Specific rules for medicinal products
Please note: from 31 January 2022, a new EU-wide regulation on clinical trials on medicinal products applies. More information is available on the Swedish Medical Products Agency’s website External link.
Find out if your idea or question involves medicinal products
If your study includes medicinal products, i.e. a clinical trial on a medicinal product, you need to find out if it is a clinical trial on medicinal products that requires a permit or not. In Sweden, a clinical trial on medicinal products must be granted a permit after examination by both the Swedish Medical Products Agency and the Swedish Ethical Review Authority before it can start up. If the study is a non-interventional study, however, the study does not need to be reviewed by or obtain a permit from the Swedish Medical Products Agency.