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How is traceability ensured on drug labels? Barcode, QR Code, and Serial Number.

How is traceability ensured on drug labels? Barcode, QR Code, and Serial Number.

Traceability on drug labels is ensured through technologies such as barcodes, QR codes, serial numbers, and data matrices. Tracking each unit of medication from production to consumption is a legal requirement. In Türkiye, under the Ministry of Health's Drug Tracking System (ITS), all medications are required to be marked with a QR code.

Why is traceability mandatory on drug labels?

  • Counterfeit drug prevention: Each unit has a unique serial number, making it easier to identify counterfeit products.
  • Recall management: Problematic batches can be quickly identified and withdrawn from the market.
  • Patient safety: Prevents the administration of incorrect medication.
  • Legal compliance: Turkey's ITS (Istanbul Technical Health System) and the EU's Falsified Medicines Directive (FLD) make it mandatory.
  • Supply chain transparency: Every stage, from production to pharmacy, is recorded.

How to Ensure Traceability on Drug Labels? Step-by-Step

  1. Serial number assignment: Each unit of medicine is assigned a unique serial number. This number is recorded in the system during the production phase.
  2. QR code or barcode printing: A QR code containing the serial number, expiration date, batch number, and product code is printed on the label.
  3. ITS registration: In Turkey, all pharmaceutical units are required to be registered in the Ministry of Health's ITS system.
  4. Distribution tracking: Movements are recorded by scanning barcodes at the drug warehouse, pharmacy warehouse, and pharmacy stages.
  5. End-user verification: The product's authenticity is verified by a final scan at a pharmacy or hospital.

Types of Barcodes and Codes Used on Pharmaceutical Labels

Code Type Feature Area of Use
QR Code (Data Matrix) It carries a lot of data in a small area and has high fault tolerance. Türkiye's ITS mandatory QR code.
QR Code Smartphone-readable patient information Patient verification, package insert access.
Linear Barcode (EAN-13) Standard product barcode Pharmaceutical warehouse and pharmacy stock tracking.
GS1-128 Barcode It bears the serial number, batch number, and date together. Hospital and supply chain management

What information is required on a drug label?

  • Product name and active ingredient
  • Serial number
  • Expiration date
  • Party number
  • QR code (ITS mandatory)
  • Manufacturer information
  • Storage conditions
  • License number

How are multi-layered labels used in the pharmaceutical industry?

Multi-layer labeling offers a solution when it becomes difficult to place all the necessary information on small packages. The bottom layer carries the QR code and basic information, while the top layer contains usage instructions, dosage information, and multilingual content. Multi-layer labeling is also widely preferred for export pharmaceuticals to meet different language requirements. For detailed information, please see our multi-layer labeling page.

Frequently Asked Questions

Is QR code mandatory on drug labels in Türkiye?

Yes. According to the Ministry of Health's Drug Tracking System (ITS), all drugs released onto the market in Türkiye are required to have a QR code. The QR code must contain the serial number, expiration date, batch number, and product code.

What is the difference between a QR code and a barcode on a medicine label?

QR codes (Data Matrix) carry much more data in a small area and have a high error tolerance. Therefore, QR codes are mandatory in the ITS (Integrated Tracking System). QR codes, on the other hand, can be easily read with smartphones and can be used additionally for patient information purposes.

How to print variable data on drug labels?

Variable data such as serial numbers and expiration dates, unique to each unit, are printed using digital printing or thermal transfer technology. Integration with inline printing systems is ensured in high-speed production lines.

Are there any additional requirements for pharmaceutical companies exporting to the EU?

Yes. Under the EU FMD (Falsified Medicines Directive), companies exporting to the EU are required to use a unique identifier, tamper protection system, and product verification system. For detailed information, please see our pharmaceutical labeling page.

Production of Pharmaceutical Labels with Doğa Barcode

As Doğa Barkod Etiket, we offer specialized labeling solutions for the pharmaceutical industry with ITS-compliant QR code printing, multi-layer labels, and high-strength material options. With our ISO 22000 and ISO 9001 certifications, we ensure safe and traceable production. You can review our pharmaceutical labels page or contact us to request a quote.

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