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 (34)
- Breast implant hub (1)
- Clinical trials (5)
- Committees and advisory bodies (2)
- Compliance and enforcement (33)
- Cosmetics (4)
- COVID-19 (11)
- Fees and payments (3)
- Import and export (9)
- Labelling and packaging (27)
- Legislation (13)
- 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
317 result(s) found, displaying 101 to 125
-
GuidanceAustralian regulatory guidelines for over-the-counter medicines (ARGOM) Appendix 3.
-
GuidanceAustralian regulatory guidelines for over-the-counter medicines (ARGOM) Appendix 4.
-
GuidanceAssists in the interpretation of the PIC/S GMP requirements when manufacturing compounded medicines
-
GuidanceGuidance on how to provide the required patient information materials with all implantable and active implantable medical devices.
-
GuidanceGuidance on requirements relating to impurities in prescription medicines entered in the Australian Register of Therapeutic Goods (ARTG).
-
GuidanceGuidance on bioavailability and/or bioequivalence aspects of medicines including information on biowaivers.
-
GuidanceGuidance on when and how to provide Product Information to us.
-
GuidanceGuidance for manufacturers of medical or surgical face masks and respirators on the standards and key performance aspects required for inclusion in the Australian Register of Therapeutic Goods (ARTG).
-
GuidanceGuidance to assist sponsors to understand the process for submitting a priority registration application.
-
GuidanceGuidance on the evaluation process and information required for new registered complementary medicines.
-
GuidanceGuidance on criteria and supporting documentation required for a medicine to be eligible for provisional determination.
-
GuidanceGuidance to assist researchers who are developing new medical devices understand the evidence requirements for market authorisation.
-
GuidanceGuidance on providing adventitious agent safety information in applications for medicines containing, or manufactured using, materials of animal or human origin.
-
GuidanceGuidance for sponsors and manufacturers of prescription medicines that contain, or are produced by, genetically modified organisms (GMOs).
-
GuidanceThis guidance helps sponsors understand the eligibility criteria and supporting documentation required for a medicine to be eligible for priority determination.
-
GuidanceGuidance on provisional registration process for prescription medicines with provisional determination.
-
GuidanceAustralian recommendations and requirements
-
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.
-
GuidanceClassifying in-vitro diagnostic medical devices (IVDs) according to the health risk that may arise from an incorrect result.
-
GuidanceGuidance on the regulation of system or procedure packs and using the special conformity assessment procedure.
-
GuidanceGuidance about how to make variations to Australian Register of Therapeutic Goods (ARTG) entries for prescription medicines.
-
GuidanceGuidance to change an OTC medicine, listed in the Australian Register of Therapeutic Goods (ARTG), using the Changes Table.
-
GuidanceThis guidance is for manufacturers of registered medicinal gases to understand our interpretation of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to GMP for medicinal products.
-
GuidanceInformation to help sponsors and manufacturers decide if antiviral‑claim products need ARTG entry to be imported or supplied in Australia.
-
GuidanceGuidance on using reports from COBs and submission requirements for evaluation of these applications.