receives revised/new product serialisation data from the EU Hub 

NMVO’s Role

The NMVOs play a pivotal role in ensuring the integrity and authenticity of medicinal products within their respective regions. Tasked with overseeing the implementation of their national system, NMVOs collaborate with stakeholders, such as pharmaceutical manufacturers, wholesalers, and pharmacies, to establish secure and efficient processes. By managing fee structures, offering guidance on compliance, and facilitating communication among key players, NMVOs contribute greatly to the overall success of the EMVS.

Contractual On-boarding

In addition to signing the mandatory Participation Agreement (PA) with EMVO, OBPs/MAHs should conclude a contract at national level and pay an annual fee. The applicable fee model depends on each NMVO. Please consult the latest version of the NMVO Fee Models Overview Presentation and the NMVO Fee Models Overview Table to identify the applicable fees. In case you need further details, please contact directly the relevant NMVO(s).