Podcast
Questions and Answers
What is the main responsibility of the European Medicines Agency (EMA)?
What is the main responsibility of the European Medicines Agency (EMA)?
- Promotion and protection of public and animal health by evaluating medicines for human and veterinary use (correct)
- Providing scientific opinions on medicines without evaluating their safety
- Issuing marketing authorisations only for medicines in EU Member States
- Supervising the manufacturing process of medicines across Europe
What does the European Medicines Agency (EMA) do after granting centralised marketing authorisation?
What does the European Medicines Agency (EMA) do after granting centralised marketing authorisation?
- Hands over all monitoring responsibilities to individual EU Member States
- Halts all evaluation processes for new medicines
- Supervises the safety of medicines in the EU and monitors their safety across their lifecycle (correct)
- Provides no further oversight or evaluation of the authorized medicines
Who issues the final decision on centralised marketing authorisations in the European Union?
Who issues the final decision on centralised marketing authorisations in the European Union?
- World Health Organization (WHO)
- Public Health organizations
- European Medicines Agency (EMA)
- European Commission (correct)
What is the scope of a centralised marketing authorisation granted by the European Commission?
What is the scope of a centralised marketing authorisation granted by the European Commission?
When can the European Medicines Agency (EMA) provide scientific opinions on medicines?
When can the European Medicines Agency (EMA) provide scientific opinions on medicines?
Which institution is responsible for defining the general political direction and priorities of the European Union?
Which institution is responsible for defining the general political direction and priorities of the European Union?
What is the role of the Pharmacovigilance Committee for Risk Assessment (PRAC) within the European drug regulatory system?
What is the role of the Pharmacovigilance Committee for Risk Assessment (PRAC) within the European drug regulatory system?
In the absence of a Mutual Recognition Agreement (MRA), where are manufacturers listed in application form one marketed medicines inspected?
In the absence of a Mutual Recognition Agreement (MRA), where are manufacturers listed in application form one marketed medicines inspected?
Who adopts the new laws proposed by the European Commission?
Who adopts the new laws proposed by the European Commission?
What happens in the event of a safety issue for a medicinal product authorized in more than one Member State?
What happens in the event of a safety issue for a medicinal product authorized in more than one Member State?
What is the role of the European Commission in the legislative process?
What is the role of the European Commission in the legislative process?
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