Amendments to the Guidelines on the Procurement of Medicines from Abroad Published

With the announcement dated 08.06.2026 shared by the Turkish Medicines and Medical Devices Agency (‘‘TMMDA’’), it has been announced that amendments have been made to the Guidelines on the Procurement of Medicines from Abroad (‘‘Guidelines’’). As is known, the procurement of medicinal products for human use—which do not possess a marketing authorization in our country or possess one but face supply shortages in the market—on a prescription basis for personal use or in bulk by hospitals, is carried out within the framework of the Regulation on the Procurement of Medicines from Abroad (“Regulation”) published in the Official Gazette dated February 3, 2023, and numbered 32093, and the provisions of the Guidelines linked thereto.

Article 8 of the Regulation and Articles 17 and 18 of the Guidelines regulate the procedures and principles regarding the bulk procurement of medicines from abroad by hospitals. Along with the recent amendments, the opportunity for bulk procurement without obtaining additional authorization has been introduced for 107 medicines announced by the TMMDA, aiming to reduce the administrative workload, utilize public resources more effectively, and accelerate access to medicines of critical importance for patient health. Under this new regulation, hospitals do not need to obtain a separate additional authorization from TMMDA for the designated 107 items of medicines. Hospitals will be able to procure the medicines on this list in bulk by directly importing them through overseas medicine suppliers, namely the Turkish Pharmacists’ Association (“TPA”) and International Health Services Inc. (“IHSI”).

According to the first paragraph of Article 17 of the Guidelines, pursuant to the 15th Revision dated 05.06.2026, the additional authorization requirement has been abolished for the medicines included in the list published by TMMDA, while the TMMDA's evaluation and compliance process within the scope of medical emergencies will continue to apply to medicines falling outside this list. Thus, the amendment has not entirely eliminated the administrative prior authorization mechanism, which remains the general rule, but has exempted the medicines deemed appropriate and announced by TMMDA from this prior authorization requirement. Thereby, the TMMDA has restricted the scope of the application by explicitly specifying the directly procurable medicines through the designated list.

Another decisive amendment in terms of implementation has been the addition of the seventh paragraph to Article 17. With this paragraph, it is regulated that for medicines deemed appropriate for direct procurement by the TMMDA, hospitals can apply directly to overseas medicine suppliers (TPA and IHSI) without the need to file a separate application to the TMMDA, and that overseas medicine suppliers will not seek separate TMMDA approval for these applications.

Consequently, with the 15th revision of the Guidelines dated 05.06.2026, the additional authorization obligation for hospitals regarding the bulk procurement of medicines from abroad has been lifted for specific medicines, whereas the TMMDA’s evaluation process has been preserved for medicines outside the list. These amendments aim to streamline processes, reduce the administrative workload, ensure a more effective and efficient utilization of public resources, and accelerate access to medicines holding critical importance for patient health.

AUTHORS

Lara Bayrakdar

Osman Tuna Kısaoğlu