The Turkish Pharmaceuticals Track&Trace System


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THE TURKISH “PHARMACEUTICALS
TRACK&TRACE SYSTEM (ITS)”

The Turkish “Pharmaceuticals Track and Trace System” defines the infrastructure  for units belonging to each pharmaceutical product in Turkey.  The abbreviation for this term is ITS. 

The ITS operates on the principle of providing track and tracing with the help of a secondary identifier and reporting the information to the system center, along with the formerly used barcode.

This operating system is being worked on by a specific group of specialists for a long period of time; and, following many of meetings to which representatives from The Ministry of Health, The Ministry of Finance, The Social Security Association, non-governmental organizations on behalf of the pharmaceutical sector, The Turkish Pharmacists Association, other non-governmental organizations and consultants giving support and providing solutions to pharmaceutical companies, the establishment of the system and the barcode type to be “Datamatrix” were adopted.

This system shall be operated by The Ministry of Health.

The works of the system shall be appraised in two stages:

1.      Providing traceability of products;

2.      Data collection and assessment for the track and tracing of products.

Works performed at the first stage may be gathered under two topics such as re-determination of identifiers to be located on product packagings, and determination of standards with regard to data transfer for track and tracing.  At the second stage, data collection shall be provided.

“Datamatrix” type, 2 dimensional barcode, appointed as a secondary identifier, shall be printed on all product packagings within 2008.  Datamatrix called as “Karekod”.

The amendment of the regulation and the barcode guideline prepared in Turkish.

Datamatrix will be printed on;

  1. Pharmaceuticals
  2. Reimbursable food supplements,
  3. Reimbursable borderline products.

Squarecode is going to be printed on products, sample products and products for hospital use.

Medical Devices are completely out of these system.

ITS infrastructure studies are currently being processed.  Barcode and data standards are being worked on with GS1 Türkiye.  On one hand, several pilot projects have been examined.  ITS was discussed at the “GS1 Healthcare Conference” work teams, in London, on 29 October 2007, and included in the “Feedback Work Teams” report under the title of “Information Sharing Model 4-Central Data Base”.

An information sharing list for those concerned with ITS has been established.

Shared documents and frequently asked questions may be accessed in our website.

 

Regulations:

 

 

Turkish Drugs Barcoding Guidance 1.1 (changes from version 1.0 are in red.) 

 

 

 

Other informations:

SECONDARY DRUG IDENTIFIER: This 2 dimensional barcode is an automated data identifier with a matrix structure which is able to store more data in a narrower area.  The use of a 2 dimensional barcode, alongside a linear barcode, a primary identifier, on drug packagings have been adopted in parallel with other studies in the world. 

A secondary identifier “Squarecode” on drugs is decided to be as such:

 

 

This identifier content to be printed on outer packagings of drugs. Squarecode has been designed to provide monitoring for the specific drug with various dimensions.   

 

It is anticipated that secondary definers and optically readible information printed on product packagings shall be demonstrated as below: (Although this illustration is merely a sample, attention should be drawn to the fact that all content of information is printed on the right hand side…)

  

Datamatrix barcodes may be printed on the products packages many of methods. Inkjet, Laser printing and labeling are also accepted.

LABELS TO BE USED ON CONVEYANCE PACKAGINGS:  It is mandatory that a identifier is printed on each parcel or other conveyance packaging while transporting items.  Provided that the conveyance packaging bears all information belonging to the packagings inside of it, necessary information shall be easily read from the outer surface without being opened.  Hence, procedures will ease and safety of the product will improve. 

Standardisation studies of codes and labels to be printed on conveyance packagings are carried out with the cooperation of GS1 Türkiye.

Information printed on conveyance packagings may be other than on a label; it may be printed directly on the packaging with regards that it is readible on all conditions. 

On grounds that conveyance packagings are opened or contents have changed, labels to be placed on conveyance packagings must be renewed. 

RFID (Radio Frequency Idenfification): Is an automated  data collection/defining vehicle.  Different from a barcode, it contains an electronic hardware.  Remote reading of information is enabled with this certain hardware.  RFID tags are classified as active and passive.  Information printed on passive tags can only be read; whereas on active tags, can be both read and written.  Little programlets resembling computer programing can be carried inside active tags; several procedures can be followed with the use of these programlets.  For instance, medium heat can be stored into an active RIFD tag on necessary circumstances.

The RIFD method is not identified in ITS.  However, its use in the field of logistic monitoring is taken under consideration.  In the draft amendment of the Labelling Regulation for Human Medicinal Products, a provision for the placement of definers on conveyance packagings has been included, yet RIFD has not been set as mandatory.  These definer contents have been regarded as to be used with RIFD tags.  Accordingly, manufacturers may readly or in the future use RIFD labels on conveyance packagings.