New framework conditions for the central electronic publication of officially mandated information materials.
The guidance document RMP ICH E2E information submission HMP has been comprehensively revised, in particular the requirements as regards the publication of officially mandated information material on the central electronic publication platform have been defined (Information intended for patients, Information intended for healthcare professionals).
Officially mandated information material makes an important contribution to medicinal product and patient safety. Since 1 July 2025, this officially mandated information material must be identified with a special symbol: “Blue safety information”.
The framework conditions for the central electronic publication of these officially mandated information materials have now been published in the current revision of the guidance document RMP ICH E2E information submission HMP. The aim is to give healthcare professionals, patients and carers access to the full, up-to-date information at all times.
The following changes in particular have been made in version 7.0:
Provision, distribution and publication of officially mandated information material
- Introduction of requirements according to section 9.2.4 “Provision and distribution of officially mandated information material” on the responsibility of marketing authorisation holders regarding provision and distribution.
- Marketing authorisation holders are responsible for the provision and distribution of the material.
- Marketing authorisation holders must ensure that healthcare professionals are informed of available material and any updates.
- Access to the full, up-to-date materials must be ensured at all times (physical and electronic).
- Initial distribution must be in an appropriate format to ensure initial implementation.
- Distribution (initial and updates) must be clearly documented.
- Introduction of requirements according to section 9.2.5 “Publication of officially mandated information material” on mandatory electronic publication on the central electronic publication platform: In general, the materials must be published in full and in all three official Swiss languages. Specific exceptions have been defined.
Time limits for implementing officially mandated information material
- Definition of time limits according to section 9.2.6 “Time limits for implementing officially mandated information material for new authorisations”: Physical and electronic provision by the time of market launch at the latest.
- Definition of time limits according to section 9.2.7 “Time limits for implementing changes to officially mandated information material”:
- Section 9.2.7.1 “Medicinal products that require an RMP”: Time limit of three months (electronic publication) or 12 months (printed).
Excerpt from the official page. The original is authoritative. Continue reading at Swissmedic ↗