Ensuring successful serialisation data management ahead of the EU FMD

Posted: 4 October 2017 | | No comments yet

Traceability and serialisation have been the talk of the industry for many years, with regulatory bodies worldwide starting to introduce legislation that will help to eradicate counterfeit medicines from the supply chain.

Despite this, it has not been top of the agenda for many pharmaceutical supply chain partners given the complexities that serialisation introduces, meaning that many marketing authorisation holders (MAHs) and contract manufacturers (CMOs) are now facing an uphill battle towards compliance.

Following the announcement that the active enforcement of the US Drug Supply Chain Security Act (DSCSA) for pharmaceutical manufacturers has been delayed due to a lack of readiness, it is vital the industry prepares for serialisation compliance not only in the US, but also in Europe. But what are the biggest challenges that companies face? And, what can contract partners learn from the DSCSA enforcement delay ahead of the EU Falsified Medicines Directive (FMD) deadline in February 2019?

The rest of this content is restricted - login or subscribe free to access

EPR Issue 1 2024Thank you for visiting our website. To access this content in full you'll need to login. It's completely free to subscribe, and in less than a minute you can continue reading. If you've already subscribed, great - just login.

Why subscribe? Join our growing community of thousands of industry professionals and gain access to:

  • bi-monthly issues in print and/or digital format
  • case studies, whitepapers, webinars and industry-leading content
  • breaking news and features
  • our extensive online archive of thousands of articles and years of past issues
  • ...And it's all free!

Click here to Subscribe today Login here


Related topics


Related organisations

Related people