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.

Related guidance

• Section 2 Safety and efficacy of OTC medicines.

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:

• 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.