Labeling Decision Tree Flowchart

This flowchart shows the decision tree used to determine the labeling requirements for medicinal products or auxiliary medicinal products for human use. The steps are as follows:

1. Initial Question:

   Is the investigational product/auxiliary medicinal product licensed in Turkey?

   Yes: The flowchart branches into two different options.

   No: Labeling is required under "Article 6" and the requirements specified in Annex I A. for investigational products must be met.

2. Following the "Yes" Option:

   Option I: Labeling requirements specified for investigational products licensed in Turkey must be met under "Article 7.1(a)."

   Option II: The same labeling requirements specified for licensed medicinal products in Turkey must be met under "Article 7.1(b)."

3. Safety of Volunteers and Data Security in Clinical Trials:

   Yes: If these conditions apply, additional labeling is required under "Article 7.2." The additional requirements specified in Annex I C. must be met.

   No: No additional labeling requirement is needed.

These steps determine the pathways to follow for product labeling and under which conditions specific requirements apply.