Calendarization Process For The Market Authorization Of Medicines

Introduction

The Guidelines for the Calendarization Process of Medicinal Products for Human Use (the "Guidelines") aims to regulate the process for the market authorization applications on medicinal products for human use filed with the Turkish Medicines and Medical Devices Agency (the "Agency"). The Agency has determined the procedures and principles for calendarization processes of the applications found eligible in the pre-assessments. The Guidelines has been initially published on the official website of the Agency in 2023 and has been updated in December 2023, February 2024 and August 2024.

Calendarization Processes

Pursuant to the Guidelines, the calendarization information of the market authorization applications found eligible in the pre-assessments, is announced with two separate lists published in the official website of the Agency in the first week of every month: "List of Active Ingredients Pending Calendarization" and "Active Ingredient List of