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Postmarketing Regulation - Prescribing
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EXPERT VIEW
Danes urge austerity as EU health issues loom large
11 January 2012
Ian Schofield
Much has been made of Denmark's announcement that its presidency of the EU Council of Ministers will be an austere one financially, in the spirit of ...
LATEST FEATURES
New pharmacovigilance rules in the EU and their impact on biosimilars and automatic substitution
10 November 2011
Burkhard Sträter describes how the new pharmacovigilance requirements for biosimilars will affect member states, doctors, pharmacists and, last but ...
Using a structured approach to assess whether your Rx product is ready for a switch to OTC in the EU
20 July 2011
Pharmaceutical companies have many factors to consider in deciding whether a switch to over the counter is the right strategy for their products. ...
Off-label use and promotion in the EU: risks and potential liability
26 October 2010
Liesbeth Weynants and Carla Schoonderbeek call for greater clarification and co-ordination of off-label requirements in the EU. The off-label use of ...
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LATEST COUNTRY PROFILES
Trademarks Briefing (Devices) - Luxembourg
08 October 2009
Please give details of the major acts and directives governing trademarks. Trademarks are governed in Luxembourg by the: Benelux Convention on ...
Regulation of Medical Devices Briefing - Spain
08 October 2009
1) Which authority is responsible for overseeing the regulation of medical devices and diagnostics in Spain? Agencia Espaņola del Medicamento, the ...
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MULTIMEDIA
Regulatory Affairs Medtech News Roundup, December 2010
09 December 2010
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