04. Has the IMA published specific instructions for product names?

For new MAs and variations regarding change of product name:

If a common Nordic packaging is intended and therefore a common Nordic name is required, this should be explicitly stated in the application cover letter. The member states concerned should be stated. The proposed common Nordic name should be stated in Annex 5.19 (or 5.18 for veterinary medicinal products) as current practice.

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. The request form is available on www.ima.is under forms.

Last updated: July 30, 2024
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