Podcast
Questions and Answers
What is the main responsibility of the European Medicines Agency (EMA)?
What does the European Medicines Agency (EMA) do after granting centralised marketing authorisation?
Who issues the final decision on centralised marketing authorisations in the European Union?
What is the scope of a centralised marketing authorisation granted by the European Commission?
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When can the European Medicines Agency (EMA) provide scientific opinions on medicines?
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Which institution is responsible for defining the general political direction and priorities of the European Union?
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What is the role of the Pharmacovigilance Committee for Risk Assessment (PRAC) within the European drug regulatory system?
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In the absence of a Mutual Recognition Agreement (MRA), where are manufacturers listed in application form one marketed medicines inspected?
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Who adopts the new laws proposed by the European Commission?
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What happens in the event of a safety issue for a medicinal product authorized in more than one Member State?
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What is the role of the European Commission in the legislative process?
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