Reporting Adverse Events in Armenia

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Reporting Adverse Events in Armenia

Reporting Adverse Events in Armenia: A Key Step for Patient Safety

Ensuring drug safety is a shared responsibility between healthcare professionals, marketing authorization holders (MAHs), and regulatory authorities. In Armenia, adverse event (AE) and adverse drug reaction (ADR) reporting is regulated by the Ministry of Health and the Scientific Center of Drug and Medical Technology Expertise (SCDMTE).

01. Who Should Report?

✔️ Healthcare professionals (physicians, pharmacists, nurses)

✔️ Pharmaceutical companies (MAHs, distributors)

✔️ Patients and consumers

02. What Should Be Reported?

✔️ Serious and non-serious AEs/ADRs

✔️ Lack of efficacy cases

✔️ Medication errors and misuse

✔️ Adverse events related to medical devices and cosmetics

HOT LINE: (+374 10) 20-05-05, (+374 96) 22-05-05

🏢 Pharmaceutical companies must comply with pharmacovigilance regulations by submitting Individual Case Safety Reports (ICSRs) and periodic safety reports to the regulatory authority.

Here is the link to the GVP regulation used in the Republic of Armenia: arlis.am/documentview.aspx?docid=178207

04. Why Is It Important?

Every report contributes to better risk assessment, regulatory decisions, and overall patient safety. Spontaneous reporting helps identify previously unknown risks and ensures safer use of medicines in Armenia.

At ETL PV Center, we support pharmaceutical companies with compliant AE reporting and regulatory submissions in Armenia and beyond. If you need assistance with pharmacovigilance in the region, feel free to reach out!