PhV non-compliance notification contact points at National Competent Authority (NCA) level

Contacts at the European Medicines Agency

CHMP-CAT - D80-210 Overview to final EPAR - Rev 04.25 (Revamp)

Guidance on the anonymisation of protected personal data and assessment of commercially confidential information during the preparation of RMPs (main body and annexes 4 and 6)

Human medicines European public assessment report (EPAR): Cinqaero, reslizumab, Date of authorisation: 15/08/2016, Revision: 12, Status: Authorised

Human medicines European public assessment report (EPAR): Edurant, rilpivirine, Date of authorisation: 28/11/2011, Revision: 22, Status: Authorised

Template for the qualified person's (QP) declaration concerning good manufacturing practice compliance of active substance manufacture "The QP declaration template" - Scientific guideline

Questions & answers - Practical arrangements on the companion diagnostics consultation procedure to the European Medicines Agency by notified bodies

Questions & answers - Practical arrangements on the companion diagnostics consultation procedure to the European Medicines Agency by notified bodies - tracked changes

Overview of NCAs participating in the voluntary Simultaneous National Scientific Advice (SNSA) project