Mandatory requirements for an assessed listed medicine application to pass preliminary assessment

Applicable for applications lodged from March 2018

Guidance about information required for an assessed listed medicine application to pass preliminary assessment and proceed to evaluation.

Published

1 March 2018

Note
This Guidance is directly referenced in legislation and must be presented in its original publication format.

Downloads

Product types

1 March 2018

Version 1.0 - Original publication.

1 March 2018

Version 1.0 - Original publication.