Adaptation of the table overview of documents to be submitted immediately

14.03.2018

The following document has been updated to reflect an adaptation of the modules 1.3.1 to 1.3.3 and 1.6. 1/2 on the divider sheet “ NA+maj. var:

To simplify the portal application the modules 1.3.1 to 1.3.3 “Product information and packaging” on the divider sheet “ NA+maj. var have been specified.

And in reference to the current Guidance document Authorisation Biosimilar the module1.6. 1/2 ERA Enviromental Risk Assessment (Non-GMO/GMO declaration), Biosimilar on the divider sheet “ NA+maj. has been specified. 

The new version of the affected document enter into force as of 14.03.2018.

https://www.swissmedic.ch/content/swissmedic/en/home/humanarzneimittel/authorisations/information/anpassung-des-verzeichnisses-einzureichende-unterlagen-per-sorfort.html