Version history

Version 2.4, 4 December 2017

Last updated

4 December 2017

Version	Description of change	Author	Effective date
V1.0	Original publication	OTC Medicines Regulatory Guidance	15 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 Guidance	15 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 team	30 November 2015
V2.1	Add new code - IHN	Management & Operations Section, Complementary and OTC Medicines Branch	13 September 2016
V2.2	Addition 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, COMB	3 February 2017
V2.3	Update 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 Section	30 June 2017
V2.4	Update to change codes to include further notifications, commencing 4 December 2017.	OTC Medicines Evaluation Section / Scientific Operations Management Section	4 December 2017