The Icelandic Medicines Agency (IMA) may grant an exemption for certain medicines and allow them to be supplied directly to individuals from a wholesaler or healthcare institution in special cases. This exemption is based on Article 33 of the Medicinal Products Act, No. 100/2020.

Supply is permitted for medicines in ATC groups B05D (peritoneal dialysis solutions) and V03AN (medical gases).

Requirements for wholesalers

It is not necessary to apply separately to IMA for a licence to supply the medicines in question to individuals. However, wholesalers must meet the requirements below.

1. Supplies must be recorded

Wholesalers must keep records of medicines supplied to individuals. For each supply to the public, the following must be recorded:

• Product number of the medicine,

• ATC group,

• name of the medicine (including strength and pharmaceutical form),

• quantity supplied,

• when the supply took place (date).

2. Annual reporting requirement

At the beginning of each year, wholesalers that supply medicines directly to individuals must send a list of the medicines supplied in the previous year. The list must be in Excel format and sent to lyfjastofnun@lyfjastofnun.is.

Download the annual reporting form (Excel).