Questions on delimitation

Swissmedic's area of responsibility is in various areas closely related to the areas of competence of other authorities or enforcement entities. As the enforcement entity regarding legislation on therapeutic products, Swissmedic is responsible for ensuring safety in medicines, and in particular regarding authorisations, market surveillance and issuing permits in the sector of medicinal products and medical devices.

Certain products are within the limit of two product categories and their classification is always a case-by-case approach. They must be considered in their entirety (consideration of the intended use and composition).

Corresponding questions on delimitation are dealt with in the areas of both human and veterinary health and concern clarification of competence in the following areas:

Latest news

02.11.2026

Focus on parenterals

Swissmedic has updated the position paper “Parenterals without an intended medical purpose – Enforcement at product level ” and the “Information sheet for the cosmetic sector – Parenterals without an intended medical Purpose”. The updates concern clarifications in the wording and do not affect the current enforcement practice. The updated versions are now available for download