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Regulatory decisions & notices (OTC medicines)
OTC medicine notices
Older, revoked and superseded notices are available in the TGA Internet site archive.
- Changes to the Medicine Shortage Reporting system
- 02 June 2021: We are improving the Medicine Shortages IT System.
- Outcomes of the Lower Risk Registered Over-the-Counter (OTC) Products Review Pilot Project
3 January 2020: A Lower Risk OTC Products Review pilot project was developed in response to recommendation 14 of the Medicines and Medical Device Regulation Review (MMDR)
- Information for sponsors on how to apply for consent to supply goods that do not conform to subsection 9(2) of Therapeutic Goods Order No. 92
31 October 2019: The TGA has published information for sponsors to apply for a Section 14 exemption regarding subsection 9(2) of TGO 92 which relates to the presentation of the medicine name on the medicine label
- Medicines Advisory Statements Specification updates
1 March 2019: Advance notice of publication of Medicines Advisory Statements Specification 2017 - including amended requirements for codeine and oral NSAIDs