Update
26.05.2014 - As a result of feedback received from the industry at the eDM information event on 16 May 2014, the following changes have been made to the new Swissmedic Guidance document:
- Chapter 2.1: additional informationen regarding the use of staples
- Chapter A.2.5.3.5: correction: 3 instead of 1 copies
- Chapter 3.22.1: correction: PSUR/PBRER core report in not necessary in Word format
- New abbreviation: RD