SFDA penalizes with 678400 riyals on 24 Pharma companies for violations
The Saudi Food and Drug Authority (SFDA) in Saudi Arabia has imposed fines totaling 678,400 riyals on 24 pharmaceutical companies for various kinds of violations. Most Viewed : How to check Digital Visitor ID in Saudi Arabia using Absher
The pharmaceutical companies did not supply their registered products in the local market. These violations include the failure to promptly report to the SFDA’s Drug Track and Trace System (RSD), the neglect to notify the SFDA of predicted shortages or supply interruptions, and failures in maintaining sufficient stock of their products.
Last month, the SFDA reported that its inspectors monitored the violations committed by these establishments, including 5 for failing to report directly to the RSD, 9 for not providing their registered products, 9 for not reporting expected shortages or supply interruptions, and one that failed to maintain sufficient stock of all its registered products for at least six months.
The SFDA announced that it has imposed penalties on the establishments that violated regulations, as detailed in "The Registration Rules of Pharmaceutical, Herbal and Health Product Manufacturers and Their Products Guideline," amounting to SR678,400. Recommend : A perfume company seized for using Saudi and Gulf figures names on its products
Pharmaceutical and herbal manufacturers and warehouses have to stick to these guidelines by ensuring they maintain adequate stock for six months of all registered products, taking into account annual consumption and need data assessed by the SFDA. All stock shortages should be resolved within a maximum of three months, unless the SFDA decides to cancel the product registrations.
Pharmaceutical and herbal manufacturers, along with their representatives, are required to inform the SFDA of any expected shortages or interruptions in the supply of registered products for a minimum period of six months from the planned duration of the disruption. They must also offer solutions to help tackle the shortage.
This is in accordance with the SFDA’s dedication to ensuring that pharmaceutical establishments comply with its regulations, fulfilling its responsibility in securing the availability of medicine for citizens and residents throughout Saudi Arabia.
The SFDA has confirmed that the penalties specified in “The Registration Rules of Pharmaceutical, Herbal and Health Product Manufacturers and Their Products Guideline" may amount to 5 million riyals, along with the possibility of facility closure or license cancellation. The SFDA encourages reporting any violations by reaching out to the unified number 19999. Join Saudi Expatriates on WhatsApp channel
SFDA penalizes with 678400 riyals on 24 Pharma companies for violations