Regulation on Procurement of Pharmaceuticals from Abroad (“Regulation”) has been published in the Official Gazette dated 3 February 2023. The Regulation regulates the procedures and principles regarding the procurement of medicinal products for human use, which are not yet licensed in Turkey, or which are licensed but not available on the market for various reasons, from abroad with a prescription for personal use and the procurement of bulk medicinal products from abroad by hospitals.
The Regulation introduces provisions that are parallel with the provisions of the Turkish Medicines and Medical Devices Agency’s (“the TMMDA”) Guideline on Procurement and Usage of Pharmaceuticals from Abroad (“Guideline”), however, regulations regarding the topics that are not covered by the Guideline have also been entered into force.
In this regard, some of the important provisions implemented by the Regulation are provided below:
Having a representative resident in Turkey has been made mandatory for medicines procured from abroad.
It has been provided that the pharmaceuticals that are not licensed by the MHRA, TGA or permanent members of the ICH can only be procured from the producer/licensee firms. This provision aims to ensure quality, efficiency and safety conditions and to prevent fake/contraband products.
Except for the bulk procurements made by the hospital in emergent cases, it has been regulated that any body or institution cannot directly apply to TMMDA for the procurement of pharmaceuticals from abroad.
· The process regarding patient-based pharmaceutical procurements from abroad has been regulated under the heading of “first medicine application and assessment” in the Regulation, which is regulated under the heading of “Application for Usage of Medicine from Abroad” in the Guideline. Detailed provisions regarding the application process and files that need to be submitted have been implemented.
You can access the Regulation from this link (in Turkish).