The Regulation on Procurement of Medicines from Abroad ("Regulation") was prepared by the Turkish Medicines and Medical Devices Agency ("Agency") and entered into force on 3 February 2023. Within the scope of the Regulation, references are made to the guideline to be published by the Agency.
The Guideline on Procurement of Medicines from Abroad has been updated in line with the Regulation and published by the Agency on 20 April 2023.
The Guideline includes detailed explanations regarding the matters below:
- Criteria for applications regarding foreign drug use, conformity of medicinal products for human use and control certificates, and evaluation processes of applications
- Criteria for foreign drug supply sources
- Criteria and obligations regarding the representative that the source residing abroad must have in Turkey
- QR code implementation and notifications to the Pharmaceutical Track and Trace System
- Information regarding list of drugs that can be procured from abroad
It is possible for foreign drug supply sources to be authorized by the license holders. Templates for these authorization certificates are available in the annex of the Guideline, but the templates will be started to use on 01 January 2024.
Import permits obtained before 20 April 2023, when the updated Guideline entered into force, will be valid for 6 months. However, the products provided within this scope cannot be put into use after 31 December 2023.
You can access the full text of the Updated Guideline through this link.
Information first published in the MA | Gazette, a fortnightly legal update newsletter produced by Moroglu Arseven.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
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