Swissmedic Updates “Formal Requirements” Guidance – Version 20.0 Now in Force
Swissmedic has released Version 20.0 of its Guidance Document “Formal Requirements” (ZL000_00_020), which became applicable on 1 March 2026. The document provides detailed administrative requirements for submitting regulatory applications related to medicinal products in Switzerland.
Although the guidance does not introduce new regulatory legislation, it defines how applications must be structured, formatted and submitted, making it a key reference for manufacturers preparing dossiers for Swissmedic review.
Purpose of the Guidance
Swissmedic states that the document serves as an administrative ordinance used internally to apply legal provisions consistently and to ensure that submissions are organised in a way that enables efficient regulatory processing.
The guidance applies to all submissions to Swissmedic, including marketing authorisation applications, variations and lifecycle management procedures. However, it explicitly excludes certain activities such as medical devices, inspections, clinical trials and laboratory orders.
Key Administrative Principles for Applicants
The guidance reiterates several important principles relevant to pharmaceutical companies submitting applications in Switzerland.
Applicant responsibility for documentation
Swissmedic emphasises that the applicant must submit the full documentation for the application. As the future marketing authorisation holder, the applicant bears legal responsibility for the authorised medicinal product and must therefore possess the complete regulatory documentation.
Accepted submission formats
The guidance describes several accepted formats for submissions:
eCTD submissions
Paper submissions
Paper submissions with an electronic copy (eDok)
For paper submissions, documentation must follow the Common Technical Document (CTD) structure with Modules 1–5, using the required dividers, cover sheets and binders.
Electronic documents must meet specific technical criteria, including machine-readable PDFs (OCR), bookmarks for longer files and size limits for individual documents.
Strict administrative validation
Swissmedic also highlights that administrative completeness is essential before scientific evaluation begins.
If formal deficiencies are identified during the validation stage, applicants are given a maximum of 60 days to correct them, and extensions are not granted.
Signature requirements
The guidance clarifies that certain regulatory documents must bear original signatures, including cover letters and specific forms. Swissmedic does not accept scanned or electronic signatures for paper submissions.
Clarifications Introduced in Version 20.0
According to the document’s change history, Version 20.0 introduces an update in Section 3.22.6 related to parallel import submissions, clarifying that translations of foreign packaging must be provided if the original packaging is not in an official Swiss language or English.
This clarification may affect companies involved in parallel import authorisations, particularly where packaging documentation originates from non-Swiss languages.
Why This Update Matters for Manufacturers
Although primarily administrative, the guidance plays a critical role in the regulatory process. Swissmedic performs a formal validation of applications before initiating the scientific review, meaning that incomplete or incorrectly formatted submissions can lead to delays.
For pharmaceutical companies preparing Swiss submissions, the updated guidance reinforces the importance of:
ensuring complete administrative documentation
following CTD structure and formatting requirements
meeting technical standards for electronic files
responding quickly to formal objections during validation
Understanding these formal expectations is essential to avoid procedural delays and ensure efficient processing of marketing authorisation applications in Switzerland.
Read the full document below.
