Swissmedic Updated Guidance Documents – February 2026
- Sharan Murugan
- 6 hours ago
- 3 min read
In February 2026, Swissmedic published updated guidance documents covering key regulatory and post-authorisation requirements for human medicinal products. These updates provide clarity on administrative changes, pharmacovigilance obligations, formal submission requirements, packaging standards, document protection, parallel import procedures, co-marketing authorisations, lifecycle management, and variations.
This guidance outlines the procedural requirements for notifying Swissmedic of changes to the name or domicile of the authorisation holder. Such changes are administrative in nature but require formal submission to ensure that regulatory records remain accurate.
The document explains documentation requirements, submission format, and applicable timelines. It clarifies that the legal entity responsible for the medicinal product must remain clearly identifiable, and any changes must not compromise pharmacovigilance or regulatory accountability.
This guidance focuses on the management and evaluation of drug safety signals for human medicinal products. It outlines expectations for marketing authorisation holders regarding detection, validation, assessment, and communication of safety signals.
The document reinforces pharmacovigilance responsibilities, including timely evaluation of emerging safety information and appropriate regulatory communication. It ensures that safety concerns are addressed proactively and that benefit–risk balance is continuously monitored throughout the product lifecycle.
Guidance: Formal Requirements
This guidance sets out the formal and administrative requirements applicable to submissions for human medicinal products. It includes details on documentation structure, required forms, formatting standards, and completeness criteria.
Compliance with formal requirements is essential to ensure validation of applications and to prevent procedural delays. The document supports applicants in preparing dossiers that meet Swissmedic’s structural and technical expectations.
Guidance: Packaging for Human Medicinal Products
The packaging guidance defines regulatory expectations relating to labelling, outer and inner packaging, and presentation of medicinal products. It ensures that packaging information supports safe and correct use by healthcare professionals and patients.
The guidance also addresses language requirements, mandatory statements, and design considerations to maintain clarity, legibility, and regulatory compliance.
Guidance: Document Protection
This document provides clarity on regulatory data protection and document protection principles. It explains how submitted documentation is protected under Swiss legislation and under what circumstances third parties may reference protected data.
The guidance supports transparency while safeguarding proprietary and confidential information submitted during the authorisation process.
This guidance describes the regulatory framework for parallel import of human medicinal products under Article 14 paragraphs 2 and 3 of the Therapeutic Products Act (TPA). It outlines eligibility criteria, documentation requirements, and compliance obligations.
Parallel import authorisation ensures that imported products meet Swiss quality, safety, and efficacy standards equivalent to authorised reference products.
This document explains the regulatory pathway for authorisation of co-marketing medicinal products. Co-marketing authorisations allow identical medicinal products to be marketed under different brand names.
The guidance outlines requirements for demonstrating product identity, alignment of product information, and regulatory responsibilities of involved parties.
This guidance addresses lifecycle management of authorised medicinal products, including renewal of authorisation, voluntary discontinuation, and change of authorisation status.
It explains procedural steps, documentation requirements, and regulatory timelines to ensure continued compliance throughout the product’s market presence.
This guidance outlines procedures for post-authorisation changes (variations) and extensions for human medicinal products. It defines classification categories, submission requirements, and assessment processes.
Effective management of variations ensures that product information, manufacturing processes, and safety updates remain aligned with regulatory standards without disrupting product availability.
Stakeholders are encouraged to review each updated document carefully to ensure alignment with Swiss regulatory expectations. For more details on these updated guidance documents, please click this link to access the official Swissmedic webpage.
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