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Common Technical Document Module 1: OTC medicines
Applicable for applications lodged from 1 July 2017
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:
- download the Summary of a Bioavailability or Bioequivalence Study form
- complete a separate form for each study
- include the form(s) in Module 1.9.1.
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.
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:
- address all the relevant points in justification for not submitting biopharmaceutic data
- include any other relevant information
- include any references used to support the justification in Module 5.