Yes, all movement of drugs should be reported on the system until the drug is sold.
Yes. Response is immediate.
No. SFDA does not specify a certain source of issuing a GLN number.
Only the successfully shipped units should be added.
Immediately in real time.
After finishing all the processes inside the establishment
No. the marketing company needs to be updated with all drug movements.
The company where the final batch release came from.
They are not exempt.
SFDA should be notified by sending the drugs’ information, no other establishment can make any operation on stolen drugs.
Yes, All drugs are tracked including unregistered drugs and then reported upon every step in the supply chain.
The system accepts scanning and reporting of batches.
All medications will be added automatically in the system.
The manufacturer that prints the 2-D Barcode and completes the batch release process should notify the system.
The registrations for manufactures outside KSA is optional. If you have scientific offices inside KSA, it is their responsibility to register their information in establishment information and add the outside manufacture as a stakeholder. If you do not have a scientific office, the manufacture should authorize one person from their agents to register and manage their account. Note that they have to request the authorization form by email.
There are two web portals (Stakeholders Management Portal and Stakeholder Operation Portal). Stakeholders Management Portal is for registrations, establishment and stakeholder management. The system will create user name for each stakeholder to login and notify the system about the operations in the stakeholder operation portal.
Yes, anyone who is dealing with drugs is considered as a stakeholder but should not be registered in the system by their agents; it is the establishment responsibility to add every stakeholder under the main establishment.
Human drugs.
You can add more than one global number (GTIN) to the same registration number and notify about all of the medications.
The drug list is the drugs that the manufacturers are allowed to produce/supply and the agents are allowed to import, it will appear only to who have registered drugs, after the registration approval, the registered drugs and GTIN will be added in the system automatically within two days and you will receive an email to inform you. You can check your drug list by clicking search button in the top of the page and all the drugs list will appear. Also, you will be able to change GTIN under the following conditions:
• This given GTIN must not be defined for another drug.
• There must be no operation on the related drug.
The GTIN will be added for all the agents who have the validity/authority on the drug.
No, the system will not accept any duplicated license number or GLN for more than one registration, and if you are renting a warehouse for storing only you have to get your own SFDA license and do not use the license of the owner. Moreover, you have to issue a new GLN for you.
You can notify the system about export operations outside KSA However; in the meanwhile, it is optional.
The local agent is the one who is responsible to report this operation as import operation.
No, you cannot use the same serial number on the drug that have the same GTIN.
If the shipment is different, you can do the following:
• Return the packages to the sender through the return operation.
• Contact the sender to dispatch the missing packages in the system.
No, (RSD) system will not effect on clearance operations, and you have to report about the operations after receiving the shipments in the warehouse.
The stakeholders can track the drug if it’s in their own stock only, but they can’t track the drug after it is dispatched to another stakeholder.
Yes, they can determine the privilege.
Yes, it is mandatory.
You have to check all the data before accepting the batch or notify about the operation; in case they are not similar, the sender have to resend it with the correct numbers.
No, the agent has to notify the system about the import operation and dispatch operation to other stakholders.
You have to notify the system about all the dispatch and accept operations for each package inside and outside the establishment.
ISD (Interface Specification Documents) a technical document for each process of the system that explain integration messages between RSD system and stakeholders’ system.
The system provides a secure way to send batch information to local agents by: Reporting the supply operation in the system then send it to the agent or by using the file transfer system (PTS).
You can use the system portals for notification (reporting) until your system is ready.
The system tracks all human drugs including tender drugs, in this case you can notify the system about the consume operation once it has started to ensure the product safety, you can also enquire about it later.
If the establishment were licensed from SFDA, the establishment can register in the system as individual establishment and do the operations as accept and dispatch.
Both of the factory and agent have to register and notify the system about the operations, since the factory will notify the system about supply operation of the drug then he will dispatch it to the agent. After that, the agent will accept this batch and dispatch it to other stakeholders.
Yes, you can.
You should print the authorization form on the official paper for the scientific office, but if there is no scientific office, you can print it on the official pepper of the factory.
You can deactivate the units that you want to destroy and write the reason then sent it to the destruction companies without dispatching it in the system.
No, each licensed warehouse from SFDA should have their own GLN.
• If the samples are for marketing, they are exempted from notifying in the system.
• If the samples are to be examined by SFDA at the (port), you have to deactivate them through the system and type the reason.
What shall I do if by mistake entered a wrong information while notifying the system?
Yes, you can deactivate one unit or more.