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Re: bas2020 post# 447823

Monday, 01/15/2024 2:41:23 PM

Monday, January 15, 2024 2:41:23 PM

Post# of 463688
I don't think that is correct. Sale and distribution plans don't seem to be part of the module list.

Modules of MAA
1. EU Administrative and Prescribing Information
Application form
Brief overview of Product characteristics
Labeling text and mock-ups
Experts’ information
Risk assessments related to the environment
Orphan market exclusivity information
Description of the pharmacovigilance system
Risk management plan
2. High Level Summaries
Quality
Non-clinical overview
Non-clinical summary
Clinical overview
Clinical summary
3. Quality Documentation
References
Body of data
4. Non-Clinical Documentation
Reports of conducted studies
References
5. Clinical Documentation
Tabular listing of conducted studies
References



Another source for MAA application module information. https://www.kolabtree.com/blog/what-is-regulatory-dossier-and-what-does-it-contain/

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