Laws and Regulations
Pharmacovigilance in Iceland is governed by the following Acts and Regulations:
Acts
Regulations and directives
- Regulation No. 545/2018 on marketing authorisations for proprietary medicinal products, their labelling and package leaflets (in Icelandic only)
- Regulation No. 340/2016 concerning registration and marketing authorisations for parallel import (in Icelandic only)
- Regulation No. 142/2011 concerning marketing authorisations for herbal medicinal products (in Icelandic only)