In the European Union there is an alarming increase in the number of falsified medicines in terms of their identity, history or source. Past experience indicates that such falsified medicines do not reach patients only through illegal means, but also through the legal supply chain. This poses a special threat to human health and can lead to a mistrust in the legal supply chain.
As a result, the European Union provided the Directive 2011/62 / EU to establish a Community code on medicinal products for human use to prevent the entry of falsified medicinal products into the legal supply chain. The Directive calls for the introduction of safety features consisting of a unique identifier and a device for protecting against illicit tampering on the packaging of certain medicinal products for human use in order to identify and authenticate them. By Delegate Regulation (EU) 2016/161, the European Commission has set out a set of detailed rules for the safety features appearing on the packaging of medicinal products for human use. As of 9 February 2019, only prescription medicines with the new safety features can be put into circulation.
Each package will carry a set of unique information that can be verified in the National Medicines Control System (SNVM) administered by OSMR (Romanian Drug Serialization Organization).
The GS1 system is used to uniquely identify medicines in line with European directives.
Encoding, serialization and aggregation of mandatory information using application identifiers in the ECC200 Data Matrix (according to ISO 16022: 2006) are solutions fully covered by GS1 services.
It is only necessary to obtain a license to use the GS1 system fromGS1 Romania and everything becomes easier!
Get Started!Companies that want to market the medicines listed on the list prescription must be registered with the EMVS (European System of Pharmacovigilance) and each batch manufactured, together with the unique series on each secondary packaging, needs to be reported.
FIND OUT MOREThis is a service for generating unique series for printing on the packaging of medicines covered by Delegate Regulation 2016/161.
FIND OUT MOREThis section allows you to get test series to test SNVM functionality together with OSMR.
FIND OUT MOREIn this section you can periodically obtain Calibration Sheets for your scanners, together with the Calibration Certificate, after following the calibration steps
FIND OUT MOREReady to start your next project with us? That's great! Give us a call or send us an email and we will get back to you as soon as possible!
+40213178031 - GS1 Romania
+40213178033
serializare@gs1.ro
copyright © 2005–2018 GS1 Romania.