Regulatory Blog

Swissmedic Guidance: The Electronic Exchange of ICSRs in E2B(R3) Format through PV Gateway

Swissmedic Guidance: The Electronic Exchange of ICSRs in E2B(R3) Format Through B2B Gateway

Swiss Medic: Guidance on Packaging for Human Medicinal Products

Swissmedic Guidance: Electronic exchange of ICSRs through PV Gateway

Swissmedic Guidance: Product Information for Human Medicinal Products

Swissmedic Guidance: Formal Requirements and SwissPAR

Swissmedic Guidance: Requesting Product Certificates (CPP)

Swissmedic Guidance: Renewal and Discontinuation of Authorization or Change of Status (Main Authorization/Export License)

Swiss Medic: Guidances on Varaiations, Temporary Authorisation, Meetings for Applicants and Time Limits for Authorisation

Switzerland’s Swissmedic: Guidance on Temporary Authorization to Use an Unauthorised Medicinal Product

Switzerland's SwissMedic: Guidance for requesting Product Certificates (CPP)

Swissmedic Guidance: Import of a Human Medicinal Product (Parallel Import)

Switzerland's SwissMedic: Guidance on Export Certificates

Swiss Medic: eCTD Guidance for Industry & Time limits for Authorisation Applications

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

Swiss Medic: Biosimilar Authorisation Guidance

Switzerland's SwissMedic: Guidance on Formal Requirements

Switzerland's SwissMedic: Harmonisation of the SwissGMP/GDP Inspection System

Switzerland's SwissMedic: Guidance on Medicinal Product Name

Switzerland's SwissMedic: Guidance on Authorisation Biosimilar