The dispencing classification for medicinal products are as follows:

H-marking

The marketing authorisation of the medicinal product/package is restricted to use in hospitals or other healthcare institutions. H-marking covers medicinal products used in healthcare institutions where the knowledge, facilities and equipment required for the use of the medicinal products are available.

The Icelandic Medicines Agency (IMA) is authorised to review/amend its previous decisions on this marking if there is reason to do so. Both marketing authorisation holders and healthcare professionals may submit comments to this effect to IMA.

Z-marking

The marketing authorisation of the medicinal product/package is based on the medicinal product being prescribed only by specialists in specific diseases or a medical subspecialty. Z-marking is based on section 4.2 of the Summary of Product Characteristics (SmPC), which sets out the marketing authorisation holder's recommendations on the use of the medicinal product, and/or, where applicable, on the approved indication of the medicinal product.

Since the medical specialties specified in this section of the product information do not always correspond to the situation in the Icelandic healthcare system, IMA always seeks to adapt the implementation to such circumstances. IMA is authorised to review/amend its previous decisions on this marking if there is reason to do so. Both marketing authorisation holders and healthcare professionals may submit comments to this effect to IMA.

X-marking

The medicinal product/package is subject to special prescription control. There is a risk of abuse, and specific rules apply to the prescribing of the medicinal product.

R-marking

The medicinal product/package is prescription-only.

L-marking

The medicinal product/package may be purchased without a prescription (the medicinal product is an over-the-counter medicine).

G-marking

Icelandic Health Insurance (SÍ) contributes to the cost of the medicinal product.

0-marking

No application has been made for reimbursement of the medicinal product. See the rules on individual reimbursement (medicine certificates), cf. Article 12 of Reglugerð um greiðsluþátttöku sjúkratrygginga í lyfjakostnaði, No. 1143/2019.