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Forms (A-Z list)
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- Add or remove a connection to your manufacturing organisation (27 October 2016)
- Add or remove an Agent from your organisation (27 April 2015)
- Additional trade names application form (30 June 2015)
- Annual Charge Exemption scheme: Forms (21 September 2020)
- Annual product report for biological prescription medicines (22 December 2015)
- Application for a new registered complementary medicine - grouped medicine (7 June 2011)
- Application for a permit to export human substances (18 December 2019)
- Application for approval to use a restricted representation in advertising (8 October 2020)
- Application for certificate of free sale or export certificate for a medical device (18 February 2019)
- Application for conformity assessment certificates (medical devices) (13 March 2019)
- Application for consent to import, supply or export goods that do not comply with standards - section 14/14A (1 July 2020)
- Application for priority review designation - medical devices (22 November 2019)
- Application to amend the Poisons Standard (2 May 2018)
- Assurances to accompany a L(A)1 application (27 March 2018)
- Assurances to accompany an OTC new medicine N1 application (29 November 2015)
- Assurances to accompany an OTC new medicine N2 application (29 November 2015)
- Australia-United States Free Trade Agreement (6 March 2019)
- Authorised Prescribers (8 October 2020)
- Certified product details (CPD) - Biological prescription medicines (17 October 2016)
- Certified product details (CPD) - Chemical prescription medicines (25 June 2013)
- Comparable Overseas Bodies (COB) checklists (4 December 2019)
- Compositional guideline template (10 August 2018)
- COVID-19-related application for consent to supply goods that do not conform with Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines - section 14/14A (14 July 2020)
- Credit card payment authorisation (29 June 2020)
- CTD Module 1: Additional forms and proformas (29 November 2018)
- CTN scheme forms (8 September 2015)
- CTX scheme forms
- Declaration of conformity templates (IVDs) (12 January 2017)
- Declaration of conformity templates (medical devices) (8 October 2020)
- Designation checklist: for sponsor seeking Orphan Drug designation (7 August 2018)
- Determination checklist: for sponsor seeking priority review determination (3 August 2018)
- Determination checklist: for sponsor seeking provisional determination (20 March 2018)
- Early scientific advice request form (22 September 2020)
- Electronic invoices nomination form
- Essential Principles - consent for noncompliance (1 July 2020)
- Essential principles checklist (medical devices) (17 September 2019)
- European Medical Device Directive - Essential requirements checklist (22 October 2010)
- Exceptional release of a biological (1 July 2014)
- GMP Clearance questionnaire (3 July 2020)
- Import/export of unapproved therapeutic goods for experimental purposes (5 August 2015)
- Inspection feedback forms (4 August 2017)
- Is your advertising for therapeutic goods compliant? (12 October 2020)
- Justification for a particular route of evaluation (29 November 2015)
- Listed medicines evidence package checklists (7 May 2014)
- Manufacturer statutory declarations (11 December 2015)
- Medicinal cannabis products (1 October 2018)
- Module 1.2.1: Assessed listed medicine general application information form (27 March 2018)
- National Adverse Events Following Immunisation (AEFI) reporting form (4 August 2016)
- Notification of a change in sponsorship (19 August 2016)
- Notification of a new proprietary ingredient (27 October 2020)
- Notification of an authorisation to use a protected ingredient (17 September 2020)
- Notification of proposal to submit supplementary data & submission of supplementary data (15 April 2005)
- Notification of selective non-disclosure of Active Herbal Extract details (23 June 2015)
- Organisation details (29 May 2015)
- OTC analytical validation summary form (3 June 2016)
- Pre-clearance application for animal-derived ingredients (1 September 2008)
- Pre-submission meeting forms (2 March 2018)
- Pre-submission Planning Form (PPF) (24 September 2014)
- Prescription medicine registration form (3 August 2020)
- Proposal for a new Australian Cell & Tissue Name (ACN) application form (4 July 2018)
- Proposal to amend the Required Advisory Statements for Medicine Labels (RASML) (25 July 2014)
- Proposed 'Approved Herbal Name' (AHN) application form (2 July 2015)
- Proposed 'Herbal Substance Name' (AHS) application form (2 July 2015)
- Proposed Australian Approved Name (AAN) application form (7 August 2014)
- Proposed Australian Biological Name (ABN) application form (7 August 2014)
- Publication order form (7 March 2017)
- Registered medicine variation form (complementary medicines) (7 June 2011)
- Report a medical device adverse event (medical device user) (28 April 2014)
- Report a medical device adverse event (sponsor/manufacturer) (1 August 2013)
- Report a medicine deficiency or defect
- Report of the manufacture of exempt therapeutic goods
- Request for advice - Biologicals (6 January 2020)
- Request for certificates or notarised copies of TGA licences and certificates
- Request to cancel an ARTG entry (19 June 2016)
- Request to reinstate an entry on the Australian Register of Therapeutic Goods (ARTG) (29 June 2020)
- Restricted representation application checklist (8 October 2020)
- Scheduling consultation coversheets (4 October 2017)
- Section 14/14A application form relating to subsection 9(2) of TGO 92 (31 October 2019)
- Section 19A application form to import and supply substitute medicines
- Special Access Scheme (30 September 2020)
- Statutory advisory committee forms (9 September 2016)
- Submission dossier checklist for prescription medicines (12 July 2013)
- Submission of an updated RMP (28 July 2020)
- Updating organisation administrator (12 June 2015)
- URPTG templates (7 February 2019)