Saudi Arabia

v. 14 – 2020/02

Market Executive Summary Phased implementation, starting with 2D coding through consolidation on GS1 standards to serialisation and finally expected traceability based on Gvt DB.

Focus remains on establishment of the GS1 – compliant coding at all packaging levels.

The traceability system guidance has now been updated.

COVID-19 Update:
SFDA postponed the aggregation (as well as integration) implementation deadline to 30 June 2020 (initially March 31, 2020) due to the COVID-19 situation. Outbound reporting of aggregation data is also postponed together with the aggregation data itself.

Key Dates
  • June 30, 2020: postponed aggregation deadline (second postponement, revising earlier change of deadline to 31st March 2020
  • January 2020: reporting implementation to be phase in from January 2020
  • Dec 2019: Scope limited to human pharmaceuticals only. Vet products will not be required during initial phase.
  • Nov 2019: Level of barcoding required on level of aggregation to include carton/case/outer pack and pallet.
  • Sept 2019: Tamper-Evident Packaging required