Flowchart of the quality requirements for medicinal products for human use

This flowchart lists the application processes according to the quality requirements for human medicines. The steps described in the diagram are:

1. Research Products

   • Research products for clinical trials of Phase I, II, and III

   • Research products without authorization from the competent authorities: For these products, the requirements of Chapter 2 apply.

   • Research products authorized by the competent authorities: For these products, the requirements of Chapter 3 and Chapter 4 apply.

   • Placebo: For placebo products, refer to Chapter 6.

2. Research Products for BE (Bioequivalence) Studies

   • Reference Products

   • Reference products with authorization from the competent authorities: For these products, the requirements of Chapter 3 apply.

   • Reference products without authorization from the competent authorities: For these products, the requirements of Chapter 4 apply.

3. Auxiliary Medicines for Human Use

   • Test Products: For these products, the requirements of Chapter 5 apply.

   • Authorized and unmodified auxiliary medicines for human use: The requirements of Chapter 3 apply to these products.

   • Authorized and modified auxiliary medicines for human use: The requirements of Chapter 4 apply to these products.

These steps list the procedures to follow during the application and which departments the application should be submitted to.