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AUSTRALIA TGA DRAFT GUIDANCE |
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Proposed changes to the regulatory requirements for hospital, household and commercial grade disinfectants
This is to seek your comment on proposed changes to the regulation of hospital, household and commercial grade disinfectant products as detailed in the attached consultant's report entitled ''A new regulatory framework for disinfectants". Full document...
Draft guidance document: Equivalence of herbal extracts
This guidance document describes the circumstances under which a herbal extract may be considered to be ‘equivalent’ to an ingredient currently included in a therapeutic good, and which therefore may be used as a substitute for the ingredient, without the product being considered to be a separate and distinct good. Full document...
Draft guidance document: The use of modified unprocessed herbal and biological materials in complementary medicines
This guidance document applies to unprocessed herbal and biological materials whose composition has been chemically modified to the extent that it is significantly different from the original material approved for use in Listed or Registered medicines. Unprocessed (raw) materials of plant or other biological origin include the whole, cut, or part of the material, either fresh or dry. Full document...
Australia New Zealand Therapeutic Products Regulatory Scheme
On 10 December 2003, the Australian and New Zealand Governments signed a Treaty for the establishment of a joint scheme for the regulation of therapeutic products in Australia and New Zealand.
DRAFT Compositional guidelines, 14 feb 2007
Draft compositional guideline - Alpha lipoic acid (pdf,10kb) (comment period closed)
Draft compositional guideline - Amylase derived from Aspergillus oryzae (pdf,84kb) (comment period closed)
Draft compositional guideline - Asparagus racemosus dried root (pdf,44kb) (comment period closed)
Draft compositional guideline - Bovine derived chondroitin sulfate (pdf,33kb) (comment period closed)
Draft compositional guideline - Bovine lactoferrin (pdf,10kb) (comment period closed)
Draft compositional guideline - Calcium-â-hydroxy-â-methylbutyrate (monohydrate) (pdf,16kb) (comment period closed)
Draft compositional guideline - Calcium lactate gluconate (pdf,14kb) (comment period closed)
Draft compositional guideline - Canarium indicum oil (pdf,32kb) (comment period closed)
Draft compositional guideline - Cellulase derived from Trichoderma longibrachiatum (pdf,84kb) (comment period closed)
Draft compositional guideline - Conifer green needle complex (pdf,34kb) (comment period closed)
Draft compositional guideline - Refined emu oil (pdf,15kb) (comment period closed)
Draft compositional guideline - Glucosamine sulfate (pdf,12kb) (comment period closed)
Draft compositional guideline - Levocarnitine and its salts and derivatives (pdf,16kb) (comment period closed)
Draft compositional guideline - Lipase derived from Rhizopus oryzae (pdf,31kb) (comment period closed)
Draft compositional guideline - Lutein (pdf,11kb) (comment period closed)
Draft compositional guideline - Lycopene (pdf,13kb) (comment period closed)
Draft compositional guideline - Molybdenum trioxide (pdf,11kb) (comment period closed)
Draft compositional guideline - Morinda citrifolia dried fruit powder (pdf,71kb) (comment period closed)
Draft compositional guideline - Morinda citrifolia juice (pdf,54kb) (comment period closed)
Draft compositional guideline - Proteases derived from Aspergillus oryzae (pdf,31kb) (comment period closed)
Draft compositional guideline - Pseudowintera colorata leaf (pdf,13kb) (comment period closed)
Draft compositional guideline - Royal jelly and derivatives (pdf,13kb) (comment period closed)
Draft compositional guideline - Santalum spicatum (Australian Sandalwood) (pdf,88kb) (comment period closed)
Draft compositional guideline - Shark cartilage (pdf,10kb) (comment period closed)
Draft compositional guideline - Shark cartilage derived chondroitin sulfate (pdf,33kb) (comment period closed)
Draft compositional guideline - Streptococcus thermophilus (pdf,10kb) (comment period closed)
Draft compositional guideline - Thiamine phosphoric acid ester chloride (pdf,14kb) (comment period closed)
Draft compositional guideline - Tilactase derived from Aspergillus oryzae (pdf,84kb) (comment period closed)
Draft compositional guideline - Tocotrienols complex - palm (pdf,52kb) (comment period closed)
Draft compositional guideline - Trametes versicolor hyphae aqueous extract - powder (pdf,76kb) (comment period closed)
Draft compositional guideline - Trametes versicolor proteoglycan concentrate (pdf,45kb) (comment period closed)
Draft compositional guideline - Undaria pinnatifida powder (pdf,15kb) (comment period closed)
Draft compositional guideline - Zeaxanthin (pdf,15kb) (comment period closed)
Draft Guidance
Draft guidelines: 13. Variants for Class III and AIMD medical devices, 17 Aug 2006
Ensuring best practice in the notification of product discontinuations - draft best practice guidelines, 13 Jul 2006
Revision of the Australian code of good wholesaling practice for therapeutic goods for human use, 04 Jul 2006
General Requirements for the Labelling of Medicines (draft - May 2006) for application by the Australia New Zealand Therapeutic Products Authority, 13 Jun2006
Consolidated advisory statement requirements for medicine labels, 23 May 2006
Consultation (Draft) Regulation Impact Statement - An impact statement on the proposed amendments to the current regulatory system for herbal and homoeopathic medicines in Australia, 23 May 2006
DRAFT compositional guideline - Trametes versicolor proteoglycan concentrate, 06 Apr 2006
Printable version of Draft fact sheet: Medical devices packaged together, 23 Mar 2006
DRAFT compositional guideline - Conifer green needle complex (CGNC), 22 Feb 2006
DRAFT compositional guideline :Undaria pinnatifida powder, 15 Feb 2006
A proposed model for the scheduling of poisons in Australia, 15 Dec 2005
Draft scheduling policy framework for medicines and poisons, 15 Dec 2005
Australian draft review of policy framework for regulating products at the cosmetics therapeutic interface - summary of responses to the recommendations. 3 Aug 2005
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