Changes to the guidance document RMP ICH E2E information submission HMP

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).
- Section 9.2.7.2 “Medicinal products that do not require an RMP”: The requirements in this subsection only apply from 1 November 2026. Time limit of four months (electronic publication) or 12 months (printed) for conformation.
Transitional provision according to section 9.2.8 “Transitional period for publication of existing officially mandated information materials”: For medicinal products that have existing officially mandated information material as at 1 August 2026, this must be made available to the electronic publication platform for publication by 1 November 2026 at the latest.
- Uploading of the material will be possible from 1 August 2026
- Initial online availability must be implemented by 1 November 2026 at the latest
- The materials uploaded to the platform will only be publicly accessible from 1 November 2026.

Additional clarifications on medicinal products that do not require an RMP: These requirements in section 10 only apply from 1 November 2026.

Clarifications on conformation of officially mandated information materials for KAS, biosimilars and co-marketing medicinal products can be found in section 10.1 “Officially mandated information material published on the electronic publication platform”:
- Section 10.1.1 “Medicinal products authorised before 1 November 2026”: Existing conditions on implementation of additional risk minimisation measures (aRMMs), analogous to those of the reference medicinal product/reference product/basic product, continue to apply unchanged.
  - Any changes necessary must be submitted to Swissmedic as application type “Removal of a condition relating to drug safety”.
  - On completion of the application, the new standard condition on conformation of the information material to the reference medicinal product/reference product/basic product will then be imposed and future changes can be made without notifying Swissmedic.
- Section 10.1.2 “Medicinal products authorised after 1 November 2026 with an authorised reference medicinal product/reference product at the time of authorisation and co-marketing medicinal products”
  - All KAS, biosimilars and co-marketing medicinal products are required under a standard condition to conform to any officially mandated information material.
  - The relevant officially mandated information material published on the electronic publication platform and the details of the RMP summary published on the Swissmedic website for the reference medicinal product/reference product/basic product serve as a reference.
- Section 10.1.3 “Medicinal product with authorisation after 1 November 2026 without reference medicinal product/reference product at the time of authorisation”: Applications for any necessary additional risk minimisation measures (aRMMs) must be submitted to Swissmedic (see form “New authorisation of human medicinal products”) and are mandated as a condition.
- Section 10.1.4 “Documentation of conformation”: Conformation must be clearly documented.
According to section 10.2 “aRMMs not published on the electronic publication platform”, additional requirements in regard to KAS/biosimilars/co-marketing medicinal products are defined by specific condition.