The definitions of biological and biotechnological substances have been revised in line with the EU definitions according to "Notice to Applicants, Volume 2A Procedures for marketing authorisation, Chapter 1, Annex I, Revision 11, July 2019" (chapter 1.1.1). The revision to be noted is that the new substance may have different properties with regard to safety and/or efficacy. The current definition reads "...with regard to safety and efficacy. "
In addition, the definitions of biological and biotechnological substances have been revised according to Art. 2 para. 1 let. d and e of the Ordinance of the Swiss Agency for Therapeutic Products on the Simplified Licensing of Therapeutic Products by the Notification Procedure (SR 812.212.23).
The revised guidance document is valid with effect from 15 September 2021.