Safety signals for human medicinal products: Modification of the guidance document effective as of 01.03.2021
The guidance document was updated and the existing procedure specified in greater detail.
The following sections were added in revised form:
- 7.2: Reporting of safety- and efficacy-related results from PSUR/PBRER/PSUSA procedures of foreign authorities
- 7.3: Reporting requirements of signals for medicinal products with the authorisation status "Known active substance (KAS)"
Changes have also been made to the reporting time limits in section 7, and the publication deadline has been added in section 11.