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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
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!