The following Acts and Regulations apply to all firms, which have licences for import and wholesale distribution of medicinal products in Iceland.

Acts

• The Medicinal Products Act No. 93/1994
• Act No 65/1974 on addictive medicinal products

Regulations

• Regulation No. 699/1996 on import and wholesale distribution of medicinal products
• Regulation No. 967/2000 on import, sale and distribution of homeopathic medicinal products and their labelling

• Regulation No. 233/2001 on addictive medicinal products and other surveillance required products

• Regulation No 893/2004 on manufacturing of medicinal products

GMP

• Icelandic translation of GMP rules from1997
• GMP rules – English unabridged version