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This Guidance is directly referenced in legislation and must be presented in its original publication format.
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Mandatory requirements for an effective application
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Version 4.1: Administrative update to reflect reference to current legislation.
Version 4.0:
- Updated to include requirements for the COR report-based process and remove Category 2 application requirements.
- Updated to include priority registration pathway.
Version 3.0: Updated.
Version 2.1: Amendments to reflect consultation outcomes regarding GMP clearance requirements at PPF lodgement and to clarify RMP formatting requirements.
Version 2.0: 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.
Version 1.0.
Version 4.1: Administrative update to reflect reference to current legislation.
Version 4.0:
- Updated to include requirements for the COR report-based process and remove Category 2 application requirements.
- Updated to include priority registration pathway.
Version 3.0: Updated.
Version 2.1: Amendments to reflect consultation outcomes regarding GMP clearance requirements at PPF lodgement and to clarify RMP formatting requirements.
Version 2.0: 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.
Version 1.0.