The Saudi Food and Drug Authority (SFDA) has imposed fines totaling 678,400 riyals on 24 pharmaceutical companies due to various violations related to product supply and stock maintenance. These violations include failure to comply with SFDA guidelines and report expected shortages.
Key Violations by Pharmaceutical Companies
- Failure to Report to SFDA’s Drug Track and Trace System (RSD)
- Neglect in Reporting Product Shortages
- Insufficient Stock Maintenance
The SFDA’s inspectors identified the following violations among the establishments:
- 5 companies failed to report directly to the RSD.
- 9 companies did not provide their registered products to the market.
- 9 companies neglected to report predicted shortages or supply interruptions.
- 1 company failed to maintain sufficient stock for at least six months.
Penalties and Regulations
The SFDA imposed fines on these companies according to “The Registration Rules of Pharmaceutical, Herbal and Health Product Manufacturers and Their Products Guideline,” which specifies a penalty amounting to SR678,400. The guideline emphasizes the following:
- Stock Requirements: Pharmaceutical and herbal manufacturers must maintain sufficient stock for six months, factoring in annual consumption.
- Shortage Notifications: Companies must inform the SFDA of any expected supply interruptions and offer solutions within three months, or face the cancellation of product registrations.
SFDA’s Commitment to Ensuring Compliance
The SFDA remains dedicated to ensuring that all pharmaceutical establishments comply with its regulations to guarantee the availability of medicine for residents and citizens of Saudi Arabia. Companies failing to adhere to these guidelines may face fines of up to 5 million riyals, along with potential facility closure or license revocation.
Encouragement to Report Violations
The SFDA encourages the public to report any violations by contacting the unified number 19999, ensuring transparency and compliance throughout the pharmaceutical industry.
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