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Awareness Campaigns of Diseases and Health Education Regulations

2015-04-01
Awareness Campaigns of Diseases and Health Education Regulations
Guide
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Regulatory Framework for Drugs Approval

2024-06-25
Regulatory Framework for Drugs Approval
Procedural rule
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Guidance for Priority Review of Product Registration

2024-02-14
Guidance for Priority Review of Product Registration
Guide
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Drug Master File : Guidance for Submission

2020-08-27
Drug Master File : Guidance for Submission
Guide
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Saudi Drug Registration (SDR)

The Saudi Drug Registration (SDR) System Is an electronic system which aims to facilitate the registration of medicinal, herbal and health products for both Human & Veterinary use

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Frequently asked questions

Target audience

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Category

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Call center

19999

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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.

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Data Requirement for Herbal & Health Products Submission

2024-02-19
Data Requirement for Herbal & Health Products Submission
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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

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Service requirements

Frequently asked questions

Target audience

Service execution time

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Category

Cost

Call center

19999

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The National Drug & Poison Information Center (NDPIC)

The National Drug & Poison Information Center (NDPIC)

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Frequently asked questions

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Call center

19999

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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


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