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 26 to 50
-
GuidanceGuidance and examples to help you understand the regulatory framework for personalised medical devices.
-
GuidanceGuidance to help applicants understand what a section 41HD application is, how to submit an application, and what evidence will be needed.
-
GuidanceUnderstand the regulatory requirements for supplying UDI compliant medical devices in Australia
-
GuidanceTimeframes for supplying UDI compliant medical devices in Australia
-
GuidanceThis guidance explains the prohibitions that apply to advertising for prescription medicines.
-
GuidanceGuidance on the process for registering new medicines with new trade names that are 'clones' of currently registered prescription medicines
-
GuidanceThis guidance supports psychiatrists in understanding their regulatory requirements when prescribing MDMA and psilocybine from 1 July 2023.
-
GuidanceGuidance explaining the post-market surveillance of listed medicines and how we undertake compliance reviews.
-
GuidanceGuidance on how to advertise health services that involve therapeutic goods, including how to comply with the Act and avoid prohibited advertising.
-
GuidanceGuidance about the Annual Charge Exemption (ACE) scheme waiver process.
-
GuidanceGuidance for preparing a technical file review, as part of your application to include an in-vitro medical device (IVD) in the Australian Register of Therapeutic Goods.
-
GuidanceThis guidance explains how overseas assessments can support our medical device certification and registration processes.
-
GuidanceGuidance on the use of market authorisation evidence from comparable overseas regulators for medical device applications.
-
GuidanceGuidance on the mandatory requirements for reporting current and anticipated reportable medicine shortages and discontinuations in Australia.
-
GuidanceThis guidance assists entities who disseminate content about therapeutic goods and vaping goods to determine if their material is considered advertising.
-
GuidanceGuidance about the requirements for advertising software-based medical devices to consumers or health professionals.
-
GuidanceGuidance on when consumer software products that promote general health or wellness may be excluded from our regulatory requirements.
-
GuidanceGuidance on when software used for clinical workflow management may be excluded from our regulatory requirements.
-
GuidanceSoftware or a combination of software and hardware that is an electronic health record (EHR) may be excluded from our regulatory requirements.
-
GuidanceGuidance on when software that is middleware intended to connect or interface applications may be excluded from our regulatory requirements.
-
GuidanceGuidance on when software that makes calculations may be excluded from our regulatory requirements.
-
GuidanceGuidance about when certain types of population-based analytics software may be excluded from our regulatory requirements.
-
GuidanceGuidance about when certain types of laboratory information management systems (LIMS) and laboratory information systems (LIS) may be excluded from our regulatory requirements.
-
GuidanceGuidance on when software that provides alerts to health professionals in relation to patient care may be excluded from our regulation.
-
GuidanceGuidance on when software products for consumers to self-manage an existing disease or health condition may be excluded from our regulatory requirements.