Licencing & Approval

This refers to the official document issued by the Authority (Turkish Medicines and Medical Devices Agency - TITCK), certifying that a human medicinal product may be manufactured and marketed in a specific formulation, pharmaceutical form, and dosage strength, in accordance with the approved product information.

The fundamental stages regarding the research, development, authorization, and marketing processes of a human medicinal product are outlined below:

1. R&D (Research & Development) Studies
2. Pre-clinical Studies
3. Clinical Trials (Phase Studies)
4. Marketing Authorization Application and Licencing Process

Marketing authorization applications are submitted by companies following the preparation of a comprehensive application dossier. In our country, the licensing procedures for medicines are conducted pursuant to the provisions of the Regulation on the Licensing of Human Medicinal Products, which entered into force on January 19, 2005, and was last updated in 2013. Application dossiers are prepared in the CTD (Common Technical Document) format, which is an internationally recognized dossier structure. The CTD consists of five modules;

• Module 1: Regional Administrative Information
• Module 2: Quality Information, Non-clinical and Clinical Summaries
• Module 3: Quality
• Module 4: Non-clinical Study Reports
• Module 5: Clinical Study Reports

The Authority (Turkish Medicines and Medical Devices Agency - TITCK) evaluates the quality, efficacy, and safety studies of products that have undergone these stages and submitted for authorization. Subsequently, the Agency grants licenses for medicinal products deemed appropriate.

5. Granting of Marketing Authorization for the Placement of the Product on the Market

Following the authorization of a medicine, all relevant studies, variations, and updates continue throughout the product’s entire life cycle.

https://www.titck.gov.tr/faaliyetalanlari/ilac/ilac-ruhsatlandirma