Change to Patient Information and Information for Healthcare Professionals Templates

Key changes

New optional section for instructions for use; updated templates must be used for new medicinal product information texts from 1 July 2026.

PV impact

MAHs must use updated PI/FI templates for new submissions and variations to ensure appropriate presentation of safety information and instructions.

Exact policy details

Use of updated templates

1 July 2026

Applies to: Applicable for new medicinal product information texts.

The updated Patient information and Information for healthcare professionals for human medicinal products templates must be used from 1 July 2026 for new medicinal product information texts. · p. 1 · High · Source

Responsibility for readability and user-friendliness

Authored by the authorization holder

Applies to: All authorization holders of human medicinal products

The authorisation holder is responsible for ensuring the Patient information and Information for healthcare professionals are readable and user-friendly. · p. 1 · High · Source

Update requirement for existing products

At the earliest opportunity

Applies to: Medicinal products already authorized

Swissmedic requests authorisation holders for medicinal products whose Patient information and/or Information for healthcare professionals include instructions for use at the end of the document to update the relevant texts using the new templates at the earliest opportunity. · p. 1 · High · Source

Submission of changes if content is altered

Appropriate application must be submitted

Applies to: When content changes are made

This editorial change can be made independently unless changes have been made to the content of the texts. In these cases, an appropriate application must be submitted. · p. 1 · High · Source

Extracted documents

• Patient information and Information for healthcare professionals for human medicinal products: Change to the templateshtmlhtml · high · 1 page
• ZL000_00_048e_VL Product information for human medicinal products (DOCX, 58 kB, 01.07.2026)docxdocx · high · 1 page
• ZL000_00_046d_VL Patienteninformation für Komplementärarzneimittel (DOCX, 76 kB, 01.07.2026)docxdocx · high · 1 page
• ZL000_00_047d_VL Patienteninformation für Phytoarzneimittel HMV4 (DOCX, 74 kB, 01.07.2026)docxdocx · high · 1 page