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Indemnity arrangements for healthcare professionals: long overdue
  • Kennedys Law LLP
  • European Union, United Kingdom
  • July 26 2013

The Department of Health's consultation on the implementation of the Health Care and Associated Professions (Indemnity Arrangements) Order 2013 (the

Taking a consistent approach
  • Kennedys Law LLP
  • European Union
  • December 31 2012

The EU proposes a major overhaul of the medical devices rules. The European Commission has recently published its plans for revising the current

European Medicines Agency jeopardizes investments in drug development
  • Jones Day
  • European Union
  • December 28 2012

The heart of a marketing authorization application ("MAA") is the pre-clinical and clinical data that proves the drug's safety and efficacy. This data is

AstraZeneca judgment: don’t game the system
  • CMS Cameron McKenna
  • European Union
  • December 12 2012

In a long-awaited judgment dated 6 December 2012, the European Court of Justice (ECJ) has confirmed that certain brand protection strategies may infringe the EU competition rules

Food industry review 26 May 2014
  • Roschier
  • European Union, Finland
  • May 26 2014

The Supreme Administrative Court of Finland has recently ruled in two cases (KHO T -1393 and KHO T- 1394) that sleep-inducing products are to be

Competition policy v IP
  • Bristows LLP
  • European Union, United Kingdom
  • May 8 2016

Conceptually, intellectual property rights (IPRs) and competition law appear to be at odds: the former grants temporary monopolies and the latter

ECJ rules on SPCs and French courts react
  • Santarelli
  • European Union, France
  • October 28 2014

From 2011 to 2013, the European Court of Justice (ECJ) handed down several important decisions concerning the interpretation of the EU Regulation on

Outside of FDA
  • Drinker Biddle & Reath LLP
  • European Union, Global, United Kingdom, USA
  • June 30 2008

The European Directorate for the Quality of Medicines & HealthCare (EDQM, Council of Europe), recently met with the Ministry of Health of India and the Indian Pharmacopoeia Commission (IPC) to discuss improving the quality and safety of medicines in both locations, and developing joint inspections of DBR Reg Sci May - June 2008 Page 7 manufacturing sites

European Commission fines Lundbeck and generic companies EUR 146 million, accusing them of delaying market entry of generic medicines
  • Baker Botts LLP
  • European Union
  • June 24 2013

On 19 June 2013, the European Commission ("Commission") fined Lundbeck and several producers of generic medicines - including Alpharma, Merck

EU adds pharmaceuticals to water pollution watch list
  • Shook Hardy & Bacon LLP
  • European Union
  • July 11 2013

The European Commission (EC) has added 12 new substances to the European Union's (EU's) priority list of chemicals known to pose a risk to the safety