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.

(November 2022)

Last updated: November 24, 2022
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