Swissmedic Forms and Portals
Short answer
Applications, reports and dossiers go through the Swissmedic Portal. Access requires the company to register and roles to be assigned. Forms are procedure-specific and updated regularly; an outdated form version leads to an extended deadline during formal review.
How do I get access?
The company registers once, names an administrative contact person, and requests roles for individual users. The roles determine who may submit, who has read-only access, and who may manage invoicing data. Staff changes must be updated promptly.
- Register the company, with commercial register details and address data.
- Name an administrative contact person who manages roles.
- Create user accounts and assign roles per procedure area.
- Enter and check invoicing and correspondence addresses.
- Deactivate and reassign access when staff change.
Which forms do I need?
Every procedure has its own forms: authorisation application, variation application, renewal application, licence application, advice request, narcotics licence, and vigilance report. All are available on swissmedic.ch in the current version, with a version date in the document.
| Procedure | Form | Common mistake |
|---|---|---|
| New authorisation | Application for authorisation of a medicinal product | Outdated form version used |
| Variation | Variation application or notification | Wrong variation category ticked |
| Renewal | Application for renewal of the authorisation | Submitted too late, less than six months |
| Establishment licence | Application for an establishment licence | Activities declared incompletely |
| Advice | Application for scientific advice | Questions worded too openly |
| Narcotics | Licence application, per-shipment licence | Substance list incomplete |
| Vigilance | Report in the electronic vigilance system | Timeline not documented |
What should you watch for with an eCTD submission?
The dossier is submitted as a sequence, with the correct sequence number, valid lifecycle operations, and the prescribed folder structures. Check the package with a validator before uploading it. Faulty sequences are rejected and cost time during formal review.
- Assign sequence numbers consecutively and without gaps.
- Set lifecycle operations correctly: new, replace, append, delete.
- PDFs searchable, without password protection, with bookmarks.
- File names and folder structure to specification.
- Run a validator before uploading and archive the log.
How does communication work during a procedure?
Questions, preliminary decisions and final decisions are delivered or made available via the Portal. Watch the notifications sent to the address on file, because response periods start on delivery. An unread message does not extend the deadline.
Frequently asked questions
Where do I find the current forms?
On swissmedic.ch under Services and Documents, organised by procedure. Every form carries a version date.
Is submission by post still possible?
Only in exceptional cases named in the procedure. The standard is electronic submission via the Portal.
Who may submit in the Portal?
Users with the corresponding role assigned by the company. Consultancies can act with a power of attorney.
What happens with a validation error?
The sequence is rejected or queried during formal review. You resubmit the correction, which shifts the timeline.
How long are documents available in the Portal?
Procedure documents remain retrievable throughout the procedure and beyond. Keep your own archive regardless, independent of the Portal.
Sources
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