Saudi Drug Information System (SDI) is an electronic system managed by SFDA that aims to be the official drug information reference for the public and health care practitioners. Therefore, SFDA requires pharmaceutical companies to upload the most updated leaflet (PIL), SPC, and the artworks of their registered products to the 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
In SDI, Pharmaceutical companies must upload the drug information files after SFDA drug registration approval. Also, after update or variation approval. The following files must be uploaded:
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.
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 (quantities 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 are obligated to inform the Authority in the event of an expected shortage or interruption in the supply of the company’s registered drug products for not less than six months before the event. The expected time of supply interruption or inventory impact, along with providing solutions that contribute to compensating the shortage
Note that although this is required by law on the distributors, the MAH should monitor their distributor compliance since the SFDA expects control from the MAH. In addition, SFDA penalties on distributors might eventually affect the MAH.
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:
First 5 working days monthly.
First 5 working days every quarter. (January-April-July-October).
January every year.
January every year.
We provide regulatory and compliances services to accelerate your commercial activities. Contact us now for a discovery meeting or registration proposals.