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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:

  • 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 to ensure successful market-entry. For more information, reach out to Freyr at sales@freyrsolutions.com.