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Newly Announced Serialization Changes by the Australian Government (TGO 106)

by Molly Majumder | Apr 16, 2021 | Compliance, Pharmaceutical, Regulations, Serialization, Track and Trace

The recently announced TGO 106 guidance by the Australian government department of Health provides guidance to sponsors and manufacturers supplying medicines in Australia.   Even though serialization and use of data matrix codes at this time continues to be optional,...

Implications of Brexit on the UK Pharmaceutical industry

by Molly Majumder | Apr 2, 2021 | Brexit, Compliance, Pharmaceutical, Regulations, Supply Chain

      The United Kingdom voted to leave the European Union in 2016, but it wasn’t until December 24th 2020 that the details of trade between the two countries was solidified. On that date, the two entities signed a 1,250-page Trade and Cooperation Agreement (TCA)...

A Primer on Alert Management Within the EU FMD Regulations

by Molly Majumder | Mar 26, 2021 | Aggregation, Compliance, Pharmaceutical, Regulations, Serialization, Supply Chain, Track and Trace

  The EU Falsified Medicines Directive (FMD) puts in a framework to track any potential falsified medicines that reach the legal supply chain.  Individual units are scanned at the dispensary to verify their legitimacy. In case of any verification failures, the...

How to best start preparing for Serialization in Brazil

by saba | Mar 12, 2021 | Compliance, Counterfeit, Pharmaceutical, Regulations, Serialization, Supply Chain, Track and Trace

Brazil’s legislation has had a complex set of requirements for putting into effect their serialization and reporting processes in order to achieve complete compliance. Back in 2016, ANVISA signed the National Medicine Control System SNCM into law (Law No....

Avoiding Mismanagement of Master Data

by saba | Feb 19, 2021 | Blockchain, Compliance, Counterfeit, Master Data, Pharmaceutical, Serialization, Supply Chain, Track and Trace

Master data management (MDM) is one of the most effective ways to help manufacturers, wholesalers and prescriber companies to work together and ensure the data shared within the network is accurate and transparent. This set of data consists of the most current records...

How does Blockchain Technology benefit Serialization?

by saba | Feb 12, 2021 | Blockchain, Compliance, Counterfeit, Pharmaceutical, Serialization, Supply Chain, Track and Trace

Before we explore the benefits of Blockchain Technology in Serialization, it’s important to quickly recap what exactly is this technology. Blockchain Technology is a network that is decentralized and it shares real time complex information with all the...
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Recent Posts

  • Newly Announced Serialization Changes by the Australian Government (TGO 106)
  • Aggregation and its Importance to Pharmaceutical Companies
  • Implications of Brexit on the UK Pharmaceutical industry
  • A Primer on Alert Management Within the EU FMD Regulations
  • 5 steps to help you improve transparency in your supply chain

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