////////////////////////////////////////////////////////////////////////
RAC /
DRUGS
/ /
EXAM QUESTIONS WITH ANSWERS
/ // // //
(EU) /
/MA //- /
/correct /
/answer(s) /
/✔✔ /
/Market /
/Authorization /
/or /
/product //license //issued //by //health //authority. //Valid //for //5 //years //and //subject //to //1 //renewal.
4/
/EU /
/procedures /
/to /
/obtain /
/an /
/MA //- /
/correct /
/answer(s) //✔✔ //National, //centralised, //mutual //recognition, //decentralized //procedures
MAH //- /
/correct /
/answer(s) /
/✔✔ //
A/
/legal /
/person /
/or /
, ////////////////////////////////////////////////////////////////////////
/legal /
/entity /
/who /
/must //be //established //in //the //European //Economic //Area //comprising //of //28 //member //states.
What //does //an //MA //include? //- //correct //answer(s) //✔✔ //Active //substance //international //non-
proprietary //name, //trade //name.
SmPC //- //correct //answer(s) //✔✔ //Summary //of //Product //Characteristics
PIL //- //correct //answer(s) //✔✔ //Product //Information //Leaflet
6/
/months //- /
/correct /
/answer(s) /
/✔✔ //How //many //months //prior //to //expiration //should //MA //renewal //be //submitted?
Qualified /
/Person /
/(QP) /
/in /
/charge /
/of? //- /
/correct /
/answer(s) /
/✔✔ /
/Pharmacovigilance, //scientific //service //in //charge //of //each //medicinal //products //scientific //info
ASMF //- /
/correct /
/answer(s) /
/✔✔ /
RAC /
DRUGS
/ /
EXAM QUESTIONS WITH ANSWERS
/ // // //
(EU) /
/MA //- /
/correct /
/answer(s) /
/✔✔ /
/Market /
/Authorization /
/or /
/product //license //issued //by //health //authority. //Valid //for //5 //years //and //subject //to //1 //renewal.
4/
/EU /
/procedures /
/to /
/obtain /
/an /
/MA //- /
/correct /
/answer(s) //✔✔ //National, //centralised, //mutual //recognition, //decentralized //procedures
MAH //- /
/correct /
/answer(s) /
/✔✔ //
A/
/legal /
/person /
/or /
, ////////////////////////////////////////////////////////////////////////
/legal /
/entity /
/who /
/must //be //established //in //the //European //Economic //Area //comprising //of //28 //member //states.
What //does //an //MA //include? //- //correct //answer(s) //✔✔ //Active //substance //international //non-
proprietary //name, //trade //name.
SmPC //- //correct //answer(s) //✔✔ //Summary //of //Product //Characteristics
PIL //- //correct //answer(s) //✔✔ //Product //Information //Leaflet
6/
/months //- /
/correct /
/answer(s) /
/✔✔ //How //many //months //prior //to //expiration //should //MA //renewal //be //submitted?
Qualified /
/Person /
/(QP) /
/in /
/charge /
/of? //- /
/correct /
/answer(s) /
/✔✔ /
/Pharmacovigilance, //scientific //service //in //charge //of //each //medicinal //products //scientific //info
ASMF //- /
/correct /
/answer(s) /
/✔✔ /
