Icelandic Medicines Agency

Pharmacovigilance and adverse reactions

Pharmacovigilance contributes to safer use of medicines and covers the science and activities relating to the detection, assessment, understanding and prevention of adverse reactions or any other problems related to the use of medicines or vaccines.

Before a medicine is placed on the market, it has been tested in groups of limited size, and therefore not all adverse reactions or risks associated with the medicine have come to light.

Through pharmacovigilance, the safety of medicines is continuously assessed and improved after a medicine has been placed on the market. Pharmacovigilance is the most effective and often the only way to detect very rare adverse reactions.

The results of pharmacovigilance are better information about the medicine and guidance for healthcare professionals, patients and their relatives that reduce risks and increase the benefits of using medicines.

An adverse reaction is a harmful and unintended/undesirable response to a medicine.

Adverse reactions are classified as serious or non-serious. A serious adverse reaction is an adverse reaction or undesirable effect of a medicine that results in death, a life-threatening condition, hospitalisation or prolongation of hospitalisation, or causes disability or a birth defect in humans.

In animals, an adverse reaction is considered serious if it results in death or causes incurable or prolonged symptoms in the animal concerned.

A safety signal is an indication of a new adverse reaction potentially associated with a medicine, or new information on a known adverse reaction, that requires further investigation to assess whether there is a causal relationship.

When a safety signal arises, it undergoes an initial assessment by IMA's experts. If the initial indications are such that further investigation is needed, the safety signal is forwarded to PRAC and EMA for further discussion and decision-making.

Pharmacovigilance takes place at both national and international level. The Icelandic Medicines Agency (IMA) participates actively in the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC). Close European cooperation and a shared knowledge base enable the authorities to respond quickly when necessary.

Report an adverse reaction

It is important to report suspected adverse reactions to medicines

Adverse reactions to veterinary medicines

IMA also receives reports of suspected adverse reactions in animals

Direct Healthcare Professional Communication (DHPC)

Communication of important safety information on medicines to healthcare professionals

Safety information

The marketing authorisation of certain medicinal products is subject to conditions relating to safe use

The black triangle

Medicines marked with a black triangle ▼ are subject to additional monitoring so that information on their safety can be obtained quickly

Adverse reaction database

EudraVigilance is the medicines agencies' joint database of adverse reactions to medicines

Request for additional information on adverse reaction reports

Guidelines for requests from agents or marketing authorisation holders