The following Acts and Regulations apply to all marketing firms/representatives of medicinal products in Iceland.

Acts

• The Medicinal Products Act No. 93/1994

Regulations

• Regulation No. 328/1995 on the advertising of medicinal products
• Regulation No. 443/2004 on clinical trials of medicinal products in humans
• Regulation No. 462/2000 on marketing authorisations for proprietary medicinal products, their labelling and PILS

Volume 9A – Guidelines on Pharmacovigilance for Medicinal Products for Human Use