Announcements

31.01.2012 | To the Attention of Representative Pharmaceutical Wholesalers and Manufacturer/Importer Stakeholders


As it has been stated in Paragraph One of the Fields to be Used in the Notifications topic of the Pharmaceutical Track and Trace System Management Guideline; Manufacturer/Importer: Manufacturers are the ones who will enter the products into the system. The manufacturers or importers will take place with their GLN codes in the system. They will only be able to send data of the drugs whose license or permits they own to the system.

In addition as it has been stated in Part One, Definitions, Paragraph Four of the 20/10/1999 dated and 23852 numbered Official Gazette Regulation on Pharmaceutical Wholesalers and Products in the Pharmaceutical Wholesalers; f) (Different Article: 24/09/2008 -27007 S.R.G. Reg/Para.1) Representative Pharmaceutical Wholesaler: Expresses the place of business which has been founded for the purpose of the stocking and packaging of products which are given the authority/permit by the Ministry with a prospectus addition, label, price tag printing, and similar secondary packaging services; which are given a permit according to the Good Stocking/Distribution Practices for reasons of wholesaler qualifications and according to Good Production Practices for reasons of production site qualifications.

In accordance with the above stated legislations; the stakeholders which hold both manufacturer/importer and pharmaceutical wholesaler functions will have to be identified as both “manufacturer company” and “pharmaceutical wholesaler” roles in the Pharmaceutical Track and Trace System. In order for this work to be done, stakeholders have to obtain a GLN from TOBB-GS1 Turkey and update their Pharmaceutical Wholesaler records in the Local Health Authorities they are depending on, and update their company records in the İEGM2007 Company Sign In part.

A pharmaceutical wholesaler GLN and a manufacturer/importer company GLN can be generated from the 7,8, or 9 digit GLN number obtained from TOBB GS1. You may download the file in the http://gs1.tobb.org.tr/saglik_kilavuz.doc link for detailed information on the GLN number and GLN derivation operations.

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