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Swissmedic: Changes to the guidance document RMP ICH E2E information submission HMP

1 August 2026

Swissmedic: Changes to the guidance document RMP ICH E2E information submission HMP

Swissmedic has comprehensively revised the guidance document "RMP ICH E2E information submission HMP", in particular defining the framework conditions for the central electronic publication of officially mandated information material intended for patients and for healthcare professionals. Such material, which since 1 July 2025 must carry a special "Blue safety information" symbol, is intended to give healthcare professionals, patients, and carers access to the full, up-to-date information at all times. Version 7.0 sets out the responsibility of marketing authorisation holders for providing and distributing the material and its mandatory publication, in full and generally in all three official Swiss languages, on the central platform, and defines the applicable implementation time limits. Under a transitional provision, material in existence on 1 August 2026 may be uploaded from that date, but must be made available for publication by 1 November 2026 at the latest, from which date it first becomes publicly accessible.

For more information, see here.

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