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Health claims to come of age the draft list, finally created, and now open for consultation
  • Eversheds
  • European Union, United Kingdom
  • October 4 2011

In December 2006, European law initiated a harmonized approach to the use of nutrition and health claims for foods across Europe


EU Court of Justice’s AstraZeneca judgment may point to more pro-innovator stance
  • Sidley Austin LLP
  • European Union
  • December 13 2012

Last week’s judgment from the Court of Justice of the European Union (“CJEU”) in the landmark AstraZeneca v Commission case appeared to represent another resounding victory for the European Commission (“Commission”) and a defeat for the innovative pharmaceutical industry


Increased European patent protection following a landmark ruling on supplementary protection certificates
  • McDermott Will & Emery
  • European Union
  • August 30 2012

The Court of Justice of the European Union (CJEU) rendered judgment relating to a preliminary reference from the English Court of Appeal, holding that the existence of an earlier marketing authorization (MA) of a pharmaceutical product does not preclude the grant of a Supplementary Protection Certificate (SPC) for a different application of the same product


No guidance on scope of Bolar exemption as CJEU case C-66113 is closed
  • Dehns
  • European Union, Germany
  • December 3 2014

At long last, a referral to the Court of Justice of the EU (CJEU) was expected to clarify the scope of the European Bolar exemption with regard to


New medical devices regulations: scrutinizing the scrutiny procedure
  • Baker & McKenzie
  • European Union, United Kingdom
  • November 19 2012

Recently, the Daily Telegraph newspaper and the British Medical Journal conducted an investigation into European medical devices regulators and uncovered some unscrupulous practices


European Medicines Agency updates guidelines on good pharmacovigilance practices
  • Hogan Lovells
  • European Union
  • May 9 2014

On 25 April 2014, the European Medicines Agency ("EMA") updated its guidelines on Good Pharmacovigilance Practices ("GVP Guidelines"). The update


European Commission clarifies position on post-authorisation efficacy studies
  • Hogan Lovells
  • European Union
  • May 8 2014

On 10 April 2014, the European Commission ("Commission") adopted Commission Delegated Regulation (EU) No 3572014 as regards situations in which


The case of ophthalmic drugs in Italy and France: a lesson to learn - parallel antitrust investigations and cooperation between national competition authorities
  • McDermott Will & Emery
  • European Union, France, Italy
  • May 7 2014

The recent investigations into two pharmaceutical companies active in the ophthalmic drugs market in Italy and France serve as a reminder of the


EFSA addresses dietary iodine
  • Shook Hardy & Bacon LLP
  • European Union
  • May 9 2014

The European Food Safety Authority's (EFSA's) Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) has published a scientific opinion


The European Medicines Agency publishes draft guideline on process validation for biologics
  • Hogan Lovells
  • European Union
  • May 9 2014

On 25 April 2014, the European Medicines Agency ("EMA") published a Draft Guideline on process validation for the manufacture of