Pharmacovigilance & Product Safety
Receiving and Reporting Product Safety Information Responsibly
Pharmacovigilance supports the identification and appropriate handling of information related to suspected adverse events and medicine safety.
As an importer and distributor, Intra Mesk Pharma's pharmacovigilance activities are proportionate to its role in the healthcare supply chain.
Our Role
Our Role in Pharmacovigilance
As an importer and distributor, Intra Mesk Pharma's pharmacovigilance activities are focused on receiving relevant safety information, documenting it, supporting appropriate follow-up, and reporting or forwarding information to the competent authorities and relevant manufacturers or responsible parties where applicable.
Our role is part of the broader product-safety system and does not replace the responsibilities of healthcare professionals, manufacturers, marketing authorization holders where applicable, or regulatory authorities.
The applicable handling and reporting pathway depends on the nature of the information, the product involved and the responsibilities that apply to the specific case.
What to Report
Information worth sharing through this channel
Suspected Adverse Event
An unwanted medical occurrence suspected to be associated with a medicinal product.
Unexpected Product-Related Safety Information
Relevant information that may indicate a potential safety concern associated with a product.
Medication / Product Error
Information concerning an error associated with the use, handling or administration of a medicinal product where relevant.
Other Relevant Safety Information
Other product-related safety information that should be directed through the appropriate channel.
Who Can Report?
A channel open to everyone
You do not need proof of identity or certainty about the cause of an event before submitting a report.
Before You Report
Where available, useful information may include the product name, strength or dosage form, batch or lot number, date of the event, a description of the event and relevant contact or product information. Provide only information that is appropriate and available to you.
The Reporting Process
From Safety Information to Appropriate Follow-Up
- 01
Receive
Relevant safety information is received through the available reporting channels.
- 02
Document
Available information is recorded to support appropriate follow-up.
- 03
Review & Route
The information is reviewed and directed through the appropriate internal or external pathway according to its nature.
- 04
Report / Forward
Where applicable, relevant information is reported or forwarded to the competent authorities and/or relevant manufacturer or responsible party.
- 05
Follow Up
Additional information may be requested and further follow-up may occur when appropriate.
Each report is reviewed individually; the sequence above is illustrative and not every report follows the same path.
This reporting channel is not an emergency medical service. Seek appropriate medical care immediately when urgent medical attention is required.
Aligned With Applicable Requirements
Intra Mesk Pharma follows the applicable requirements relevant to its role as an importer and distributor, including the requirements and reporting expectations of the competent pharmaceutical and health authorities.
Where SBDMA requirements apply, relevant safety information is handled and reported or forwarded through the appropriate channels according to the applicable process.
Pharmacovigilance Hotline
For urgent safety concerns that should not wait for a form:
+967 713 500 090For Everyone — Not Only Professionals
Reporting is not limited to healthcare professionals
Patients, parents, caregivers and members of the public can use the reporting channel to describe what they observed. A report does not require medical terminology or certainty about the cause — a clear description of the observation is sufficient to support documentation and appropriate follow-up.
Reports are handled through the applicable reporting and review process, and relevant information is directed to the responsible function.
Report a Suspected Adverse Event
If you have information about a suspected adverse event associated with a medicinal product, use our dedicated reporting channel.