SFDA Imposes SAR 678,400 In Penalties On Pharmaceutical Establishments For Non-Compliance With Regulations

The Saudi Food and Drug Authority (SFDA) has discovered 24 violations among pharmaceutical companies for not supplying their registered products in the local market. These breaches include failing to report to the SFDA’s Drug Track and Trace System (RSD), not informing about potential shortages, and lacking adequate stock.

In August 2024, SFDA inspectors found that five establishments did not report directly to the RSD. Nine failed to supply their registered products, another nine did not report expected shortages or supply interruptions, and one did not maintain sufficient stock for at least six months.

The SFDA imposed fines on these establishments as per "The Registration Rules of Pharmaceutical, Herbal and Health Product Manufacturers and Their Products Guideline," amounting to SAR678,400. These guidelines require manufacturers to keep a six-month stock of all registered products based on annual consumption data reviewed by the SFDA.

Manufacturers must address any stock shortages within three months unless the SFDA decides to cancel product registrations. They must also notify the SFDA of any anticipated supply disruptions lasting at least six months from when they are expected.

This requirement aligns with the SFDA's commitment to ensuring pharmaceutical establishments comply with regulations. It aims to guarantee medicine availability for citizens and residents across Saudi Arabia. The SFDA confirmed that penalties could reach up to SAR5 million, including potential facility closure or license cancellation.

The SFDA encourages reporting violations by contacting their unified number (19999). This initiative underscores their dedication to maintaining a steady supply of medicines in the Kingdom.

With inputs from SPA