Drugs

Guidance for Presenting the Labeling Information, SPC and PIL

2023-12-06
Guidance for Presenting the Labeling Information, SPC and PIL
Guide
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Saudi Arabia to Host Sustainable Production in the Health Sector Global Forum 2020

2020-11-15

The 3rd Saving Lives Sustainably: Sustainable Production in the Health Sector Global Forum 2020 is taking place on 18-19 November 2020, under the theme, “Recovering Better after COVID-19 with Sustainable Production and Procurement of Health Commodities.”

Other News

News List

Checklist for The Submission of Veterinary Product Applications

2020-11-11
Checklist for The Submission of Veterinary Product Applications
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Warning Date
    2020-09-10
Manufacture Company

“SFDA” Warns against Using two Batches of Rozana Antiseptic Spray and Rozana Antiseptic Gel

2020-09-10

The Saudi Food & Drug Authority (SFDA) warned consumers to stop using two batch of Rozana Antiseptic Spray and Rozana Antiseptic Gel, produced by SN KIMYA factory for containing 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 and compliance with the technical specifications.

  • To report sector-related issues

  • Call Centre 19999

Other Warnings

All Warnings

Regulations and procedures for approving advertisements for non-prescription medications

2017-03-26
Regulations and procedures for approving advertisements for non-prescription medications
Guide
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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

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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