## [What is a Marketing Authorization Application (MAA)?](/index%2Ephp/what-is-a-marketing-authorization-application-maa) 1 min read Your browser does not support the audio element. A Marketing Authorization Application (MAA) is an application submitted to the European Medicines Agency (EMA) to market a medicinal product in the EU member states. ## 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 ## Submitting an MAA To submit an MAA, applicant should notify the EMA at least 7 months before the submission to provide an estimate date of submission to the agency. MAA can be filed in the [following ways](/what-is-national-mutual-recognition-decentralized-centralized-procedures): - **Centralized Procedure** – For submitting a single MAA - **National Procedure** – For obtaining market access in specific EU states - **Mutual Recognition Procedure** – For manufacturers who already have market access in one of the EU member states - **Decentralized Procedure** – For medicines which are not yet authorized in the EU MAA is the most important part of placing a medicinal product in the EU market. Failing to submit a compliant MAA may lead to unwanted consequences. Therefore, it is advised to consult a [Regulatory expert](https://regulatoryaffairs.freyrsolutions.com/contact-us) to ensure successful market-entry. For more information, reach out to Freyr at .