alexa Abstract | Different Approaches and Timeframes in Anti-Counterfeiting Medicinal Products: Europe vs. United States
ISSN: 2167-7689

Pharmaceutical Regulatory Affairs: Open Access
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Abstract

Tracking and tracing pharmaceutical products is a key element of any effective solution to the problem of counterfeit medicines. This paper aims to provide an updated assessment of the timeframes for implementing the European medicinal trace-and-trace system in the wake of the delays and uncertainties that stand in the way of meeting the deadlines proposed at the end of 2007. Across the USA, federal and state laws advocating ePedigrees (RFID) have been proposed and enacted to address the criminal activities and increasing threats to public health posed by counterfeit drugs. In order to implement the EU Directive, stakeholders have agreed to develop and implement an “end-to-end” concept aiming at verifying the packaging of medicinal products using a Data-Matrix Code.

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Author(s): Rampinelli P and Argenta G

Keywords

Pharmaceutical tracin, Directive 62/2011/EU, Falsified,Counterfeit, Data matrix, RFID, Pharmaceutical care,Regulatory requirements of pharmaceutical products,Regulatory services and market analysis

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