Article originally published in PLC Life Sciences Handbook 2009/2010
With sales of counterfeit pharmaceuticals predicted to increase at nearly twice the rate of sales of legitimate products, it is not surprising that tackling pharmaceutical crime is high on the agendas of both global policymakers and pharmaceutical manufacturers. The US-based Center for Medicine in the Public…
Article originally published in the In Vitro Diagnostics: The Complete Regulatory Guide (Chapter (8) with permission from FDLI), 2010
I. Introduction
This chapter discusses the European Union (EU) regulation of in vitro diagnostic (IVD) medical devices, covering both pre- and postmarket regulatory requirements. In order to understand these rules and the manner in which they…
Article originally published in the Food Packaging Bulletin, January 2010
As with virtually all goods manufactured in, or imported into, the European Economic AreaI, food packaging is subject to the stringent requirements of Regulation (EC) No. 1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals (the so-called “REACH Regulation”)II. Indeed, while substances “used in…
