Organization : Saudi Food & Drug Authority
Type of Facility : Importing Batch Release & Clearance System
Country: Saudi Arabia
Website : https://ibrcs.sfda.gov.sa/
Importing Batch Release & Clearance System :
Importing, Batch-Release & Clearance System (IBRCS) is an electronic system that issues importing and clearance permissions of pharmaceutical shipments at points of entry.
Related : Saudi Food & Drug Authority Gulf Rapid Alert System For Food : www.statusin.org/10145.html
Moreover, IBRCS is used to notify the SFDA about any batch released to the market by the local manufacturers.
Security and Confidentiality of Data:
All data submitted online will be protected and encrypted via the IBRCS security infrastructure.
FAQs:
Q. What is the IBRCS?:
A. Importing, Batch-Release & Clearance System (IBRCS) is an electronic system established to issue importing and clearance permissions of pharmaceutical shipments at the points of entry. Moreover, IBRCS is used to notify the SFDA about any batch released to the market by the local manufacturers.
Q. Why do I need to use IBRCS?:
A. You need to use IBRCS to be able to import and release the imported pharmaceutical products from the points of entry. For the locally manufactured products, the SFDA should be notified about all the batches released to the market.
Q. Who/when should use IBRCS?:
A. IBRCS should be used by all local manufacturers of pharmaceutical products and any organization interested to import and/or release pharmaceutical shipments such as pharmaceutical companies, agents and hospitals. Also the local manufacturers should use the IBRCS to notify the SFDA about all the batches released to the market.
Q. How could I use IBRCS?:
A. If you have an account in the Drug Establishment National Registry (DENR), you could use IBRCS through the same account.
Q. When I should request an importing permission?:
A. You should request an importing permission if you are importing one of the followings:
1.Un-registered pharmaceutical products.
2. Pharmaceutical products for tenders which may follow an installment clearance procedure.
Q. When I should request a clearance permission?:
A. You should request a clearance permission if you have pharmaceutical products shipments at the points of entry. Then, the applicant will receive a reference number to follow up with the SFDA clearance office at the point of entry.
Q. When I should apply for batch-release notification?:
A. Local manufacturers should apply for batch-release notification when they are releasing a batch of any pharmaceutical products into the market.
Q. What should I do after submitting a clearance permission request?:
A. After submitting a clearance permission request, you will receive a reference number to follow up with the SFDA clearance office at the point of entry. The company representative should have the reference number with him at the point of entry along with all the original required documents, the SFDA staff at the point of entry will inspect the shipment and authenticate all the information within the provided documents, if the shipment and all the provided information follows the SFDA regulations, they will issue a clearance permission.
Q. Can I enter the shipment information prior its arrival to the point of entry?:
A. Yes, you can.
Q. What are the required documents to clear the shipments?:
A. All the required documents are provided at the SFDA website. However, you can view it directly by clicking on the following link:- Required Documents To Clear The Shipment
Q. What are the required documents for importing drugs?:
A. All the required documents are provided at the SFDA website. However, you can view it directly by clicking on the following link: Required Documents for Importing Drugs