TURKISH MEDICINES AND MEDICAL DEVICES AGENCY
PHARMACEUTICAL TRACK AND
TRACE SYSTEM
(İTS)
1
WHAT IS PHARMACEUTICAL TRACK AND TRACE SYSTEM?
Desciption
İTS is an abbreviation of Turkish Pharmaceutical Track and Trace System (İlaç Takip Sistemi).
İTS is the infrastructure designed for track and trace all medicine in supply chain of Turkey.
System covers every medicine box in all steps of supply chain, from production / import until
consumption.
First In TheWorld
İTS is first and biggest scope project in the world, that many countries are interested in. As
Agency, we accept visits from other countries to introduce and share information about our
succesful project.
RIGHT RIGHT RIGHT LOW
PRODUCT TIME PLACE COST
Turkish Medicines and Medical Devices Agency 2
WHAT IS DATAMATRIX?
(01) GTIN
Global Trade Item Number
(0barcode)
(01)08691234567890 (21) SN
Serial Number
(21)111323424679
(17)100331
(17) XD
(10)X2512061322 Expiration Date
GTIN + SN = unique identifier
(10) BN
Batch Number
Turkish Medicines and Medical Devices Agency 3
ROLE OF GS1 STANDARDS IN OUR PROJECT
GS1 Standards are being used in ITS Project
GTIN (Global Trade Item Number) is used for identification of products (medicine)
GLN (Global Location Number) is being used for identifying stakeholders.
ITS
GTIN GLN
(GlobalTradeItemNumber) (GlobalLocationNumber)
Turkish Medicines and Medical Devices Agency4
ROLE OF GS1 STANDARDS IN OUR PROJECT
Pharmaceutical
Track&Trace System
LICENCE
HOLDER CONSUMPTION
WAREHOUSE PHARMACY
(PRODUCER/ CENTER
IMPORTER)
Turkish Medicines and Medical Devices Agency 5
HISTORY
DecisionSupport
Webservices Phase2 Systemis
announced Started plannedto start
2007 2010 2014
2009 2012 2019
KickOff Project published ITS Mobile Application
(Phase 1) developed
TurkishMedicines and Medical Devices Agency 6
RIGHT PLACE
İTSallows to track instant medicine
stocks in Turkey. And medicine can be
supplied for the regions which don’t
have necessary medicine.
We can control all stakeholders in
supply chain by İTS.
The stakeholders are:
• Producer / Importer
• Pharmaceutical Warehouse
• Pharmacy
• Hospital
Turkish Medicines and Medical Devices Agency 7
MARKET CONTROL
Various limitations can be applied
by İTS due to the Ministry politics.
For Example: Selling of controlled
medicine is limited depending on
the risk groups. Illegal medicine
have been prevented due to this
limit which is applied on medicine
movements.
For Example: Supplying quality
data for insurance institutes.
Turkish Medicines and Medical Devices Agency 8
İTS SCREENS
Turkish Medicines and Medical Devices Agency9
RIGHT PRODUCT
İTS allows all kind of movementssafe
of medicinein
1 supply chain. It protects patients and whole supply
chain from counterfeit products.
Estimatedsaving
in 2017-> 316m TL≈90m $
in 2018 -> 391m TL ≈72m $
* based on all type of rejected transactions
2 İTS prevents
resaleof medicine.
3 İTS expedites recallingof medicine.
4 İTS prevents sale of expiredmedicine.
TurkishMedicinesandMedicalDevicesAgency 10
STAKEHOLDERS
LICENCE
HOLDERS (PRODUCERS/IMPORTERS) 412
PHARMACEUTICAL WAREHOUSES 550
PHARMACIES 26.006
CONSUMPTION CENTERS 16.312
REİMBURSEMENT AGENCIES 50
Stakeholdersarebeing Largest reimbursement agency is SGK
trackedbyGLN (global (Social Security Instution) and %85 of
locationnumber) medicine sold from pharmacies are
payed back by SGK.
Turkish Medicines and Medical Devices Agency11
PARAMETERS
TOTAL STAKEHOLDERS ≈ 42.705
MEDICINE TYPES ≈ 8.950
MEDICINE UNITS ≈ 18.272.358.106
MEDICINE UNITS SOLD BY PHARMACIES ≈ 12.730.093.485
MEDICINE UNITS RECALLED ≈ 16.829.923
MEDICINE UNITS IN PHARMACY STOCK ≈ 513.237.738
DAILY AVERAGE TRANSACTIONS ≈ 79.177.448
(Dec.2018 avg.)
TRANSACTIONS IN A SECOND ≈ 916.4
RESPONSE TIME <0.5 Second
Turkish Medicines and Medical Devices Agency12
FOR OUR PEOPLE:
İTS MOBILE
Our citizens are able to inquire their own medicine
using their smartphones.
Citizens are able to learn the,
• Data Matrix Information,
• Name,
• Expiration Date,
• Price of the Medicine;
Also;
• If the Medicine is Recalled,
• If the Medicine is Registered on the System.
Insecure Medicine Notifications and Adverse Effect Notifications
can be made by citizens thru İTS Mobile.
Turkish Medicines and Medical Devices Agency 13
RESTRICTED PRESCRIPTION SYSTEM PROJECT
Restrictedpresciptionsystem is developed for providing dosage control and prevention of medicine abuse
controlled medicine, blood products and hemophilia products.
The information that collected by the system is used to obtain reliable statistical information.
This database is also useful for better inspection processes countrywide.
OurPrescriptionGroups
Redprescription Narcoticsandopiates(Examples
: pethidinehcl, methylphenidat…etc)
medicine
RightDosage,WhenNeeded Greenprescription
medicine
Pyschotropicmedicine. (Examples
: tramadol, biperidenhcl…etc)
Restrictedpresciption system ensures Purpleprescription Bloodproducts. (Examples
: humanalbumins,IgG…etc)
medicine
patientsto useonlynecessarymedicine
at right time and right dosage. For Orangeprescription Hemophiliamedicine. (Examples
: factorVIII, IX…etc)
medicine
ensuringpatient and medicine safety,
the systemcontrols the dosageat the Whiteprescription Medicinethat haveabusepotential(Examples
: pseudoephedrine
, gabapentin
, pregabalin
…etc.)
controlledmedicine
prescriptionstep.
Whiteprescription
othermedicine
Turkish Medicines and Medical Devices Agency14
RESTRICTED PRESCRIPTION SYSTEM
PROJECT SCREENS
Turkish Medicines and Medical Devices Agency15
UTS (PRODUCT TRACKING SYSTEM) PROJECT
The Product Tracking System Project aims at
developing infrastructure to track medical devices
and cosmetic products manufactured in our country
or imported from the production band to the place
where they are sold and used.
Purposeof the Project
• To keep track of medical devices and cosmetic products.
• To establish a National and Original infrastructure which meets
performance requirements to keeptrack of products.
• To contribute to ensuring patientsafetyand protection of public
health.
• To provide an infrastructure to ensure healthy and efficient
execution of inspectionservices.
• To ensure rapid measuresare taken against possible risks to ocur
during use of the products.
Turkish Medicines and Medical Devices Agency 16
UTS (PRODUCT TRACKING SYSTEM) PROJECT
Turkish Medicines and Medical Devices Agency17
THANK YOU
www.its.gov.tr | www.uts.saglik.gov.tr
