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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 1.4 - Information about the experts

This section holds documents about the experts who reviewed the supporting data for the application, and prepared the summaries and overviews that constitute Module 2.

Include information about the:

  • quality expert in Module 1.4.1 for any N5 level application where any subsection of Module 2.3 has been provided in the dossier
  • nonclinical expert in Module 1.4.2 for any N4, N5, C3 or C4 level application where any subsection of Module 2.4 and/or 2.6 has been provided in the dossier
  • clinical expert in Module 1.4.3 for any N4, N5, C3 or C4 level application where any subsection of Module 2.5 and/or 2.7 has been provided in the dossier.

Information required

For each expert responsible for compiling a Module you must provide both:

  • a declaration completed and signed by the expert as detailed in Table 1, below
  • a curriculum vitae (CV) outlining the expert's educational background, training and occupational experience.

For the Australian expert

Download the form for the expert's declaration and complete as per the instructions on the form.

Ensure the declaration is signed by the expert making the declaration.

Expert from the European Union

Provide a copy of the expert's declaration from the application lodged with the EMA.

Alternatively, you can use the form for the Australian expert.

Other overseas expert

Complete the form for the Australian experts.

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