Here’s how to report a side effect
You can report side effects in two different ways.
We recommend that you use option 1.
Option 1: Report through SRQ side effect module
The report also automatically goes to the Swedish Medical Products Agency’s database and on to Eudravigilance (the European Medicines Agency’s – EMA – side effect database).
The advantage of reporting via SRQ is that the ARTIS group can follow the side effect reporting for drugs used in rheumatology.
Option 2: Report directly to the SMPA
There is also an opportunity to report side effects directly to the Swedish Medical Products Agency via their web form at www.lakemedelsverket.se.
The disadvantage of reporting side effects via a web form on the Swedish Medical Products Agency’s website is that, according to current regulations, the report will not be available to SRQ and ARTIS.
What rules apply?
This is stated in the Swedish Medical Products Agency’s regulations LVFS 2012: 14, 19§:
“Anyone operating in the health service should report all suspected side effects of medicines to the Swedish Medical Products Agency as soon as possible.”
“It is especially important to report serious and / or unknown suspected adverse reactions or those that appear to increase in frequency. Adverse reactions related to misuse, poisoning, overdose, abuse or use outside approved indication shall also be reported in accordance with EU rules.”
When approving new drugs, only the most common side effects are known. Knowledge of more unusual side effects is often very limited. Therefore, good adverse reaction reporting is of great importance in clarifying the risk profile of drugs when they have come into normal use by patients. It is especially important to report side effects for drugs that are subject to so-called extended monitoring, marked with a black triangle: