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Table of contents
- Post-authorisation measure (PAM) assessment report templates
- Signal assessment report templates
- Risk-management-plan assessment report templates
- PRAC advice template
- Imposed PASS assessment report templates
- PSUR/PSUSA assessment report templates
- Variation assessment report templates
- Annual re-assessment and Renewal assessment report templates
- Extension of market/data protection assessment report templates
Post-authorisation measure (PAM) assessment report templates
Document(s) | Language | Status | First published | Last updated | Effective Date |
---|---|---|---|---|---|
CHMP rapporteurs' assessment report for post-authorisation measures (PAMs) | (English only) | 2014-05-28 | 2015-03-23 | ||
CHMP rapporteurs' assessment report for paediatric studies submitted in accordance with Article 46 | (English only) | 2014-05-28 | 2015-03-23 |
Signal assessment report templates
Document(s) | Language | Status | First published | Last updated | Effective Date |
---|---|---|---|---|---|
Signal assessment report - template | (English only) | 2014-10-29 | 2018-02-19 |
Risk-management-plan assessment report templates
Document(s) | Language | Status | First published | Last updated | Effective Date |
---|---|---|---|---|---|
PRAC rapporteur risk-management-plan assessment report - report template | (English only) | 2013-05-13 | 2013-07-03 | ||
Risk management plan (RMP) assessment report sub-template for type II variations and periodic safety update reports (PSURs) | (English only) | 2017-08-04 |
PRAC advice template
Document(s) | Language | Status | First published | Last updated | Effective Date |
---|---|---|---|---|---|
PRAC advice template | (English only) | 2017-08-04 |
Imposed PASS assessment report templates
Document(s) | Language | Status | First published | Last updated | Effective Date |
---|---|---|---|---|---|
PRAC rapporteur post-authorisation-safety-study-protocol assessment-report template | (English only) | 2012-12-11 | 2017-11-30 |
PSUR/PSUSA assessment report templates
Document(s) | Language | Status | First published | Last updated | Effective Date |
---|---|---|---|---|---|
PRAC periodic-safety-update-report assessment report template CAP and NAP | (English only) | 2013-03-05 | 2016-12-19 | 2013-02-21 | |
PRAC periodic-safety-update-report assessment report template CAP only | (English only) | 2016-01-11 | 2016-12-19 | ||
PRAC periodic-safety-update-report assessment report template NAP only | (English only) | 2016-01-11 | 2016-12-19 |
Variation assessment report templates
Document(s) | Language | Status | First published | Last updated | Effective Date |
---|---|---|---|---|---|
Post-authorisation efficacy studies (PAES) assessment report sub-template for type II variations | (English only) | 2017-08-04 | |||
Non-imposed post-authorisation safety study (PASS) final results assessment report sub-template for type II variations | (English only) | 2017-08-04 |
Annual re-assessment and Renewal assessment report templates
Document(s) | Language | Status | First published | Last updated | Effective Date |
---|---|---|---|---|---|
Annual re-assessment assessment report template | (English only) | 2017-08-04 | |||
Annual renewal assessment report template | (English only) | 2017-08-04 | |||
Renewal assessment report template | (English only) | 2017-08-04 |
Extension of market/data protection assessment report templates
Document(s) | Language | Status | First published | Last updated | Effective Date |
---|---|---|---|---|---|
One year of additional market protection for new indication assessment report template | (English only) | 2017-08-04 | |||
One year extension of data protection for legal status switch assessment report template | (English only) | 2017-08-04 | |||
One year extension of data protection for new indication of well-established use product assessment report template | (English only) | 2017-08-04 |