Patients are entitled to the best care.
Historically, healthcare has been a strongly regulated sector that follows national solutions. With an increasingly mobile world population, harmonising standards is critical.
The use of GS1 global standards in healthcare can:
Leverage our deep experience in the healthcare industry to solve complex policy issues.
Counterfeit drugs have become an increasing global threat over the last few decades and more and more regulatory authorities, including Argentina, Brazil, India, South Korea, Saudi Arabia and the EU, have adopted or will adopt requirements for the use of globally unique drug identifiers and serialisation in order to protect the supply chain.
The Unique Device Identification (UDI) is a system used to mark and identify medical devices within the healthcare supply chain.
The IMDRF (International Medical Device Regulator Forum) and other regultors across the world are aiming for a globally harmonised and consistent approach to increase patient safety and help optimise patient care by proposing a harmonised legislation for Unique Device Identification (UDI), using global standards.
On 17 December 2013, GS1 has been accredited by the U.S. Food and Drug Administration (FDA) as issuing agency for unique device identifiers (UDIs).
This database provides the latest relevant regulatory requirements, stakeholder agreements and user requests related to Healthcare product identification, product catalogues and traceability at national, regional and local levels. It contains information received by the worldwide network of over 112 GS1 Member Organisations (MOs), members of the global GS1 Healthcare community, and governmental bodies and regulators involved in the Healthcare sector.
“As a global manufacturer we supply billion of packs to hundreds of countries all over the world. There is no other way that my organisation could know about standards, traceability, aniti-counterfeiting, patient safety, product coding, in every single country. But what we have in GS1 is this incredible network. And they collaborate in healthcare in the public policy work group and there isn’t a better place to go to really know what’s going on. I call it my radar.” - Grant Courtney, Manager, Falsified Medicines Directive Project Pharma Europe, GSK
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Traceability of medicines has been the object of a broad and fruitful evolution, resulting in Argentina in the National Medicines Traceability System at the end of 2011 and representing a change in the paradigm for the national market of medicines