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

The Regulation on the Withdrawal of Medicinal Products for Human Use and Foods for Special Medical Purposes was published in the Official Gazette dated October 23, 2024 and numbered 32701 and entered into force as of the date of publication.

The Regulation on the Withdrawal of Medicinal Products for Human Use and Foods for Special Medical Purposes (“Regulation”) sets out the rules, authorities, responsibilities and control principles to be applied in the investigation and, where necessary, effective withdrawal of products that are found to be faulty or that are inconvenient to use.

The important headings of the Regulation are as follows:

• The Regulation consists of five chapters: “Initial Provisions” (Art. 1-4); “Duties and Responsibilities, Notifications and Decision Process” (Art. 5-8); “Classification, Levels and Reasons for Withdrawal” (Art. 9-11); “Announcement, Execution and Completion of Withdrawal” (Art. 12-17); and “Miscellaneous and Final Provisions” (18-22).
• Under the introductory provisions, the scope of the Regulation is defined as the recall activities of authorized or approved human medicinal products, the active substances used in their production, and special medical-purpose foods. The definitions of the concepts included within the scope of the Regulation are also provided
• The second chapter regulates the actions to be taken by the Turkish Medicines and Medical Devices Institution (“Institution”) if a faulty or suspected faulty product is evaluated and, if necessary, withdrawn from the market, the responsibilities of the marketing authorization/permit holder, the notification procedures and processes for suspected or faulty products, and the decision-making processes. In this context, the following actions have been regulated for the Institution’s control and oversight activities: requesting information and explanations when deemed necessary, deciding to recall, blocking related products in the Pharmaceutical Tracking System, conducting inspection procedures, halting the production and importation of defective products, and other similar actions. Additionally, the duties and responsibilities of the license/permit holder are outlined in this section, with detailed information on the actions that the license/permit holder must take within the recall process. The processes related to notifications about products suspected or found to be defective are also regulated under this framework, specifying that notifications can be made by the license/permit holder, individuals, or different institutions and organizations. It has been established that the notifications will be evaluated by the Recall Assessment Committee formed within the Institution, and if necessary, opinions will be sought from other committees and boards within the Institution.
• Under the third chapter, the classes and levels of withdrawal are regulated and the procedures regarding the withdrawal process are set out. In this context, three levels have been established for product classification under the recall process, based on the risk levels to public health and the distribution chain of the products. Additionally, it has been clarified that recalls will be initiated due to reasons such as quality defects, packaging errors, and non-compliance with regulations. The procedures to be followed in case the recall is initiated either by the Institution or the license/permit holder have been outlined.
• In the fourth section, the procedures and principles for announcing, executing, and completing a recall have been regulated. In this context, when a recall decision is made, the license/permit holder is required to notify all institutions, organizations, and individuals that may hold the product, according to the recall level, as quickly as possible. Following this notification, the license/permit holder must take the necessary measures to control the defective product in the market. Additionally, the obligation of the license/permit holder to compensate for any harm caused to the affected parties due to the recalled products has been regulated, and it is specified that the product will be destroyed in a manner appropriate to its nature. The continuation of the fourth section includes regulations regarding the preparation of preliminary and final reports on the defective product and the recall process.
• The fifth chapter regulates the penal sanctions to be imposed in case of recalls and states that guidelines for the implementation of the Regulation will be published on the website of the Turkish Medicines and Medical Devices Institution.

The full text of the Regulation dated 23 October 2024 can be reached through this link. (Only Available in Turkish)