Section: Lesson 3: Principles and submission of Marketing Authorisation Applications (MAAs) and their types, including the Common Technical Document (CTD) | Regulatory procedures- Marketing-Authorisations and their lifecycle management | EUPATI Open Classroom

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Section outline

Learning outcomes of this lesson:
	Describe and discuss the regulatory steps in a marketing authorisation application (MAA) for a medicine, including the different types of MAAs and their legal basis

Select activity 1. Introduction and recap

1. Introduction and recap Page

Learners must

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Select activity 2. Pre-submission

2. Pre-submission Book

Learners must

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Select activity 3. Format of the Submission – the Common Technical Document (CTD)

3. Format of the Submission – the Common Technical Document (CTD) Book

Learners must

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Select activity 4. Submission

4. Submission Book

Learners must

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Select activity 5. Assessment, opinion and EC decision

5. Assessment, opinion and EC decision Page

Learners must

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Select activity 6. Tabular recap of the procedural steps of a MAA

6. Tabular recap of the procedural steps of a MAA Page

Learners must

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Select activity 7. Types of Marketing Authorisation Applications

7. Types of Marketing Authorisation Applications Book

Learners must

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Select activity References legal basis

References legal basis Page

Learners must

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