News - 1 July 2013 10:00

Global Tracking Regulations Present Challenges and Benefits

Drug makers are facing an ever-increasing challenge as more countries implement serialization and tracking regulations and set compliance deadlines in an effort to ensure the safety and quality of prescription drugs being sold within their borders. Complying with regulations coming into effect will be a demanding task due to a lack of global harmonization.

The foundation of any tracking system is serialization, which entails affixing to finished drugs a unique serial number and barcode or radiofrequency identification (RFID) that can then be verified at the point of sale. But this basic step is fraught with complexities and variants.

Torben Vogt, life sciences expert at NNIT explains how you prepare for serialization and make use of the benefits. Read the article published online at RAPS (Regulatory Affairs Professionals Society)

Topics

Data, Telecom, IT

Contacts

Lars B. Petersen

Press contact Senior Vice President Communications, Marketing & Commercial Excellence lbop@nnit.com +45 3075 9102

Make the most of serialization

Change is afoot for pharmaceutical companies, with new serialisation legislation on the agenda. To help stem the problem of drug counterfeiting, they will be required to adopt a unique serial number labelling system and adapt their business processes accordingly. How can companies derive real business value from the investments they are now required to make?

19 June 2013 09:00

ISO IDMP is the next after xEVMPD

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12 April 2013 09:00

BI tool for smooth submission planning and execution

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31 May 2013 09:00

PSMF establishment and maintenance, business as usual?

Since the implementation of Directive 2010/84 and Regulation 1235/2010, marketing authorisation holders (MAHs) with products on the European market are obliged to maintain, and make available upon request, a Pharmacovigilance System Master File (PSMF).