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Common Technical Document Module 1: OTC medicines

Applicable for applications lodged from 1 July 2017

10 July 2017

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Module 1.9 - Summary of biopharmaceutic studies

Module 1.9.1 Summary of a bioavailability or bioequivalence study

You must include the summary of a bioavailability or a bioequivalence study for any N4, N5, C3 or C4 level application that includes a bioavailability or bioequivalence study in the dossier.

To prepare a summary of a bioavailability or bioequivalence study:

Module 1.9.2 Justification for not providing biopharmaceutic studies

You must include a justification for not providing biopharmaceutic studies when biopharmaceutic studies are required (as outlined in Section 2 Safety and efficacy of OTC medicines), but have not been provided.

Further guidance

Justification for not complying with technical requirements in the Mandatory requirements for an effective over-the-counter medicines application.

The justification for not providing biopharmaceutic studies must:

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