Articles

In Australia, a cosmetic is defined under the Industrial Chemical (Notification and Assessment) Act1989 as a substance or preparation intended for placement in contact with any external part of the human body which includes the mouth and teeth. Cosmetics are used to cleanse, perfume, protect and change the appearance of the body or to alter its odors. They are made up of mixtures of chemical substances.

Fragrance chemicals are organic compounds that add odours, usually pleasant ones, to cosmetics such as perfumes. They are not only used in cosmetics but are also found in detergents, fabric softeners and other products to mask unpleasant odours from raw materials. They can also be found naturally in foods such as herbs and spices, complementary medicines, and Over-The-Counter (OTC) products, sometimes at higher levels than may be used in a fragrance.

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Detailed guidance on policy in specific areas is provided in the following sections:

· Section 2 – Levels and kinds of evidence to support indications and claims
· Section 3 – Minimizing the risk of Transmissible Spongiform Encephalopathies (TSEs)
· Section 4 – Quantified by Input
· Section 5 – European Union (EU) Guidelines referenced in the ARGCM
· Section 6 – Section 7 declarations
· Section 7 – Confidentiality

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This part also provides information on exempt medicines, combination complementary/pharmaceutical medicines, and the food/medicine interface.

Detailed guidance is provided in the following sections:
Section 2. – Homoeopathic Preparations and Mother Tinctures
Section 3. – Traditional Herbal Medicines
Section 4. – Aromatherapy
Section 5. – Practitioner Products
Section 6. – Exempt / Excluded Goods
Section 7. – Proprietary Ingredients
Section 8. – Interface Issues
Section 9. – Australian Native and Endangered Species in Therapeutic Goods
Section 10. – Other Legislation
Section 11. – Certificates of Analysis – Product
Section 12. – Product Specifications
Section 13. – Enforcement Procedures
Section 14. – Review of Decisions
Section 15. – Genetically Modified Organisms
Section 16. – Medicines for Export
Section 17. – Naming of New Substances and Terminology
Section 18. – Colourings Permitted in Medicines for Oral Use
Section 19. – Herbal Ingredients – Quality
Section 20. – Ingredients of Human or Animal Origin
Section 21. – Glossary of Terms Used in the ARGCM
Section 22. – Abbreviations and Acronyms Used in the ARGCM

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This part covers new complementary medicine substances, “switch” substances.
The primary reason for the evaluation of new complementary medicine substances and switch substances is to determine whether the substances are of sufficiently low risk to allow their inclusion in Listed medicines. It should be noted that, once it is approved for use in Listed medicines, the substance may be used by any sponsor. and excipients used in Listed and Registered complementary medicines.

The regulatory requirements for Registered medicines are discussed in Part I.

The regulatory requirements for Listed medicines are discussed in Part II.

This section provides an overview of the guidelines for the evaluation of new complementary medicine substances. Detailed guidance is provided in the following sections:
• Section 2 – Eligibility for evaluation as a complementary medicine substance
• Section 3 – Evaluation process
• Section 4 – Quality
• Section 5 – Safety.

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This first section provides an overview of the requirements for including complementary medicines as Listed goods.

Detailed guidance is provided in the following sections:

• Section 2. – Eligibility for including Listed complementary medicines on the ARTG
• Section 3. – The Listing Process
• Section 4. – The Electronic Listing Facility – Version 3 (ELF 3)
• Section 5. – Quality
• Section 6. – Safety and efficacy
• Section 7. – Labelling and presentation
• Section 8. – Post market review
• Section 9. – Product changes
• Section 10. – Other requirements.

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This guidance provides specific information on the clinical evidence requirements for the following types of devices:

  • Total and partial joint prostheses
  • Cardiovascular devices to promote patency or functional flow
  • Implantable pulse generators
  • Heart valve prostheses
  • Supportive devices – meshes, patches, and tissue adhesives
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