2025 Amendments to Turkey's Licensing Regulation: New Key Date 1 January 2027

Marketing authorisation of human medicinal products in Turkey is governed by the Regulation on the Licensing of Human Medicinal Products, published in the Official Gazette of 11 December 2021, No. 31686. The regulation is implemented by the President of the Turkish Medicines and Medical Devices Agency (TİTCK) and was amended twice in 2025.

The amendment published in the Official Gazette of 23 May 2025, No. 32908 added the phrase "components used in the preparation of magistral radiopharmaceuticals" next to magistral radiopharmaceuticals approved by the Agency in the fifth paragraph of Article 5. The amendment entered into force on the date of publication.

The amendment published in the Official Gazette of 30 December 2025, No. 33123 extended transition periods. The deadline for radionuclide generators, kits and radiopharmaceuticals placed on the market with a registration certificate and awaiting licensing (Temporary Article 1) moved from 31 December 2025 to 1 January 2027; the temporary permission arrangement for allergen products (Temporary Article 6) and the exception period for accepting clinical trials (Temporary Article 10) moved from 1 January 2026 to 1 January 2027. For warehouses and suppliers handling these product groups, 1 January 2027 is the new key date to track.

Source: Official Gazette of 23 May 2025, No. 32908; Official Gazette of 30 December 2025, No. 33123; Regulation on the Licensing of Human Medicinal Products (mevzuat.gov.tr); Tunca Law Firm briefing note.