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The “SFDA” Inspects 124 Domestic and Foreign Pharmaceutical Manufacturers and Suspends the Registration of 11 of them in 2019.

2020-08-17

The SFDA inspectors visited 124 domestic and foreign pharmaceutical manufacturers during 2019.

It aims to ensure compliance with Good Manufacturing Practice (GMP) requirements before starting market and sell the products in the local markets, to guarantee the safety of medicine in the Saudi Arabia.

Other News

Data Requirement for Herbal & Health Products Submission

2024-02-19
Data Requirement for Herbal & Health Products Submission
Guide
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Saudi Drugs information system (SDI)

An electronic system that enables drug companies and agents to upload PIL, SPC, and drug’s picture. It aims to be a reference for registered medicines as a reliable source of drug information

Service steps

Conditions

Service requirements

Frequently asked questions

Target audience

Service execution time

Service delivery channels

Category

Cost

Call center

19999

Service guide

User's guide

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The National Drug & Poison Information Center (NDPIC)

The National Drug & Poison Information Center (NDPIC)

Service steps

Conditions

Service requirements

Frequently asked questions

Target audience

Service execution time

Service delivery channels

Category

Cost

Call center

19999

Service guide

User's guide

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Warning Date
    2020-06-12
Manufacture Country

Manufacture Company

"SFDA" Withdraws Several Batches of "Priorin N Capsules"

2020-06-12

The Saudi Food and Drug Authority (SFDA) withdrew several batches from Bayer's "Priorin N" due to contain Bacillus Cereus bacteria, which is one of the potential causes of food poisoning.
This action took a place after consumers reported about unpleasant smell in some of the product batches. After consumer reports, the Authority carried out the necessary examinations and analyses to ensure the safety of the product.

  • To report sector-related issues

  • Call Centre 19999


Other Warnings

Data Requirement for Renewal the Marketing Authorizations of Veterinary Medicinal Products

2020-05-31
Data Requirement for Renewal the Marketing Authorizations of Veterinary Medicinal Products
Guide
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Registration According to Verification and Abridged

2024-05-02
Registration According to Verification and Abridged
Guide
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Warning Date
    2020-04-23

"SFDA" Warns Consumers against 5 Hand Sanitizer Products

2020-04-23

The Saudi Food and Drug Authority (SFDA) issued warning against the use of five hand sanitizers gel.
 SFDA has determined that most of the products contain elevated levels of Methyl Alcohol (Methanol) and contain less than the permitted limits of Ethyl Alcohol (Ethanol) and Isopropyl alcohol (Isopropanol).
The authority has explained that it collected and examined samples of hand sanitizer products from the local markets to ensure their safety.
Laboratory results found that the first product "Genfex" contains elevated levels of Methanol.

  • To report sector-related issues

  • Call Centre 19999


Other Warnings

Warning Date
    2020-04-09
Manufacture Country

Correction Actions
Advices to Consumer

"SFDA" Warns Consumers not to Use "Clean Touch Hand Sanitizer Gel"

2020-04-09

The Saudi Food and Drug Authority (SFDA) warned against the use of "Clean Touch Hand Sanitizer Gel" due to contain less than the allowable limits of Isopropyl alcohol.

The SFDA has explained that it collected and examined samples of hand sanitizer products from the local markets to ensure their safety.

Examination results revealed that "Clean Touch Hand Sanitizer Gel" contains less than allowable limits of Isopropanol, which resulting in poor effectiveness of the product.

  • To report sector-related issues

  • Call Centre 19999


Other Warnings

Guidance for Naming of Medicinal Products

2021-04-07
Guidance for Naming of Medicinal Products
Guide
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