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Regulatory Affairs
Regulatory procedures - Marketing-Authorisations and their lifecycle management
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References legal basis
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References
Regulation (EC) No 726/2004
Directive 2001/83/EC
, as amended
Annex I in
Directive 2001/83/EC
, as amended
The Rules governing Medicinal Products in the European Union, Notice to Applicants, Volume 2A, Chapter 1
CHMP guideline on similar biological medicinal products
7. Types of Marketing Authorisation Applications
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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
1. Introduction
2. Early access
3. Off-label use
Assessment
1. Introduction
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Regulatory procedures - Marketing-Authorisations and their lifecycle management
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Lesson 3: Principles and submission of Marketing Authorisation Applications (MAAs) and their types, including the Common Technical Document (CTD)
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