Emergency Line: (002) 01061245741
Mon - Fri: 8.00am - 7.00pm

Get In Touch:

Information about Turkey-TITCK (Türkiye İlaçveTıbbiCihazKurumu)- Approval Processes

Regulatory Authority:

Turkish Medicines and Medical Devices Agency (TMMDA)

Link for Regulatory Authority:

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

Local Authorised:

Yes

Classification:

Novelty, Therapeutic Category, and Risk.

Preparation and Documentation:

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.

  1. 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.

  1. 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.

  1. Reference Medicinal Product:

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

  1. 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.

  1. 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).

  1. 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.

  1. Regulatory Articles:

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

  1. Registry of Officials:

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

  1. Risk Management Plan:

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

  1. 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.

  1. 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.

  1. 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.

Registration Timeline:

30 to 60 months

Registration Fee:

  • 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)

License Validity:

5 Years

bola gacor https://ecomama.com.vn/storage/pages/ways/ https://portia-bazar.com/import/ https://chatgptitaliano.com/ https://www.studio98.com/ https://acunmedyaakademi.com/ https://trailer.best/ https://klicfon.com/ iblbet iblbet https://www.studio98.com/ https://iniciarbr.com/ https://bntva.ru/css