Ensuring human medicinal products and patient safety is one of the main goals of the healthcare sector. To achieve this, medicinal products traceability is a necessity. Many countries have implemented the Pharmaceutical Track and Trace System (“PTTS”) to prevent smuggling, ensure the reliability of medicines reaching patients, and strengthen patient confidence in medicinal products by tracking every stage of the supply chain.
By giving administrative authorities, the ability to carefully keep track of data, the PTTS supports the decision-making process by providing market data. With the currently available-to-download PTTS Mobile Application, users can check barcodes and determine whether a medicine is registered in PTTS, whether it is subject to a recall decision, PTTS current price, expiry date, and whether it is counterfeit. As a result, people have more control and knowledge over the medicines they use.
Following the increase in counterfeit medicines and related corruption in Türkiye, the Pharmaceutical Track and Trace System, implemented by the Ministry of Health since 2010[1], was formally included in Turkish legislation through the Regulation on the Packaging Information, Package Leaflet and Tracking of Human Medicinal Products (“Regulation”), published on the Official Gazette dated 25.04.2017 and numbered 30048. According to the definition in the Regulation[2], the purpose of the PTTS is to ensure human medicinal product and patient safety by enabling real-time monitoring of all movements of human medicinal products in the supply chain from production/import to the end consumer.
Under Article 15 of the Regulation, marketing authorization or permit holders, pharmaceutical warehouses and export-authorized companies, community pharmacies, healthcare supply centers, and both public and private reimbursement institutions are required to make notifications through the PTTS. Each party’s notification obligations and the cases requiring notification are separately regulated.
All transactions involving human medicinal products, including purchases, sales, returns, cancellations of sales, exports, product transfers, cancellations of transfers, expiration, and theft, must be reported via the PTTS. As of December 31, 2018 radiopharmaceuticals and large-volume parenteral products (serums) are now covered under the PTTS.
All parties with notification obligations must keep original or legible copies of documents such as production/import records, invoices, waybills, and prescriptions for five years, in physical or electronic form, and present them to the Authority upon request.
Notifications made through the PTTS, and subsequent product tracking are recorded using Data Matrix codes for human medicinal products and Global Location Numbers (“GLN”) for stakeholder actions. These records are stored in the Ministry of Health Data Center. The rules for barcoding and data matrix labeling that ensure traceability are detailed in the Human Medicinal Products Barcode and Data Matrix Application Guide. Products manufactured solely for export that will not be marketed or used in Türkiye are excluded from the barcode and data matrix requirements.
Circular No. 2019/3 dated 25.12.2019 on PTTS Production/Import Notifications
The Circular No. 2019/3, titled PTTS Production/Import Notifications, was issued by the Turkish Medicines and Medical Devices Agency (“TMMDA”) on 25 December 2019.[3] The circular regulates the deadlines for production and import notifications. Accordingly:
Production notifications must be made within 60 days from the production date. The compatibility between the production notification date and the expiry date will be checked by the PTTS, considering the product’s shelf life.
Import notifications must be made within 45 days from the date of the Customs Entry Declaration. In addition, a copy of the Customs Entry Declaration and the invoice must be submitted to the TMMDA within 15 days after importation.
Notifications made after 60 or 45 days will not be accepted by the PTTS.
The Circular refers to the Regulation on Licensing of Human Medicinal Products, stating that failure to make mandatory notifications within the specified time limit through the PTTS. Failure to comply with this will result in the suspension of the product’s marketing authorization. The procedures and time limit in the Circular have been effective since 1 February 2020.
Static IP Usage for Pharmacies
To ensure secure pharmacy access to the PTTS, a static IP restriction has been implemented in accordance with the Law on the Protection of Personal Data No. 6698. This practice began on 2 January 2025 and became mandatory on 31 January 2025. Pharmacies can access the PTTS only from their registered fixed IP addresses. Therefore, it is important that pharmacies correctly register their IP addresses in the system. Incorrect or incomplete registration may cause access problems. Pharmacists are encouraged to study the static IP Usage Guide and perform the necessary steps as soon as possible, according to the TMMDA notice[4] published on January 14, 2025.
Conclusion
In conclusion, considering that the failure to comply with the procedures and principles set out in the Circular and to make notifications within the specified time limit through the PTTS may lead to the suspension of the product’s marketing authorization, it is crucial that the PTTS requirements under the Regulation and Circular are carefully fulfilled. It is also important to regularly monitor announcements and regulations issued by the TMMDA regarding the system.
Kind regards,
[1] https://www.TMMDA.gov.tr/faaliyetalanlari/ilac/ilac-takip-sistemi-PTTS
[2] Article 4/i: “Pharmaceutical Track and Trace System” means the central registration and monitoring system that tracks, in real time, all movements or cancellations of movements of human medicinal products in the supply chain — including production, import, export, purchase, sale, transfer, consumption, loss, or reimbursement — using unique data matrix codes, and manages operations such as product recall and blocking.
[3] https://TMMDA.gov.tr/storage/Archive/2019/news/a9dfe9e6-ea39-4534-b4c1-8f1d3072ce94.pdf
[4] https://www.TMMDA.gov.tr/duyuru/5080
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