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SwissMedic updated Guidance: Packaging for Human Medicinal Products

Recently on 14-July 2022, SwissMedic updated their "Packaging for human Medicinal Products" guidance.


This guidance document explains how primary and secondary packaging (packages) for human medicinal products must be labelled and how they may be designed.

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.


This guidance document is valid for the Authorisation division of Swissmedic and is applicable to the labelling and design of packaging for human medicinal products.


Unless these Annexes of the TPLRO contain more detailed or different regulations, the corresponding medicinal products with no indication are subject to the requirements of this guidance document


CLICK this LINK to know more about the Packaging requirements for Human Medicinal Products.

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