The new guidance document on Medicinal Product Names HMV4 describes the requirements relating to the naming of medicinal products. For applicants, this document is designed to clarify the specific requirements that must be fulfilled in line with Swissmedic practice so that corresponding applications can be processed by Swissmedic as quickly and efficiently as possible. Swissmedic also uses the guidance document as a resource for applying the legal provisions on medicinal product names in a uniform and equitable manner.
The guidance document does not contain any new requirements, but merely reflects the current review practice. It can be accessed by applicants on the Swissmedic website and is valid from 1 January 2020.