The Pharmaceutical Tracking System (İlaç Takip Sistemi, “ITS”) is the system adopted by the Turkish Medicines and Medical Device Agency (the “Agency”) for pharmaceutical industry, enabling to determine the locations of pharmaceuticals in the supply and distribution chain in Turkey. A data matrix is printed on the products’ packaging which allows the tracking of each transaction in the supply chain as of the product’s production or importation.
ITS is defined under the Regulation on the Labeling, Package Leaflet and Tracing of Human Medicinal Products (the “Labeling Regulation”) dated April 25, 2017. According to Article 15 of the Labeling Regulation, MA holders are obliged and authorized to register each unit of their products to the ITS with production or importation notification. In addition, they are obliged to notify through ITS transactions such as the purchase, sale, return, sale cancellation, exportation, exportation cancellation, overturn, cancellation of overturn and the deactivation process for products which have lost their qualifications due to expiration, theft, degradation, etc. However the Labeling Regulation does not foresee a timeline for such notifications.
On December 25, 2019, the Medicines and Medical Devices Agency (“Agency”) published a circular numbered 2019/3 (“Circular”) and regulated the terms for notifications to be made through the Pharmaceutical Tacking System (“ITS”) for the manufactured and imported products.
Pursuant to the Circular, production notifications for the manufactured pharmaceuticals shall be made within 60 days after the date of production. The conformity of the production notification date and expiration date shall be checked by the ITS according to the product’s shelf life. In terms of imported pharmaceuticals, the importation notification shall be made within 45 days after the date of last customs entry. In addition, the customs entry and the billing samples shall be submitted to the Agency within 15 days after the import. Notifications made after the specified terms shall not be accepted.
The Circular refers to the article on the suspension of the market authorization in the Regulation on Licensing of the Human Medicinal Products and it is informed that in case of incompliance with the notification terms, the market authorization of the pharmaceutical shall be suspended.
The requirements will be in force as of February 01, 2020. However, the notifications for the already produced products and products which customs entry transactions are completed is required to be immediately completed.
First published by Practical Law in Feb 01, 2020.
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