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SwissMedic Guidance on Packaging for Human Medicinal Products

On 11-March-2022, SwissMedic released updated guidance on "Packaging for Human Medicinal Products".

The purpose of this document is to describe how packaging (packages) for human medicinal products must be labeled and how they should be designed. This guidance document is valid for the Authorisation division of Swissmedic and is applicable to the labeling and design of packaging for human medicinal products.


Swissmedic uses the document as a resource for implementing the legal provisions on requirements

pertaining to packaging texts in a uniform and equitable manner. The guidance document is intended

to clarify the specific requirements that must be fulfilled so that corresponding applications can be

processed as quickly and efficiently as possible.


Click the LINK for more detailed information.


Also, a new updated variation form was released. Click the LINK to download the Variation Form

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