Understanding Saudi Arabia’s Serialization and Aggregation requirements
Introduction to the SFDA
The Saudi Food and Drug Authority also known as the SFDA has created the standardized RSD identification system to track the entire supply chain for drugs manufactured and imported in Saudi Arabia. The track and trace system starts with the production until it reaches the consumer to ensuring that counterfeit drugs are identified and removed swiftly.
Each stakeholder including the manufacturers and importers must register with the SFDA. The SFDA also has other measures to track the verification of medications by consumers including simplified reporting of adverse reactions.
The management and control of the drug supply chains have gradually been changing in order to ensure efficiency and integrity in the operations. The SFDA regulations and standards began having an impact in early 2019 and have grown to bring about impressive changes in the health industry. In order to enhance a reliable tracking system, the SFDA had to adopt and implement GS1 standards for pharmaceutical products which were also inclusive of non-prescription medicine. The GS1 standards are designed in a way that they refine the safety, visibility and efficacy of supply chains across both physical and digital channels. The SFDA has always had a vision and objective of ensuring the pharmaceutical supply chains are secure, systematic and meet the subjective needs of all parties involved. With such an ambitious goal, it is crystal clear that it can only be achieved if the set laws and regulations are strictly adhered
What pharmaceutical companies need to do
Implement the GS1 2D Data Matrix which includes
- Expiration date, format YYMMDD
- lot/batch number
- Alphanumeric Serial number, variable in length with up to a maximum of 20 characters,.
SFDA allows different variants of the printed information. In most variants, the expiration date must also be printed on the outer packaging in human-readable form.
Pharmaceutical companies in Saudi Arabia are mandated to deploy the GSI Data Matrix Barcodes for the sole purpose of tracking and tracing the drugs. In addition, the drug companies have to ensure their drugs have been approved and registered before being supplied to the market.
As proof of approval and registration, each drug has to have a Saudi Arabia Drug Code (SADC) assigned to it. This is done by the Saudi’ Drug Code (SOC). The SFDA also mandates the use of RSD Stakeholder Management and Operation Portals to ensure all information concerning shipments is disclosed to Saudi authorities. The pharmaceutical companies that have already adopted the RSD systems will only deal with online registration and thus terminate the setbacks associated with manual registration of data. Subsequently, the global location numbers have to be issued to products. This gives them a unique identity when it comes to their tracing.
Since October 2019, aggregation of individual packages has been mandatory in Saudi Arabia. An 18-digit Serial Shipping Container Code (SSCC) must be applied at the carton and pallet level. Each whereabouts of an aggregated drug unit will be marked via the GLN.
Initially, only human medicines will be tracked throughout the supply chain but eventually will include other healthcare products as well including medicines for animals. Some products are exempt from the track-and-trace process in Saudi Arabia which include, for example, not for sale sample units, medicines for personal use, or those approved for repacking. This will also eventually extend to food and medical technology sectors.
The complexity of the Saudi Arabia pharmaceutical requirements shows the urgent need for companies to act fast in implementing the regulations. It is quite evident how the health economy would benefit from adhering to the SFDA requirements resulting in enhanced patient safety.
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References and citations:
Jadi, Amr. “Enhancing the monitoring system of sfda in Saudi markets.” International Journal of Software Engineering & Applications 7.4 (2016): 31-45.
This information is being provided ‘As Is’ with no claims of suitability for a particular purpose. It represents just one possible interpretation of information available in the public domain or through membership organizations, and that interpretation is subject to change. This information does not constitute legal advice. Users must refer to the source material for the complete requirements and form their own interpretation before making business decisions.