Complying with Saudi Food and Drug Authority requirements for drug identification and traceability

The Saudi Food and Drug Authority (SFDA) has been established under the Council of Ministers resolution as an independent body corporate that directly reports to The President of Council of Ministers. The Authority objective is to ensure safety of food and drug for man and animal, and safety of biological and chemical substance as well as electronic products.

Country: 
Saudi Arabia
Industries: 
Healthcare
Results

The SFDA mandated the use of GS1 standards for drug traceability, in two phases:

  • By 21 March 2015: all drugs marketed in Saudi Arabia must be identify at the secondary level packaging with a GS1 GTIN, batch/lot number and expiry date, encoded into a GS1 DataMatrix 
  • By 12 March 2017: a serial number must be added to the GTIN, batch/lot number and expiry date
Situation

The Drug Sector in Saudi Food and Drug Authority (SFDA) believes that a standardised identification system for drugs from the manufacturer to the patient is imperative to comply with the increasing need for product integrity and traceability.

The responsible department of the Saudi FDA had therefore released requirements on barcoding of drugs imposing all drug manufacturers in Saudi Arabia and international manufacturers exporting to Saudi Arabia to adopt GS1 supply chain standards.

Approach

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

The GS1 DataMatrix barcode 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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