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Results: 1-10 of 301

European Medicines Agency launches consultation on Good Pharmacovigilance Practices for educational materials
  • Hogan Lovells
  • European Union
  • May 13 2015

On 27 April 2015, the European Medicines Agency ("EMA") launched a public consultation on its Good Pharmocoviligance Practices ("GVP") concerning


EMA updates product information templates for medicinal products for human use
  • Hogan Lovells
  • European Union
  • June 19 2015

On 10 June 2015, the European Medicines Agency published the revised Human Product Information templates for medicinal products in the European Union


Common EU logo for online pharmacies and retailers to come into effect from 1 July 2015
  • Hogan Lovells
  • European Union
  • June 22 2015

On 1 July 2015, the new common logo for online pharmacies and retailers offering medicinal products for human use in the European Union ("EU") will


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


European Medicines Agency fine-tunes Guideline on fixed combination medicinal products
  • Hogan Lovells
  • European Union
  • May 22 2015

On 13 May 2015, the European Medicines Agency released for consultation the draft Guideline on the clinical development of fixed combination


Revised guideline adopted on core SmPC for plasma-derived fibrin sealant haemostatic products
  • Hogan Lovells
  • European Union
  • July 8 2015

On 25 June 2015, the Committee for Medicinal Products for Human Use (“CHMP”) adopted a revised Guidance on core SmPC for plasma-derived fibrin


EMA confirms that access to clinical study reports for preparation of health technology dossiers will be permitted within the new EMA Disclosure Policy
  • Hogan Lovells
  • European Union
  • April 13 2015

According to the minutes of a meeting between the European Medicines Agency ("EMA") and the European Network for Health Technology Assessment


EMA permits the use of a comparator product authorised outside the EEA in clinical studies for biosimilars
  • Hogan Lovells
  • European Union
  • April 13 2015

The European Medicines Agency's ("EMA") revised overarching guideline on biosimilars("Guideline"), which was published on 23 October 2014, will come


The treatment of health data under the EU Data Protection Regulation cause for hope?
  • Hogan Lovells
  • European Union
  • April 30 2015

On 9 March, the Council of the EU issued a partial general approach on a key chapter (Chapter II) of the EU Data Protection Regulation which has