ANC/CNACompetent National Authority, as per the Delegated Regulation EU 2016/161, is the National Agency for Medicines and Medical Devices (NAMMD);

EMVO – The European Medicines Verification Organization (EMVO) – created as a joint initiative of EU stakeholders, has taken responsibility for setting up the European Medicines Verification System (EMVS),  in accordance with the EU’s Falsified Medicines Directive (FMD) 2011/62 and the Delegated Regulation (DR) EU 2016/161;

OSMRThe Romanian Organization for Serializing Medicines (OSMR) is a non-governmental, autonomous, independent, apolitical and non-profit organization, established for the implementation of the European Directive no. 2011/62/EU of June 8th on falsified medicines and the Delegated Regulation EU 2016/161;

SNVM/NMVSNational Medicines Verification System (NMVS) – a verification platform through which pharmacies or other stakeholders, such as wholesalers in Romania, can verify the authenticity of a product, OSMR is responsible for implementing and managing this system;

DAPP/MAHMarketing Authorization Holder;

DAIP/PIAHParallel Import Authorization Holder;

TANS –  Supply of medicines for special needs authorization holder

OBP – Onboarding Partner  – a legal entity that is part of a Corporation or a Group and will send data to the EU Hub on behalf of Marketing Authorization Holders that are also part of that corporation;

Repository or medicines verification system  – The repository system stores information about the safety features of medicinal products and it enables their verification, it consists of the following electronic repositories:

  • The Hub – central information and data rooter;
  • The national repository – servicing the territory of one Member State, connected with the Hub;

The repositories system shall not include the physical scanning equipment used for reading the unique identifier.

UF/End-User – Legal entity which has a set of responsibilities related to the checking and/or changing the status of a medicine identified with a Unique Identifier through NMVS, namely: wholesaler, community pharmacy, local distribution center, closed circuit pharmacy, drugstore, dialysis center, as well as any other entity authorized by the Ministry of Health to provide medical assistance, with or without closed circuit pharmacy, as well as persons entitled to provide medicines to the population in Romania, according to the active legislation;

End-User account administrator – A person nominated and empowered by the End-User’s legal representative to administer his account, with functional rights included in the specific role of Client ADMIN;

FSIT/IT Solutions Provider – The End User’s internal IT department or the external IT service provider, that has a contract with the End User, and ensures the creation and configuration of the interface between the End User and NMVS and supports the local configuration processes, initiation of registration in NMVS SIMI and subsequent technical support;

UIUnique Identifier  – Safety feature placed on the pack of a medicinal product, printed on the individual pack as a two-dimensional barcode, which allows the identification and verification of the authenticity of an individual pack of a medicinal product.

It consists of the following data elements:

  • Product code (PC) , allowing the identification of at least the name, the common name, the pharmaceutical form, the strength, the pack size and the pack type of the medicinal product bearing the unique identifier;
  • Batch number;
  • Expiry date;
  • Serial number – a numeric or alphanumeric sequence of maximum 20 characters;

LUF/End-User Location – any physical or functional location of the End-User accessing the NMVS in order to cover the legal obligations whilst performing current activities;

PTC/TCPTechnical Connection Point  – is the IT terminal connected to the scanner, having internet access, on which the digital certificate (it’s own or End-User Location) used for authentication is installed and which has the NMVS connecting application installed to send and receive automated messages to/from the NMVS;

SL/WS – Work Station (WS) – PTC and any other LUF IT terminal that allows access to the NMVS web interface, if applicable;

PKI Portal – Public Key Infrastructure – the application that manages the digital certificates needed by any user to access NMVS;

GTIN Code – Global Trade Item Number – The Global Number of the commercial item – unique identification code for a commercial item, encoded, most often, as a bar code;

GLN Code– Global Location Number according to ISO:6523 Information Technology  – Structures for identifying organisations and parts of the organisations;

NMVS IQE – IQE Environment – NMVS IQE (Integrated Qualified Environment) represents the NMVS test environment;

NMVS PROD – PROD Environment – NMVS PROD represents the operational environment of NMVS. NMVS IQE and NMVS PROD are identical environments from a functional point of view;

GUI – Graphical User Interface – Graphical Interface for the user;

SIMI – Registering and Incident Management System – OSMR CRM (Client Relationship Management)  type support system with the purpose of ensuring the legal obligations under Art. 37 letter b) of the Delegated Regulation 2016/161;

Arvato Systems GmBH – supplier, accredited by EMVO, of the Blue Print System application for Romania.