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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
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
The GS1 system is used to uniquely identify medicines in line with
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!