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In order to combat the global problem of manufacturing and trafficking counterfeit drugs the majority of leading countries in the world opted for implementing serialization in the pharmaceutical industry. Regulations governing this process were created, as well as deadlines for their implementation. Other industries are exempt for implementing obligatory serialization. However, companies striving to optimize their manufacturing and distribution processes and improve communication with consumers and customers are nevertheless implementing it.

GLOBAL SERIALIZATION STANDARDS

THE EU
Deadline: February 2019
Packaging level: Secondary, Rx
Data carrier: GS1 Datamatrix, IFA Datamatrix
Type: End to End
ARGENTINA
Deadline: Partially since 2013
Packaging level: Secondary, Rx
Data carrier: GS1 Datamatrix
Type: Track and Trace

BRAZIL
Deadline: N/A
Packaging level: Secondary, Rx
Data carrier: GS1 Datamatrix
Type: Track and Trace

CHINA
Deadline: 2015.
Packaging level: Primary, Secondary, Rx
Data carrier: 1D barkod, ISO 128
Type: Track and Trace
SOUTH KOREA
Deadline: 2015.
Packaging level: Primary, Secondary, Rx
Data carrier: GS1 Datamatrix, GS1 128
Type: Track and Trace
INDIA
Deadline: N/A
Packaging level: Primary, Secondary, Rx
Data carrier: GS1 Datamatrix, GS1 128
Type: Track and Trace
MEXICO
Deadline: 2018.
Packaging level: Secondary, Rx
Data carrier: GS1 Datamatrix
Type: End to End
RUSSIA
Deadline: 2019.
Packaging level: Primary, Secondary, Rx
Data carrier: GS1 Datamatrix
Type: Track and Trace
SAUDI ARABIA
Deadline: 2016.
Packaging level: Primary, Secondary, Rx
Data carrier: GS1 Datamatrix
Type: Track and Trace
TAIWAN
Deadline: 2018.
Packaging level: Sekundarno, Rx
Data carrier: GS1 Datamatrix
Type: End to End
TURKEY
Deadline: existing
Packaging level: Primary, Secondary, Rx
Data carrier: GS1 Datamatrix
Type: End to End
USA
Deadline: Studeni 2017. -2023.
Packaging level: Secondary, Rx.
Data carrier: GS1 Datamatrix
Type: Track and Trace

Serialization is obligatory for drugs manufacturers, companies that distribute drugs and pharmacies that sell them.

Manufacturing associations in EU member-states are required to establish a national institution that will manage a central repository – a database containing serial numbers of all drugs circulating at that particular market. Member-states are free to implement their own regulations concerning standards related to packaging levels that need to be serialized, data carriers and type of serialization. The majority of states where serialization is obligatory choose GS1 Datamatrix and GS1 128 standards for the data carrier, i.e. the sign on the product package.

  • GS1 Datamatrix Standard
  • GS1 128 Standard

Implementing serialization and advancing business processes in other industries

Easy to use and affordable, serialization is an advanced technology for combating counterfeit products in many industries. It provides consumers with an easy means to check the authenticity of products, ensuring greater safety and encouraging both offline and online shopping. It also offers a multitude of modes for communicating with consumers and providing them with additional information. And finally, it facilitates manufacturing and distribution process optimization.

  • verification of authenticity
  • increased safety
  • a two-way customer communication channel
  • additional information

TYPES OF SERIALIZATION

„End to end“

“End to end” serialization type defines two checkpoints for registration of a serialized product. The first checkpoint is the manufacturing process itself, where drug packaging is assigned a unique code. The second checkpoint is at the time-point the drug is being sold – in order to establish its authenticity. This type of serialization will be used by multiple countries, including all EU member-states.

„Track and trace“

“Track and trace” serialization type, along with two checkpoints used in the “End to end” type, includes additional checks aimed at tracking the product throughout manufacturing and distribution chains. This type will also be used by multiple countries, with the USA being among them.

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