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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?
- European Council (correct)
- Council of Ministers
- European Parliament
- European Commission
Which institution proposes new laws in the European Union?
Which institution proposes new laws in the European Union?
- European Parliament
- European Commission (correct)
- Council of Ministers
- European Council
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?
- Committee for Orphan Medicinal Products
- Pharmacovigilance Committee for Risk Assessment (correct)
- Committee for Advanced Therapies
- Committee on Medicinal Products for Human Use
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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