02. Does the Icelandic Medicines Agency (IMA) check acceptability of new names of medicinal products before an application is submitted?

Human: No, IMA checks acceptability of the name of medicinal product during the application procedure.
Veterinary: Yes, change in the name of the medicinal product is considered to be a variation not requiring assessment in accordance with the new veterinary regulation (2019/6). Therefore, check for acceptability of the proposed veterinary medicinal product name has to be finalised before the variation is submitted via Union Product Database.
(dd.mm.2022)

(November 2022)

Var efnið hjálplegt Yes No

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