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European Medicines Evaluation Procedure Steps

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European Medicines Evaluation Procedure Steps

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Questions and Answers

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?

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?

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?

Valid in all EU Member States, Iceland, Norway, and Liechtenstein Signup and view all the answers

When can the European Medicines Agency (EMA) provide scientific opinions on medicines?

At the request of Member States or the European Commission Signup and view all the answers

Which institution is responsible for defining the general political direction and priorities of the European Union?

European Council Signup and view all the answers

What is the role of the Pharmacovigilance Committee for Risk Assessment (PRAC) within the European drug regulatory system?

Monitoring the safety of medicines Signup and view all the answers

In the absence of a Mutual Recognition Agreement (MRA), where are manufacturers listed in application form one marketed medicines inspected?

By an EU competent authority Signup and view all the answers

Who adopts the new laws proposed by the European Commission?

Both European Parliament and Council Signup and view all the answers

What happens in the event of a safety issue for a medicinal product authorized in more than one Member State?

Same regulatory measures across the EU Signup and view all the answers

What is the role of the European Commission in the legislative process?

Proposing new laws Signup and view all the answers