Submissions

The regulatory requirements regarding the following submission formats accepted by Swissmedic can be found under the sections "eCTD" and "Paper submissions":

Formal requirements:

ZL000_00_001e_WL Formal requirements
(14.12.2016, 1138 KB, PDF)
ZL000_00_002e_VZ Overview of documents to submitted
Additional table, formal requirements
(07.04.2017, 65 KB, XLSX)

A prioritisation sheet must be placed on top of each dispatch. It provides information on the submission format and type of transmission.
The prioritisation sheet is provided by Swissmedic in electronic form:

OS000_00_004e_VL Priorisation sheet
(14.02.2017, 144 KB, DOCX)