Transcription of EU GMP Requirements
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EU GMP Requirements
Trade & Industry Inspection Agency ofLower Saxony / Germany, Hannover officeBernd BoedeckerGMP Inspectorate of Hannover / GermanyEU GMP Requirements - Investigational Medicinal Products -at Turkish Ministry of HealthAnkara, 20-21 Oct 2009 TMH, Ankara, 20-21 Oct 2009 Bernd Boedecker2 Trade & Industry Inspection Agency ofLower Saxony / Germany, Hannover officecontact dataBernd BoedeckerStaatliches Gewerbeaufsichtsamt HannoverDezernat 74 (GMP Inspectorate)Am Listholze 74D-30177 Hannoverphone: +49 (0)511 / 9096-464fax : +49 (0)511 / Ankara, 20-21 Oct 2009 Bernd Boedecker3 Trade & Industry Inspection Agency ofLower Saxony / Germany, Hannover officeContents covered Legislationrelated to Investigational Medicinal Products(IMPs) IMP terminology Focal points of inspectionsat IMP manufacturing sites Revision of Annex 13 current status GMP level of Active Ingredientsfor Use in IMPsTMH, Ankara, 20-21 Oct 2009 Bernd Boedecker4 Trade & Industry Inspection Agency ofLower Saxony / Germany, Hannover officeLegal framefor manufacture & import of IMPs Directive 2001/20/EC (Good Clinical Practice basics) Article 9: conduct of a clinical study subject to ethical evaluation and authorisation Article 13: manufacture and import of IMPs subject to holding of an authorisation Directive 2005/28/EC (Clinical Trials Directive) Article 10: requirem
Trade & Industry Inspection Agency of Lower Saxony / Germany, Hannover office Bernd Boedecker GMP Inspectorate of Hannover / Germany EU GMP Requirements
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