Swissmedic Updates Formal Requirements Guidance Document to Version 22.0
Swissmedic has updated its guidance document “Formal requirements” to version 22.0, valid from 1 September 2026.
The document, identified as ZL000_00_020, sets out formal and administrative requirements for submissions to Swissmedic.
Purpose and Scope
Swissmedic explains that the guidance document is an administrative ordinance document used by Swissmedic as a resource for applying legal provisions in a uniform and equitable manner.
The publication provides transparency on how applications should be structured so that they can be processed efficiently and in line with Swissmedic practices and systems.
The guidance applies to all submissions to Swissmedic, but specifically does not apply to areas such as medical devices, legal cases, inspections, certificates, clinical trials, notifications for narcotics and laboratory orders.
Submission Formats and Documentation Requirements
The guidance describes requirements for different submission formats, including paper submissions in CTD format, paper submissions in NTA format for veterinary medicinal products, eDok copies, eCTD submissions and additional Word or PDF documents.
It also clarifies that PDF documents must be machine-readable using OCR, that scanned documents must comply with OCR standards, and that PDF files should not exceed 200 MB. Larger files should be split into smaller parts.
Time Limits and Signatures
Swissmedic states that the applicable time limits are those set out in the guidance document on time limits for authorisation applications.
Where formal objections are raised, applicants have a maximum of 60 days to rectify the shortcoming, and extensions cannot be granted.
The guidance also clarifies signature requirements. Cover letters, forms and other documents requiring an original signature must be submitted in paper form and bear the original signature of an authorised signatory. Swissmedic does not accept scanned, electronic or printed-out signatures on paper submissions.
Module 1, Cover Letters and Forms
The document includes detailed requirements for Module 1, including cover letters, forms, medicinal product information, packaging, environmental risk assessment documentation, foreign authority decisions, pharmacovigilance planning documents, paediatric investigation plans, GCP inspection information and GMP-related documentation.
For cover letters, Swissmedic requires information such as the medicinal product name, active substance, authorisation number if known, application type, scientific justification and a list of submitted administrative documents and documentation.
The guidance also states that current form versions are available on the Swissmedic website and that use of forms that are no longer valid after the applicable transitional period may result in a formal objection.
Medicinal Product Information and Packaging
Swissmedic sets out when medicinal product information must be submitted for human medicinal products and veterinary medicinal products, including requirements by dispensing category and specific exceptions for certain complementary medicinal products.
The guidance also clarifies that changes to medicinal product information must be clearly marked using Word’s Track Changes function, and that other forms of marking or highlighting are not accepted.
For packaging, Swissmedic states that colour laser print-outs in original format, or mock-ups, can be submitted instead of original packaging prints, and that packaging should also be submitted on a data carrier as a single searchable OCR file.
Combination Products With Medical Device Components
The guidance includes a specific section on combination products, meaning medicinal products with a medical device component.
Swissmedic distinguishes between non-separable medical device components and separable combinations. The document also refers to integral, co-packaged and referenced combinations in line with EMA terminology.
For non-separable integral medical device components with CE marking, the corresponding declaration of conformity must be provided in Module 3.2.R. For higher-risk classes, certification from a designated conformity assessment body must also be provided. For non-CE marked components in higher risk classes, a Notified Body Opinion must be provided in Module 3.2.R.
For separable referenced combinations, medical device components must meet conformity requirements, and the declaration of conformity must be provided in Module 3.2.R. For higher-risk classes, certification from a designated conformity assessment body must also be provided.
Variations and Extensions
Swissmedic provides detailed formal requirements for variations and extensions, including variation applications, multiple applications, collective applications and collective-multiple applications.
The guidance states that forms must include the administrative part and the corresponding variation templates, and that extensions cannot be submitted as a collective application.
For type IA and IAIN variations for human medicinal products and variations without assessment for veterinary medicinal products, an implementation date must generally be provided in the format DD.MM.YYYY.
The document also clarifies that updates to documentation may only be submitted in connection with one or more variation applications, and that spontaneous documentation updates without a variation application will be returned at the applicant’s expense.
DMF/ASMF and Plasma Master Files
For DMF/ASMF submissions, the guidance explains that the applicant’s part must be submitted in Module 3 for human medicinal products and Part II for veterinary medicinal products, while the full DMF, including the applicant’s and restricted parts, must be submitted separately by the DMF/ASMF holder.
Swissmedic also states that the DMF/ASMF must be accompanied by a Letter of Access from the manufacturer, and that the Letter of Access must be submitted by both the DMF/ASMF holder and the applicant.
For Plasma Master Files, annual updates should be submitted with an appropriate cover letter, and PMF variations must be submitted using the form for variations and extensions.
Change Introduced in Version 22.0
The change history states that version 22.0 introduces a change in section 2.5.3.2, described as a simplification of applications for a change of status between main authorisation and export licence for veterinary medicinal products, without submission of medicinal product information.
This makes the update particularly relevant for companies managing Swiss veterinary medicinal product authorisations and status changes.
Impact on Medicinal Product and Combination Product Applicants
For marketing authorisation holders, applicants and regulatory teams submitting to Swissmedic, the updated guidance is relevant because it defines the formal structure and administrative expectations for a broad range of procedures.
Stakeholders should pay particular attention to:
correct submission format selection;
eCTD, eDok, paper and eGov Portal requirements;
OCR and PDF file requirements;
cover letter and form completeness;
valid Swissmedic form versions;
original signature requirements;
medicinal product information templates and Track Changes marking;
packaging mock-ups and searchable packaging files;
formal requirements for medical device components in combination products;
variation templates and implementation date requirements;
DMF/ASMF submission timing and Letter of Access requirements;
renewal deadlines and discontinuation procedures.
For companies submitting medicinal product applications in Switzerland, the key message is that formal completeness remains essential. Incomplete, outdated or incorrectly structured submissions may lead to formal objections and delay Swissmedic review.
