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OTC new medicines registration process
Step 6 - Compiling data for your application
You will need to prepare your OTC medicine dossier of administrative and technical documentation to submit for evaluation.
General requirements for your dossier
You must submit an electronic application dossier.
To compile your dossier, follow the General dossier requirements.
Organisation and structure of the dossier
Compile your electronic dossier according to the Common Technical Documentation (CTD).
To identify the CTD Modules you need for your application check:
Meeting the mandatory requirements
Ensure your application dossier contains all of the administrative and technical data required for the application level.
It is important that you check to ensure your dossier:
- is complete
- is in the required format
- includes the required information for an effective application detailed in:
- CTD Module 1: OTC medicines
- Mandatory requirements for an effective OTC medicine application.
- the guidance to prepare your cover letter
We will check whether the application meets the requirements for an effective application during screening (Step 9). If your application does not meet the requirements to be effective, we will not accept it for evaluation.