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Forms for complementary medicine sponsors

These forms are for the complementary medicines industry.

Complementary medicines forms

• Application for a new registered complementary medicine
  Information on lodging an application for a new registered complementary medicine
• Application for a new registered complementary medicine - grouped medicine
  Use to make an application for the registration of a new complementary medicine that would be subject to 'grouping' with a medicine already registered
• Application for an evaluation of a new complementary medicine substance
  Use to request the TGA Office of Complementary Medicines to assess whether a new complementary medicine substance should be permitted in listable or non-prescription registrable products
• Compositional guideline template
  This template is for prospective sponsors and substance manufacturers to supply with their applications as described in the Australian Regulatory Guidelines for Complementary Medicines, Part 3, section 4.4
• Justification for a particular route of evaluation
  Use when an applicant wishes to have their product or substance evaluated by an area of the TGA other than as specified in Schedule 10 to the Therapeutic Goods Regulations
• Notification of a proprietary ingredient
  Use to request proprietary ingredient formulations to be entered onto the ARTG
• Notification of selective non-disclosure of Active Herbal Extract details
  Allows confidential active herbal extract details to be entered onto the ARTG, following an assessment process by the TGA to ensure that the herbal ingredient and manufacturing process comply with the definition of a herbal substance
• Pre-clearance application for animal-derived ingredients
  Assist users of the Electronic Listing Facility (ELF) seeking preclearance for animal derived ingredients by detailing what the TGA is looking for and what supporting documents need to be provided
• Proposal to amend the Required Advisory Statements for Medicine Labels (RASML)
  Use this form to propose an amendment to the Required Advisory Statements for Medicine Labels (RASML)
• Proposed 'Approved Herbal Name' (AHN) application form
  Use this form to propose a botanical name for a herb (an 'Approved Herbal Name' (AHN))
• Proposed Australian Approved Name (AAN) application form
  Use this form to apply for an Australian Approved Name
• Proposed Australian Biological Name (ABN) application form
  Use this form to apply for an Australian Biological Name.
• Proposed 'Herbal Component Name' (HCN) application form
  Use this form to apply for the name of a component comprising either a single chemical constituent or a particular group of chemical constituents found in herbal ingredients, where the ingredient is standardised to the constituent or group of constituents (a 'Herbal Component Name' (HCN)).
• Proposed 'Herbal Substance Name' (AHS) application form
  Use this form to apply for a name for a herbal material that is fully characterised in a monograph or pharmacopoeia (a 'Herbal Substance Name' (AHS)).
• Registered medicine variation form (complementary medicines)
  This form is used to vary the particulars of complementary medicines which are already registered in the ARTG

Related forms

• Australia-United States Free Trade Agreement
  The Australia-US Free Trade Agreement (the Agreement) came into force on 1 January 2005
• Client details form
  This form should be completed by or for each client involved with the supply of therapeutic goods in Australia for which the TGA requires address details
• Request to transfer the sponsorship of an ARTG entry
  Use by the accepting company and the relinquishing company to request to transfer the sponsorship of an ARTG entry