Conditions for Marketing

List of medicinal products with conditions and restrictions regarding safe and effective use Marketing authorisation holders (MAH's) must ensure that restrictions and conditions to the marketing authorisation of medicinal products, regarding their safe and effective use, are implemented to minimize the risk of their use. In many cases the MAH's must publish and distribute educational material for healthcare professionals and/or patients. All such material must be approved by the IMA before it is published and distributed.   Healthcare professionals and dentists that prescribe or dispense these medicinal products must be aware of these conditions and follow the guidelines to ensure their safe and effective use.

Instructions for submitting educational materials (aRMM) for evaluation and review        (updated 10.10.2018)

Application form for request of review of educational materials

List of medicinal products with conditions and restrictions regarding safe and effective use that are marketed in Iceland.  

List of medicinal products with conditions and restrictions regarding safe and effective use that are not marketed in Iceland.

Publication of educational materials on the medicinal product information website www.serlyfjaskra.is

Marketing authorisation holders are encouraged to submit both new and previously approved educational materials for publishing at www.serlyfjaskra.is. Please follow the instructions here below.

Instructions on electronic publication of educational materials at www.serlyfjaskra.is
(updated 10.10.2018)