Turkey Track and Trace Update
Title: Turkey Track and Trace Update
Date Posted: 06/17/09
Tags: REGULATORY UPDATE, REST OF WORLD, TURKEY
While there have been rumors about a possible delay in the serialization deadline by the Turkish Ministry of Health (MOH), the official word is that they are sticking to July 1, 2009 as the serialization deadline (the original deadline was January 1, 2009). This means that all products entering the Turkish market after July 1, 2009 (even if manufactured prior to July 1, 2009) would have to be serialized by either the manufacturer (company responsible for manufacturing the product in Turkey or the original "license holder" of the product responsible for importing product into Turkey) or the local Turkish distributor and serial numbers submitted to MOH prior to them being sold in the Turkish market. However, products that entered Turkey before July 1, 2009 and are not yet serialized would have until December 31, 2009 to be sold without being serialized. January 1, 2010 onwards, only serialized products would be able to be sold in Turkey.
Since the MOH mandate at this point is driven mostly by government reimbursements and not by patient safety, only the saleable item at the point of dispensing (unit) is required to be serialized by the July 1, 2009 deadline. In a future phase of implementation, it will be required to have additional stages of transport to be serialized (Parcel, Pallet) which would include aggregated serialization data. The information below details the serialization deadlines.
Unit — July 1, 2009
The lowest dispensing unit by the hospital or the pharmacy. For example, a box of 20 bottles would require each bottle to be serialized and data submitted for reimbursement purposes. The bottle in this case would be the "unit."
Bundles — Deadline TBD
Transport unit packages which tie a small number of products to each other. There is talk of a December 31, 2009 date but it is not confirmed yet.
Boxes (Cases) — Deadline TBD
Transport packages used for transporting the products to the pharmacies without being opened. There is talk of a December 31, 2009 date but it is not confirmed yet.
Parcels (Pallets) — Deadline TBD
Used for carrying a high number of products or a certain number of boxes or bundles. There is talk of a December 31, 2009 date but it is not confirmed yet.