Laws and Regulations

Pharmacovigilance in Iceland is governed by the following Acts and Regulations:


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)

 Last updated 03.12.2019