Version | Description of change | Author | Effective date |
---|---|---|---|
V1.0 | First version | Office of Prescription Medicines | 1/02/2010 |
V2.0 | Second version to reflect outcomes from the public and stakeholder consultation, the introduction of a separate workflow for generic medicines and the opportunity for applicants to consider all evaluation reports at milestone 3 | Office of Prescription Medicines | 1/05/2013 |
V2.1 | Addition of link to guidance on orphan drug designations | Office of Medicines Authorisation | 09/09/2014 |
V2.2 | Update to reflect new legislation | Prescription Medicines Authorisation Branch | 01/07/2017 |
V2.3 | Updated to reflect Provisional approval pathway | Prescription Medicines Authorisation Branch | 20/03/2018 |
V2.4 | Minor updates to Submissions | Prescription Medicines Authorisation Branch | August 2020 |
V2.5 |
Updates to expert advisory review phase
|
Prescription Medicines Authorisation Branch | August 2021 |
Version history
Last updated