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Guidance
Our Guidance explains the laws and regulations governing the development, manufacturing, marketing, and supply of therapeutic goods in Australia.
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- Advanced therapies (2)
- Advertising (33)
- Advisory bodies and committees (2)
- Artificial Intelligence (AI) (3)
- Assessed listed medicines (23)
- Australian Register of Therapeutic Goods (ARTG) (26)
- Biological medicines (21)
- Blood and blood components (10)
- Breast implant hub (1)
- Clinical trials (5)
- Complementary medicines (31)
- Cosmetics (4)
- COVID-19 (9)
- Disinfectants/Sterilants (5)
- Fees and payments (3)
- Import and export (8)
- In Vitro Diagnostic medical devices (IVDs) (39)
- Labelling and packaging (25)
- Legislation (8)
- Listed medicines (23)
- Manufacturing (40)
- Medical devices safety (24)
- Medicinal cannabis hub (4)
- Medicines safety (8)
- Metal-on-metal hip replacement implants hub (1)
- Non-prescription medicines (48)
- Over the counter (OTC) medicines (35)
- Prescription medicines (46)
- Registered complementary medicines (15)
- Regulatory compliance (25)
- Safety (15)
- Scheduling (national classification system) (4)
- Shortages (4)
- Software as a medical device (1)
- Sunscreens (1)
- TGA conformity assessment certification (7)
- Therapeutic goods regulation (29)
- Vaping hub (4)
- Weight loss products (1)
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265 result(s) found, displaying 176 to 200
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GuidanceGuidance to help manufacturers and sponsors navigate packaging terms across the industry, to meet regulatory requirements.
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GuidanceGuidance on how exempt disinfectants are defined and meeting the regulatory requirements for their manufacture, supply and advertising.
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GuidanceThis guidance provides for a nationally uniform approach to retail storage of Schedule 6 and Schedule 7 poisons.
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GuidanceGuidance on whether medicines are evaluated as prescription medicines or complementary or over-the-counter (OTC) medicines.
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GuidanceGuidance to help you understand which therapeutic goods will be regulated as a biological.
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GuidanceGuidance on regulatory requirements for IVD companion diagnostics.
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GuidanceGuidance to determine the level of regulation of PRP, PRF or conditioned serum products for therapeutic use.
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GuidanceGuidance explaining how to find out which statements (if any) are required by the RASML for a particular over-the-counter (OTC) or complementary medicine.
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GuidanceGuidance for sponsors and manufacturers on regulatory responsibilities associated with first aid kits supplied using the special conformity assessment procedure.
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GuidanceGuidance to help manufacturers of active medical devices, including software-based medical devices, to classify their devices.
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GuidanceGuidance to assist sponsors with the reclassification of surgical mesh devices.
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GuidanceGuidance for sponsors and manufacturers about pathways for exporting a ventilator from Australia.
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GuidanceGuidance on mandatory warning statements for labels of medicines containing neuromuscular blocking agents.
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GuidanceGuidance on the priority applicant determination criteria and process for medical devices including in vitro diagnostics (IVDs).
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GuidanceGuidance for manufacturers and sponsors on the product standards that apply to haematopoietic progenitor cells (HPCs).
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GuidanceGuidance for sponsors on the eligibility criteria for reduced application and evaluation fees for major variation applications for prescription medicines.
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GuidanceGuidance on the application of the Therapeutic Goods (Vaping Goods - Possession and Supply) Determination 2024.
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GuidanceGuidance about the Annual Charge Exemption scheme waiver process.
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GuidanceGuidance on the regulatory requirements for therapeutic goods that contain, or are produced from, human blood or plasma
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GuidanceGuidance on generic and originator medicines in the context of over-the-counter (OTC) non-prescription medicine applications.
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GuidanceGuidance for sponsors and manufacturers about medical device definitions and requirements for system or procedure packs.
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GuidanceGuidance on mandatory requirements and ongoing responsibilities for all manufacturers and sponsors of medical devices.
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GuidanceThis guidance applies to manufacturers of medical devices that are regulated as system or procedure packs and supplied using the special conformity assessment procedure regulatory pathway.
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GuidanceGuidance on how medical devices must comply with the Essential Principles, which set out fundamental safety and performance requirements.
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GuidanceGuidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.