Pharma (Saudi Arabia)

March 2017 – Serialization SSU – All Products must be labeled in compliance with Legislative Decree No. 41 of 2017.

February 2018 – Registration DENR – All local manufacturers and warehouses have to register their GLN’s in the DENR authority portal. Do not apply for overseeing suppliers.

7 January 2019 – Reporting DTTS – Stakeholders start reporting SNs through the new authority platform called DTTS, Drug Track & Trace System.

August 2020 – Aggregation – All Companies representing Manufacturers/MAHs are required to be compliant with Aggregation reporting requirements.

Who is affected?

Manufacturers
Warehouses
Pharmacies
Medical and Dispense Centers

Local manufacturers and importers/distributers have to notify the authorities through DTTS about all activities done to the drug packs.

The external manufacturers (oversee suppliers with production outside the KSA) have the possibility to provide their agents with a flat list of SN.

Saudi Arabia Track & Trace regulations for pharmaceuticals

Stakeholders and serialized products must be registered in SFDA DTTS. All stakeholders in the system must have a unique GLN ID obtained from SFDA/GS1.

The product is serialized at the manufacturing SA by applying a 2D DataMatrix on the saleable unit pack with info: GTIN, Unique random serial number, Lot Number, and Expiry Date. Each pack is further aggregated into cases and pallets which are uniquely identified with SSCC coding. The "Supply notification" is triggered to DTTS after the production process. It is used to register a product in the DTTS system, which is manufactured in the country. This operation is the initial step in a product lifecycle.

Manufacturer ships the product to either oversee or to the supply chain partner (e.g. Distribution Warehouse) in the country. In the case of export the "Export Notification" is sent to DTTS. Otherwise, the "Dispatch Notification" is sent to DTTS.

The Manufacturer may receive the produced goods from overseeing Partener or CMO. In this case, the "Import Notification" is triggered to DTTS during the receiving procedure. This operation is the initial step in a product lifecycle for imported goods. The manufacturer may receive the return deliveries from supply chain partners. In this case, the "Dispatch Cancel" is triggered during the receiving procedure.

The distributor receives the goods shipped from MAH or from overseeing partner. | In case of importation the "Import Notification" is triggered to DTTS during the receving procedure. In the case of domestic movement the "Accept Notification" is triggered to DTTS.

The Distributor is able to return the received goods back to the supplier and can export them to oversee partners or send them to the consumption centers or pharmacies. Depending on the scenario the corresponding notification must be sent to DTTS.

Consumption Centers or Pharmacies must report the "Accept Notification" to DTTS during the receiving procedure.

Consumption Centers or Pharmacies may return the goods back to the MAH or Distributor or transfer product between each same type of stakeholders. Pharmacies can transfer products between only pharmacies and Consumption Centers can transfer products only between Consumption Centers. Depending on the scenario the corresponding notification must be send to DTTS.

Consumption centers and Pharmacies may consume or sell the product to the patient or deactivate it due to damage, etc. The corresponding notification must be sent to DTTS.

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