Notifications Notifications (‘requests’) Process for For submissions lodged lodged under one of the preparing and between 1 November 2010 following: lodging remains and 28 February 2011 unchanged. (inclusive), refer to the s. 9D(1) of the Act i.e. transitional CTD Module 1 - as requests for at September 2010 document. corrections to ARTG entries For submissions lodged from 1 March 2011, refer to the s. 9D(2) of the Act i.e. transitional draft CTD Module ‘safety related’ 1 - as at January 2011 notifications document. s. 9D(3) of the Act for For details on processes and ‘self assessable’ other regulatory notifications as requirements, refer to the . described in Part B of Appendix 12 and Appendix 13 of the ARGPM s. 9D(3) of the Act for ‘minor editorial changes’ as described in the ARGPM. Non-assessable changes Unchanged. For details on processes and as described in Part A of other regulatory changes Appendix 12 of the requirements, refer to the . ARGPM. Section 14 Request for exemption Processes for For exemptions lodged exemption from compliance with preparing and between 1 November 2010 standards under s.14 of lodging remains and 28 February 2011 the Act. unchanged. (inclusive), refer to the transitional CTD Module 1 - as at September 2010 document. For requests lodged from 1 March 2011, refer to the transitional draft CTD Module 11 - as at January 2011 document. For details on processes and other regulatory requirements, refer to the .
Notifications Notifications (‘requests’) lodged under one of the following: s. 9D(1) of the Act i.e. requests for corrections to ARTG entries s. 9D(2) of the Act i.e. ‘safety related’ notifications s. 9D(3) of the Act for ‘self assessable’ notifications as described in Part B of Appendix 12 and Appendix 13 of the ARGPM s. 9D(3) of the Act for ‘minor editorial changes’ as described in the ARGPM. Process for preparing and lodging remains unchanged. For submissions lodged between 1 November 2010 and 28 February 2011 (inclusive), refer to the transitional CTD Module 1 - as at September 2010 document. For submissions lodged from 1 March 2011, refer to the transitional draft CTD Module 1 - as at January 2011 document. For details on processes and other regulatory requirements, refer to the . changes Non-assessable changes as described in Part A of Appendix 12 of the ARGPM. Unchanged. For details on processes and other regulatory requirements, refer to the . Section 14 exemption Request for exemption from compliance with standards under s.14 of the Act. Processes for preparing and lodging remains unchanged. For exemptions lodged between 1 November 2010 and 28 February 2011 (inclusive), refer to the transitional CTD Module 1 - as at September 2010 document. For requests lodged from 1 March 2011, refer to the transitional draft CTD Module 11 - as at January 2011 document. For details on processes and other regulatory requirements, refer to the .