Risk Management Plans

Report a Side Effect


To put patient safety in our first priorities

We Sudair Pharma collaborate with the health practitioners to put patient safety in our first priorities to provide Integrated health care based on high quality through the concept of Pharmacovigilance which is seeking to monitor, evaluate & prevent any adverse event or any other drug problems through reporting.
The Saudi Food & Drug Authorities (SFDA) & Ministry of Health (MOH) in Saudi Arabia & other Competent authority in Gulf Country & All the World have some Legal requirements that control how to deal with the adverse event of medicinal products.

What is pharmacovigilance?
Pharmacovigilance is defined by world health organization as “The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems”.

What is adverse drug reaction (ADR)?
ADR is defined as “A noxious and unintended response to a medicine that occurs at normal therapeutic doses used in humans for the prophylaxis or therapy of disease.”

What is the benefit from reporting ADR?
Reporting on the adverse drug reaction provide to us a very important reaction that help pharmacovigilance department in Sudair Pharma to analyze and make the right procedure to minimize the risk & provide a better guidance on how to use our products knowing that these reports will be sheared with the Saudi Food & Drug Authority (SFDA) to fulfill our responsibilities of reporting the adverse drug reaction.

How does Sudair Pharma handle the privacy of reported adverse drug reaction (ADR)?

All personal information related to the reporting of an adverse drug reaction is processed in accordance with the data protection legislation.

Your report is used solely for the scientific evaluation of the medicine.

After careful evaluation of each report received, it will be filed in our safety database and regularly used to look for overall patterns. Sudair Pharma will share the details of reported side effects with the Saudi Food & Drug Authority (SFDA) as mandated by law.

Who can report adverse drug reaction?

All health practitioners and members of society can report adverse events.

How to report adverse drug reaction?

You can use the electronic way through our website and once you click “send”, it will go to pharmacovigilance department in Sudair Pharma.
Alternatively, contact us through the below details and we will fill the form on behalf of you.

Pharmacovigilance Department

Tell: +966 920001432 Ext. 107

Mobile: +966 546030507