18 Questions
Who is the authorising body for all centrally-authorised products in the EU?
European Commission
What is the role of the European Medicines Agency (EMA) in the marketing authorization process?
Formulates scientific opinions and recommendations
When does the European Commission issue its final legally binding decision on marketing authorization?
67 days after receipt of EMA's recommendation
What role does the European Commission play in decisions on patient access to medicines?
Decides on pricing and reimbursement at national levels
Who takes the final legally binding decision on whether a medicine can be marketed in the EU?
European Commission
What happens after EMA sends its scientific opinions and recommendations to the European Commission?
European Commission issues the final decision
What is the main responsibility of the European Medicines Agency (EMA) according to the text?
Providing scientific opinions on marketing authorisations
What happens following the centralized procedure for marketing authorizations?
The European Commission grants centralized marketing authorisation valid in all EU Member States
In what way does the EMA contribute to public health according to the text?
Monitoring the safety of medicines across their lifecycle
What does the EMA do once granted with centralised marketing authorisation applications?
Monitor the safety of Medicines across their lifecycle
Which organization is involved in the process of cooperation with other EU institutions and Agencies according to the text?
World Health Organization (WHO)
What is the responsibility of EMA regarding antibiotic resistance according to the text?
Provide scientific opinions on medicines as requested
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)
In addition to GMP, GCP, GLP, and GVP, what other aspects of supervision do inspections by EMA verify compliance with?
Distribution chain integrity
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
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
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
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
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)
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.
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