Safeguarding Patient Health in Iraq
At Alpha Iraq, patient safety is our absolute highest priority.
Our responsibility as a leading pharmaceutical distributor extends far
beyond logistics; it encompasses continuous, rigorous monitoring of
the safety profile of every medicinal product we supply.
Our dedicated Pharmacovigilance (PV) system is a fundamental component of our operation, ensuring we meet and exceed both the requirements of our multinational partners and the stringent regulations set by the Iraqi Pharmacovigilance Center (IPhvC) under the Ministry
of Health.
Our PV Commitment
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problem. Our system is designed
to provide
• Continuous Monitoring: We ensure the safety of medicines
throughout their entire lifecycle in the Iraqi market, long after they
leave the manufacturing line.
• Risk Minimization: We actively work to identify, assess, and
manage any potential risks associated with product use,
supporting the optimization of the product’s overall benefit-risk
profile.
• Full Regulatory Compliance: We adhere strictly to the Good
Pharmacovigilance Practice (GVP) guidelines for Marketing Authorization Holders (MAHs) and their representatives in Iraq, including mandatory procedures for reporting to the IPhvC.
Reporting Adverse Events (AEs) and Quality Complaints
Timely reporting is essential to drug safety. Alpha Iraq serves as the
critical link between healthcare professionals, patients, our international
partners, and the Iraqi regulatory authorities.
We are mandated to collect and report all information concerning
1. Adverse Events (AEs) / Adverse Drug Reactions (ADRs): Both
serious and non-serious cases.
2. Decreased or Lack of Efficacy: Including cases of suspected
drug resistance.
3. Medication Errors and Off-Label Use associated with adverse
outcomes.
4. Quality Complaints: Reports of suspected substandard or
falsified (SF) products.
How to Report a Safety Concern
If you are a patient, healthcare professional, or stakeholder and suspect
an adverse event or quality issue related to any product distributed by
Alpha Iraq, please report it immediately.
Dr. Zahraa Iyad
QPPV@alphairaq.com
9647717776220
Optional: Link to an online or downloadable Adverse Event Reporting Form
Note: All reports are handled with the utmost confidentiality and are used solely for safety
monitoring and regulatory reporting purposes to ensure the continued safe use of medicines.
