04. Has the IMA published rules/guidelines for product names?

Human and veterinary products: IMA has not published specific guidelines for acceptability of names for medicinal products but refers to published guideline from EMA “Guideline on the acceptability of names for human medicinal products processed through the centralised procedure

Veterinary only: A filled out Request form for Proposed (invented) product name(s) should be submitted to the Icelandic Medicines Agency before the variation application is submitted via Union Product Database, as a change in product name is considered to be a variation not requiring assessment. Up to 3 product names can be suggested for each check. If the product is to be marketed in a Nordic-language packaging this should be stated.

(November 2022)

Last updated: November 24, 2022
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