Changing a registered complementary medicine RCM: application levels and changes tables
Guidance for sponsors if you are changing information in the Australian Register of Therapeutic Goods (ARTG) for registered complementary medicines.
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Purpose
Guidance for sponsors on changing information in the ARTG for registered complementary medicines:
- Application levels for RCM changes
- Timeframes and fees for RCM change applications
- Supportive documentation for RCM change applications
- How to use the code tables to determine RCM change type
- Registered Complementary Medicines (RCM) changes tables
Legislation
Guidance
This Guidance is presented as downloadable files because of its length.
Page history
Original Publication.
Information for original publication extracted from ARGCM V9 (pages 207-238). Changes include:
- restructuring information on change application levels into a table
- renaming change application levels from C1 - C4 to RCM C1 - RCM C4 to be consistent with legislation and clearly identify that these changes are for RCMs
- including information on timeframes and fees for RCM change applications
- including information on supportive documentation for RCM change applications
- including information on how to use the code tables
- inclusion of a list of the changes tables
- numbering of the change tables
- addition of information on applying to use the TGA assessed claim
- inclusion of the data matrix for data requirements for RCM changes
changing headings and numbers in change tables to be consistent with docu-bridge.
Original Publication.
Information for original publication extracted from ARGCM V9 (pages 207-238). Changes include:
- restructuring information on change application levels into a table
- renaming change application levels from C1 - C4 to RCM C1 - RCM C4 to be consistent with legislation and clearly identify that these changes are for RCMs
- including information on timeframes and fees for RCM change applications
- including information on supportive documentation for RCM change applications
- including information on how to use the code tables
- inclusion of a list of the changes tables
- numbering of the change tables
- addition of information on applying to use the TGA assessed claim
- inclusion of the data matrix for data requirements for RCM changes
changing headings and numbers in change tables to be consistent with docu-bridge.