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    10. Roadmap of the Submission Process of a Clinical Trial
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    10. Roadmap of the Submission Process of a Clinical Trial

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    Article summary

    10.1 Clinical Trial with Investigational Medicinal Product

    10.2 Pediatric Investigation Plan (PIP)

    There is no requirement for a PIP in Brazil.

    10.3 Clinical Study (Interventional or Observational)

    Clinical trial applications are only required for interventional studies.

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