Laws and Regulations

The following Acts and Regulations apply to Pharmacovigilance in Iceland.

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 726/2004/EC

  IMA strives to comply with the new pharmacovigilance legislation (Regulation No 1235/2010/EU and Directive 2010/84/EU), although, it has not been incorporated into the EEA-Agreement.