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Mandatory requirements for an effective application

Applicable for applications lodged from 9 February 2018

21 February 2018

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Version history

Version history
Version Description of change Author Effective date
V1.0 First version Office of Medicines Authorisation 02/2010
V2.0 Second version: Amendments to reflect consultation outcomes, changes to business rules, inclusion of specific requirements relating to sterile products, sterile drug substances and biological and improve clarity on justifications. Office of Medicines Authorisation 05/2013
V2.1 Amendments to reflect consultation outcomes regarding GMP clearance requirements at PPF lodgement and to clarify RMP formatting requirements Office of Medicines Authorisation 04/2014
V3.0 Updated Medicines Authorisation branch 07/2015
  • Updated to include requirements for the COR report-based process and remove Category 2 application requirements.
  • Updated to include priority registration pathway.
Prescription Medicines Authorisation Branch/Scientific Evaluation Branch 02/2018

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