On 23.02.2024, the Turkish Medicines and Medical Devices Agency ("TMMDA") announced that the Guideline on the Procurement of Medicines from Abroad ("Guideline") has been updated. The reason for the update was explained as the purpose of harmonization with the Regulation on the Supply of Medicinal Products from Abroad, which entered into force in February 2023.
In this context, the Guideline has been amended in the following subjects:
The TMMDA may request license holder companies to open an Early Access to Medicines for Compassionate Use as a result of the evaluation of initial drug applications.
A provision has been added stating that the TMMDA may, if necessary, request updated documents previously submitted to the TMMDA for products added to the list of medicinal products that can be procured from abroad.
The "Doctor's Stamp" section has been added to the signature section of the Informed Consent Form for Medicines to be Procured from Abroad, which is attached to the Guideline.
You can access the updated version of the Guideline from this link (in Turkish).