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Results: 1-10 of 327

TEAM-NB releases a new version of its Code of Conduct for notified bodies
  • Hogan Lovells
  • European Union
  • August 7 2014

On 29 July 2014, the European Association for Medical Devices of Notified Bodies (TEAM-NB) issued a press release on its website to announce the


EU orphan drug exclusivity
  • Hogan Lovells
  • European Union
  • January 26 2015

On 22 January 2015, the General Court of the Court of Justice of the European Union issued its judgment in the case between Teva and the European


CJEU judgment on Merck Canada Inc. & Merck Sharp & Dohme Ltd v Sigma Pharmaceuticals plc, case C-53913, 12 February 2015
  • Hogan Lovells
  • European Union
  • February 16 2015

The CJEU has recently clarified when patent and SPC rights can be relied on under the Specific Mechanism to prevent parallel imports within the EU


Entry in force of the new amendments to the EU pharmacovigilance rules
  • Hogan Lovells
  • European Union
  • November 7 2013

Obligations related to pharmacovigilance in the EU are governed by the Community Code on medicinal products. Amendments to the pharmacovigilance


The Final GDPR Text and What It Will Mean for Health Data
  • Hogan Lovells
  • European Union
  • January 20 2016

The EU General Data Protection Regulation ("GDPR") has been called the most lobbied piece of legislation in the history of the EU. Before Christmas


EMA Update concerning EU Clinical Trials portal and database
  • Hogan Lovells
  • European Union
  • January 24 2017

Regulation (EU) No 5362014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 200120EC (“the Clinical


Chemical substance can qualify as a “new active substance”
  • Hogan Lovells
  • European Union
  • February 11 2016

On 17 December 2015, the European Medicines Agency ("EMA") published a Reflection Paper on the chemical structure and properties criteria to be


Eudravigilance access policy revision
  • Hogan Lovells
  • European Union
  • February 12 2016

On the 12 January 2016, the European Medicines Agency ("EMA") published an overview of comments in response to a public consultation regarding a


The Council adopts its position on revised medical devices package
  • Hogan Lovells
  • European Union
  • June 23 2015

On 19 June 2015, the Council of the European Union ("Council") came to a common position, during a meeting of the Employment, Social Policy, Health


New Belgian Innovation Office to Accelerate Availability of Novel Medicines
  • Hogan Lovells
  • European Union
  • December 14 2016

In July 2016, the Belgian Agency for Medicines and Healthcare Products (“FAMHP”) took steps to establish a National Innovation Office as part of the