Cette rubrique recense les documents spécifiques à Swissmedic avec les données sur leur validité. Les versions précédentes de chaque document dans lesquelles les modifications éventuelles auront été mises en évidence sont également fournies.
Ces documents seront mis à jour en cas d’adaptation technique ou de modification des procédures relatives à la solution eCTD, et des périodes transitoires suffisantes seront prévues.
| Swiss Module 1 Specification for eCTD | ||
|---|---|---|
| CH M1 v.1.5 | Legacy version: CH M1 v1.4 | |
| status | Applicable as of 01 April 2020 | For reference only |
| specification | view (PDF, 1 MB, 18.07.2024) | view v1.4 (PDF, 1009 kB, 18.01.2019) |
| dtd | download (ZIP, 3 kB, 14.10.2020) | download v1.4 (ZIP, 3 kB, 27.09.2018) |
| stylesheet | download (ZIP, 5 kB, 14.10.2020) | download v1.4 (ZIP, 5 kB, 27.09.2018) |
| examples | download (ZIP, 1 MB, 01.04.2020) |
download v1.4 (ZIP, 901 kB, 22.11.2018) |
| Implementation guidance | view (PDF, 426 kB, 22.05.2024) | download v1.4 (PDF, 292 kB, 01.11.2018) |
| Swiss M1 Checksums 1.5 | view (TXT, 194 B, 01.04.2020) | download v1.4 (TXT, 195 B, 01.11.2018) |
| Changes to previous version |
view (PDF, 2 MB, 01.04.2020) | |
| Swiss eCTD Validation Criteria | ||
|---|---|---|
| Validation Criteria v1.5 | Legacy version: v1.4 | |
| status | Applicable for DTD v1.5 | For reference only |
| document | view (XLSX, 75 kB, 01.04.2020) | view archive (XLSX, 94 kB, 01.11.2018) |
| release notes for new version | view (XLSX, 222 kB, 01.04.2020) | |
| Guidance for Industry | ||
|---|---|---|
| Guidance v1.15 | Legacy version: v1.13 | |
| status | Applicable as of 11.03.2024 | For reference only |
| document | view (PDF, 4 MB, 11.03.2024) | view archive (PDF, 2 MB, 20.06.2022) |
| changes to previous version | view (PDF, 3 MB, 11.03.2024) | |
| Guidance Article 13 TPA | ||
|---|---|---|
| Guidance Article 13 TPA v1.6 | Legacy version: v1.5 | |
| status | Applicable as of 01 March 2024 | For reference only |
| document | view (PDF, 514 kB, 01.03.2024) | view archive (PDF, 564 kB, 01.04.2020) |
| Questions & Answers of Swiss eCTD Implementation | ||
|---|---|---|
| Q&A v2.2 | Legacy version: v2.1 | |
| status | Applicable as of 01 April 2020 | For reference only |
| document | view (PDF, 281 kB, 19.07.2023) | view archive (PDF, 182 kB, 18.01.2019) |
