Anyone can report an adverse reaction to the Icelandic Medicines Agency (IMA), a suspicion that an adverse reaction has occurred is sufficient to submit a report.
Please note that if you need advice or medical assistance following the use of a medicine or vaccination, contact your primary healthcare centre, the out-of-hours medical service or an emergency department (in an emergency).
IMA’s role is to receive and assess adverse reaction reports collectively; it therefore does not provide information on the assessment of individual adverse reaction reports or advice on how to respond to possible adverse reactions or on the use of medicines.
What is an adverse reaction?
An adverse reaction is a harmful and unintended/unwanted effect of a medicine.
If you suspect that an adverse reaction has occurred, please:
make a note of the possible adverse reactions
consult a healthcare professional and
report the adverse reactions to IMA
Seriousness of adverse reactions
Adverse reactions are classified as serious or non-serious.
A serious adverse reaction is an adverse reaction or unwanted effect of a medicine that results in death, is life-threatening, requires hospitalisation or prolongs an existing hospital stay, or causes disability or a birth defect in humans. Reports considered clinically important are also classified as serious.
In an animal, an adverse reaction is considered serious if it results in death or causes incurable or prolonged symptoms of disease in the animal concerned.
Adverse reaction reports
Adverse reaction reports play an important role in identifying the risks associated with medicines once they enter general use.
A link between a medicine and an adverse reaction does not need to be proven before a report is submitted. A suspected adverse reaction to a medicine is sufficient reason to submit a report.
Experts working on behalf of the European Medicines Agency (EMA) then assess what constitutes an adverse reaction and what does not.
Who should report?
Anyone can report an adverse reaction to IMA. Information provided in adverse reaction reports submitted to IMA is confidential.
What should be reported?
all suspected adverse reactions associated with medicines marked with a black triangle
serious adverse reactions to medicines
previously unknown adverse reactions to medicines
adverse reactions to medicines that appear to be increasing in frequency
adverse reactions resulting from misuse, overdose, abuse, off-label use, medication errors or falsified medicines
all other adverse reactions, even if they are listed in the product information
The following should also be reported, even if no adverse reaction occurs:
lack of efficacy, misuse, overdose, abuse, off-label use, medication errors and suspected transmission of an infectious agent via a medicine
use of medicines at conception, during pregnancy, during childbirth and while breastfeeding, even if no adverse reaction has been observed, as little is known about / there is a lack of research on the use of medicines in these circumstances.
How to report?
To report suspected adverse reactions to medicines used in humans or animals, complete the online form.
It is very important to use the online form to ensure that personal data are handled with care and that all the necessary information is provided.
Limit personal data to what is necessary to process the report. All information received by IMA is recorded in its adverse reaction reporting system and will be transferred to the National Archives of Iceland for preservation in accordance with the Public Archives Act.
If you encounter any problems, please contact aukaverkun@lyfjastofnun.is
If, for any reason, users are unable to report an adverse reaction by completing the online form, IMA staff may, in exceptional circumstances, assist with completing the form by telephone on 520-2100.
What information is required?
IMA’s forms specify the information requested when reporting an adverse reaction. However, only four items are required for an adverse reaction report to be considered valid. These are:
Who is reporting (patient, healthcare professional, relative)
The patient’s age and/or sex
The medicine suspected to be associated with the adverse reaction (full name of the proprietary medicinal product or active substance)
A description of the adverse reaction
Other information that should preferably be included:
A more detailed description of the adverse reaction
Are symptoms still present, or has the patient recovered?
How long the patient has been taking the medicine and when the adverse reaction began in relation to this
Has the dose been changed, or has use of the medicine been discontinued?
The patient’s medical history
Other medication
The healthcare professional’s assessment of the relationship between the medicine and the adverse reaction
The consequences of the adverse reaction for the patient
Reports received by IMA are assessed by its experts, and further information is requested if necessary.
What happens to the report?
When IMA receives an adverse reaction report concerning medicines marketed in the European Economic Area (EEA), the report is assessed and entered into EudraVigilance, the European Medicines Agency’s (EMA) database. No personally identifiable information is sent to this database.
Medicines agencies in other EEA Member States have access to the information in EudraVigilance, and marketing authorisation holders have access to certain information about their medicines. EudraVigilance enables a comprehensive assessment of all adverse reaction reports for each medicine. Such an assessment may conclude that the information in the Summary of Product Characteristics (SmPC) and the package leaflet needs to be amended.
Medicines agencies in each country may also require the marketing authorisation holder to initiate a detailed investigation into the safety of a medicine or to implement measures to minimise the risks associated with its use. In very serious cases, a medicine may need to be withdrawn from the market.
Service provider
Icelandic Medicines Agency