Announcements

21.02.2011 | About the Complaint Petition Application for Products Receiving a Dispatched Message


As it is already stated in the Turkish Pharmaceutical Track and Trace System of Ministry of Health of the Republic of Turkey and the Turkish Medicines and Medical Devices Agency, the Turkish Pharmaceutical Track and Trace System preserves thge pharmaceuticals from counterfeiting and provides their traceability for safety reasons. With the notifications received from the manufacturers, importer wholesalers, pharmaceutical wholesalers and pharmacies and the dispatch approvals from the reimbursement companies the Pharmaceutical Track and Trace System will provide and control that a drug unit is sold only once. The gathering of data for the system is done via notifications and the inspection of data is done by the system management. The limitations for the notification times are as follows:

  • Products whose production or importation notifications are not made cannot be released to the market by manufactureres or importers.
  • Pharmacies will not give DataMatrixed products which have not been verified by the system to the patients.
  • Pharmaceutical wholesalers will not accept returns of products with DataMatrix which have not been notified to the system.
  • Exportations should only be notified after the exportation has taken place.

In addition it is stated that pharmacies are obliged to make “Product Purchase Notificaitons” according to the 2010/39 numbered circular.

If the another pharmacy has already made a dispatch notification for the specified product after the product query operation has been completed through the ITS Management Panel, the procedure to be followed is as follows.

  • PHARMACIES, PHARMACEUTICAL WHOLESALERS AND COMPANIES WILL SEND THE COMPLAINT PETITION APPLICATION FORM (attached file) TO THE E-MAIL ADDRESS WE HAVE SPECIFIED.
  • PRODUCTS WITH THE SAME GTIN INFORMATION CAN TAKE PLACE IN THE SAME FORM. A NEW FORM NEEDS TO BE PREPARED FOR DIFFERENT PRODUCTS. SO PRODUCTS WITH DIFFERENT GTIN INFORMATION CAN DEFINATELY NOT TAKE PLACE IN THE SAME APPLICATION FORM.
  • THE PRODUCT MUST BE STORED WITH ITS ORIGINAL PACKAGE AND SUBMITTED IF REQUESTED.

     

CONDITIONS NECESSARY FOR PHARMACY COMPLAINT APPLICATIONS
 

  • PRODUCT PURCHASE NOTIFICATION DATE OF THE RELATED PRODUCT,
  • PHARMACY COMPLAINT APPLICATION FORM,
  • ATTACHMENT OF THE PRODUCT’S INVOICE PHOTOCOPY,
  • ATTACHMENT OF THE QUERY RESULT MADE FROM THE ITS MANAGEMENT PORTAL SCREEN (IN EXCEL FORMAT),
  • A PHOTO OF THE PRODUCTS IN WHICH THE INFORMATION OF THE PRODUCTS CAN BE CLEARLY SEEN SHOULD BE TAKEN AND SENT TO THE itsbasvuru @ iegm.gov.tr ADDRESS.
     

CONDITIONS NECESSARY FOR PHARMACEUTICAL WHOLESALER COMPLAINT APPLICATION
 

  • PHARMACEUTICAL WHOLESALER COMPLAINT APPLICATION FORM,
  • ATTACHMENT OF THE PRODUCT’S INVOICE PHOTOCOPY,
  • ATTACHMENT OF THE QUERY RESULT MADE FROM THE ITS MANAGEMENT PORTAL SCREEN (IN EXCEL FORMAT),
  • A PHOTO OF THE PRODUCTS IN WHICH THE INFORMATION OF THE PRODUCTS CAN BE CLEARLY SEEN SHOULD BE TAKEN AND SENT TO THE itsbasvuru @ iegm.gov.tr ADDRESS.
     

CONDITIONS NECESSARY FOR MANUFACTURER COMPANY COMPLAINT APPLICATION
 

  • COMPANY COMPLAINT APPLICATION FORM,
  • ATTACHMENT OF THE QUERY RESULT MADE FROM THE ITS MANAGEMENT PORTAL SCREEN (IN EXCEL FORMAT),
  • ATTACHMENT OF THE PRODUCT’S INVOICE PHOTOCOPY SUBJECT TO COMPLAINT,
  • A PHOTO OF THE PRODUCTS IN WHICH THE INFORMATION OF THE PRODUCTS CAN BE CLEARLY SEEN SHOULD BE TAKEN AND SENT TO THE itsbasvuru @ iegm.gov.tr ADDRESS.
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