Who should report ADRs to the IMCA

Consumers

The Icelandic Medicines Control Agency (IMCA) has in the past only received reports on adverse reactions from healthcare professionals. As of May 1st 2007 IMCA has started a trial project to receive comsumer reports. IMCA advises consumers to contact a physician or pharmacist if they experience what they believe to be an adverse reaction. A physician will be able to evaluate if the adverse reaction calls for changes in the drug treatment and can add relevant information to the report. If a consumer does not wish to contact a doctor or pharmacist direct reporting to the IMCA is now possible.

Note that reports via telephone will not be accepted. Please complete the reporting form and send to the IMCA.

Animal owners should contact a veterinarian if they suspect that the animal is experiencing an adverse reaction from a veterinary medicinal product.

Healthcare professionals

IMCA receives reports on adverse reactions from healthcare professionals, i.e.

• Physicians
• Dentists
• Pharmacists
• Nurses
• Veterinarians

Marketing authorisation holders (MAHs) and their Icelandic representatives

IMCA receives reports on adverse reactions from marketing authorisation holders (MAHs) and their representatives. When an Icelandic representative of a marketing authorisation holder receives a report from a healthcare professional the IMCA requires a copy of the report that is sent to the Qualified Person.

IMCA has posted a letter on the EudraVigilance website on how MAHs should report to IMCA and to EMEA.

The above mentioned letter 

What should be reported to  IMCA

 IMCA wishes only to receive reports of cases occurring in Iceland:

•  All serious reports
• All unexpected reports, both serious and non-serious
• All reports of drugs registered within the past 5 years, druglist, if the ADR is not listed as common in the SPC.
• All reports of ADRs that are not listed as common in the SPC and seem to be more frequent or serious.

It is important to note that you should report even if you only suspect an adverse reaction.