Before revision: Per Article 23, the QPPV is responsible for: a) Establishing and maintaining a pharmacovigilance system b) Preparing pharmacovigilance reports as defined by regulations c) Answering requests from Health Authorities d) Providing Health Authorities with any other information relevant to product safety Volume 9A provides further guidance regarding these responsibilities of the QPPV (Part I, Chapter 1.2, Section 1.2.1: The Role and Responsibilities of the Qualified Person Responsible for Pharmacovigilance).
After revision: Per Article 23, the QPPV is responsible for: Establishing and maintaining a pharmacovigilance system Preparing pharmacovigilance reports as defined by regulations Answering requests from Health Authorities Providing Health Authorities with any other information relevant to product safety Volume 9A provides further guidance regarding these responsibilities of the QPPV (Part I, Chapter 1.2, Section 1.2.1: The Role and Responsibilities of the Qualified Person Responsible for Pharmacovigilance).