Swissmedic on Thursday released an updated guidance document on the eDok submission which as included new templates with minor other changes.
What is eDok format?
The eDok format is Swissmedic's own submission format for applications. Swissmedic provides folder structure templates for the electronic submission of documents, and electronic files should be placed in the corresponding folders according to the definition of the Common Technical Document (CTD) and the Notice To Applicants (NTA).
When submitted via the portal, the eDok format is considered to be a purely electronic format without the need for any paper documents. When submitted by post, the eDok format is considered to be a paper format requiring the submission of a complete paper copy as the original paper version.
Swissmedic carries out its review based on the documentation submitted electronically and archives the paper original as a legally binding document.
eDoc submissions are possible for:
Authorisation and variation requests regarding
Human medicinal products (Common Technical Document, CTD)
Veterinary medicinal products (Notice to Applicants, NTA)
Homeopathic and anthroposophic medicines, including those for which authorisation is sought via the notification procedure (HOMANT)
Click this LINK to know more about the eDok submissions and their Technical requirements.
Also, they released another guidance document "Temporary authorisation for human medicinal products" that describes the conditions that must be met before a request for temp. auth. can be approved, and outlines the detailed procedure for the processing and evaluation of this request.
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