Legislation

MEDICAL DEVICES Directive EC 93/42 and Regulation EU 2017/745

RESIDUAL SOLVENTS: ICH Harmonized Guideline Q3C

NOVEL FOOD: Regulation EU 2283/2015

GENOTOXIC IMPURITIES: ICH Harmonized Guidelines in mutagenic impurities M7

ELEMENTAL IMPURITIES: ICH Harmonized Guideline Q3D 2014

PDE: EMA/CHMP/CVMP/SWP/169430/2012

BIOCIDE Regulation EC 528/2012

PMC NATIONAL AUTHORISATION

ERA: EMA/CHMP/SWP/44609/2010 and following modification and suggestions

COSMETIC Regulation EC 1123/2009

AGROCHEMICAL Regulation EC 1107/2009 and following amendments

GOOD LABORATORY PROCEDURES

CLP Regulation EC 1272/2008 and following ATPs (Adaptation to the Technical progress)

REACH Regulation EC/1907/2006 and following amendments

IMPURITIES: ICH Harmonized Guideline Q3A

FOOD CONTAC MATERIALS: Regulation EC 1935/2004 and following amendments