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 an important key system which aims to improve drug safety. It is often the only means by which to detect rare adverse reactions. Every medicine is tested on limited groups of people before it is marketed and therefore not all adverse reactions have been detected. With pharmacovigilance the safety of the drug is valuated and improved after the marketing of the medicine.

Pharmacovigilance is the most powerful tool the agencies have at its disposal and often the only way to detect very uncommon adverse reactions. Medicines that can cause serious adverse reactions need to be re-evaluated or removed from the market to protect public health. The results of pharmacovigilance are better information and instructions that reduce the risk and improve the benefit of the use of medicines.

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

All adverse reactions, or suspicion of an adverse reaction, which occur in Iceland should be reported to IMA. IMA receives reports on adverse reactions from all healthcare professionals, veterinarians and members of the public.

Adverse reactions which are listed as common or very common in the Summary of Product Characteristics/Patient Information Leaflet do not need to be reported unless they are serious.

Members of the public, healthcare professionals and veterinarians are encouraged to use the report adverse reaction webform of IMA when adverse reaction needs to be reported.

IMA is a Webtrader in the European Medicines Agency´s (EMA) database, EudraVigilance , and reports all adverse reactions received from healthcare professionals and members of the public to that database.

Last updated: December 17, 2021
Var efnið hjálplegt Yes No

Hvað þarf að laga?