Laws and Regulations
The following Acts and Regulations apply to Pharmacovigilance in Iceland.
Regulations and directives
Regulation No. 141/2011, on marketing authorisations for proprietary medicinal products, their labelling and package leaflets
- Regulation No. 582/1995 concerning registration and marketing authorisations for parallel import (not available in English)
- Regulation No. 142/2011 concerning marketing authorisations for herbal medicinal products (not available in English)