The Romanian Organization for Serializing Medicines (OSMR) informs about a new step in the implementation of the European Medicines Verification System (EMVS) at national level – setting the base for the PILOT phase

According to the OSMR Working Plan, the next period is dedicated to setting the base for the implementation of the PILOT phase, which, according to the decision of the Steering Committee of July 16th 2018, will begin in August and will last until the end of October, this year.
A significant milestone in implementing the NMVS (National Medicines Verification System) has been recently reached: OSMR has successfully passed the 1st assessment organized by EMVO (European Medicines Verification Organization) and consequently, the NMVS testing environment (Integrated Qualified Environment – IQE), is now connected to the EMVS (European Medicines Verification System) IQE, allowing for the connectivity between the two systems to be tested from the end-user locations.
The notion of end-user refers to any legal entity (organization) that has legal obligations or access right, based on the Commission Delegated Regulation (EU) 2016/161 and which, through authorized representative, after completing the registration process, can access NMVS to perform the activities for which it is authorized.
OSMR informs that starting with July 31st, the data collection process on the end-users that want to take part in the PILOT testing phase of the NMVS productive (operational) environment (PROD), will be carried out. It is reminded that installing the PROD environment will be possible only after OSMR has successfully passed the second EMVO assessment. It should be noted that the enrollment of the end-users in the PILOT phase can take place anytime during the testing period without any limitation to registration!
It is important that the following types of end-users are involved in the PILOT phase:
– A community pharmacy that has not signed a contract with the health insurance agency,
– A community pharmacy that has signed a contract with the health insurance agency,
– A chain / mini-chain of community pharmacies,
– A pharmacy or more pharmacies with closed circuit from a unit that belongs to a ministry with its own sanitary facilities,
– A closed circuit pharmacy from a hospital subordinated to the City Hall / Local Council,
– A medical care center,
– A hospital with a small number of beds,
– A hospital subordinated to the Ministry of Health,
– A section from a clinical hospital,
– A hospital without ERP (Enterprise Resourse Planning),
– A hospital that has not signed a contract with the health insurance agency,
– A private hospital with and without a pharmacy,
– A distribuitor with a single type of products in his portfolio,
– A distributor authorized only for invoicing,
– A large distributor with several working points (a local point and the central one),
– A distributor with a single distribution place,
– A distributor which does not get its supply directly from a Marketing Autorisation Holder (MAH), or it not designated by the MAH,
– A local producer with at least one medicine which is released based on presciption,
– An international medicines producer,
– A parallel distributor,
– One or more ERP companies (with more that 100 cliențs from the pharmaceutical domain),
– Mobile data providers, according to the internet connection

Taking part in the PILOT phase involves fulfilling the following conditions by the entities responsible with verifying / decommissioning the unique identifier:
– making sure, beforehand, that the IT supplier provides assistance for each end-user location registered by the entity;
– the required technical and operational conditions available in the end-users locations, namely:

• terminal/s with upgraded software application, allowing thus the connectivity with NMVS,
• scanner that decodes two-dimensional Data Matrix ECC 200 code, linked to the terminal / application,
• operator and internet connectivity (direct or through local server);

– filling in and electronically signing the “Declaration of consent for voluntary participation in the PILOT phase” form which will be later on sent to the following address: [email protected] ;
– successfully completing the registration and testing process in the NMVS IQE environment, for each end-user location, according to the OSMR Working Instruction related to the use of NMVS.

The organizations which do not have upgraded software applications, can initially take part in the PILOT phase using only the NMVS graphic web interface for testing those transactions which are accessible only from the web interface.