Regulation on the Withdrawal of Human Medicinal Products and Foods for Special Medical Purposes

The Regulation on the Withdrawal of Medicinal Products for Human Use and Foods for Special Medical Purposes (“Regulation“) was published in the Official Gazette, and entered into force on 23 October 2024. With the Regulation coming into force, the Withdrawal Regulation published in the Official Gazette on 19 November 2015 (“Previous Regulation”) was abolished. Unlike the Previous Regulation, the scope of the Regulation merely includes medicinal products for human use and active substances used in the production of medicinal products for human use as well as matters regarding the withdrawal activities, production, placing and keeping on the market medicinal products for human use.

The Regulation introduces detailed provisions as per which the Turkish Medicines and Medical Devices Agency (“TMMDA”) shall evaluate faulty or suspicious products, request information from the marketing authorization holder where necessary, conclude on withdrawal, conduct relevant proceedings in the Drug Tracking System (İTS), ensure oversight of the processes, halt the production of faulty products and take the necessary measures to prevent incompliance, and conduct necessary checks before re-introducing products to the market. In this regard, a “Withdrawal Evaluation Commission” has been introduced along with a number of new practices. Ultimately, the aim is to adopt an effective and integrated system for the withdrawal of medicinal products for human use and foods for special medical purposes through putting in place comprehensive regulations and sanctions.