Read publication

Welcome to the December 2019 edition of the EMEA Healthcare & Life Sciences Industry Group Newsletter, your regular digest of legal developments affecting the life science and healthcare industries across the region.

In this issue:

Europe

  • An early holiday gift for Class I device manufacturers: EU proposes four-year extension to up classification.
  • The European Commission releases revised draft guidance on Clinical Trials Regulation EU 536/2014.
  • The European Commission issues aide-memoire for Good Distribution Practice (GDP) inspections in relation to Safety Measures Regulation EU 2016/161.

Germany

  • German government initiates legal mechanisms in order to tackle increasing supply bottlenecks for pharmaceuticals.

Hungary

  • Recent case law of the National Institute of Pharmacy and Nutrition regarding pharmaceutical promotional activities.

Italy

  • AIFA – Standard template for clinical trial agreements.
  • New guideline for assessors of centralized applications on wording of therapeutic indications.
  • Exclusion from a tender procedure if offer includes an accessory not bearing the CE mark.
  • The precautionary principle in tender procedures for the supply of vaccines.

The Netherlands

  • First MAH applicant of MEB-ZIN Parallel Procedures pilot.
  • Amendment of the Medicines Prices Act.

Spain

  • The Spanish Council of Ministers approve amendment.

UK

  • High return, high risk? AML risks arising from investment in the cannabis industry.
Explore More Insight