Laws and Regulations

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

Acts

• The Medicinal Product Act No. 93/1994

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)
  
  

• Directive 2001/83/EC
• Regulation (EC) No 726/2004/EC
  
  
  

 Last updated 03.12.2019