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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