Complying with Saudi Arabian requirements for drug identification and traceability

The Saudi Food and Drug Authority (SFDA)’s objective is to ensure safety of human and veterinary food and drugs, safety of biological and chemical substances as well as electronic products. In the GCC Region, Saudi Arabia is the first country to establish a national system of drug traceability. Alignment on global standards to ensure harmonisation across the region is critical.

Country: 
Saudi Arabia
Industries: 
Healthcare
Results

The SFDA published a circular stating the dates of implementation in two phases:

  • Use of 2D bar codes with Batch or Lot Number, Expiration
  • Date and SFDA code will be due on the 21 February 2015
  • All of the above plus a Serial Number due on the 21 March 2017

The SFDA is working with GS1 KSA on similar requirements for medical devices identification (UDI) and for cosmetics.

Situation

SFDA believes in a standardised identification system for drugs from the manufacturer to the patient to comply with increasing need for product integrity and traceability.

SFDA released requirements on barcoding of drugs imposing that all Saudi and international drug manufacturers exporting to Saudi Arabia adopt GS1 supply chain standards.

Approach

All drugs’ markings must be upgraded from linear bar codes to GS1 DataMatrix bar codes.

The GS1 DataMatrix bar code must, at minimum, carry the GTIN (Global Trade Item Number), Expiration Date, Batch or Lot Number.

The new requirements must be applied by drug manufacturers on all type of pharmaceutical products (both human and veterinary drugs).

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