May 2011 Amendment of Section A.1 new 20 – Amendment of Section C 2 new 2d, 2f, 2g, 2h; – renumbered Version 5, June 2011 Implementation With immediate effect Amendment of Section A.1 new 14 – March 2012 and Section A.2 new 13 and renumbered accordingly – Version 5_1, June 2011 Implementation With immediate effect Amendment of Section A.1 reference to paper – March 2013 submissions in the heading, new 4, renumbered, inclusion Version 6, March 2013 of section on type of application Amendment of Section A.2 new 4, renumbered – Inclusion of new Section A.3 for eCTD Amendment of Section D - Inclusion of new 8, 9, 10 Implementation With immediate effect Amended to include Complementary Medicines April 2014 Section A.1 - new 6, 20a amended, new 20b & c, renumbered, new Type of Applications Version 7, April 2014 Section A.2 - new 6, new 15, 17 amended, renumbered A.3.1 Submission type included. Correction B 3g Implementation With immediate effect Removal of eCTD to separate template June 2014 Amendment to Type of Application, Orthodox (non-clinical) Version 8, Aug 2014 Amendment to Type of Application, Complementary, Data Implementation With immediate effect
May 2011 Amendment of Section A.1 – new 20 Amendment of Section C 2 – new 2d, 2f, 2g, 2h; renumbered Version 5, June 2011 With immediate effect Implementation March 2012 Amendment of Section A.1 – new 14 and Section A.2 – new 13 and renumbered accordingly Version 5_1, June 2011 With immediate effect Implementation March 2013 Amendment of Section A.1 – reference to paper submissions in the heading, new 4, renumbered, inclusion of section on type of application Amendment of Section A.2 – new 4, renumbered Version 6, March 2013 Inclusion of new Section A.3 for eCTD Amendment of Section D - Inclusion of new 8, 9, 10 With immediate effect Implementation April 2014 Amended to include Complementary Medicines Section A.1 - new 6, 20a amended, new 20b & c, renumbered, new Type of Applications Section A.2 - new 6, new 15, 17 amended, renumbered A.3.1 Submission type included. Correction B 3g Version 7, April 2014 With immediate effect Implementation June 2014 Removal of eCTD to separate template Amendment to Type of Application, Orthodox (non-clinical) Amendment to Type of Application, Complementary, Data Version 8, Aug 2014 With immediate effect Implementation
6.15_Screening_template_SA_Jun14_v8.docx