A Circular that the products without a DataMatrix should be labeled with a DataMatrix has been published by our Ministry.

DataMatrix labels will be produced BY THE MANUFACTURERS as it has been stated in the circular and applied on to the products without a DataMatrix. However the production of DataMatrix labels stated in the circular as such;

• A temporary 2D DataMatrix (G2D) will be applied to the products without a DataMatrix which take place in the stocks of the pharmaceutical wholesalers and pharmacies so that these products can be activated in the system.
• The 2D DataMatrix will not include the expiration date and production serial numbers so that difficulties in practice are not experienced and that the GMP requirements can be met. G2D will contain the EAN barcode (13 digits) which is still in application and the serial number to be produced by the company.

Will not be out of the standards indicated in the Regulation Regarding the Packaging and Labeling of Medicinal Products for Human Use and the all four fields will be in the sequence indicated in the guideline. The expression “will not be printed” in the circular should be understood as “it does not have to be the same with the expiration date and batch number on the drug unit” and a virtual batch number is needed to be generated for this field and a date to express the date ’31.12.2010’ should be printed for this field. An application other than the application stated above will be made by no means.

DataMatrices printed in this way will absolutely be notified to the Turkish Pharmaceutical Track and Trace System.

The temporary DataMatrices to be created will be designed as shown in the image below and will be notified to the system through services in the exact same way.

Since the expiration dates and batch numbers of the products in the market cannot be known as shown in the image, a label will be produced as if all the products to be labeled are of a single batch and their expiration dates will be 31.12.2010 latest.

The expression “virtual” shown in the image in parentheses will not be printed on the labels.

Pharmacists will show sensitivity to dispatch products according to their real expiration date if it is earlier than the indicated date no matter what date is printed on the temporary DataMatrix.