RAC DRUGS EXAM QUESTIONS WITH CORRECT
ANSWERS
(EU) |MA |- |CORRECT |ANSWER✔✔-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✔✔-National, |centralised, |mutual |
recognition, |decentralized |procedures
MAH |- |CORRECT |ANSWER✔✔-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✔✔-Active |substance |international |non-
proprietary |name, |trade |name.
SmPC |- |CORRECT |ANSWER✔✔-Summary |of |Product |Characteristics
PIL |- |CORRECT |ANSWER✔✔-Product |Information |Leaflet
6 |months |- |CORRECT |ANSWER✔✔-How |many |months |prior |to |expiration |should |MA |renewal |
be |submitted?
Qualified |Person |(QP) |in |charge |of? |- |CORRECT |ANSWER✔✔-Pharmacovigilance, |scientific |
service |in |charge |of |each |medicinal |products |scientific |info
ANSWERS
(EU) |MA |- |CORRECT |ANSWER✔✔-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✔✔-National, |centralised, |mutual |
recognition, |decentralized |procedures
MAH |- |CORRECT |ANSWER✔✔-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✔✔-Active |substance |international |non-
proprietary |name, |trade |name.
SmPC |- |CORRECT |ANSWER✔✔-Summary |of |Product |Characteristics
PIL |- |CORRECT |ANSWER✔✔-Product |Information |Leaflet
6 |months |- |CORRECT |ANSWER✔✔-How |many |months |prior |to |expiration |should |MA |renewal |
be |submitted?
Qualified |Person |(QP) |in |charge |of? |- |CORRECT |ANSWER✔✔-Pharmacovigilance, |scientific |
service |in |charge |of |each |medicinal |products |scientific |info
