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Swissmedic Guidance: Navigating Variations, Product Information, and Electronic ICSRs through PV Gateway

Yesterday (06 February 2024) Switzerland's Swissmedic released updated guidance on "Electronic exchange of ICSRs through PV Gateway", and last week released "Variations and Extensions" and "Product Information for Human Medicinal Products".

This guidance document explains the requirements pertaining to variations and extensions for human medicinal products and applies to the Authorisation, Licensing and Market Surveillance divisions of Swissmedic for applications for a change and/or extension relating to human medicinal products.

  • Variations: A variation refers to any change to the marketing authorization of a medicinal product that may impact its quality, safety, or efficacy. This includes changes to the manufacturing process, specifications, formulation, packaging, or labeling.

  • Extensions: An extension of a marketing authorization allows for the expansion of the authorized use of a medicinal product to include additional indications, dosage forms, or patient populations.

Switzerland recognizes the following application types, depending on the possible implications for quality, safety, and efficacy:

  • Minor variations to be reported subsequently, type IA/IAIN

  • Minor variations to be reported in advance, type IB

  • Major variations, type II

  • Extensions

This guidance document outlines the product information requirements for human medicinal products and is primarily targeted at administrative bodies. For applicants, this document aims to clarify the precise requirements that need to be met for the expedited and efficient processing of product information texts. The guidance document applies to medicinal product information texts for human medicinal products, including complementary medicines, herbal medicinal products and radiopharmaceuticals.

To have detailed insights on the Notes on the Information for healthcare professionals, Notes on the individual sections, and Notes on the Patient Information click this LINK.

This guidance intends to assist all marketing authorization holders (MAHs) in preparing the electronic transmission of Individual Case Safety Reports (ICSRs) in pharmacovigilance and discusses general issues related to the electronic transmission of ICSRs, aiming to achieve common standards to achieve a successful electronic exchange of ICSRs.

In this guideline, Swissmedic outlines the requirements for MAHs to participate in the E2B electronic exchange of ICSR on a bidirectional basis and provides guidance on the technical and procedural standards it applies.


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