Open Mic Session: Serialization Regulatory Landscape

The serialization landscape is complex and changing fast. The information is not necessarily easy to find and to interprete. 

During a 45 minute session, our experts picked and answered more than 20 questions your peers had submitted about different topics including the Track & Trace regulations for pharmaceutical products in Russia, the countries requiring aggregation, the latest guidance documents for product coding in China, the outcomes of the EU FMD go-live and many more.

Some questions we answered

  • Can you give a clear picture of the Russian serialization requirements and an approach in more detail? 
  • Where aggregation is mandatory and when?
  • Is the list of master data (from regulatory point of view) already defined  for the pharma products in the Russia Market? Which are the Product information that must be uploaded to MDLP system?
  • Do we see pharmaceutical serialization crossing over to other industries, like cosmetics? What is the state of UDI in the industry?

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Brigitte Naftalin

Regulatory Affairs, Adents

Andreas Andersson

Regional Sales Manager, Adents