Recently (01 march, 2023) Swissmedic released an updated guidance document on "Product information for human medicinal products" and "Packaging for human medicinal products".
Guidance: Packaging for Human Medicinal Products
The term Packaging texts refer to the texts and other information, including graphic elements, on the packaging (primary and secondary packaging).
As part of this guidance document, Swissmedic explains how primary and secondary packaging (packages) for human medicinal products must be labeled and how they can be designed. The document serves as a resource for implementing uniform and equitable requirements regarding packaging texts under the legal provisions.
For more detailed information on the texts that need to be on the primary and secondary packaging, click this LINK.
The document describes the requirements for product information for human medicinal products. It is intended primarily for administrative bodies, and Swissmedic uses the document as a resource for applying the legal provisions uniformly and fairly.
Applicants may use this document to clarify the specific requirements for processing product information texts quickly and efficiently. This guidance applies to information texts for human medicinal products (Healthcare professionals and Patients), including complementary medicines, herbal products, and radiopharmaceuticals.
The guidance document presents information on the Patient Information for allopathic medicines in part A, while complementary and herbal medicines are covered in parts B, C, and D.
The new version of the guidance enters into force on 1 March 2023.