The "Draft Guidelines on the Application for Licensing of Foods for Special Medical Purposes" and the "Draft Guidelines on the Stability Studies of Foods for Special Medical Purposes" prepared by Turkish Medicines and Medical Devices Agency are opened for review.
In the draft guideline that regulates the license applications; all information and documents required to be submitted by the applicant regarding the license file format have been explained in detail, and the sample application form has been added to the guidline.
The draft guideline on stability studies, on the other hand, includes the requirements for stability studies to be included in the license application file of foods for special medical purposes. In addition, it is regulated in the draft that an opinion application can be made to the Agency, limited to the parameters to be studied before the stability studies and the requirement for a new study after the primary packaging change.
You can reach the drafts via the link below:
https://lnkd.in/dCn9WeB9