category 1 Applications for new Processes for For ATN submissions lodged applications Register entries made preparing and between 1 November 2010 solely for under s. 23 of the Act lodging and 28 February 2011 additional where the sponsor seeks submission (inclusive), refer to the trade names only to register an ATN remain transitional draft CTD Module (ATN) for an existing unchanged. 1 - as at September 2010 registration. document. For ATN 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 . category 1 All other submissions All category 1 For all other category 1 (other than that are either: submissions, with submissions lodged between 1 submissions the exception of November 2010 and 28 applications for new solely for ATN applications, February 2011 (inclusive), Register entries made additional lodged with the refer to the transitional CTD under s. 23 of the Act trade names) TGA from 1 Module 1 - as at September to which Regulation November 2010 2010. 16C applies will be processed For all other category 1 through the OR submissions lodged from streamlined 1 March 2011, refer to the requests for submission transitional draft CTD Module variations under s. process (i.e. a 1- as at January 2011 9D(3) of the Act to document. which Regulation 16D planning form applies. (PPF) must be For details of processes and lodged with the other regulatory TGA between 2½ requirements, refer to the and to 6 months before the documents. the submission).
category 1 applications solely for additional trade names (ATN) Applications for new Register entries made under s. 23 of the Act where the sponsor seeks only to register an ATN for an existing registration. Processes for preparing and lodging submission remain unchanged. For ATN 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 ATN 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 . category 1 (other than submissions solely for additional trade names) All other submissions that are either: applications for new Register entries made under s. 23 of the Act to which Regulation 16C applies OR requests for variations under s. 9D(3) of the Act to which Regulation 16D applies. All category 1 submissions, with the exception of ATN applications, 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 all other category 1 submissions lodged between 1 November 2010 and 28 February 2011 (inclusive), refer to the transitional CTD Module 1 - as at September 2010. For all other category 1 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 and the documents.
pm-ctd-module1-1101-a.docx