Saudi Arabia SFDA Archives - rfxcel.com

Saudi Arabia’s Traceability Requirements for Imported Food

The Kingdom of Saudi Arabia imports about 80 percent of its food, according to a June 2020 report from the U.S. Department of Agriculture. To prevent food-borne illnesses and increase visibility in the food supply chain, the Saudi Food and Drug Authority (SFDA) strictly regulates imported food.

Let’s take a look at what food companies must do to comply with SFDA regulations when shipping their products to Saudi Arabia.

Saudi Arabia’s requirements for imported food

The Department of Agriculture report lists the following import procedures. First, companies must create an “E-account” with the SFDA and register their food products. They must have a Commercial Register, which includes imports and distribution of food
products. They must also submit an original invoice certified by a chamber of commerce in their home country. Last, depending on the product being imported, the may be asked to present some of following certificates:

  • Certificate of origin (copy)
  • Halal certificate (original). A Halal certificate is proof that the product meets Islamic Law requirements and is acceptable for consumption in Muslim-majority countries, as well as Western countries with a large Islamic population.
  • Certificate of slaughtering for meat and poultry (original)

Other requirements for imported food items

The GCC Standardization Organization (GSO) was established in 2001 and began operations in 2004. It is exactly what its name says: a standards organization for Gulf Cooperation Council (GCC) members. GSO requirements for Saudi Arabia’s imported foods are listed below. Many of these regulations also apply to domestic food items.

GCC Standards Organization (GSO) 9/2007

Since the end of 2010, Saudi Arabia has enforced the Gulf Standard 9/2007. Per this standard, all prepackaged and domestic foods must at minimum contain the following data points:

  • Product name
  • Packer’s name
  • Country of origin or manufacture
  • Listing of ingredients
  • Instructions for use (if applicable)
  • Shelf life

GSO 2233/2018 requirements for nutritional labeling

In 2013, the SFDA began enforcing GSO 2233/2012, a regulation from the GSO that requires labels to clearly disclose a product’s nutritional information (e.g., calories, carbohydrates, proteins, and fats) that may affect its nutritional value and consumers’ health or safety. The labels must list the ingredients, and nutritional information must be presented in a standardized, easy-to-read table so customers can readily understand what they’re purchasing. The labeling is also designed to increase people’s nutritional education to improve overall health. Some products are exempt from labeling, including bottled water, fresh fruits and vegetables, one-nutrient foods such as rice and coffee, and foods for special dietary uses, including infant formula.

Final thoughts

Keeping up with food traceability and regulations in Saudi Arabia — or any market — is a challenge. But rfxcel can help. Our solutions for food and beverage cover everything from farm to fork, from compliance to environmental monitoringContact us to book a demo of our award-winning rfxcel Traceability System and see how this  customizable, scalable platform will simplify and accelerate all of your supply chain operations.

Saudi Pharma Compliance: New Aggregation Deadline & More

Things have been relatively quiet with Saudi pharma compliance. The country’s Food and Drug Authority (SFDA) established the Drug Track and Trace System (RSD) to track all human registered drugs that are manufactured in Saudi Arabia or imported. Regulations that took effect in January 2019 have changed how the Saudi drug supply chain operates.

The RDS is a standardized identification system that tracks drugs from the manufacturer to the patient. It adopts GS1 standards and applies to all pharmaceutical products on the Saudi market, including over-the-counter (OTC) medicines. According to GS1, the SFDA is working on similar requirements for medical devices and cosmetics.

The SFDA’s goal is to create a safer and more efficient pharmaceutical supply chain. To succeed in the Saudi market, companies that produce, distribute, and dispense pharmaceuticals must fully understand and comply with the regulations. Let’s take a look at what’s been happening.

New Aggregation Deadline

Aggregation has been a sticking point in the Saudi pharma compliance requirements, with many delays for enactment. Here’s a quick timeline:

  • July 2019: The SFDA published guidelines for barcodes that included details for packaging hierarchies. This included barcoding, serialization, and pallet-level aggregation.
  • August 2019: The SFDA published a reminder about an upcoming October aggregation deadline.
  • December 2019: The SFDA moved the aggregation deadline to March 31, 2020.
  • April 2020: The SFDA moved the aggregation deadline to June 30, 2020.
  • June 28, 2020: The SFDA once again moved the aggregation deadline, this time till August 20, 2020.

So, as of today, companies have a little more than a month to comply with the aggregation requirements. This means they’ll have to prepare their packaging lines, coordinate with their trading partners, and have systems that can capture and report data to the RSD.

Overview of Saudi Pharma Compliance

Here’s quick rundown of what’s required for Saudi pharma compliance.

Data Matrix barcodes

Saudi regulations stipulate that all drugs must be marked with a GS1 Data Matrix barcode that contains, at minimum, a 14-digit Global Trade Identification Number (GTIN-14), a serial number, the expiry date, and the batch/lot number. This information must also be printed on labels. All transactions for drug packages must be reported to the RSD, and all manufacturers licensed by the SFDA must acquire a Global Location Number (GLN).

Saudi Drug Code

Every registered drug in the Saudi market is assigned a Saudi Drug Code (SDC) that contains four variables: a fixed prefix, the year, a letter to identify the type of drug, and a serial number (e.g., SFDA12D001). The SDC will eventually replace the current code.

Global Location Numbers

From March 2018, companies had to register the locations of their factories and warehouses using their Global Location Numbers (GLNs).

RSD Stakeholder Management and Operation Portals

Companies use the Stakeholder Management Portal for initial registration in the RSD. The Stakeholder Operation Portal is where companies and their stakeholders report movements of drugs inside the supply chain. This ensures that information about all shipments are reported to Saudi  authorities.

According to the SFDA website, after a company has integrated its system with the RSD, all drug movements will be recorded automatically; companies/stakeholders won’t have to log in to the Stakeholder Operation Portal manually or register transactions manually.

Final thoughts

Saudi pharma compliance is complex. Manufacturers, warehouses, and pharmacies have a lot to think about. Though the date for implementing aggregation requirements has changed a few times, you should assume the August 20 deadline will hold firm.

The time to start preparing is now. rfxcel can help you be ready for all Saudi pharma compliance requirements. Our signature rfxcel Traceability Platform (rTS) can help you keep track of all the products in your supply chain and ensure you’re complying with all SFDA requirements — or regulations in any country.

Contact us for more information. Our supply chain experts are ready to help!

Saudi Food and Drug Authority: A Quick Guide to Saudi Arabia’s Pharma Regulations

Saudi Arabia is the first of the six countries in the Gulf Cooperation Council to require drug traceability. Initiated by the Saudi Food and Drug Authority (SFDA), the Drug Track and Trace System (RDS) tracks all human registered drugs that are manufactured in Saudi Arabia or imported to the country.

SFDA is charged with ensuring the safety of human and veterinary drugs. It also oversees biological substances, chemicals, and electronic products. It has three primary objectives: preventing counterfeit drugs, improving drug availability, and achieving drug safety. To meet these goals, it is working to monitor all supply chain operations, gather reliable data about commonly counterfeited drugs, and utilizing technology (e.g., smartphones) so patients can get information about medications and receive real-time notifications about recalled drugs or similar warnings.

RDS is a standardized identification system that tracks drugs from the manufacturer to the patient. It adopts GS1 standards and applies to all pharmaceutical products on the Saudi market, including over-the-counter (OTC) medicines. According to GS1, Saudi Food and Drug Authority (SFDA) is working on similar requirements for medical devices and cosmetics.

Saudi regulations stipulate that all drugs must be marked with a GS1 Data Matrix barcode that contains, at minimum, the GS1 Global Trade Identification Number (GTIN), the expiry date, and the batch/lot number. This information must also be printed on labels. All transactions for drug packages must be reported to a national Drug Track & Trace System (DTTS), and all manufacturers licensed by the SFDA must acquire a Global Location Number (GLN).

Every registered drug in the Saudi market is assigned a Saudi Drug Code (SDC) that contains four variables: a fixed prefix, the year, a letter to identify the type of drug, and a serial number (e.g., SFDA12D001). The SDC will eventually replace the current code.

Furthermore, Saudi Food and Drug Authority will require products to be aggregated beginning October 1, 2019. All individual saleable units must be linked to the case they’re shipped in.

The SFDA and SDC requirements are complex and will be challenging for an array of stakeholders, including manufacturers, warehouses, and pharmacies. The aggregation requirement is particularly pressing, especially for companies that have not begun to prepare for the October deadline. To comply with the aggregation regulations, they’ll have to ensure their packaging lines are prepared, coordinate with trading partners, and have systems that can capture and report data to the DTTS.

rfxcel is ready to help your company comply with all Saudi regulations. We’re cultivating a presence in the region, including being an exhibitor at this year’s CPhI Middle East & Africa (MEA) conference in Abu Dhabi, United Arab Emirates. Our Traceability Platform (rTS) can help you keep track of all the products in your supply chain and ensure you’re complying with all SFDA and SDC requirements — or regulations in any country. Contact us for more information. Our supply chain experts are ready to help!