General Information

What is pharmacovigilance?

Pharmacovigilance is an important system which aims to find adverse reactions which are connected to a specific medicinal product. Every medicinal product is tested on a group of people before it is marketed and therefore not all adverse reactions have been detected. With pharmacovigilance the safe of the medicinal product is valuated and improved after the marketing of the medicinal product. Pharmacovigilance is the most powerful and often the only way to detect very uncommon adverse reactions. Medicinal products 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 medicinal products.

Who reports what?

Marketing Authorisation Holders (MAHs):

When a MAH receives a report on a serious adverse drug reaction occurring in Iceland it shall be registered in the European Medicines Agency´s (EMA) database, EudraVigilance (EV), and sent to ID = EVHUMAN. IMA has access to reports registered in EV.

As of 4 December 2012, IMA no longer requires MAHs to submit non-serious individual case safety reports (ICSRs) for cases occurring in Iceland, neither to IMA nor to EMA.

Healthcare professionals and veterinarians:

All adverse reactions, or suspect of an adverse reaction, which occur in Iceland should be reported to IMA.

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.

IMA receives reports on adverse reactions from all healthcare professionals and veterinarians.

Healthcare professionals and veterinarians are encouraged to use the webform of IMA when adverse reaction needs to be reported.

Consumers

IMA advises consumers to contact a physician or pharmacist if they experience what they believe to be an adverse drug reaction. A physician will be able to evaluate if the adverse drug reaction calls for changes in the treatment and can add relevant information to the report. It is preferable that animal owners contact a veterinarian if they suspect that an animal is experiencing an adverse reaction from a (veterinary) medicinal product.

If a consumer does not wish to contact a doctor or pharmacist, the reaction can be reported directly to IMA. 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.

Consumers are encouraged to use the webform of IMA when adverse reaction needs to be reported.