In 2014, the Turkish Medicine and Medical Device Institution's ("Institution") New Year's resolution list included two remarkable items: (i) ensuring people's access to safe human medicinal products, and (ii) battling the grey economy. In order to do achieve these goals, the Institution, with the collaboration of Turkey's Scientific and Technological Research Council, has rolled up its sleeves to establish the Product Tracking System ("Tracking System"), which would enable the tracking and auditing of imported and locally manufactured human medicinal products.
After a working process of nearly three years, the Institution announced on its website (on January 1, 2017) that, for company activations and control of the data transferred from the Turkish Medicine and Medical Device National Data Bank, the Tracking System would be available for medical device companies' use, as of the date of the announcement. The Institution's guide for using the Tracking System can be found at uts.saglik.gov.tr.
- Current Status of the Tracking System
The announcement mentioned above included the following updates regarding the current status of the Tracking System:
(i) Company information of manufacturers, importers and distributors that had registry certificates in the Turkish Medicine and Medical Device National Data Bank system on December 18, 2016, (regardless of whether such companies were registered under the Data Bank as of December 18, 2016), company user information, registered certificate information, registered product information (including company, document and product links) are transferred to the Tracking System.
(ii) Information and documents relating to the Opticianry Institutes, Custom Made Prosthesis Orthesis Institutes, Hearing Aid Implementation Institutes and Dental Prosthesis Laboratories registered under the Core Funding Management System and Pharmacies registered under the Institution's data base are not transferred to the Tracking System, since these institutions do not possess documents and products which will be used under the Tracking System. Updates regarding the transfer of these institutions' information will be announced in the upcoming days.
(iii) While registrations under the Medical Device National Data Bank, which comply with the barcode rules of "GS1" and "HIBC" institutions, are transferred, product registrations with temporary barcodes are not transferred to the Tracking System.
(iv) Distribution liaisons between companies are not transferred to the Tracking System.
- What Should Medical Device Companies Do at This Stage?
Medical device companies (i.e., manufacturers, importers, and distributors) should log in to the Tracking System and activate their company registries as of January 1, 2017. However, the announcement specifies that companies that are not duly licensed within the scope of the Regulation on Sale, Advertising and Promotion of Medical Devices, will not be able to engage in any transaction through the Tracking System.
Furthermore, companies' activation of their registries will pave the way for access to their registered user, document and product information. In this respect, users should cross check the accuracy of the information under the Tracking System with the information transferred from the Medical Device National Data Bank. The relevant authorities will have to be notified about any deficient and/or incorrect data thus detected through the Tracking System's fault-notification interface.
- Future of the Medical Device National Data Bank
At this stage, operations will continue to run through the Medical Device National Data Bank, until the Tracking System is fully operational. The Institution will make a separate announcement regarding the deactivation of the Medical Device National Data Bank.
This article was first published in Legal Insights Quarterly by ELIG, Attorneys-at-Law in March 2017. A link to the full Legal Insight Quarterly may be found here
This article was first published in Legal Insights Quarterly by ELIG, Attorneys-at-Law in March 2017. A link to the full Legal Insight Quarterly may be found here.
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