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Tech Alert: New and Updated Legislation

12 Jan 2023 12:30 PM | Anonymous member (Administrator)

Please find below a list of legislative updates for 2023. In particular, complementary medicine sponsors should note that for medicines listed form 24 December 2022, standard conditions of listing are no longer applied through ELF at the time of Listing or by a Notice from the TGA, but applied through a NEW Determination.

- New Conditions of Listing Determination will apply to listed medicines included on the ARTG from 24 December 2022, replacing the previous application of conditions by a Notice (Letter) from the TGA. However, the content of the conditions remain unchanged. 

-New TGO Standard for Medicines using Serialisation or GTIN data matrix codes

- Updated Advertsising Code Compilation to include the most recent Covid-19 vaccine advertising permission.

- Updated Poisons Standard from 2023– changed format, definitions, substantive provisions. The TGA state there are no change to Scheduling of substances. CMA will be monitoring if there are impacts on herbs and asks members to note the below information (page 5 of this alert) regarding complex preparations that have more than one substance restricted by scheduling.

- Updated Therapeutic goods Regulations – to reflect changes to devices including nanomaterials and IVDs.

More information and details are available via this tech alert.

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