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RAC Devices Exam Prep (EU) Questions and Answers
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RAC Devices Exam Prep (EU) Questionsand Answers
Who iiis iithe iiEuropean iiMedicines iiAgency ii(EMA) ii- iiAnswers ii-an iiagency iiof iithe
iiEuropean iiUnion ii(EU) iiin iicharge iiof iithe iievaluation iiand iisupervision iiof iimedicinal
iiproducts. iiThe iiprimary iireason iifor iiestablishing iiEMA iiwas iito iiharmonise iithe iiwork
iibeing iidone iiby iithe iiindividual
regulatory iibodies iiin iiEurope.
Relevance iiof iiEMA iiin iiEU ii- iiAnswers ii-founded iiin ii1995, iiworking iiacross iithe iiEU iito
iiprotect
human iiand iianimal iihealth iiby iiassessing iimedicines iito iirigorous iiscientific iistandards
iiand iiby iiproviding iipartners iiand iistakeholders iiwith iiindependent, iiscience-based
iiinforma iition iion iimedicines
Mission iiof iiEMA ii- iiAnswers ii--Facilitate iidev iiand iiaccess iito iimedicines
-Evaluate iiapplications iifor iimarketing iiauthorisation
-Monitor iisafety iiof iimeds
-Provide iiinfo iion iihuman iiand iivet iimeds iito iiprofessionals iiand iipatients
New iiApproach ii(EU) ii- iiAnswers ii-The iibasic iiconcept iiis iiincluding iiEssential
iiRequirements iifor iisafety iiand iiperformance iiin iithe iicore iilegal iitext iiand iipublishing iithe
iitechnical iispecifications iiin iiharmonised iistandards.
Other iidef: iiA iiinnovative iiregulatory iitechnique iitha iiincludes iimandatory iiEssential
iirequirements, iiconformity iiassessment iiprocedures iiand iiCE iimarking.
1990s, iiNew iiApproach ii(impact iion iiMDs) ii- iiAnswers ii-EU iiregulations iirelating iito
iimedical iidevices' iisafety iiand iiperformance iiwere iiharmonised iiin iithe ii____(date) ii_,
iifollowing iithe ii_____ ii_____ iilegislative iiprinciples.
AIMDD ii(# iiand iidate) ii- iiAnswers ii-Council iiDirective ii90/385/ iiEEC, ii20 iiJune ii1990
MDD ii(# iiand iidate) ii- iiAnswers ii-Council iiDirective ii93/42/EEC, ii14 iiJune ii1993
IVDD ii(# iiand iidate) ii- iiAnswers ii-Directive ii98/79/EC iiof iithe iiEuropean iiParliament iiand
iiof iithe iiCouncil, ii27 iiOctober ii1998
key iihistoric iidevelopments iiinfluencing iitoday's iiEU iihealthcare iiregulations ii- iiETHICS ii-
iiAnswers ii-the iiNuremberg iiCode, iiwas iidrafted iiin ii1947.
The iiHelsinki iiDeclaration iiof ii1964 iifurther iideveloped
, the iiNuremburg iiCode's iiprinciples, iiand iitied iithem iito
the iiDeclaration iiof iiGeneva ii(1948), iian iiinternationally
acknowledged iistatement iiof iiphysicians' iiethical iiresponsibilities.
medicinal iiproduct iiadvertising iiand iipromotion ii(#) ii- iiAnswers ii-EU iiDirective
ii2001/83/EC
Six ii(6) iibasic iiprinciples iiin iiEU iiDirective ii2001/83/EC ii- iiAnswers ii-1. iimedicines
iiwithout iia iimarket iiauthorisation iishall iinot iibe iiadvertised
2. iino iioff-label iiindications iiadvertising
3. iiadvertising iiof iia iimedicine iimust iicomply iiwith
the iispecifics iiin iithe iisummary iiof iiproduct iichar-
acteristics ii(SmPC)
4. iiadvertising iiof iia iimedicine iishall iiencourage iithe
rational iiuse iiof iithe iiproduct iiby iian iiobjective iipre-
sentation iiand iishall iinot iibe iimisleading
5. iiprescription iimedicines iimay iionly iibe iiadvertised
to iiHCPs iiwith iithe iiqualifications iito iiprescribe iior
supply iithem
6. iiOTC iimedicines iimay iibe iiadvertised iito iithe iigen-
eral iipublic, iisubject iito iicertain iirules.
EU's iicurrent iiposition iion iimedical iidevice iiadvertising ii- iiAnswers ii-there iiare iino iiEU-
level iirules iithat iiprovide iian iioverarching
regulatory iiframework iifor iithe iiadvertising iiand iipromotion
of iimedical iidevices.
prohibited iito iiuse iitext, iinames, iitrademarks, iipictures iiand
figurative iior iiother iisigns iithat iimay iimislead iithe iiuser iior
the iipatient iiwith iiregard iito iithe iidevice's iiintended iipurpose, iisafety iiand iiperformance
differences iibetween iiEU iiMember iiState iinational iirules iion iimedicinal iiproduct
iipromotion iiversus iithe iiEU iiDirective ii- iiAnswers ii-Some iiMember iiStates iihave
iiimplemented iiprocesses iifor
preapproval iiof iipromotional iimaterial iiin iitheir iilocal iimar-
ket iisurveillance iiregulations.
the iiimpact iiand iiaims iiof iiinternational iiand iiEuropean iicodes iiof iiconduct iiand iitheir
iiimplementation iiinto iinational iicodes iiof iiconduct
via iitrade iiassociations ii(PLACEHOLDER) ii- iiAnswers ii-
Blue iiGuide ii- iiAnswers ii-The iiguide iito iithe iiimplementation iiof iidirectives iibased iion iithe
iiNew iiApproach iiand iithe iiGlobal iiApproach
from ii2000. iiGives iia iidetailed iidescription iiof iiNew iiApproach iiand iiGlobal iiApproach
iidirectives
Although iinot iiformal iilaw, iithe ii___ ii___
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