Guidance
Our Guidance explains the laws and regulations governing the development, manufacturing, marketing, and supply of therapeutic goods in Australia.
We recently introduced new features to improve your experience using Guidance on our website.
Use the filters below to narrow your search.
Filter results
You can narrow down the results using the filters.
Topic
- Advertising (32)
- Breast implant hub (1)
- Clinical trials (5)
- Committees and advisory bodies (2)
- Compliance and enforcement (32)
- Cosmetics (4)
- COVID-19 (11)
- Fees and payments (3)
- Import and export (9)
- Labelling and packaging (26)
- Legislation (9)
- Manufacturing (42)
- Medicinal cannabis hub (3)
- Metal-on-metal hip replacement implants hub (1)
- Safety monitoring and information (46)
- Scheduling (national classification system) (6)
- Shortages and supply disruptions (4)
- Sunscreens (2)
- Unique Device Identification (UDI) hub (3)
- Vaping hub (5)
- Weight loss products (1)
Search
312 result(s) found, displaying 226 to 250
-
GuidanceGuidance for sponsors on the eligibility criteria for reduced application and evaluation fees for major variation applications for prescription medicines.
-
GuidanceGuidance on generic and originator medicines in the context of over-the-counter (OTC) non-prescription medicine applications.
-
GuidanceGuidance for manufacturers and sponsors on the product standards that apply to haematopoietic progenitor cells (HPCs).
-
GuidanceGuidance for sponsors and manufacturers about medical device definitions and requirements for system or procedure packs.
-
GuidanceGuidance on the application of the Therapeutic Goods (Vaping Goods - Possession and Supply) Determination 2024.
-
GuidanceGuidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.
-
GuidanceThis guidance applies to manufacturers of medical devices that are regulated as system or procedure packs and supplied using the special conformity assessment procedure regulatory pathway.
-
GuidanceLearn the regulatory obligations for exempt medical devices in Australia, including manufacturer responsibilities, safety, record‑keeping and compliance requirements.
-
GuidanceGuidance for sponsors on how and when to use a boxed warning in PI or a CMI.
-
GuidanceGuidance on the documents that may be required to include a medical device in the Australian Register of Therapeutic Goods (ARTG), including In Vitro Diagnostic medical devices (IVDs).
-
GuidanceGuidance on how medical device labelling requirements help manufacturers and sponsors fulfil their responsibilities.
-
GuidanceAustralian Regulatory Guidelines for Biologicals (ARGB). This guidance will help you understand how to classify your biological.
-
GuidanceGuidance on the requirements that specifically apply to active medical devices.
-
GuidanceGuidance for industry on how to apply for consent to supply therapeutic goods that do not comply with subsection 9(2) of TGO 92.
-
GuidanceGuidance on our risk-based approach and criteria for autologous human cell and tissue exemptions, exclusions and regulation.
-
GuidanceGuidance on when software is classified as an in vitro medical device and how it is regulated.
-
GuidanceGuidance on preliminary assessment requirements for medical devices, including in-vitro diagnostics (IVDs), being included in the Australian Register of Therapeutic Goods (ARTG).
-
GuidanceGuidance for new sponsors on how to supply, import, and export disinfectant products.
-
GuidanceGuidance on the rules governing COVID-19 rapid antigen tests (RATs) advertising.
-
GuidanceGuidance for sponsors of certain medical devices who are required to submit annual reports.
-
GuidanceGuidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.
-
GuidanceGuidance on equivalence of herbal extracts in complementary medicines.
-
GuidanceLearn how to report adverse events for medical devices in Australia, including requirements, reporting processes, and responsibilities for sponsors and manufacturers.
-
GuidanceGuidance on the use of a medical device in a way that is not included in the intended purpose in the Australian Register of Therapeutic Goods (ARTG), and rules for advertising off-label uses.
-
GuidanceGuidance clarifying the interaction between our requirements and AHPRA advertising guidelines.