Guidance Document: Product Information for Human Medicinal Products

Updated Guidelines for Drug Information on Pharmaceuticals 

This document outlines the updated requirements for drug information related to pharmaceuticals for human consumption, including radiopharmaceuticals, herbal medicines, and complementary medicinal products. Key points include:

Transparency for Applicants: Clear requirements to ensure efficient processing of applications. 

Recent Updates: 

• Renaming of templates for phytotherapeutic products.
• Removal of requirements for herbal active substances.
• Expanded scope to cover all complementary medicinal products.
• Clarifications: Details on specific indications and frequency categories. 

The guidelines provide comprehensive coverage of various aspects such as: 

• Application and Public Information: Requirements for submission and public accessibility.
• Declaration of GMOs: Clarifications on GMO-related information.
• Product Information: Including technical details, package leaflets, and medicines under additional monitoring.
• Warnings and Additives: Guidelines on active substances, pharmaceutical additives, and warnings. 
• Swissmedic Submission: Directions for transmitting texts to Swissmedic.
• Packaging and Labeling: Detailed information on containers, packaging materials, and labeling.
• Patient Information: Clear guidelines for patient-facing documentation.

The updated document ensures better clarity and alignment with regulatory requirements for all stakeholders involved in the pharmaceutical industry.

Region: Switzerland

Source:https://www.swissmedic.ch/dam/swissmedic/de/dokumente/zulassung/zl_hmv_iv/zl000_00_027d_wlarzneimittelinformation.pdf.download.pdf/zl000_00_027d_wlarzneimittelinformation.pdf