We are aware of an issue causing the title of some ARTG entries to disappear. We are investigating as a priority and hope to have this resolved as soon as possible.
Resources
Search our resources for user guides, checklists, international scientific guidelines, compositional guidelines and forms.
Can't find what you’re looking for? You can also:
- search our Publications
- use the site search bar in the top right of this screen for more results.
Use the filters below to narrow your search.
Filter results
You can narrow down the results using the filters.
Topic
- Prescription medicines (271)
- Listed medicines (147)
- Complementary medicines (110)
- Therapeutic goods regulation (86)
- Safety (51)
- Biological medicines (46)
- Over the counter (OTC) medicines (43)
- Clinical trials (42)
- Non-prescription medicines (39)
- In Vitro Diagnostic medical devices (IVDs) (26)
- Regulatory compliance (19)
- Medicines safety (18)
- Assessed listed medicines (17)
- Manufacturing (16)
- Medical devices safety (16)
- Advertising (15)
- Registered complementary medicines (12)
- Labelling and packaging (11)
- Scheduling (national classification system) (11)
- Import and export (9)
- Legislation (9)
- Australian Register of Therapeutic Goods (ARTG) (8)
- Medicinal cannabis hub (6)
- Disinfectants/Sterilants (5)
- Shortages (5)
- Fees and payments (4)
- Vaping hub (4)
- Alert/Advisory (3)
- Sunscreens (3)
- TGA conformity assessment certification (3)
- Advisory bodies and committees (2)
- COVID-19 (2)
- Electronic submissions (2)
- Blood and blood components (1)
- COVID-19 vaccines (1)
- Implantable medical devices (1)
- Personalised medical devices (1)
- Pharmacovigilance (1)
- Prescription opioids hub (1)
- Software as a medical device (1)
Results for
"[search-keyword]"
Search
623 result(s) found, displaying 501 to 525
-
FormsSponsors should note that the Bioequivalence Study Information Form (BSIF) has been amended
-
Reference materialIn addition to the legislated requirements, there are other features of leaflet and card design that can be very helpful for patients
-
Reference materialHow we regulate sunscreens as listed or registered medicines in the Australian Register of Therapeutic Goods.
-
International scientific guidelines adopted in AustraliaCPMP/EWP/239/95 final adopted by the Therapeutic Goods Administration (TGA)
-
-
Reference materialgeneral guidance on the regulation of listed medicines and registered complementary medicines in Australia
-
FormsUse this form to propose a new approved herbal name or herbal substance name.
-
Reference materialFrom 30 November 2020 certain sports supplements are regulated as therapeutic goods (medicines)
-
User guideA user guide for evaluations of substance for use in listed medicines and assessed listed medicines.
-
Reference materialCovers the general principles of manufacturing requirements for therapeutic goods and includes a case study
-
Reference materialDevice Requirements version 4 (DR4) provides guidance on transition arrangements for 'retained registered disinfectants'
regulated under the pre- 4 October 2002 regulatory framework for medical devices. -
User guideThe Special Access Scheme (SAS) & Authorised Prescriber (AP) Online System (SAS & AP online system) is the preferred method of submission for AP applications.
-
Reference materialThe conformity assessment certification and audit requirements for certain medical devices have changed.
-
Reference materialThis standard sets out minimum safety and quality requirements for unapproved and export only nicotine vaping products that are imported into, manufactured or supplied in, or exported from, Australia.
-
User guideA how to fill in a device incident report
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/302620/2017.
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/341363/2014.
-
User guideUser guide updated to include final report and additional information requirements following amendments to the Therapeutic Goods (Medical Devices) Regulations 2002.
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/500825/2016
-
Reference material
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/BMWP/118264/2007 Rev. 1.
-
Reference materialN2 applications involve reduced requirements for data assessment by the TGA and consequently shorter evaluation timelines.
-
Reference materialThis guidance outlines the broad approach adopted by the TGA to identify and manage risk associated with therapeutic goods
-
Reference materialUnderstanding the requirements of Section 11 of the Therapeutic Goods Advertising Code.
-
FormsProposal form for a new Approved Cell and Tissue Name (ACN)