CTD Dossier for Swissmedic and the Swiss Module 1

How are the five modules structured?

Module 1 is regional and therefore Switzerland-specific. Module 2 contains the summaries and overviews, Module 3 the quality data on the active substance and finished product, Module 4 the preclinical reports, and Module 5 the clinical study reports. Only Module 1 has to be newly prepared for Switzerland.

What belongs in the Swiss Module 1?

Module 1 requires the current Swissmedic forms, the prescribing information and patient information in German, French and Italian, packaging drafts with all mandatory particulars, proof of domicile and licences, and details on pharmacovigilance and the risk management plan.

• Application forms in the current version, complete and signed.
• Prescribing information and patient information in German, French and Italian.
• Packaging drafts for every pack presentation, with authorisation number, dispensing category and batch details.
• Commercial register extract for the future marketing authorisation holder.
• Manufacturing, import or wholesale dealing licence, GMP certificates for the manufacturing sites.
• Details of the person responsible for pharmacovigilance and the risk management plan.
• For Art. 13 TPA: foreign decisions, assessment reports and a deviation table.

How do you plan the trilingual medicinal product information?

The German version is finalised first, since the assessment is generally conducted against it. French and Italian follow as checked translations. After every round of questions, all three versions must be updated in sync; this needs version management that reconciles changes across languages.

1. Align the German version with the current Swissmedic template, not the EU SmPC layout.
2. Cross-check technical terminology against the prescribing information of comparable products authorised in Switzerland.
3. Have the French and Italian versions prepared by specialist-trained translators.
4. Manage all three versions with a change log that links corresponding passages.
5. After every round of questions, update and proofread all languages at the same time.
6. After authorisation, publish the approved versions via AIPS.

What technical format requirements apply?

Swissmedic accepts eCTD and works via the Swissmedic Portal. What matters is correct sequence numbering, valid lifecycle operations, searchable PDFs without password protection, and compliance with file-naming and folder conventions. Validation errors lead to extended deadlines during formal review.