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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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Topic
- 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 76 to 100
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GuidanceGuidance on the mandatory requirements for reporting current and anticipated reportable medicine shortages and discontinuations in Australia.
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GuidanceGuidance about application pathways and data requirements for new generic medicines, and variations to existing medicines.
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GuidanceGuidance explaining types of variations, for registered medicines and biologicals, that can be submitted as notifications due to being very low risk.
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GuidanceGuidance to understand the quality requirements of Therapeutic Goods Order No. 101 - Standard for tablets, capsules and pills (TGO 101, the Order).
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GuidanceThis guidance explains requirements for registering a non-prescription over-the-counter (OTC) medicine on the Australian Register of Therapeutic Goods (ARTG).
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GuidanceThis guidance will help you understand our pharmacovigilance inspection program (PVIP).
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GuidanceGuidance on the application process and information required for a substance to be evaluated for use in listed medicines.
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GuidanceOTC medicine monograph guidance: Bromhexine hydrochloride.
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GuidanceOTC medicine monograph guidance: Topical nasal decongestants.
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GuidanceGuidance for sponsors about how to apply for orphan drug designation for a prescription medicine.
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GuidanceThis guidance is to help sponsors and manufacturers of in-vitro diagnostic (IVD) medical devices transition to new manufacturer evidence requirements.
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GuidanceGuidance on the use of modified unprocessed herbal materials in complementary medicines
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GuidanceGuidance on using literature based submissions for applications for listed, assessed listed and registered complementary medicines.
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GuidanceGuidance for making an offer of enforceable undertaking to us.
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GuidanceGuidance to understand if your medical device product should be in the ARTG.
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GuidanceGuidance explaining how the Comparable Overseas Bodies report-based process is associated with shortened evaluation timeframes for applications.
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GuidanceGuidance for biological sponsors on the eligibility criteria and supporting documents required for priority determination applications
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GuidanceGuidance explaining how the method of preparation influences classification and whether autologous HCTs are eligible for exemptions.
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GuidanceGuidance on submitting the CPD for prescription medicines.
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GuidanceInformation that must be submitted in order for an application to list an assessed listed medicine in the Australian Register of Therapeutic Goods (ARTG).
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GuidanceGuidance on how to interpret Essential Principle 13B and how it applies to your device.
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GuidanceGuidance about how you can use terms such as 'natural' without misleading consumers.
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GuidanceThe trade name of a therapeutic good must comply with therapeutic goods legislation, including advertising legislation.
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GuidanceGuidance and examples to help you understand the regulatory framework for personalised medical devices.
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GuidanceGuidance on the market authorisation requirements for over-the-counter (OTC) New Medicine N2 applications for new products that contain aspirin as a single active ingredient.