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.1.4
status  Applicable as of 01 November 2018
specification  view (PDF, 1 MB, 18.01.2019)
dtd  download (ZIP, 3 kB, 01.11.2018)
stylesheet  download (ZIP, 5 kB, 01.11.2018)
examples  download (ZIP, 901 kB, 10.12.2018) 
Implementation guidance  view (PDF, 463 kB, 01.11.2018)
checksums  view (TXT, 195 B, 01.11.2018)
Changes to previous version
Please note: Due to technical issues it was not possible to track changes in table 4. 
 view (PDF, 1 MB, 18.01.2019) 
Swiss eCTD Validation Criteria
   Validation Criteria v1.4
status  Applicable for DTD v1.4
document  view (XLS, 93 kB, 18.01.2019)
release notes for new version  view (XLS, 453 kB, 18.01.2019)
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, 809 kB, 01.10.2018)
changes to previous version  view (PDF, 601 kB, 01.10.2018)
Questions & Answers of Swiss eCTD Implementation
   Q&A v2.1
status Applicable as of 18 January 2019
document  view (PDF, 302 kB, 18.01.2019)
https://www.swissmedic.ch/content/swissmedic/it/home/services/submissions/ectd/dokumentenhistorie.html