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Rac Drugs Exam Questions With Answers.

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RAC DRUGS EXAM QUESTIONS WITH ANSWERS.

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////////////////////////////////////////////////////////////////////////




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) /


/✔✔ /

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