BACKGROUND The increasing therapeutic possibilities offered by tissues and cells during the last years, the existing discrepancies in regulation between Member States (MS), and the associated risks have led legislators in the European Union (EU) and its MS to establish a set of supranational standards that ensure quality and safety of human tissues/cells as well as processes related to donation...

The effects of the fungicide carbendazim (formulation Derosal) on enchytraeids were determined in Terrestrial Model Ecosystem (TME) tests. TMEs consisted of intact soil columns (diameter 17.5 cm; length 40 cm) taken from three grassland sites (Amsterdam (The Netherlands), Bangor (Wales, England) and Flörsheim (Germany)) or an arable site (Coimbra (Portugal)). Results for each TME site were eval...

Legal basis for publishing the detailed guidelines: Article 47 of Directive 2001/83/EC on the Community code relating to medicinal products for human use and Article 51 of Directive 2001/82/EC on the Community code relating to veterinary medicinal products. This document provides guidance for the interpretation of the principles and guidelines of good manufacturing practice (GMP) for medicinal ...