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
- (-) Manufacturing (41)
- 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)
- 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 (2)
- Vaping hub (5)
- Weight loss products (1)
Search
77 result(s) found, displaying 51 to 75
-
GuidanceGuidance to help manufacturers of active medical devices, including software-based medical devices, to classify their devices.
-
GuidanceGuidance for sponsors on the eligibility criteria for reduced application and evaluation fees for major variation applications for prescription medicines.
-
GuidanceGuidance for manufacturers and sponsors on the product standards that apply to haematopoietic progenitor cells (HPCs).
-
GuidanceGuidance on mandatory requirements and ongoing responsibilities for all manufacturers and sponsors of medical devices.
-
GuidanceGuidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.
-
GuidanceAustralian Regulatory Guidelines for Biologicals (ARGB). This guidance will help you understand how to classify your biological.
-
GuidanceGuidance on our risk-based approach and criteria for autologous human cell and tissue exemptions, exclusions and regulation.
-
GuidanceThis guidance supports psychiatrists in understanding their regulatory requirements when prescribing MDMA and psilocybine from 1 July 2023.
-
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 preliminary assessment requirements for medical devices, including in-vitro diagnostics (IVDs), being included in the Australian Register of Therapeutic Goods (ARTG).
-
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.
-
GuidanceGuidance on regulatory requirements for Ahpra registered dental practitioners making and adapting personalised medical devices for patients.
-
-
GuidanceGuidance explaining types of variations, for registered medicines and biologicals, that can be submitted as notifications due to being very low risk.
-
GuidanceGuidance on submitting an effective prescription medicines application.
-
GuidanceThis guidance is for sponsors and manufacturers supplying medicines in Australia that are serialised or have data matrix codes.
-
GuidanceTips for sponsors, distributors and retailers on creating prescription medicine labels that are compliant with Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91).
-
GuidanceGuidance to assist manufacturers of medical devices and their component parts with meeting their regulatory obligations.
-
GuidanceGuidance on obligations during provisional registration period, process for applying for extension of provisional registration and transition to full registration.
-
GuidanceGuidance on how to access and use the Permissible Ingredients Determination for the purposes of submitting applications for substances in listed and assessed listed medicines.
-
GuidanceGuidance on our approved terminology for medicines.
-
GuidanceRisk management plans for medicines and biologicals has been updated with new content, new Australia-Specific Annex and a new form.
-
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 on the two mechanisms to provide information about a drug substance sourced from a third-party manufacturer.