Track & Trace

Why Track & Trace?

Counterfeit protection and supply chain control

The marking and tracking of individual products on their way through the supply chain is moving into focus, not just in the pharmaceutical industry. Traceability and supply chain transparency – a long-standing requirement in the automotive and food industries – are becoming increasingly important due to the dramatic global increase of counterfeits in industrial and consumer goods.

Global

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Global Regulations

Argentina

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Ministro de Salud de la Nación

Resolution 435/2011

Brazil

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ANVISA

N° 11.903 / 2009

China

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CFDA

EU

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European Parliament

European Falsified Medicine Directive 2011/62/EU, Delegated Regulations

India

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Directorate General of Foreign Trade

Public Notice N° 4 /2015-2020

Korea

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Korea National Institute of Health

Notification 2011 – 58

Russia

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FGIS MDLP

Saudi Arabia

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Saudi Food and Drug Authority

Turkey

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Turkish Ministry of Health

ITS

USA

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U. S. Food and Drug Administration

Drug Supply Chain Security Act

Various national regulations have been established in order to protect the legal supply chain of prescription drugs. These differ not only in terms of required data carriers and contents, but also range from straightforward serialisation of individual sales units (e.g. EU FMD) to product e-pedigree that illustrate the complete path of a product through the supply chain to the point of dispense.

Regardless of whether compliance requirements need to be fulfilled or whether the objective is to achieve greater transparency in the supply chain, Track & Trace supports the structuring of processes and increases product safety.

Secure Track & Trace Solutions

Modular solutions for all requirements

  • Track & Trace with MV-50togo

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  • The broad range of Track & Trace solutions reflects the various requirements of the pharmaceutical industry. The scope of Secure Track & Trace Solutions (S-TTS) ranges from MV-50 to go, a preconfigured Pack Handling System for the serialisation of folded boxes,  to serialisation and multi-level aggregation on various packaging lines with integration into higher-level business IT solutions of global pharmaceutical corporations.

    Secure Track & Trace Solutions (S-TTS) from Laetus reliably cover all current and future requirements on product tracking.

  • 3-Level-Architecture Multiple Lines

    Track & Trace Solutions
  • Secure Track & Trace Solutions

     


     

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Track & Trace Academy

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Do you have questions about the various regulations, or are your compliance requirements unclear? The Track & Trace Academy offers a comprehensive modular training programme, tailored to the individual needs and relevant issues. An overview of current training modules is available here:

http://trackandtraceacademy.com/inquiry.html