Podcast
Questions and Answers
Who defines the general political direction and priorities of the European Union?
Who defines the general political direction and priorities of the European Union?
Which institution proposes new laws in the European Union?
Which institution proposes new laws in the European Union?
What committee is responsible for drug safety for human use within the EMA?
What committee is responsible for drug safety for human use within the EMA?
Which authority inspects manufacturers listed in application form one marketed medicines?
Which authority inspects manufacturers listed in application form one marketed medicines?
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In the absence of a Mutual Recognition Agreement (MRA), where are manufacturers outside the EU inspected?
In the absence of a Mutual Recognition Agreement (MRA), where are manufacturers outside the EU inspected?
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When a safety issue arises for a medicinal product authorized in multiple Member States, what regulatory measures are taken?
When a safety issue arises for a medicinal product authorized in multiple Member States, what regulatory measures are taken?
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Who adopts new laws proposed by the European Commission?
Who adopts new laws proposed by the European Commission?
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