Forms
14 May 2013
The links below are categorised by topic. This list is also available in an A-Z list.Advertising forms
- Application for advertising approval
- Application for approval to use a restricted representation in advertising
Blood, tissues & biologicals forms
- Application for assessment of Australian publicly funded facility or not-for-profit hospital supply unit for biologicals
- Biological application
- eBusiness Services forms
- Exceptional release of a biological
- Human blood & tissues recall report form
Clinical trials forms
Complementary medicines forms
- Application for a new registered complementary medicine - grouped medicine
- Application for an evaluation of a new complementary medicine substance
- Authorisation to cancel a licence from the ARTG
- Compositional guideline template
- eBusiness Services forms
- Guide to the completion of the 'Notification of selective non-disclosure of Active Herbal Extract details' form
- Justification for a particular route of evaluation
- Notification of a proprietary ingredient
- Pre-clearance application for animal-derived ingredients
- Proposal to amend the Required Advisory Statements for Medicine Labels (RASML)
- Proposed 'Approved Herbal Name' (AHN) application form
- Proposed Australian Approved Name (AAN) application form
- Proposed Australian Biological Name (ABN) application form
- Proposed 'Herbal Component Name' (HCN) application form
- Proposed 'Herbal Substance Name' (AHS) application form
- Registered medicine variation form (complementary medicines)
Import/export forms
- Application for certificate of free sale or export certificate for a medical device
- European Medical Device Directive - Essential requirements checklist
Labelling & packaging
Manufacturing forms
- Application for conformity assessment certificates (medical devices)
- Audit feedback forms (pilot)
- Declaration of conformity templates (IVDs)
- Declaration of conformity templates (medical devices)
- eBusiness Services forms
- Manufacturer statutory declarations
- Request for certificates or notarised copies of TGA licences and certificates
Medical devices & IVDs forms
- Application for certificate of free sale or export certificate for a medical device
- Application for conformity assessment certificates (medical devices)
- Authorisation to cancel a licence from the ARTG
- Declaration of conformity templates (IVDs)
- Declaration of conformity templates (medical devices)
- eBusiness Services forms
- Essential principles - consent for noncompliance
- Essential principles checklist (medical devices)
- European Medical Device Directive - Essential requirements checklist
Miscellaneous forms
- Australia-United States Free Trade Agreement
- Client details form
- Credit card payment authorisation
- Electronic funds transfer agreement
- Electronic invoices nomination form
- Low value turnover application forms
- Publication order form
- Register as a small business with the TGA
- Request to transfer the sponsorship of an ARTG entry
- Statutory expert committee forms
- Transmissible spongiform encephalopathies (TSEs) questionnaire for sponsors
- Website feedback or error reporting
OTC medicines forms
- Analytical validation summary form
- Authorisation to cancel a licence from the ARTG
- eBusiness Services forms
- Justification for a particular route of evaluation
- Notification of a proprietary ingredient
- Proposal to amend the Required Advisory Statements for Medicine Labels (RASML)
- Proposed Australian Approved Name (AAN) application form
Prescription medicines forms
- Annual batch release report for biological prescription medicines
- Authorisation to cancel a licence from the ARTG
- Certified product details (CPD) - Biological prescription medicines
- Certified product details (CPD) - Chemical prescription medicines
- eBusiness Services forms
- Justification for a particular route of evaluation
- Minor variations to registered prescription medicines: chemical entities and biological medicines
- Notification of a proprietary ingredient
- Notification of proposal to submit supplementary data & submission of supplementary data
- Prescription medicine registration form
- Pre-submission planning form
- Proposed Australian Approved Name (AAN) application form
- Proposed Australian Biological Name (ABN) application form
- Report of the manufacture of exempt therapeutic goods
- Summary of a bioavailability or bioequivalence study
- Therapeutic goods and use of human embryos or human embryonic stem cells or material derived therefrom
Problem reporting
- 'Blue card' adverse reaction reporting form
- Human blood & tissues recall report form
- Report a medical device adverse event (medical device user)
- Report a medical device adverse event (sponsor/manufacturer)
- Report a medicine deficiency or defect
- Report a perceived breach or questionable practices
Scheduling forms
Unapproved therapeutic goods forms
Web page last updated: Tuesday, 14 May 2013
URL: http://www.tga.gov.au/about/forms.htm