Skip to main content
Side panel
About
About Open Classroom
EUPATI Fellows
Our Impact
Learning Pathways
FAQ
Open Classroom
Learning Catalogue
Patient Expert Training Programme
Resources
Glossary
EUPATI Toolbox
Accessibility Resources
More
You are currently using guest access
Log in
About
Collapse
Expand
About Open Classroom
EUPATI Fellows
Our Impact
Learning Pathways
FAQ
Open Classroom
Collapse
Expand
Learning Catalogue
Patient Expert Training Programme
Resources
Collapse
Expand
Glossary
EUPATI Toolbox
Accessibility Resources
Home
Regulatory procedures - Marketing-Authorisations and their lifecycle management
Announcements
Announcements
Return to course
Open course index
General news and announcements
Search forums
Search forums
(No announcements have been posted yet.)
Jump to...
Jump to...
1. Introduction: Regulatory affairs in the medicines development process
2. Legal framework – EU legislation - EudraLex
3. Legal bodies responsible for regulatory procedures
4. Marketing authorisation
5. EU Regulatory procedures for a marketing authorisation (MA)
6. Refusal of a Marketing Authorisation
1. Non-standard marketing authorisations
2. Accelerated assessment
3. Special cases in marketing authorisations: Orphan Medicines
4. Special cases in marketing authorisations: Advanced therapy medicines (ATMPs)
5. Special cases in marketing authorisations: Paediatric medicines
6. Special cases in marketing authorisations:Homeopathic medicines
7. Special cases in marketing authorisations: Herbal medicines
8. Post-Approval
Additional resources
1. Introduction and recap
2. Pre-submission
3. Format of the Submission – the Common Technical Document (CTD)
4. Submission
5. Assessment, opinion and EC decision
6. Tabular recap of the procedural steps of a MAA
7. Types of Marketing Authorisation Applications
References legal basis
1. Introduction
2. Early access
3. Off-label use
Assessment
1. Introduction: Regulatory affairs in the medicines development process ►