KAG Krankenanstaltengesetz (Österreich)
KAG Konzertierte Aktion im Gesundheitswesen
KBS Konformitätsbewertungsstellen
KBV Kassenärztliche Bundesvereinigung (s. KV)
KHG Krankenhausfinanzierungsgesetz
KRG Krebsregistergesetz
KV Kassenärztliche Vereinigung auf Landesebene s. KBV

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Wer versucht, mich zu ändern, ....muß mit Nebenwirkungen rechnen!

LAN Local Area Network
LASV Landesamt für Soziales und Versorgung
LIF Swedish Pharmaceutical Industry Association
LKP Leiter der Klinischen Prüfung nach AMG
LLT Lowest Level Term (siehe MedDRA)
LME Landesamt für Meß- und Eichwesen
LMHV Lebensmittelhygiene-Verordnung
LOA Letter of Agreement
LOC Letter of Clarification
LOCF Last-observation-carried-forward
LOI Letter of Indemnification
LOI Letter of Intend
LPCA Last Evaluation, Predefined Change – Abnormal
LPI Last Patient In
LPO Last Patient Out
LREC Local Research Ethics Committee
LRS Laser Recording Systems

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Wer versucht, mich zu ändern, ....muß mit Nebenwirkungen rechnen!

MA Marketing Application
MA Medicines Agency
MAA Marketing Authorization Application
MAA Marketing Authorization Approval
MAGOYSZ Hungarian Pharmaceutical Manufacturers Association
MAH Marketing Authorization Holder
MANSEV Market Authorisation by Network Submission and Evaluation
MANSEV Market Authorisation by Network Submission and Evaluation
MAPP Manual of Practice Procedures
MBO Muster-Berufsordnung für Ärztinnen/Ärzte in der BRD
MC Managed Care
MCA Medicines Control Agency (UK)
MCA Multiple Classification Analysis
MCA Medicines Control Agency, UK
MCB Manufacturer’s Cell Bank
MCO Managed Care Organization
Mcomp Managed Competition
MCT Multicentre Clinical Trial
MDA Medical Devices Agency (UK)
MDC Medical Documentation Center
MDD Medical Device Directives (EU)
MDK Medizinische Dienste der Krankenkassen
MDR Medical Device Reporting (USA)
MDS Medizinische Dienste der Spitzenverbände der GKV
MDV Medical Device Vigilance
MED Minimal Effective Dose
MED- LARS Medical Literature Analysis and Retrieval System
MEDDEV MEDical DEVice
MedDRA Medical Dictionary for Drug Regulatory Activities
MEDDRA Medical Dictionary for Drug Regulatory Affairs
MedR Medizinrecht
MEFA Danish Domestic Pharmaceutical Industry Association
MEMO Medicines Evaluation and Monitoring Organisation
MERS Multiagency Electronic Regulatory Submission
MERS Multi-agency Electronic Regulatory Submission
MESH Medical Subjects Headings
MFPM Member of the Faculty of Pharmaceutical Medicine
MFRG Mutual Recognition Facilitation
MHS Message Handling Services (Austausch von Dokumenten)
MHW Ministry of Health and Welfare (Koseisho – Japan)
MINE Medical Information Network for Europe (EMEA)
MIS Management Information System
MNC Multinational Company
MoH Ministry of Health
MOU Memorandum of Understanding
MP-BetreibV Medizinprodukte-Betreiberverordnung
MPD Medical Product Directive
MPG Gesetz über Medizinprodukte
“Medizinproduktegesetz”
MPI Manufacturing Process Information
MPL Manufacturing, Packaging and Labelling (Protocol)
MPV Verordnung über Medizinprodukte
(Medizinprodukte-Verordnung)
MPVerschrV Verordnung über die Verschreibungspflicht von Medizinprodukten
MPVertV Verordnung über Vertriebswege für Medizinprodukte
MR Mutual Recognition
MRA Medical Research Associate
MRA Mutual Recognition Agreement
MRC Medical Research Council
MRD Maximum Repeatable Dose
MREC Multicentre Research Ethics Committee (UK)
MRER Medical Research Event Report
MRFG Mutual Recognition Facilitation Group
(Gruppe von Behördenvertreter der CPMP — Medicines Control
Agency, um unterschiedliche Beurteilungen im gegenseitigen EUAnerkennungsverfahren
auszugleichen und zentrale
Zulassungsverfahren zu erleichtern)
MRL Maximum Residue Limit
MRP Materials Requirement Planning
MRP Mutual Recognition Procedure
MS EC Member State bei gemeinsamen Zulassungen siehe auch CMS
MSSO Maintenance and Support Services Organisation
MTA Medical Technology Assessment
MTD Maximum Tolerated Dose
MVP Master Validation Plan
MW Ministerium für Wirtschaft, Mittelstand und Technologie
MWCB Manufacturer’s Working Cell Bank

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Wer versucht, mich zu ändern, ....muß mit Nebenwirkungen rechnen!

NADA New Animal Drug Application (animal drugs)
NAF Notice of Adverse Findings (FDA post-audit letter)
NAI No Action Indicated (FDA post-audit letter)
NAPM National Association of Pharmaceutical Manufacturers (USA)
NAS New Active Substance (UK)
NAS-NRC National Academy of Sciences-National Research Council
NATRIC National Reporting and Investigation Centre (UK)
NB Notified Bodies
NC New Combination
NCE New Chemical Entity
NCHS National Center for Health Statistics
NCI National Cancer Institute (USA)
NCL National Consumers League (USA)
NCP Normal Clinical Practice
NCPIE National Council on Patient Information and Education
NCR paper No Carbon Required Paper
NDA New Drug Application (FDA – human drugs)
NDAB National Drugs Advisory Board (Ireland)
NDAS New Drug Application Summary
NDF New Dosage Form
NDMA Non-prescription Drug Manufacturers Association
NDS New Drug Study
NE-FARMA The Dutch Association of the Innovative Pharmaceutical Industry
NEL No Effect Level
NfG Note for Guidance
NGO Non-government Organisation
NH&MRC National Health and Medical Research Council (Australien)
NHI National Health Institute
NHLBI National Heart, Lung and Blood Institute
NHS National Health Service (UK)
NHW National Health and Welfare Department (Canada)
NIAID National Institute of Allergies and Infectious Diseases (USA)
NICE National Institute for Clinical Excellence (Effectiveness) (UK)
NIDA National Institute on Drug Abuse
NIEHS National Institute of Environmental Health Science (USA)
NIH National Institute of Health (USA)
NINDS National Institute of Neurological Disorder and Stroke
NIOSH National Institute for Occupational Safety and Health
NLM National Library of Medicine
NLN Nordic Council of Medicines
NME New Molecular Entity (incl. Biologics and Biotech)
NNT Number Needed/Necessary to Treat
NOAEL No Observed Adverse Effect Level
NOEC No Observed Effect Concentration
NOG Gesetz zur Neuordnung von Selbstverwaltung und
Eigenverantwortung in der
gesetzlichen Krankenversicherung
NOPR Notice of Public Release
NOS Not Otherwise Specified
NRB Noninstitutional Review Board (independent review board)
NRZ Nationale Referenzzentren
NtA
(NTA)
Notice to Applicants der EU
- CPMP-Zulassungshinweise für den Anmelder
NTI Narrow Therapeutic Index
NTIS National Technical Information Service
NTP National Toxicology Program
NUB Neue Untersuchungs- und Behandlungsmethoden
- Richtlinien des Bundesausschusses der Spitzenverbände der Ärzte
und Krankenkassen
NUB-Ausschuß Unterausschuß für neue Untersuchungs- und Behandlungsmethoden
des
Bundesausschusses der Spitzenverbände der Ärzte und Krankenkassen
NUIS Non-Urgent Information System (EMEA)
NVA National Vaccine Authority (USA)
NVAC National Vaccine Advisory Committee
NW Nebenwirkung siehe UAW

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Wer versucht, mich zu ändern, ....muß mit Nebenwirkungen rechnen!

OAI Official Action Indicated (letter)
OC Office of Compliance (FDA)
OCPB Office of Clinical Pharmacology and Biopharmaceuticals
OCR Optical Character Recognition
ODE Office of Device Evaluation (FDA)
ODE Orphan Drug Exclusivity
OECD Organisation for Economic Cooperation and Development
ÖES Ökonomische Evaluations-Studien
OGD Office of Generic Drugs (FDA)
OGD Office of Govemment Drugs
OGE Office of Government Ethics
OID Optimal Immunomodulatory Dose
OJC Official Journal of the European Communities
OJL Official Joumal of the EU – L Series (Legislation)
OMD Orphan Medical Drugs siehe OMP
OMB Office of Management and Budget (USA)
OMCL Official Medicines Control Laboratories
OMP Orphan Medicinal Product
OMR Outcome Monitoring Review
ONDC Office of New Drug Chemistry (USA)
OPCS Office of Population, Censuses and Surveys (UK)
OPD Office of Orphan Products Development (FDA)
OPDRA Office of Post-Marketing Drug Risk Assessment (FDA)
OPPI Organisation of Pharmaceutical Producers of India
OPRR Office of Protection from Research Risks
OPS Office of Pharmaceutical Science (FDA)
ORI (Division of Research Investigations of the) Office of Research
Integrity (USA)
ORWH Office of Research on Woman’s Health (USA at NIH)
OSHA Occupational Safety and Health Administration (USA)
OTA Office of Technology Assessment
OTC Over The Counter (Drugs) – frei verkäufliche Arzneimittel
OTIS Teratology Information Services
OVG Oberverwaltungsgericht

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Wer versucht, mich zu ändern, ....muß mit Nebenwirkungen rechnen!

PA Product Authorization
PAGB Proprietary Association of Great Britain
PAHO Pan-American Health Organisation
PANDA Paper-assisted New Drug Application
PASS Post Authorisation Safety Studies
PBAC Pharmaceutical Benefits Advisory Committee (Australien)
PBM Pharmaceutical Benefit Management
PBM Pharmacy Benefit Management
PBM Prescription Benefits Management
PBS Pharmaceutical Benefit Scheme (Australien)
PCA Predefined Change –Abnormal
PCC Poison Control Center
PD Pharmacodynamics
PDE Permitted Daily Exposure
PDF Portable Document Format (Adobe Systems Inc.)
PDMA Prescription Drug Marketing Act
PDP Product Development Protocol/Profile (Medical Devices – USA)
PDQ Physicians‘ Data Query (NCI-sponsored cancer trial registry)
PDR Physicians‘ Desk Reference (USA)
PDUFA Prescription Drug User Fee Act (USA)
PE Pharmacoeconomics
PEC Predicted Effective Concentration
PED Pediatric Exclusivity
PEDI Pharmaceutical Electronic Data Interchange
PEFRAS Pan European Federation of Regulatory Affairs Society
PEI Paul-Ehrlich-Institut — Bundesamt für Sera und Impfstoffe siehe RKI
PEM Prescription-Event Monitoring (UK)
PEM Privacy Enhanced Mail
PER Pharmaceutical Evaluation Reports Scheme (EMEA-CPMP)
PER Pharmaceutical Evaluation Report Scheme
PERI Pharmaceutical Education and Research Institute
PHAGRO Bundesverband des pharmazeutischen Großhandels e.V.
Pharm. Ind. Die Pharmazeutische Industrie
(Pharma-Zeitschrift des ECV — Editio Cantor Verlag)
PharmBetrV. Betriebsverordnung für pharmazeutische Unternehmer
(Pharmabetriebsverordnung)
PhRMA Pharmaceutical Research and Manufactures of America –
amerikanischer Pharmaverband mit 67 Mitgliedern)
PhVWP Pharmacovigilance Working Party (der CPMP bzw. EMEA)
PIC Pharmaceutical Inspection Convention
PKV Verband der privaten Krankenversicherungen e.V.
PL Package Leaflet
PM Produktmanagement
PNEC Predicted No-Effect Concentration
ProdHaftG Produkthaftungsgesetz
PU (Pu) Pharmazeutischer Unternehmer
PU (Pu) Pharmazeutischer Unternehmer

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Wer versucht, mich zu ändern, ....muß mit Nebenwirkungen rechnen!

QA Quality Assurance
QC Quality Control
QU-S (QS) Qualitätssicherungssystem
QWP Quality Working Party

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Wer versucht, mich zu ändern, ....muß mit Nebenwirkungen rechnen!

RAS Rapid Alert System der EU
(Risiko-Schnellwarnsystem der EU-Behörden)
RIVM Rijksinstitute voor Volksgezondheid en Milieu, Netherlands
RKI Robert-Koch-Institut — Bundesinstitut für Infektionskrankheiten und
nicht übertragbare Krankheiten siehe auch PEI
RL Richtlinie (directive)
RMS Reference Member State
- Referenzland bei dezentralem Zulassungsverfahren bei
Erstzulassung

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Wer versucht, mich zu ändern, ....muß mit Nebenwirkungen rechnen!

SE Surrogate Endpoint
SEA Single European Act of 1987
SEC Securities and Exchange Commission (USA)
SEER Surveillance, Epidemiology, and End Results (Registry of NCI)
SGB Sozialgesetzbuch
SGB V Sozialgesetzbuch V
SGML Standard Generalised Markup Language, ISO (International
Organization for Standardization) 8879: construction of code
structures for text coding, stored as ASCII (American Standard Code
for Information Interchange)
SGML (sgml) Standard Generalized Markup Language
SIDC State Institute for Drug Control, Slovak Republic
SIMG International Society of General Practice
SMART Submission Management and Review Tracking
SMDA Safe Medical Devices Act
SME Significant Medical Event
SMO Site Management Organisation
SMRC Senior Management Review Committee (Canada)
SND Standard Nomenclature Database (FDA)
SNIP French Pharmaceutical Industry Association
SNOMED Systematized Nomenclature of Medicine
SOC System Organ Classes (MedDRA)
SoCRA Society of Clinical Research Associates
SOEP Socio-economic Panel
SOP Standard Operation Procedures
SOP Standard Operation Procedure — Standardarbeitsanweisung
SPAC State Pharmaceutical Administration of China
SPC Supplementary Patent
SPC Supplementary Protection Certificate (for pharmaceutical patents)
SPC (SmPC) Summary of Product Characteristics
SQAP Systems Quality Assurance Plan
SQL Standard/Structured Query Language
- ISO 9075: methods for defining tables according to relational data
base model, data storage and retrieval
SR Spontaneous Report
SRM Specific Risk Material
SRS Spontaneous Reporting Schemes
SSC Special Search Category (MedDRA)
SSC Study Site Coordinator
SSCT Swedish Society for Clinical Trials
SSFA Società di Scienze Farmacologiche Applicate (Italy)
STT Short Term Tests
SUAW Schwerwiegende, unerwünschte Arzneimittelwirkung
Serious Adverse Drug Reaction (Serious ADR)
SUE Schwerwiegendes, unerwünschtes Ereignis
Serious Adverse Event (SAE)
SUKL State Institute for Drug Control, Czech Republic
SWEDIS Swedish Drug Information System
SWP Safety Working Party

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Wer versucht, mich zu ändern, ....muß mit Nebenwirkungen rechnen!

TA Technology Assessment
TC Technical Committee (MPs)
TC Telematic Committee (Directorate General III)
TDDS Transdermal Delivery Device Systems
TDDSG Teledienste-Datenschutzgesetz
TDI Tolerable Daily Intake
TDM Therapeutic Drug Monitoring
TE Toxizitätsäquivalent
TE True Endpoint
TESS Treatment Emergent Signs and Symptoms
TGA Therapeutic Goods Administration (Australia)
TIFF Tagged Image File Format
TIFF Tagged Image File Format
TIND Treatment IND
TIS Teratology Information Services
TK Toxicokinetics
TMF Trial Master File
TMO Trial Management Organisation
TQM Total Quality Management
TRIPS Trade-related Aspects of Intellectual Property Rights
TTK Tagestherapiekosten Technischer
TÜV Technischer Überwachungsverein

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Wer versucht, mich zu ändern, ....muß mit Nebenwirkungen rechnen!