Forms for complementary medicine sponsors
These forms are for the complementary medicines industry. For a complete list of forms, see: Forms
- Application for an Assessed listed medicine
This application form is to be used to apply under section 23B of the Therapeutic Goods Act 1989 (the Act) to list a complementary medicine under section 16AE of the Act. This form is to be completed in conjunction with the Module 1.2.1: Assessed listed medicine general application form. Complete the form as per the instructions in the guidance for completing the application form for an assessed listed medicine.
- Assurances to accompany a L(A)1 application
This form must be completed and submitted for all L(A)1 applications in Module 1.5.7 of the application. Completing this form provides the assurances required to accompany a L(A)1 application.
- 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
- 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
- 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
- Module 1.2.1: Assessed listed medicine general application information form
This form is to be completed in conjunction with the Assessed listed medicines application form. Complete the form as per the instructions in the guidance for completing the application form for an assessed listed medicine.
- 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
- 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)).
- 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
- TGA Business Services forms
Forms for sponsors, agents and manufacturers to apply for access to TGA Business Services