Modifications to guidance document "Formal requirements" and Modifications to the table "Documents to be submitted"

28.05.2018 

Update Guidance document for formal requirements:

  • Chapter 2.5.4 Packaging elements: Clarification.

Update to the table "Documents to be submitted"

  • Divider sheet “NA+maj. var.” column “NA Parallel import“: Clarification of the modules 1.3.1 and 1.3.3.
  • Divider sheet “Var. req. app.+maj. var.” column “Change co-mktg -> own auth - own doc” and “Var req. app/no sc. ass. co-mktg-> own auth doc basis”: Clarification of the modules 1.0; 1.2.1 and 1.2.2.1.
  • Divider sheet “Var. req. app.+maj. var.”, deletion of the column “Var req. app/sc. ass. Co-M.->own auth, own doc” and deletion of the line “Authorisation certificats for all products concerned, originals” (modules 2-5). 

The adapted versions enter into force immediately.

https://www.swissmedic.ch/content/swissmedic/en/home/humanarzneimittel/authorisations/information/anpassung-per-28052018.html