Drug Information and Stock Reporting to SFDA (SDI) Platform

The Saudi Drug Information System (SDI) is an SFDA electronic system that aims to be the official drug information reference for the public and healthcare practitioners. Post drug approval, the SFDA requires pharmaceutical companies to submit the most up-to-date drug labeling information, such as the leaflet (PIL), SPC, and the artwork of their registered drugs, to the SDI system. SFDA also uses SDI to monitor drug availability. They require companies to periodically upload their actual stock figures, maintain safety stock levels, report expected demand, and feed the system back with the consumption figures.

Drug Information Upload

Pharmaceutical companies must submit the approved drug information files to SDI and resubmit them after any variation approval affecting their information. The following files must be provided:

• Patient Information Leaflet (PIL)
• Summary of Product Characteristics (SPC)
• Artworks (Carton picture).

The purpose of that is to provide the following benefits for the HCP and patients:

• Easy access to approved drug information.
• Documentation of all variations performed on the drug.
• Up-to-date drug indications and safety information, such as cautions and side effects.

Stock Reporting

According to the pharma laws and regulations in Saudi Arabia, the following must be met:

• Local distributors must report the consumption (quantities dispensed during the past year) and the demand (amounts expected to be consumed during the current year) of all their registered preparations.
• Local distributors must report the actual stock of all their registered drugs(currently available quantities).
• The Authority will review the entered data and plans for providing registered drugs to ensure that the market need is met as planned.
• Local distributors must report the safe stock of their registered drug products (quantities of permanent stock that are sufficient for six months), provided that the Authority reviews the data, with compensation for any decrease within a maximum of three months.
• Local distributors must supply their registered drugs unless a decision is issued by the Authority to cancel their registration.
• Pharma companies must inform the Authority of any expected shortage or interruption in the supply of the company’s drug products at least six months before the event. The expected time of supply interruption or inventory impact, along with providing solutions for the shortage.

Note that panlties might be applied to MAH through their distributors in Saudi.

In summary, here is what must be reported:

• Shortage of drug supply: To report any expected shortage to SFDA with clarification of the reason.
• Actual stock: Currently available quantities are in all warehouses in the officially registered package.
• Safety stock: Quantities that are enough for 6 months.
• Consumption: The amount that was consumed within the last year.
• Demand: Quantities expected to be consumed during the current year.

Stock Reporting timeline:  

Type	Time
Actual Stock	First 5 working days monthly.
Safety Stock	First 5 working days every quarter. (January-April-July-October).
Consumption	January every year.
Need	January every year.

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SFDA Registration