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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!