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Switzerland's SwissMedic: Guidance on Medicinal Product Name

Yesterday (07 July 2023) Switzerland's Swissmedic released an updated guidance on "Medicinal Product Name" that describes the requirements relating to medicinal product names.

Swissmedic has published this guidance to clarify to third parties the requirements that must be met in accordance with its practice. In this guidance, the agency explains what requirements must be met for human medicinal product authorizations, and supplemental medicines without indication will not be covered by this guidance.

Medicinal product names are rejected if they are not objectionable from the health policy standpoint, in particular, the case if, the choice of product name, causes

  1. 1. confusion with other medicinal products is possible

  2. 2. the composition/quality, effect/efficacy or risks/safety of the medicinal product can be wrongly assessed, or

  3. 3. the improper consumption of the medicinal product is promoted

The names of two different marketing authorization holders can appear in the same medicinal product name, even if only one of them is associated with it.

In general, all medicinal products distributed under the same core brand are provided with a specific name extension, so that the medicinal products may be identified and clearly distinguished by their names. The same marketing authorisation holder usually distributes all medicinal products under the same core brand.

To know more extensively about the Assessment principles, Preconditions for a name extension etc click this LINK.


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