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TermCountryDefenition
AADAIntAbbreviated Antibiotic Drug Application
AAPSUSAmerican Association of Pharmaceutical Scientists
ABCUSAmerican Botanical Council
ABPIUKAssociation of British Pharmaceutical Industries
ACSIUSAmerican Customer Satisfaction Index
ADMEIntAbsorption, Distribution, Metabolism, and Excretion
ADRIntAdverse Drug Reaction
AFIntApplication Form
AFIITAssociazione Farmaceutici Industria
AFSSPSFRAgence Francaise de Securite Sanitaire des Produits de Sante
AICITAutorizzazione Immissione in Commercio
AICQITAssociazione Italiana per la Qualità
AICRCUKAssociation of Independent Clinical Research Contractors
AIFAITAgenzia Italiana del Farmaco
AMGDEArzneimittelgesetz (German Drug Law)
ANDAUSAbbreviated New Drug Application
ANDSIntAbbreviated New Drug Submission
AOITAzienda Ospedaliera
AUAITAutorizzazione Utenze Aziendali
APIIntActive Pharmaceutical Ingredients
ASLITAzienda Sanitaria Locale
ARIntAssessment Report
ASMFIntActive Substance Master Files
BAIDIntMedicinal Product Batch Identifier
BAPPUKBritish Association of Pharmaceutical Physicians
BfArMDEBundesinstitut für Arzneimittel und Medizinprodukte (German: Federal Institute for Drugs and Medical Devices
BLAIntBiologics License Application
BPUKBritish Pharmacopoeia
BPDIntBiocidal Products Directive
BPLITBuona Pratica Laboratorio
BSEIntBovine Spongiform Encephalopathy
CAPRACNDCanadian Association of Pharmaceutical Regulatory Affairs
CATIntCommittee for Advanced Therapies
CAPAIntCorrective And Preventive Action
CAS NumberIntChemical Abstracts Service Number
CBERUSCenter for Biologics Evaluation and Research
CDCUSCenters for Disease Control
CDERUSCenter for Drug Evaluation and Research
CDRHUSCenter for Devices and Radiological Health
CEITConsiglio Europeo
CENIntComité Européen de Normalisation
CEPIntCertificate European Pharmacopoeia
CESITComitato Economico e Sociale
CGMPsIntCurrent Good Manufacturing Practices
CHMPIntCommittee for Medicinal Products for Human Use
CIOMSIntCouncil for International Organizations of Medical Sciences
CIPEITComitato Interministeriale per la Programmazione Economica
CLP regulationIntClassification, Labelling and Packaging Regulation
CLVITCertificato di Libera Vendita
CMCUSChemistry, Manufacturing, and Controls
CMD(h)IntCo-ordination Group for Mutual Recognition and Decentralised Procedures – Human
CMD(v)IntCo-ordination Group for Mutual Recognition and Decentralised Procedures – Veterinary
CMSIntConcerned Member State
CNDITClassificazione Nazionale dei Dispositivi Medici
COLIPAIntComité de Liaison des Associations Européennes de LIndustrie de la Parfumerie, des Produits Cosmetiques et de Toilette
COMPIntCommittee for Orphan Medicine Product
COPRIntControl of Pesticides Regulations
CoSIntCertificate of Suitability
CPIntCentralized Procedure
CPPITCertificato di Prodotto Farmaceutico
CRCIntClinical Research Coordinator
CROIntContract Research Organisation
CSDUKCommittee on Safety of Medicines
CSRIntClinical Study Report
CSSITConsiglio Superiore di Sanità
CTAInt Clinical Trial Application
CTDIntCommon Technical Dossier
CTCUKClinical Trial Certificate
CTSITCommissione Tecnico Scientifica
CTXUKClinical Trial Exemption
CUFITCommissione Unica del Farmaco
CVMPIntCommittee for Medicinal Products for Veterinary Use
DCPIntDecentralised Procedure
DDIntDue Diligence
DDDIntDear Doctor Letter
DDDIntDefine Daily Dose/ Dose Define Die
DdLITDisegno di Legge
DLITDecreto Legge
D.Lgs.ITDecreto Legislativo
D.M.ITDecreto Ministeriale
DMITDispositivo Medico
DMFIntDrug Master File
DPIITDispositivi per la Protezione Individuale
DRGIntDiagnosis Related Groups
DDPSDetailed Description Pharmacovigilance System
ECHAIntEuropean Chemical Agency
ECMITEducazione Continua in Medicina
eCTDIntelectronic Common Technical Dossier
EDQMIntEuropean Directorate for the Quality of Medicines & HealthCare
EEAIntEuropean Economic Area
EFPIAIntEuropean Federation of the Pharmaceutical Industries and Associations
EFQMIntEuropean Foundation for Quality Management
EFSAIntEuropean Food Safety Authority
EFTAIntEuropean Free Trade Association
EGAIntEuropean Generic medicines Association
EINECSIntEuropean Inventory of Existing Commercial Chemical Substances
EMAIntEuropean Medicine Agency
EMVOIntEuropean Medicines Verification Organisatio
EMVSEuropean Medicines Verification System
EOQIntEuropean Organization for Quality
EPARIntEuropean Public Assessment Report
EPOIntEuropean Patent Organisation
ESOPIntElectronic Standard Operating Procedure
ESTRIIntElectronic Standards for the Transmission of Regulatory Information
ETOMEPIntEuropean Technical Office for Medicinal Products
EUCOMEDIntEuropean Confederation of Medical Devices Association
EUDRAIntEuropean Union Drug Regulatory Authorities
EUNDBEuropean Union Network Data Board
EVCTMIntEudraVigilance Clinical Trial Module
EVDASIntEudraVigilance Data warehouse Analysis System
EVIEuropean Medicines Verification System Information
FANSITFarmaci Anti-infiammatori non Steroidei
FDAUSFood and Drug Administration
FMDFalsified Medicines Directive
FMEAIntFailure Mode and Effects Analysis
FSCIntFree Sale Certificate
FUITFarmacopea Ufficiale
GCPIntGood Clinical Practice
GDPIntGood Distribution Practice
GHSIntGlobally Harmonised System
GHTSIntGlobal Harmonisation Task Force
GLPIntGood Laboratory Practice
GMDNIntGlobal Medical Device Nomenclature
GMPIntGood Manufacturing Practice
GPvPIntGood Pharmacovigilance Practise
GTINGlobal Trade Identification Number
GVPIntGood Vigilance Practises
GUITGazzetta Ufficiale
HACCPIntHazard Analysis Critical Control Point
HMAIntHeads of Medicines Agency
HMPCIntCommittee on Herbal Medicinal Products
HPFBIntHealth Products and Food Branch
HPLCIntHigh-performance liquid chromatography
HSEUKHealthy Survey for England
ICDRAIntInternational Conference of Drug Regulatory Authorities
ICHIntInternational Conference on Harmonisation
ICSRIntIndividual Case Safety Report
IDEUSInvestigational Device Exemption
IDMPIdentification of Medicinal Products
IFPMAIntInternational Federation of Pharmaceutical Manufacturers & Associations
IfUIntIstruction for Use
INCIIntInternational Nomenclature of Cosmetic Ingredients
INDUSInvestigational New Drug Application
IRDIntInitial Receipt Dates
ISBNIntInternational Standard Book Number
ISOIntInternational Organization for Standardization
ISPRAITIstituto Superiore per la Protezione e la Ricerca Ambientale
ISSITIstituto Superiore di Sanità
ISTATITIstituto Nazionale di Statistica
IUCLIDIntInternational Uniform Chemical Information Database
IUPACIntInternational Union of Pure and Applied Chemistry
IVDIntIn Vivo Diagnostic
JPMAIntJapan Pharmaceutical Manufacturers Association
LARNITLivelli di Assunzione giornalieri Raccomandati di energia e Nutrienti
LoAIntLetter of Access
MAIntMarketing Authorization
MAAIntMarketing Authorization Application
MAHIntMarketing Authorization Holder
MBTCIntManagement Board Telematics Committee
MCAUKMedicines Control Agency
MDIntMedical Device
MDMAUSMedical Device Manufacturers Association
MDRIntMedical Devices Regulations
MdS – MinSalITMinistero della Salute
MEAIntManaged Entry Agreements
MedDRAIntMedical Dictionary for Drug Regulatory Affairs
MHRAUKMedicines and Healthcare Products Regulatory Agency
MIURITMinistero dell’Istruzione, dell’Università e della Ricerca
MNDSGPMinistry of National Development
MPIDMedicinal Product Identifier
MRPIntMutual Recognition Procedure
NASITNucleo Antisofisticazione e Sanità
NASIntNew Active Substance
NBIntNotified Body
NBFITNorme di Buona Fabbricazione
NCAUKNational Competent Authority
NCIUSNational Cancer Institute
NCNPRIntNational Center Natural Products Research
NDAUSNew Drug Application
NDSIntNew Drug Submission
NIHIntNational Institutes of Health
NMVONational Medicines Verification Organisations
NOISITNulla Osta Igienico Sanitario
NPAUKNational Pharmaceutical Association
OBPOn-Boarding Partner
ODIntOrphan Drug
ONITOrganismi Notificati
NSAIDIntNonsteroidal Anti-inflammatory Drug
OGDUSOffice of Generic Drugs
OGMITOrganismo Geneticamente Modificato
OMCLIntOfficial Medicines Control Laboratories
OMSITOrganizzazione Mondiale della Sanità
OTCIntOver the Counter
PATIntProcess Analytical Technology
PCIDPackaged Medicinal Product Identifier
PDCOIntPediatric Committee
PhPIDPharmaceutical Product Identifier
PHTITProntuario ospedale-territorio
PhVWPIntPharmacovigilance Working Party
PICSFRProgrammes Internationaux de Coopération Scientifique
PICSIntPharmaceutical Inspection Cooperation Scheme
PILIntProduct Information Label
PIMIntProduct Information Management
PIPIntPediatric Investigation Plan
PMAUSPre-market Authorization for approval of class III devices
PMCITPresidio Medico Chirurgico
PMIITPiccole e Medie Imprese
PRRIntProportional Reporting Ratio
PRACPharmacovigilance Risk Assessement Committee
PSMFIntPharmacovigilance Sistem Master File
PSURIntProduct Safety Update Report
PVARIntPreliminary Variation Assesment Report
RMSIntReference Member State
QAIntQuality Assurance
QCIntQuality Control
QOSIntQuality Overall Summary
QPIntQualified Person
QPPVIntQualified Person Pharmacovigilance
QRDIntQuality Review of Documents
RAEEITRifiuti di Apparecchiature Elettriche ed Elettroniche
RAPEXIntRapid Exchange about Safety Product
RAPSIntRegulatory Affairs Professionals Society
RCPITRiassunto delle Caratteristiche del Prodotto
REACHIntRegistration, Evaluation, Authorisation and Restriction of Chemicals
R&DIntResearch and Development
RMPIntRisk Management Plan
RPSGBUKRoyal Pharmaceutical Society of Great Britain
SAEIntSerious Adverse Event
SAGIntScientific Advisory Group
SCIITSocietà Chimica Italiana
SDRsIntSignals Disproportionate Reporting
SMFIntSite Master File
SMEIntSmall and Medium-sized Enterprise
SOPUSStandard Operating Procedure
SOPITSenza Obbligo di Prescrizione
SIAFITSistema Informatico Anagrafe Fondi
SIARITSocietà Italiana Attività Regolatorie
SPCIntSummary of Product Characteristics
SPORSubstance, Product, Organisations and Referentials
SSNITServizio Sanitario Nazionale
SUSARIntSuspected, Unexpected, Serious Adverse Reaction
SVHCIntSubstances of Very High Concern
THRIntTraditional Herbal Registration
THRMSIntTraditional Herbal Medicines Registration Scheme
TNGIntTechnical Note for Guidance
ToCIntTable of Contents
TOPRAIntThe Association for Regulatory Affairs Professionals
TRACSUSTransit Rail Advisory Committee for Safety
TSE0IntTransmissible Spongiform Encephalopathy
USANUSUnited States Adopted Names
USMAFITUffici Sanità Marittima Aerea e di Frontiera
USPUSUnited States Pharmacopeia
USRIntUrgent Safety Restriction
VAMFIntVaccine Antigen Master File
VNRITValori Nutritivi di Riferimenti
WHOIntWorld Health Organisation