other Serialization requirements around the world:
a quick overview

Discover the Global Serialization Landscape

Take a look at our global serialization landscape for pharmaceutical products to have an overview of the state of the different laws and regulations pertaining to drug serialization and aggregation around the world as well as the main milestones.

RUSSIA

To make the pharmaceutical supply chain safer and ensure patients get the medicines they need, the Russian Ministry of Health intends to put in place serialization and aggregation requirements for drugs.

PAKISTAN

To ensure a safe and efficient pharmaceutical supply chain, the Drug Regulatory Authority of Pakistan (DRAP) is planning to implement serialization and track&trace measures. As per a notification published in June 2017, all drugs will have to be uniquely identified and serialized in the future.

SAUDI ARABIA

The Saudi Food and Drug Authority (SFDA) has published the latest version of the Saudi Drug Code (SDC) in November 2016. Its aim is to fight against counterfeit pharmaceuticals and to make Saudi Arabia’s drug supply chain safer and more efficient.

BRAZIL

On December 28, 2016, after lengthy discussions and a temporary suspension of already active legislation related to pharmaceutical serialization, the Brazilian President signed the law 13.410, thus amending the ones dating back to 2009 and 2013.

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Final countdown for dscsa and eu fmd: everything you need to know

DSCSA Serialization and Track & Trace Requirements and Their Impact

The DSCSA (Drug Supply Chain Security Act) sets out serialization and track and trace requirements for the US drug supply chain: from manufacturer to dispensers.

The EU Falsified Medicines Directive: Serialization and Track & Trace requirements

The European Falsified Medicines Directive or EU FMD was enacted in 2013 to fight against falsified medicines and counterfeit drugs entering the European pharma supply chain.