alexa Different Approaches and Timeframes in Anti-Counterfeit
ISSN: 2167-7689

Pharmaceutical Regulatory Affairs: Open Access
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Case Report

Different Approaches and Timeframes in Anti-Counterfeiting Medicinal Products: Europe vs. United States

Rampinelli P and Argenta G*

Universita degli Studi di Bologna, Bologna, Italy

Corresponding Author:
Argenta G
Universita degli Studi di Bologna, Bologna, Italy
Tel: +393288787312
E-mail: [email protected]

Received date: February 01, 2016; Accepted date: February 04, 2016; Published date: March 09, 2016

Citation: Rampinelli P, Argenta G (2016) Different Approaches and Timeframes in Anti-Counterfeiting Medicinal Products: Europe vs. United States. Pharmaceut Reg Affairs 5:160. doi:10.4172/2167-7689.1000160

Copyright: © 2016 Rampinelli P, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.



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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