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Tuesday, Jun 24, 2025

SFDA slaps penalties on 17 pharmaceutical firms for violations

SFDA slaps penalties on 17 pharmaceutical firms for violations

The Saudi Food and Drug Authority (SFDA) has imposed penalties on 17 pharmaceutical firms for their violations of the Law of Pharmaceutical Establishments and Preparations.
The violations included non-compliance with provision of registered pharmaceutical preparations to the local market; failure to directly report the movement of drugs in the electronic tracking system; and failure to inform the authority about an expected shortage or interruption in the supply of the preparations registered with the company.

The SFDA stated that during the month of April its inspectors monitored that five pharmaceutical establishments were failed to comply with provision of their registered pharmaceutical products to the market. The inspectors also detected that eight pharmaceutical establishments failed to notify directly or instantaneously the movement of drugs in the electronic tracking system, while another four establishments were non-compliant with reporting in the event of an expected shortage or interruption in supply of drugs that are registered with the company.

Consequently, the SFDA imposed on these firms penalties prescribed in the Law of Pharmaceutical Establishments and Preparations and its Executive Regulations. The law obliges factories and warehouses trading in pharmaceutical and herbal preparations to have a permanent stock of all their registered preparations that are sufficient for six months.

These establishments must inform SFDA in the event of an expected shortage or interruption in the supply of the company’s registered preparations for a period of not less than six months from the expected time of supply disruption or inventory impact, with offering solutions that contribute to compensating the shortages.
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