As per the Pharmaceutical and Herbal Facilities and Products Law and its implementing regulations, the Saudi Food and Drug Authority announced that it has imposed penalties and financial fines exceeding SR121,000 ($32,000) against six pharmaceutical facilities that either failed to have registered products available for the local market or failed to report an expected shortage or interruption in supply. The violations were discovered by the authority’s inspectors during monitoring and inspection visits in July, according to the Saudi Press Agency.
According to the law, manufacturers and warehouses of pharmaceutical and herbal products must maintain a permanent stock of their registered preparations sufficient for a period of six months, based on consumption data and annual demand reviewed by the authority. Unless a decision is issued by the authority to cancel the registered product, the law requires manufacturers and warehouses to address any shortage in stock within a maximum of three months.
Manufacturers and warehouses of pharmaceutical and herbal products are required by law to notify the relevant authorities of any anticipated shortage or disruption in the supply of registered products for a minimum of six months following the anticipated shortage date. It is also expected of them to offer solutions that help offset the deficit.
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