These forms are for the complementary medicines industry. For a complete list of forms, see: Forms

A C J L N P R T

A

• 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 to assess whether a new complementary medicine substance should be permitted in listed medicines
• Australia-United States Free Trade Agreement
  The Australia-US Free Trade Agreement (the Agreement) came into force on 1 January 2005

C

• 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

J

• 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

L

• Listed medicines evidence package checklists
  These package checklists help sponsors and applicants of listed complementary medicines assess, record and present the available evidence for the indication/s for their medicine

N

• Notification of a change in sponsorship
  Use to notify of a change in sponsorship of an ARTG entry
• Notification of a new proprietary ingredient
  Use to supply TGA with information about a proprietary ingredient
• 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

P

• 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 to propose an amendment to the Required Advisory Statements for Medicine Labels (RASML)
• Proposed 'Approved Herbal Name' (AHN) application form
  Use to propose a botanical name for a herb (an 'Approved Herbal Name' (AHN))
• Proposed Australian Approved Name (AAN) application form
  Use to apply for an Australian Approved Name
• Proposed Australian Biological Name (ABN) application form
  Use to apply for an Australian Biological Name.
• Proposed 'Herbal Component Name' (HCN) application form
  Use 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 to apply for a name for a herbal material that is fully characterised in a monograph or pharmacopoeia (a 'Herbal Substance Name' (AHS)).

R

• Registered medicine variation form (complementary medicines)
  Use to vary the particulars of complementary medicines which are already registered in the ARTG
• Request to cancel an entry/entries from the Australian Register of Therapeutic Goods (ARTG)
  Use to cancel an entry from the ARTG

T

• TGA Business Services forms
  Forms for sponsors, agents and manufacturers to apply for access to TGA Business Services