Common Technical Document Module 1: OTC medicines

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Applicable for applications lodged from 1 July 2017

10 July 2017

CTD Module 1 consists of the administrative information to support an OTC medicine application to either:

The information on these pages:

  • explains the format and content for Module 1 of a dossier
  • describes what must be included in Module 1.

Further information

OTC dossier document matrix - A summary of the CTD document requirements for each application level.

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