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.
Audience
Product type
Topic
- (-) Unique Device Identification (UDI) hub (2)
- Advertising (32)
- Breast implant hub (1)
- Clinical trials (5)
- Committees and advisory bodies (2)
- Compliance and enforcement (30)
- Cosmetics (4)
- COVID-19 (11)
- Fees and payments (3)
- Import and export (9)
- Labelling and packaging (26)
- Legislation (9)
- Manufacturing (41)
- Medicinal cannabis hub (4)
- Metal-on-metal hip replacement implants hub (1)
- Safety monitoring and information (46)
- Scheduling (national classification system) (6)
- Shortages and supply disruptions (3)
- Sunscreens (2)
- Vaping hub (5)
- Weight loss products (1)
Search
20 result(s) found, displaying 1 to 20
-
GuidanceProvides guidance on the regulatory requirements for labels and other medicine presentation.
-
GuidanceUnderstand the regulatory requirements for supplying UDI compliant medical devices in Australia
-
GuidanceTimeframes for supplying UDI compliant medical devices in Australia
-
GuidanceAustralian regulatory guidelines for over-the-counter medicines (ARGOM) Appendix 3.
-
GuidanceAustralian regulatory guidelines for over-the-counter medicines (ARGOM) Appendix 4.
-
GuidanceGuidance for data requirements for microorganisms used as active ingredients in listed or registered complementary medicines. These are generally referred to as probiotics or postbiotics.
-
GuidanceGuidance for industry organisations applying to add a medicine to the Australian Register of Therapeutic Goods (ARTG).
-
GuidanceAn overview of the Data Protection Scheme for assessed listed medicines, and the criteria that must be met for information to be considered protected under the Scheme.
-
GuidanceThis guidance explains requirements for registering a non-prescription OTC medicine on the Australian Register of Therapeutic Goods (ARTG).
-
GuidanceThis guidance will help you understand our pharmacovigilance inspection program (PVIP).
-
GuidanceGuidance on changing information in the ARTG for listed or assessed listed medicines.
-
-
GuidanceGuidance explaining types of variations, for registered medicines and biologicals, that can be submitted as notifications due to being very low risk.
-
GuidanceGuidance about evidence required to substantiate the quality of the product, for over-the-counter (OTC) medicine registration applications.
-
GuidanceGuidance on submitting an effective application to register an over-the-counter (OTC) medicine.
-
GuidanceGuidance for sponsors on changing information in the Australian Register of Therapeutic Goods (ARTG) for registered complementary medicines.
-
GuidanceGuidance about information required for an assessed listed medicine application to pass preliminary assessment and proceed to evaluation.
-
GuidanceThis guidance describes the safety and efficacy data you will need for Common Technical Document (CTD) Module 4 and Module 5 to support applications for over-the-counter (OTC) medicines.
-
GuidanceGuidance providing an overview of the Common Technical Document (CTD), modules 1-5. The CTD is a set of dossier specifications for the registration of medicines.
-
GuidanceGuidance to assist you with submitting acceptable applications for registration of over-the-counter (OTC) medicines.