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OTC new medicines registration process

27 August 2020

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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:

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.

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