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614 result(s) found, displaying 1 to 25
- FormsNotification of a new proprietary ingredientUpdated form used to notify the TGA of proprietary ingredient mixtures for use in therapeutic goods
- GuidanceLabels for COVID-19 vaccinesTo enable timely distribution of COVID-19 vaccines, international labels are being used during the initial global rollout, including in Australia.
- GuidanceExceptional release of biologicals (post-market)Release on non-conforming biologicals is only permitted under prescribed circumstances and for an individual patient. Access to the request form and instructions are within the guidance document.
- GuidanceRegulatory framework for personalised medical devices: Frequently asked questionsFrequently asked questions to further clarify the new regulatory framework for personalised medical devices
- GuidanceBlack Triangle Scheme information for sponsorsInformation about what to include in the PI and CMI for products included in the Black Triangle Scheme.
- GuidancePersonalised medical devices (including 3D-printed devices)Information and examples to help you understand the regulatory framework for personalised medical devices.
- GuidanceAustralian regulatory guidelines for medical devices (ARGMD)New landing page for the ARGMD and associated guidance
- GuidanceExemption for Certain Clinical Decision Support SoftwareTGA has designed detailed guidance for Exempt Clinical Decision Support Software which complements the general guidance already published.
- GuidanceLabels for COVID-19 treatmentsTo enable timely distribution of COVID-19 treatments, international labels may be used during initial supply in Australia.
- GuidanceRegulation of software based medical devicesSoftware based medical devices are medical devices that incorporate software or are software.
- FormsOrganisation detailsThis form collects information about the legal entity making applications under the Therapeutic Goods Act 1989.
- GuidanceAuthorised Prescribers of unapproved nicotine vaping productsAs of 20 June 2022, the TGA has approved 882 Authorised Prescriber applications for unapproved nicotine vaping products.
- GuidanceUpdate to listed medicine ingredients in August 2022Listed medicine ingredients and requirements are updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2022
- Compositional guidelinesEPA-rich Nannochloropsis oculata oilCompositional guideline for 'EPA-rich Nannochloropsis oculata oil' permitted for use in listed medicines
- GuidanceChanges to the Permissible Ingredients DeterminationWe review the Permissible Ingredients Determination to ensure the ingredients are safe for use in low-risk medicines.
- FormsApplication for priority applicant determination - medical devicesInformation and links to the medical devices priority applicant determination application form.
- FormsSponsor six monthly reporting formSponsors must report every six months in relation to unapproved therapeutic goods supplied under the SAS and Authorised Prescriber (AP) schemes.
- FormsSpecial Access SchemeThe TGA has updated the Special Access Scheme Category C list of medicines and devices with an established history of use.
- FormsAuthorised Prescribers'Authorised Prescriber application form' and 'List of medicines with an established history of use' have been updated
- GuidanceHow to determine if your product should be included in the ARTGAssistance for sponsors with products included in the ARTG as Class I medical devices to decide if their products are included correctly
- GuidanceInformation for medical practitioners on up-classification of surgical mesh devicesGuidance for medical practitioners and hospitals of potential supply disruption of some surgical mesh devices from 1 December 2021.
- GuidanceCustom-made medical devicesInformation for manufactures, sponsors and health professionals on the definition of a custom-made medical device and how they are regulated by the TGA.
- GuidanceSurrogate viruses for use in disinfectant efficacy tests to justify claims against COVID-19Frequently asked questions added
- GuidanceReclassification of active implantable medical devices (AIMD)This guidance is to assist sponsors comply with new regulations.
- GuidanceReclassification of spinal implantable medical devicesUpdated guidance to reflect new amendments made to the regulations.