On 28 September 2022 Swissmedic updated and released their "Guidance document Medicinal product name HMV4 ".
This guidance document describes the requirements relating to medicinal product names and is aimed at administrative bodies, it does not directly specify the rights and obligations of private individuals.
The medicinal product name is the proprietary name of the medicinal product and medicinal products that are distributed under the same core brand must be identifiable and distinguishable from each other by a name extension (prefix or suffix). The name extension combined with the main name forms a unit.
Swissmedic uses this document first and foremost as a resource for applying the legal provisions on authorisation in a uniform and equitable manner. The publication of the guidance document is designed to make it clear to third parties what requirements must be fulfilled according to the practice of Swissmedic.
This guidance document applies to the authorisation of human medicinal products. The guidance document is not applicable to complementary medicines without indication.
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