Saudi SFDA issues SAR1.7mn in fines for violations of drug tracking system

The Saudi Food and Drug Authority (SFDA) has imposed fines totalling more than SAR1.7 million ($453,300) on 10 pharmacies for violations related to the electronic Drug Track and Trace System, known as RSD.

In a statement reported by Saudi Gazette, the SFDA said the penalties were issued after identifying multiple breaches of the system’s requirements for tracking pharmaceutical products.

Pharmacies breach RSD tracking rules

According to the authority, seven pharmacies failed to report drug movements directly through the system. Two other pharmacies did not provide registered products regardless of price or consumption, while another pharmacy failed to report expected shortages or supply disruptions at least six months in advance, as required.

The SFDA said the RSD system is designed to track and monitor human medicines from the manufacturing stage until they reach consumers. The system aims to ensure drug safety and quality, prevent tampering and counterfeiting, and reduce the risk of shortages in the market.

The authority noted that penalties under the regulations can apply to pharmaceutical establishments and warehouses. Fines can reach up to SAR5 million ($1.33 million), and sanctions may also include the temporary closure of a violating establishment for up to 180 days or the cancellation of its licence.

The SFDA said the RSD system is a key tool for ensuring drug safety by providing full visibility across the supply chain, from production to consumption. Its objectives include preventing counterfeit medicines, ensuring the availability of approved drugs and safeguarding public health.

The authority launched the RSD system as part of its efforts to support the goals of Saudi Vision 2030, which include the adoption of advanced technologies to regulate and monitor pharmaceuticals manufactured locally and imported into the kingdom.

The SFDA said the system strengthens its role in protecting society and ensuring the safety of medicines by enabling the identification of a drug’s origin and movement throughout the supply chain.