Title

Regulatory Authority

Turkish Medicines and Medical Devices Agency (TMMDA)

https://www.titck.gov.tr/iletisim

Yes

Novelty, Therapeutic Category, and Risk.

PRE-EXAMINATION UNIT

1.  Submission Format

Applications should be submitted in the corrected application file format, not as attachments.

Corrections in the Electronic Document Management System (EBYS) should also be added in the Common Technical Document (CTD) format.

2. Documentation from Competent Authorities

Official documents issued by a competent authority outside Turkey (place of production) should be included.

Documents (e.g., permit, Good Manufacturing Practices (GMP), CPP documents, license) from other countries must be apostilled or consulate approved.

3. Application Information

Information in the license application files (Modules 1 to 5) must be compatible and arranged according to the Guide on File Requirements for Electronic License Applications.

4. Reference Medicinal Product

Information about the reference medicinal product, including where it is registered and where it was first used, should be provided.

5. Preliminary Examination

A second preliminary examination application for incomplete applications must be submitted within 30 days.

Additional applications with documents cannot be included in file modules and are not accepted.

6. Regulatory Compliance

The licensing date, legal status of the product, and packaging size differences must be stated.

The Application Form should include information on containers, lids, application devices, and Summary of Product Characteristics (SPC) or KullanmaTalimatı (KT).

7. Specific Sections in Application Form

Section 2.6.2: Specify only ‘used in the manufacturing process of the medical product.’

Section 2.3.2: Corrections post should be mentioned.

8. Regulatory Articles

Compliance with Regulation on Licensing of Medicinal Products for Human Use Article 9, 1-b for hybrid applications.

9. Registry of Officials

Maintain a registry of officials who have signed the Contract Manufacturing Agreement, as outlined in Annex 6.22.

10. Risk Management Plan

Submit a risk management plan for drugs containing a medical device during the registration application.

11. Certificates of Analysis for Excipients

Certificates of analysis for excipients should be submitted in Module 3.2.P.4.4. If not applicable, select the ‘None’ option, ensuring this information aligns with the application file.

12. New Active Ingredient, Biotechnological Drugs, Biosimilars, and Reference Drugs

For drugs containing a new active ingredient, biotechnological drugs, biosimilar drugs, and reference drugs, relevant information should be presented.

13. Finished Product Packaging Specifications and Certificates of Analysis

In Module 3.P.7 Section 2.2.4, complete information related to finished product packaging specifications and certificates of analysis. Attestations must be submitted.

30 to 60 months

• Full MMA: TRY 100,000 – TRY 500,000 (approx. USD 5,000 – USD 25,000)
• Conditional MMA: TRY 50,000 – TRY 250,000 (approx. USD 2,500 – USD 12,500)
• Import Permit for Clinical Trials: TRY 10,000 – TRY 50,000 (approx. USD 500 – USD 2,500)

5 Years