Last Updated on August 28, 2024 by The Health Master
Saudi FDA
The Saudi Food and Drug Authority (Saudi FDA) has taken a firm stance against pharmaceutical companies that have failed to meet their obligations to the local market.
In a recent crackdown, six companies were found to be in violation of drug availability regulations.
Violations and Penalties
Saudi FDA inspectors conducted routine checks in July and uncovered serious lapses in the pharmaceutical supply chain.
These companies were either unable to provide registered products or neglected to inform the authority about impending shortages or supply disruptions.
The consequences for these violations were severe.
The Saudi FDA imposed hefty fines totaling over SAR 121,000 on the errant companies.
These penalties align with the strict regulations outlined in the Pharmaceutical and Herbal Facilities and Products Law.
Strict Drug Supply Regulations
To ensure uninterrupted access to essential medications, Saudi law mandates pharmaceutical manufacturers and warehouses to maintain a six-month supply of all registered products.
This stockpile should be based on historical consumption data and annual demand projections approved by the Saudi FDA.
In case of unforeseen shortages, companies are required to rectify the situation within three months unless the Saudi FDA grants permission to discontinue the product.
Moreover, companies must provide a six-month advance notice of any anticipated supply issues and propose alternative solutions to mitigate the impact on patients.
Consumer Protection and Reporting
The Saudi FDA has made it clear that it will not tolerate negligence in the pharmaceutical industry.
To deter such practices, penalties can reach up to a staggering 5 million Saudi riyals.
Additionally, the authority has the power to shut down non-compliant facilities or revoke their licenses.
To aid in their efforts, the Saudi FDA urges consumers to report any suspected violations by contacting the unified number 19999.
Public participation is crucial in maintaining a reliable and accessible drug supply.
By imposing strict penalties and encouraging public vigilance, the Saudi FDA aims to safeguard public health and ensure the availability of essential medications in the Saudi market.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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