Legislation

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

Download pdf: MEDICAL-DEVICES_REG_2017_745_ENGLISH.pdf

RESIDUAL SOLVENTS: ICH Harmonized Guideline Q3C

Download pdf: ICH_Q3CR6_Residual-solvents-ENGLISH.pdf

NOVEL FOOD: Regulation EU 2283/2015

Download pdf: NOVEL-FOODS_-REG-2283_2015_ENGLISH.pdf

GENOTOXIC IMPURITIES: ICH Harmonized Guidelines in mutagenic impurities M7

Download pdf: ICH_M7_Genotoxic-impurities_ENGLISH.pdf

ELEMENTAL IMPURITIES: ICH Harmonized Guideline Q3D 2014

Download pdf: ICH_Q3D_Elemental-impurities_ENGLISH.pdf

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

Download pdf: EMA-Guidance-2014_PDE_ENGLISH.pdf

BIOCIDE Regulation EC 528/2012

Download pdf: CELEX_02012R0528-20140425_EN_TXT.pdf

PMC NATIONAL AUTHORISATION

Download pdf: PROVVEDIMENTO_5_FEBBRAIO_1999.pdf

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

Download pdf: EMA_2011-QA-ERA_ENGLISH.pdf
Download pdf: EMEA_2010_QA_ERA_ENGLISH.pdf

COSMETIC Regulation EC 1123/2009

Download pdf: COSMETICS_REG-1123_2009_ENGLISH.pdf

AGROCHEMICAL Regulation EC 1107/2009 and following amendments

Download pdf: AGRO_REG.-1107_2009_ENGLISH.pdf

GOOD LABORATORY PROCEDURES

Download pdf: GLP_HANDBOOK_ENGLISH.pdf

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

Download pdf: CLP-REG-1272_2008_ENGLISH.pdf

REACH Regulation EC/1907/2006 and following amendments

Download pdf: REACH-REGULATION_ENGLISH.pdf

IMPURITIES: ICH Harmonized Guideline Q3A

Download pdf: ICH_Q3A_Impurities-in-a-new-drug-substance_ENGLISH.pdf

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

Download pdf: FCM_REG_1935_2004_ENGLISH.pdf