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:
- 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- The European Commission releases revised draft guidance on Clinical Trials Regulation EU 536/2014.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.
- German government initiates legal mechanisms in order to tackle increasing supply bottlenecks for pharmaceuticals.
- Recent case law of the National Institute of Pharmacy and Nutrition regarding pharmaceutical promotional activities.
- 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.
- First MAH applicant of MEB-ZIN Parallel Procedures pilot.
- Amendment of the Medicines Prices Act.
- The Spanish Council of Ministers approve amendment.
- High return, high risk? AML risks arising from investment in the cannabis industry.