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Saudi Vigilance System

The Pharmacovigilance Electronic Reporting Service is an online spontaneous reporting system for adverse events and pharmaceutical products defects to facilitate the reporting for health care professionals and the public.​

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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Controlled Drugs System (CDS)

An electronic system that used by the authorized organizations and companies which are dealing with controlled drugs and psychotropic substances. This system links between beneficiaries and the Saudi Food and Drug Authority (SFDA). So, SFDA can control and track controlled drugs and psychotropic substances electronically.

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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Drug Track and Trace System (RSD)

RSD is an electronic system that aims to insure drug safety by tracking all drugs in the supply chain from manufacturing till it reaches the consumer.

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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Guidelines for Variation Requirements

2025-03-25
Guidelines for Variation Requirements
Guide
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Meeting Requirements Between Drug Sector and Applicants

2025-04-07
Meeting Requirements Between Drug Sector and Applicants
Requirement
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GVP - Product- or Population-Specific Considerations I: Vaccines for prophylaxis against infectious diseases

2020-01-23
GVP - Product- or Population-Specific Considerations I: Vaccines for prophylaxis against infectious diseases
Guide
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Guideline on Pharmacovigilance for Veterinary Products

2020-01-21
Guideline on Pharmacovigilance for Veterinary Products
Guide
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DMFs List Received​

2024-05-12
DMFs List Received​
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The Implementing regulations of the chemicals import Law

2021-10-01
The Implementing regulations of the chemicals import Law
List
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Classification Table of Violations and Fines Prescribed in the Veterinary Products Law in Gulf Cooperation Council (GCC) Countries

2018-02-11
Classification Table of Violations and Fines Prescribed in the Veterinary Products Law in Gulf Cooperation Council (GCC) Countries
List
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