7 Questions
Who defines the general political direction and priorities of the European Union?
European Council
Which institution proposes new laws in the European Union?
European Commission
What committee is responsible for drug safety for human use within the EMA?
Pharmacovigilance Committee for Risk Assessment
Which authority inspects manufacturers listed in application form one marketed medicines?
EU competent authority
In the absence of a Mutual Recognition Agreement (MRA), where are manufacturers outside the EU inspected?
By an EU competent authority
When a safety issue arises for a medicinal product authorized in multiple Member States, what regulatory measures are taken?
"One size fits all" approach across the EU
Who adopts new laws proposed by the European Commission?
European Parliament
This quiz covers an overview of the core EU legal regulatory environment directives governing the regulation of drugs, including Directive 2001/83/EC, Regulation (EC) No 141/2000 for orphan medicines, Regulation (EC) No 726/2004 for the centralised procedure, and more.
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