Documenti tecnici

Qui figurano i documenti specifici di Swissmedic, completi del loro stato di validità, e inoltre si può accedere a una versione precedente con le modifiche evidenziate.

In caso di modifiche tecniche o procedurali alla soluzione eCTD, i documenti vengono adattati di conseguenza, concedendo tuttavia periodi di transizione sufficienti.

Swiss Module 1 Specification for eCTD
   CH M1 v.1.5
status Applicable as of 01 April 2020
specification  view (PDF, 1 MB, 01.04.2020)
dtd  download (ZIP, 3 kB, 01.04.2020)
stylesheet  download (ZIP, 5 kB, 01.04.2020)
examples  download (ZIP, 1 MB, 01.04.2020)
Implementation guidance  view (PDF, 934 kB, 01.04.2020)
Swiss M1 Checksums 1.5  view (TXT, 194 B, 01.04.2020)
Changes to previous version
 view (PDF, 2 MB, 01.04.2020)
Swiss eCTD Validation Criteria
   Validation Criteria v1.5
status  Applicable for DTD v1.5
document  view (XLS, 76 kB, 01.04.2020)
release notes for new version  view (XLS, 222 kB, 01.04.2020)
Guidance for Industry
   Guidance v1.11
status  Applicable as of 01 April 2020
document  view (PDF, 1 MB, 01.04.2020)
changes to previous version  view (PDF, 1 MB, 01.04.2020)
Guidance Article 13 TPA
   Guidance Article 13 TPA v1.5
status  Applicable as of 01 April 2020
document  view (PDF, 787 kB, 01.04.2020)
changes to previous version  view (PDF, 782 kB, 01.04.2020)
Questions & Answers of Swiss eCTD Implementation
   Q&A v2.2
status Applicable as of 01 April 2020
document  view (PDF, 500 kB, 01.04.2020)
https://www.swissmedic.ch/content/swissmedic/it/home/services/submissions/ectd/dokumentenhistorie.html