Specific rules for medicinal products

Approval from the Medical Products Agency

Clinical medicine studies must be approved by the Medical Products Agency. Information about how to apply is available on the Medical Products Agency’s website. There are special regulations that govern how this type of studies shall be conducted. The Medical Products Agency has made a summary of the regulations that apply for clinical medicine studies.

Application for clinical medicine studies External link, opens in new window.
Regulations for clinical medicine studies (in Swedish) External link, opens in new window.