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Prescription medicines registration process

3 August 2020

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Version history

Version history of Prescription medicines registration process
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

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