Templates for assessors

Post-authorisation measure (PAM) assessment report templates

Assessment report for post-authorisation measures (PAMs)

CHMP rapporteurs' assessment report for paediatric studies submitted in accordance with Article 46

PRAC rapporteurs' assessment report for non-imposed non-interventional PASS protocol

Signal assessment report templates

Signal assessment report - template

Risk-management-plan assessment report templates

Risk management plan (RMP) assessment report sub-template for type II variations and periodic safety update reports (PSURs)

Generics - Hybrids - PRAC D94 Rapporteur RMP assessment report template rev. 01.23

Reference Number: Rev. 01.23 Legal effective date: 16/08/2018

PRAC advice template

PRAC advice template

Variation assessment report templates

Post-authorisation efficacy studies (PAES) assessment report sub-template for type II variations

Non-imposed post-authorisation safety study (PASS) final results assessment report sub-template for type II variations

Extension of market/data protection assessment report templates

One year of additional market protection for new indication assessment report template

One year extension of data protection for legal status switch assessment report template

One year extension of data protection for new indication of well-established use product assessment report template