Amendments to the eDok Guidance document, the eDok templates, the eDok cover sheets and the Swissmedic eGov Portal – Standard Functions information sheets

12.01.2018 - The eDok Guidance document and the eGov Portal information sheets have undergone a number of content updates and amendments.

eDok Guidance document
The heading of section 1.2.2.5 has been brought into line with the eCTD standard. For TAM, sections p5 and p6 have been inserted as per EMA.

The eDok templates and eDok cover sheets have also been adapted accordingly.

Swissmedic eGov Portal – Standard Functions information sheets
A number of work processes have now been added. Chapters have been rearranged for better transparency and more detail provided.