SFDA RSD track and trace: a guide for drug warehouses and pharmacies

RSD (رصد) is the Saudi Food and Drug Authority's Drug Track and Trace System. It follows every pack of human medicine made in or imported into Saudi Arabia, using the pack's GS1 DataMatrix serial number. If you run a drug warehouse or a pharmacy, you must register with RSD and report each movement of stock you make. Your ERP or warehouse system therefore has to know each pack's serial as well as its batch.

Note: SFDA's main website could not be reached while we prepared this guide on 1 October 2026. The obligations below come from the RSD portal FAQs and SFDA documents found through search, plus industry summaries. Confirm details against the current RSD portal and circulars before you act.

What is RSD and why does it exist?

SFDA built RSD as part of Saudi Vision 2030. It has three aims: to stop counterfeit medicines, to make sure medicines are available, and to protect patient safety (RSD portal). The system follows GS1 standards. Each medicine pack carries a 2D DataMatrix barcode with four data elements:

• GTIN: identifies the product and pack size.
• Serial number: unique to the pack, alphanumeric, up to 20 characters.
• Batch or lot number.
• Expiry date, in YYMMDD format.

Cartons and pallets carry an 18-digit SSCC that links the packs inside them. Industry summaries report that this aggregation has been mandatory since October 2019. Published figures for the system report more than 6,000 registered stakeholders by the end of 2021, more than 3 billion operations recorded, and 15 million boxes recalled through the system. We could not confirm these against a current SFDA page.

Who must report to RSD?

The RSD FAQs say that anyone dealing with drugs is a stakeholder. In practice this covers:

Each warehouse needs its own SFDA licence and its own GLN (Global Location Number). The FAQs say licences cannot be shared between sites.

Which movements must a warehouse report?

From the RSD FAQs:

1. Supply, dispatch and accept are mandatory for every movement of product, including transfers between your own warehouses.
2. Accept is reported after the shipment has been received into the warehouse.
3. Return is available for shipments sent in error.
4. Deactivate is used for destroyed drugs or samples taken for SFDA testing, with a reason.
5. Export may be reported but is optional.

The FAQs say operations should be reported after all processes inside the establishment are complete. RSD gives an immediate response, which tells you straight away whether a pack was accepted, rejected or blocked.

How can you connect to RSD?

The FAQs describe three options:

• System integration using SFDA's Interface Specification Documents and the DTTS integration guide. This suits warehouses and busy pharmacies.
• CSV file upload through the portal.
• Manual entry in the Stakeholder Operation Portal, for low volumes or while your system is not ready.

Many Saudi pharmacy and ERP vendors offer RSD integration as a standard or add-on feature. Some companies use a specialist middleware provider between their ERP and RSD.

What must your ERP or WMS do for RSD?

RSD asks for the exact serial numbers you moved. Your system needs:

1. DataMatrix scanning at receipt and dispatch. Parse GTIN, serial, batch and expiry from each scan. Laser scanners cannot read DataMatrix codes, so use 2D imagers.
2. SSCC aggregation handling. Scanning one pallet or carton code should expand to the packs inside, so you do not scan every box.
3. Serial-level stock. Batch and expiry drive FEFO picking. Serials tell RSD which packs moved.
4. Customer and supplier GLNs on master data, because RSD operations identify parties by GLN.
5. Reject handling. If RSD rejects an accept or dispatch, for example because the pack is recalled, stolen or already dispensed, the stock goes to quarantine and cannot be sold.
6. Deactivation workflow for destruction and damaged stock, with reason codes.
7. Reconciliation. A daily report of operations sent, accepted and rejected, so gaps are fixed before they build up.

How does RSD affect recalls?

SFDA describes RSD as enabling a real-time stop of recalled medicines. Once a batch is recalled, any attempt to dispatch or dispense its packs can be blocked centrally. You still have to quarantine the physical stock, notify your customers and return or destroy the packs as SFDA and the marketing authorisation holder instruct. Keep your own batch-to-customer trace so you can reconcile what RSD shows with what you actually hold.

What should a warehouse check this quarter?

• Confirm every site has its own SFDA licence and GLN registered in RSD.
• Check your RSD rejection rate for the last month and the three most common reasons.
• Test a receipt of an aggregated pallet and check that every pack is accepted.
• Confirm deactivations for destroyed or expired stock have been reported.
• Pick one recalled batch and check that your system and RSD agree on where every pack is.

How Asli Pharma ERP helps

Asli Pharma ERP already does the batch-level work: it scans GS1 DataMatrix codes, captures batch and expiry at receipt, picks by FEFO, and keeps quarantine with authorized QC release. Its batch recall includes a full customer trace. It has an EPCIS event module built for the UAE's Tatmeen system, which models serial and aggregation events. SFDA RSD integration, ZATCA Phase 2 and an Arabic interface are on the roadmap and are not available today. Asli is not SFDA-integrated. In Saudi Arabia it is currently suitable only for design partners who accept that.

Frequently asked questions

Sources

1. SFDA: The SFDA's Track-and-Trace System (RSD)
2. SFDA RSD portal: home
3. SFDA RSD portal: FAQs
4. SFDA RSD portal: registration and e-services
5. SFDA: Integration Guide for Drug Track and Trace System (English PDF)
6. SFDA: Stakeholder Operation Portal user manual
7. tracekey: Track and trace in Saudi Arabia (industry summary)