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 (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)
- Unique Device Identification (UDI) hub (3)
- Vaping hub (5)
- Weight loss products (1)
Search
309 result(s) found, displaying 251 to 275
-
GuidanceGuidance to assist sponsors and manufacturers of medicinal cannabis products to conform with TGO 100.
-
GuidanceGuidance on the use of market authorisation evidence from comparable overseas regulators for medical device applications.
-
GuidanceGuidance about regulatory changes for software based medical devices, including software as a medical device (SaMD).
-
GuidanceGuidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.
-
GuidanceThis guidance helps Australian health practitioners, that manufacture, supply, and use medical devices, to understand whether you are regulated by us, and how to comply.
-
GuidanceGuidance on regulatory requirements for Ahpra registered dental practitioners making and adapting personalised medical devices for patients.
-
GuidanceGuidance on the transitional arrangements and obligations.
-
GuidanceGuidance on the transitional arrangements and obligations of sponsors and manufacturers.
-
GuidanceGuidance for sponsors of medical devices intended to be used in direct contact with the heart, central circulatory system (CCS) or the central nervous system (CNS) on transitional arrangements and obligations.
-
GuidanceGuidance to assist sponsors of medical devices that administer medicines or biologicals by inhalation meet their obligations and comply with regulations
-
GuidanceGuidance about how to apply for a permit to export human substances under the Customs (Prohibited Exports) Regulations 1958.
-
-
GuidanceGuidance to assist sponsors and manufacturers when applying for inclusion in the Australian Register of Therapeutic Goods (ARTG) and selecting a GMDN term.
-
GuidanceGuidance about how we define and regulate listed disinfectants, including how to submit a product application and the supporting data and other information required.
-
GuidanceThis guidance is for sponsors applying for a variation to the Australian Register of Therapeutic Goods (ARTG) entry of a biological
-
GuidanceGuidance explaining types of variations, for registered medicines and biologicals, that can be submitted as notifications due to being very low risk.
-
GuidanceThis guidance aims to assist sponsors of active implantable medical devices (AIMD) with meeting their obligations.
-
GuidanceGuidance for manufacturers and sponsors of HIV tests on meeting regulatory requirements and expectations.
-
GuidanceGuidance about when information released to the public about therapeutic goods is considered advertising.
-
GuidanceGuidance on the mandatory reporting scheme for medicine shortages and permanent discontinuations, and our approach to compliance.
-
GuidanceGuidance on what information to include in an application to vary the Therapeutic Goods (Permissible Ingredients) Determination.
-
GuidanceThis guidance is for sponsors intending to use the priority review pathway for biologicals.
-
GuidanceGuidance to help sponsors understand the process of submitting a priority inclusion application.
-
GuidanceGuidance explaining sponsor requirements for IVD Conformity Assessment through manufacturer agreements and regulatory compliance.
-
GuidanceGuidance on the stages of preparing and submitting an application for inclusion of a Class 2, 3 or 4 biological in the ARTG.