category 3 Requests for variations Processes for For category 3 submissions under s. 9D(3) of the Act preparing and lodged between 1 November to which Regulation 16F lodging 2010 and 28 February 2011 applies submission (inclusive), refer to the remain transitional draft CTD Module OR unchanged. 1 - as at September 2010 Applications for new document. Register entries made For category 3 submissions under s. 23 of the Act to lodged on or after 1 March which Regulation 16G 2011, refer to the transitional applies. draft CTD Module 1 - as at January 2011 document. For details on processes and other regulatory requirements, refer to the Australian regulatory guidelines for prescription medicines (). category 2 Applications for new All category 2 For category 2 submissions Register entries made submissions lodged between 1 November under s. 23 of the Act to lodged with the 2010 and 28 February 2011 which Regulation 16C(4) TGA from 1 (inclusive), refer to the applies November 2010 transitional CTD Module 1 - as will be processed at September 2010 document. OR through the For category 2 submissions Requests for variations streamlined lodged from 1 March 2011, under s. 9D(3) of the Act submission refer to the transitional draft to which Regulation process (i.e. a CTD Module 1 - as at January 16D(4) applies. 2011 document. planning form (PPF) must be For details of processes and lodged with the other regulatory TGA between 2½ requirements, refer to the to 6 months before document. the submission).
category 3 Requests for variations under s. 9D(3) of the Act to which Regulation 16F applies OR Applications for new Register entries made under s. 23 of the Act to which Regulation 16G applies. Processes for preparing and lodging submission remain unchanged. For category 3 submissions lodged between 1 November 2010 and 28 February 2011 (inclusive), refer to the transitional draft CTD Module 1 - as at September 2010 document. For category 3 submissions lodged on or after 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 Australian regulatory guidelines for prescription medicines (). category 2 Applications for new Register entries made under s. 23 of the Act to which Regulation 16C(4) applies OR Requests for variations under s. 9D(3) of the Act to which Regulation 16D(4) applies. All category 2 submissions lodged with the TGA from 1 November 2010 will be processed through the streamlined submission process (i.e. a planning form (PPF) must be lodged with the TGA between 2½ to 6 months before the submission). For category 2 submissions lodged between 1 November 2010 and 28 February 2011 (inclusive), refer to the transitional CTD Module 1 - as at September 2010 document. For category 2 submissions lodged from 1 March 2011, refer to the transitional draft CTD Module 1 - as at January 2011 document. For details of processes and other regulatory requirements, refer to the document.