OSMR wishes to inform the NMVS’s (National Medicines Verification System) End-Users that after analyzing the alerts generated by the NMVS, it has been revealed that certain internal applications, connected to the NMVS, do not clearly highlight the alert generated upon scanning the medicine pack.
Therefore, OSMR is reminding the End-Users of the responsibilities outlined by the Delegated Regulation (EU) 2016/161 and by the Order of the Ministry of Health no. 1.473 of November 22nd, 2018:
Pharmacies and Hospitals verify the safety features on the medicine packs when decommissioning the medicines to the patient, thus also decommissioning the Unique Identifier (DR, Art. 25).
The wholesalers verify the authenticity of the Unique Identifier (OMS 1.473, Art 17, paragraph 1). Moreover, they verify the medicine packs which they received from a wholesaler who is neither the manufacturer, nor the wholesaler holding the marketing authorization, nor the wholesalers who is designated by the marketing authorization holder (DR, Art. 20).
The configuration of the End-Users’ internal applications, connected to the NMVS, in such a way that they do not signal the alerts generated upon scanning, allows the entry in the legal medicines’ distribution chain of medicines that may not be authentic, potentially harmful to the patient, the responsibility belonging exclusively to those End-Users, in accordance with the legislation specific to the pharmaceutical field.
Thus, OSMR outlines the need to raise awareness on the importance of the correct use of the NMVS, of compliance with legal obligations and implicitly the importance of ensuring patient safety.
