European Medicines Agency and Public Health

Podcast

Play an AI-generated podcast conversation about this lesson

Questions and Answers

Who is the authorising body for all centrally-authorised products in the EU?

European Commission (correct)

EMA

European Medicines Agency

European Parliament

What is the role of the European Medicines Agency (EMA) in the marketing authorization process?

Grants EU-wide marketing authorisation

Oversees pricing and reimbursement decisions

Makes the final decision on marketing authorization

Formulates scientific opinions and recommendations (correct)

When does the European Commission issue its final legally binding decision on marketing authorization?

Within 120 days of initial assessment

After clock stop 2 at day 210

67 days after receipt of EMA's recommendation (correct)

Once EMA completes further consultations

What role does the European Commission play in decisions on patient access to medicines?

Decides on pricing and reimbursement at national levels Signup and view all the answers

Who takes the final legally binding decision on whether a medicine can be marketed in the EU?

European Commission Signup and view all the answers

What happens after EMA sends its scientific opinions and recommendations to the European Commission?

European Commission issues the final decision Signup and view all the answers

What is the main responsibility of the European Medicines Agency (EMA) according to the text?

Providing scientific opinions on marketing authorisations Signup and view all the answers

What happens following the centralized procedure for marketing authorizations?

The European Commission grants centralized marketing authorisation valid in all EU Member States Signup and view all the answers

In what way does the EMA contribute to public health according to the text?

Monitoring the safety of medicines across their lifecycle Signup and view all the answers

What does the EMA do once granted with centralised marketing authorisation applications?

Monitor the safety of Medicines across their lifecycle Signup and view all the answers

Which organization is involved in the process of cooperation with other EU institutions and Agencies according to the text?

World Health Organization (WHO) Signup and view all the answers

What is the responsibility of EMA regarding antibiotic resistance according to the text?

Provide scientific opinions on medicines as requested Signup and view all the answers

What are the main principles that the European Medicines Agency (EMA) verifies compliance with?

Good manufacturing practice (GMP), good clinical practice (GCP), good laboratory practice (GLP), and good pharmacovigilance practice (GVP) Signup and view all the answers

In addition to GMP, GCP, GLP, and GVP, what other aspects of supervision do inspections by EMA verify compliance with?

Distribution chain integrity Signup and view all the answers

Which regulations specify the roles and responsibilities of EMA in ensuring compliance with various practices?

Regulation (EC) 726/2004, Directive 2001/83/EC, and Directive 2001/82/EC Signup and view all the answers

What is the main objective of the sampling and testing programme implemented by EMA?

To check compliance of products on the market with their authorised specifications Signup and view all the answers

What does the sampling and testing programme specifically involve according to the text?

Monitoring quality throughout the distribution chain and ensuring control methods are satisfactory Signup and view all the answers

Apart from monitoring quality through the distribution chain, what else does the sampling and testing programme assist with?

Investigating suspected quality defects and assisting with testing of falsified medicines Signup and view all the answers

Study Notes

European Medicines Agency (EMA)

Provides scientific opinions on medicines
Responsible for protecting and promoting public and animal health by evaluating medicines for human and veterinary use

Centralised Marketing Authorisation

Covers all European Union (EU) Member States, Iceland, Norway, and Liechtenstein
Valid after grant by the European Commission
Includes evaluation of marketing authorisation applications (MAA)

Steps in Centralised Procedure

Initial assessment and list of questions (by day 120)
Clock stop 1: Further assessment and list of outstanding issues (by day 180)
Clock stop 2: Further consultations (by day 210)
Final discussion and adoption of opinion
Possible re-examination

EMA's Role

Recommends to the European Commission on marketing authorisation
Supervises safety of medicines in the EU after authorisation
Monitors safety of medicines across their lifecycle
Provides scientific opinions on medicines at request of Member States or the European Commission

Decisions on Patient Access to Medicines

Decisions made at national and regional level on pricing and reimbursement
EMA has no role in decisions on pricing and reimbursement

EMA's Inspections

Coordinates inspections to verify compliance with good manufacturing practice (GMP), good clinical practice (GCP), good laboratory practice (GLP), and good pharmacovigilance practice (GVP)
Verifies compliance with other aspects of supervision of authorised medicinal products in use in the EU

Sampling and Testing

Supervises quality of centrally authorised medicines available on the European market through yearly sampling and testing programme
Checks compliance of products on the market with authorised specifications
Monitors quality of finished products in all parts of the distribution chain throughout the authorised shelf-life
Ensures control methods are satisfactory
Investigates suspected quality defects (if required)
Assists with testing of falsified medicines (if required)

Studying That Suits You

Use AI to generate personalized quizzes and flashcards to suit your learning preferences.

Description

Learn about the European Medicines Agency's responsibilities, including scientific opinions, marketing authorisations, and cooperation with other EU institutions and global health organizations like WHO.EMA.