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The road to authorisation

A number of requirements must be fulfilled before a medicinal product can be authorised in Switzerland – starting with a correct establishment licence, passing through many reviews and ending with the official authorisation. 

Step 1: The establishment licence

  

Step 2: The criteria

  

Step 3: The submission

  

Step 4: The preliminary decision

  

Step 5: The official decision

How the preclinical phase protects before a medicine cures

Before a medicine is tested or used in humans, it is checked in the preclinical phase. The purpose of this phase is to investigate how an active substance works in the body and identify the associated risks and potential side effects.

This video shows why the preclinical phase is a crucial step in protecting patients.

Last modification 04.03.2026

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