Seralization Global Regulatory Review

June 8, 2018 10:41 am | Posted by Claire Blair

ESP Global Regulatory Review

Serialization, the marking and tracking at unit of sale level of prescription pharmaceuticals, is an established requirement in most major markets worldwide.  Implementation of global serialization is an ongoing process and one which must be managed carefully.

ESP has released this Global Regulatory Review chart to demonstrate how important it is to understand the different types of serialization, their respective timelines and the associated business risks resulting from those two key factors. The chart demonstrates these three key issues in relation to the manufacture and distribution of prescription pharmaceutical medicines from 2013 into the future (accurate as at June 08, 2018 but subject to change).

*June 2018. Chart refers to the manufacture and distribution of prescription pharmaceutical medicines

It is vital to approach serialization with a strategy which:

  • Is not sensitive to subtle changes in regulations
  • Allows for phased execution
  • Avoids unnecessary complexity

ESP’s experience over the past decade has evolved to support changing requirements to create serialized  product that meets statutory obligations to place serialized information on the product and then to store that information in a centralized repository in line with specific regulatory requirements.

Through it’s partnership with GS1, ESP is ensuring the adoption of best in class global product identification standards to the life science industry across the world.

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