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Guidance on Packaging for Human Medicinal Products, Med.Prod Names & eSubmissions platform - Swiss

Guidance document Packaging for Human Medicinal Products HMV4

This guidance document explains how primary and secondary packaging (packages) for human medicinal products must be labeled 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 labeling and design of packaging for human medicinal products.

Guidance document for Medicinal Product Name

This guidance document describes the requirements relating to medicinal product names. 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 authorization of human medicinal products. The guidance document is not applicable to complementary medicines without indication.

Also, there was a new release On 19-July-2021, regarding the Swiss Medic eSubmissions platform was updated which is used for the electronic submission of applications for authorization or variations and the electronic delivery of correspondence from Swissmedic.


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