RAC DRUGS EXAM WITH CORRECT
DETAILED ANSWERS
(EU) yMA y- ycorrect yanswers y-Market yAuthorization yor yproduct ylicense yissued yby
yhealth yauthority. yValid yfor y5 yyears yand ysubject yto y1 yrenewal.
4 yEU yprocedures yto yobtain yan yMA y- ycorrect yanswers y-National, ycentralised,
ymutual yrecognition, ydecentralized yprocedures
MAH y- ycorrect yanswers y-A ylegal yperson yor ylegal yentity ywho ymust ybe yestablished
yin ythe yEuropean yEconomic yArea ycomprising yof y28 ymember ystates.
What ydoes yan yMA yinclude? y- ycorrect yanswers y-Active ysubstance yinternational
ynon-proprietary yname, ytrade yname.
SmPC y- ycorrect yanswers y-Summary yof yProduct yCharacteristics
PIL y- ycorrect yanswers y-Product yInformation yLeaflet
DETAILED ANSWERS
(EU) yMA y- ycorrect yanswers y-Market yAuthorization yor yproduct ylicense yissued yby
yhealth yauthority. yValid yfor y5 yyears yand ysubject yto y1 yrenewal.
4 yEU yprocedures yto yobtain yan yMA y- ycorrect yanswers y-National, ycentralised,
ymutual yrecognition, ydecentralized yprocedures
MAH y- ycorrect yanswers y-A ylegal yperson yor ylegal yentity ywho ymust ybe yestablished
yin ythe yEuropean yEconomic yArea ycomprising yof y28 ymember ystates.
What ydoes yan yMA yinclude? y- ycorrect yanswers y-Active ysubstance yinternational
ynon-proprietary yname, ytrade yname.
SmPC y- ycorrect yanswers y-Summary yof yProduct yCharacteristics
PIL y- ycorrect yanswers y-Product yInformation yLeaflet
