Pharmacovigilance

Pharmacovigilance has been defined by the World Health Organization as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.

Pharmacovigilance is often the only means by which to detect rare adverse reactions. Healthcare professionals should be made aware of the importance of the first five years after the marketing of a medicinal product. In clinical trials the medicinal product is used by a limited population. When marketed the product is used by a much larger and more diverse population and that is when rare adverse reactions are often detected.

Pharmacovigilance involves patients, healthcare professionals, regulators and the pharmaceutical industry.

EudraVigilance

The IMA is a webtrader in EMA's EudraVigilance database, and is thus E2B compliant. Marketing authorisation holders (MAHs) are required to send all Individual Case Safety Reports of cases occurring in Iceland electronically to EudraVigilance.

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What is to be reported

All medicines can cause adverse reactions. Some may not yet be known so it's important to report them. Many are mild, but some can be serious and life-threatening. More information on what should be reported can be found in this section.

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General Information

Adverse Drug Reaction Reports (ADRs)  from the general public as well as healthcare professionals can really make a difference in recognizing unexpected side effects. This section covers general information about PharmacoVigilance.

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