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.1.3
status  Applicable as of 11 September 2015
specification  view (PDF, 1 MB, 01.10.2015)
dtd  download (ZIP, 8 kB, 01.10.2015)
stylesheet  download (ZIP, 6 kB, 01.10.2015)
examples  download (ZIP, 1 MB, 01.10.2015)
Implementation guidance  view (PDF, 382 kB, 01.10.2015)
checksums  view (PDF, 184 kB, 01.10.2015)
Changes to previous version  view (PDF, 1 MB, 01.10.2015)
Swiss eCTD Validation Criteria
   Validation Criteria v1.3
status  Applicable for DTD v1.3
document  view (XLS, 342 kB, 01.10.2015)
release notes for new version  view (XLS, 332 kB, 01.10.2015)
Guidance for Industry
   Guidance v1.10
status  Applicable as of 01 October 2018
document  view (PDF, 1 MB, 01.10.2018)
changes to previous version  view (PDF, 1 MB, 01.10.2018)
Guidance Article 13 TPA
   Guidance Article 13 TPA v1.4
status  Applicable as of 01 October 2018
document  view (PDF, 796 kB, 01.10.2018)
changes to previous version  view (PDF, 601 kB, 01.10.2018)
Questions & Answers of Swiss eCTD Implementation
   Q&A v2.0
status Applicable as of 01 October 2015
document  view (PDF, 379 kB, 31.05.2018)
changes to previous version  view (PDF, 544 kB, 01.10.2015)
https://www.swissmedic.ch/content/swissmedic/it/home/services/submissions/ectd/dokumentenhistorie.html