Abkürzungen. Anatomisch Therapeutisch Chemischer Code der WHO. Bundesinstitut für Arzneimittel und Medizinprodukte (
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1 Abkürzungen AE Adverse Event AMG Arzneimittelgesetz API Active Pharmaceutical Ingredient AR Assessment Report ARD Applicant s Response Document ASMF Active Substance Master File ATC-Code Anatomisch Therapeutisch Chemischer Code der WHO BAnz Bundesanzeiger BfArM Bundesinstitut für Arzneimittel und Medizinprodukte ( BLA Biologic license application BMG Bundesministerium für Gesundheit ( BMWP Biosimilar Medicinal Products Working Party BOB Bundesoberbehörde BVL Bundesinstitut für Verbraucherschutz und Lebensmittelsicherheit ( BWP Biotechnology Working Party CA Competent Authority 1
2 CAT Committee for Advanced Therapies CBER Center for Biologics Evaluation and Research (der FDA) CDER Center for Drug Evaluation and Research (der FDA) CCDS Company Core Data Sheet CCSI Company Core Safety Information CDS Core Data Sheet CHMP Committee for Medicinal Products for Human Use CIOMS Council for international organisations of medical sciences CMC Chemistry, Manufacturing, Control CMD(h) Coordination group for mutual recognition and decentralised procedures CMS Concerned Member States COMP Committee for Orphan Medicinal Products CP Centralised Procedure CRD Common Renewal Date CRO Contract Research Organisation CTA Clinical Trial Application CTD Common Technical Document CTS Communication Tracking System 2
3 CVMP Committee for Medicinal Products for Veterinary Use DAR Draft Assessment Report (DCP) DCP Decentralised procedure DIMDI Deutsches Institut für Medizinische Dokumentation und Information ( DLP DMF Data Lock Point Drug Master File DRA Drug Regulatory Affairs DSUR Development Safety Update Report EBD EMEA/EMA European Birth Date European Medicines Agency ( EPAR European Public Assessment Report EK Ethikkommission EudraCT European Union Drug Regulating Authorities Clinical Trials EUDRANET European Union Drug Regulatory Authorities Network (EMEA) EuGH Europäischer Gerichtshof (curia.eu.int) EVMPD FDA Eudra Vigilance Medicinal Product Dictionary Food and Drug Administration (amerikanische Zulassungsbehörde) FRAR Final Renewal Assessment Report 3
4 FVAR Final Variation Assessment Report GA Gegenanzeige GCP Good Clinical Practice GDP Good Distribution Practice GK Gemeinschaftskodex, Richtlinie 2001/83/EG GLP Good Laboratory Practice GMP Good Manufacturing Practice HMPC Herbal Medicinal Products Committee HWG Heilmittelwerbegesetz IBD International Birth Date ICH International Conference on Harmonisation (of Technical Requirements for Registration of Pharmaceuticals for Human Use) IMPD Investigational Medicinal Product Dossier INN International Non-proprietary Name Kom Europäische Kommission (pharmacos.eudra.org) LoQI List of Outstanding Issues LoQ List of Questions MAA Marketing Autorisation Application 4
5 MA Marketing Authorisation MAH Marketing Authorisation Holder MedDRA Medical Dictionary für Drug Regulatory Affairs MHRA Medicines and Healthcare products Regulatory Agency (UK) MICE Medicine in Children (EU Initiative) MPG Medizinproduktegesetz MRP Mutual Recognition Procedure MS Member States NBE New Biological Entity NCE New Chemical Entity NDA New drug application (bei der FDA) NtA Notice to Applicants OOS Out of Specification OTC Over-the-Counter PAES Post authorisation efficacy study PASS Post authorisation safety study PDCO Paediatric Commitee der EU-Kommission PEI Paul-Ehrlich-Institut, Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel ( 5
6 PhVWP Pharmacovigilance Working Party (nicht mehr existent) PIL Patient Information Leaflet PIP Pediatric Investigation Plan/pädiatrisches Prüfkonzept PL Package leaflet PMS Plasma Master File PrAr Preliminary Assessment Report PRAC Pharmacovigilance Risk Assessment Advisory Committee PSRPH Potential Serious Risk to Public Health PSU/PSURS Periodic Safety Update Report PU Pharmazeutischer Unternehmer PUMA Paediatric Use Marketing Authorisation PV Pharmakovigilanz PVAR Preliminary Variation Assessment Report QP Qualified Person QPPV Qualified Person for Pharmacovigilance QWP Quality Working Party RKI Robert-Koch-Institut ( RL Richtlinie 6
7 RMP Reference Medicinal Product RMS Reference Member State RSI Request for Supplementary Information SA Scientific Advice SAE Serious Adverse Event SAWP Scientific Advice Working Party SMEs Small- and medium-sized enterprises SmPC Summary of Product Characteristics SPC Supplementary Protection Certificate SSI SUSAR Structured Substance Information file Suspected Unexpected Serious Reaction SWP Safety Working Party WH Warnhinweise WW Wechselwirkungen XEVPRM EudraVigilance Product Report Message 7
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