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Version history

Version 2.4, 4 December 2017
Last updated
VersionDescription of changeAuthorEffective date
V1.0Original publicationOTC Medicines Regulatory Guidance15 April 2013
V1.1
  • Clarified requirement for analytical validation summary forms and included hyperlink
  • Clarified requirement for applications to be in common technical document (CTD) format
  • Included reference to 'different strength or size' in the Groups Order - Summary section
  • Changed references from SUSDP to SUSMP
  • Added new change codes (previously referred to as TBD)
OTC Medicines Regulatory Guidance15 April 2013
V2.0
  • Guidance reformatted, restructured and redrafted as web pages
  • Added new codes (identified in the tables as NEW)
  • Removed duplicated and redundant change codes and consolidated other change codes for clarity
  • Amended change codes to include examples where necessary
  • Combined the 'Label changes (including package insert)' and 'Product detail changes' sections
  • Updated the 'Assurance codes' table and updated the assurance codes within the Changes Table accordingly
OTC CMB and Regulatory guidance team30 November 2015
V2.1Add new code - IHNManagement & Operations Section, Complementary and OTC Medicines Branch13 September 2016
V2.2Addition of two new codes (identified in table as New), amendment of an existing code (identified in table as Amended) and deletion of a redundant code (LLO)OTC Medicines Evaluation and Management & Operations Section, COMB3 February 2017
V2.3Update to change codes (PSC, LLN, LSP, PSR, AOV, EST, QFP, QSP, KBT, KBL, KCL, KRR, MMA, MMD, AMS, MSD) to reflect the new notification process commencing 1 July 2017.OTC Medicines Evaluation Section / Scientific Operations Management Section30 June 2017
V2.4Update to change codes to include further notifications, commencing 4 December 2017.OTC Medicines Evaluation Section / Scientific Operations Management Section4 December 2017

This webpage on the TGA website was printed on 21 Sep 2024. Printed content may be out of date. For up-to-date information, always refer to the digital version: https://www.tga.gov.au/resources/resource/guidance/changing-otc-medicine-using-changes-tables/version-history

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