NLClinicalTrialsIMP object
Applicable national regulations
National Act on Medicinal Products
Other
Transposition of (CT) Directive 2001/20/EC (or comparable national legal framework)
(1) Medicinal Products Act SFS 1992:859 (in Swedish)
(2) LVFS 2003:6 (en/sv): The Medical Product Agency’s provisions and guidelines on clinical trials of medicinal products for human use
These regulations also apply to radioactive medicinal products, products manufactured using gene technology as well as natural remedies, homeopathic products and certain external remedies.
Other applicable regulations/ implementing provisions (Acts, laws, decrees, ordinances, circulars, etc)
Insurance:
Patient Injury Act (Patientskadelag, SFS 1996:799)
