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The EMA has adopted new guidelines on good pharmacovigilance practices in paediatric populations
  • Hogan Lovells
  • European Union
  • November 26 2018

The EMA Good Pharmacovigilance Practices consist of several chapters of the Notice to Applicants that are regularly updated. A new GVP Considerations

Timeline of Recent Actions by FDA Center for Tobacco Products; Focus on Addressing Increase in Underage Use of Certain E-Cigarettes
  • Keller and Heckman LLP
  • USA
  • November 15 2018

The U.S. Food and Drug Administration (FDA) is expected to announce today detailed plans to curtail the growing number of youth who are using certain

Cannabis: what's new for the 6000 year old medicine?
  • Taylor Wessing
  • United Kingdom
  • November 8 2018

Recent changes to the rules in the UK have raised some interesting possibilities and questions

CJEU confirms SPC ineligibility for Medical Device authorisations
  • Potter Clarkson LLP
  • European Union
  • October 29 2018

On 25 October 2018, the Court of Justice of the European Union (CJEU) handed down a judgment in Boston Scientific (C-52717) concerning Supplementary

Transferring marketing authorizations as a result of Brexit: key tax considerations
  • Baker McKenzie
  • United Kingdom, European Union
  • October 18 2018

Developing, producing and marketing medicinal products involves a significant amount of regulation grounded in EU law for pharmaceutical companies to

Parallel import of medicinal products - when a name change is a game changer
  • Hogan Lovells
  • Italy
  • October 10 2018

The Lazio Administrative Court recently decided that, as a rule, parallel importers of medicinal products have no right to change the trademark

EU: Falsified Medicines Directive: Implications for parallel importers and of Brexit
  • AA Thornton & Co
  • United Kingdom, European Union
  • October 4 2018

Directive 201162EU, better known as "The Falsified Medicines Directive" or "FMD", came into force on 2 January 2013, with the aim of preventing

Importing Medical Devices in Egypt
  • Youssry Saleh & Partners
  • Egypt
  • September 23 2018

Medical Devices are used in the healthcare for the diagnosis, prevention, monitoring or treatment of illness or disability. The Egyptian Ministry of

Dismissal of the preliminary injunction request based on SPC covering the combination of ezetimibe and simvastatin
  • France
  • July 6 2018

Interpretation of articles 3 (c) and 3 (d) of Regulation (EC) No. 4692009 The Paris Court of Appeal uphold the Interim Order of the Paris Court of

Shire v EMA: Clarification on orphan designation for products with the same active substance
  • CMS Cameron McKenna Nabarro Olswang LLP
  • European Union
  • April 24 2018

On 22 March 2018 the EU General Court handed down its judgment in Case T-8016 Shire Pharmaceuticals Ireland Ltd v European Medicines Agency (EMA)