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889 result(s) found, displaying 276 to 300
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FormsTemplates to help you with your communications under the Uniform recall procedure for therapeutic goods (URPTG).
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Reference materialGuidance on procedure to undertake recalls and non-recall actions for therapeutic goods.
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Compositional guidelinesCompositional Guideline for Theanine permitted for use in listed medicines.
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Reference materialUpdate about the transitionary arrangements for reformatting Product Information, including accessing a fee waiver
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FormsTemplates for manufacturers to make Australian Declarations of Conformity for an in vitro diagnostic medical device.
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User guideThis document replaces AU eCTD specification - Module 1 and regional information Version 3.0 and contains updated information.
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FormsSponsors can use this form to apply for an additional trade name for a registered prescription medicine, under section 23 of the Therapeutic Goods Act 1989.
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FormsUse this form for Category 1 and Comparable Overseas Regulator (COR) report-based prescription medicines applications, or variations.
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Reference materialUpdated guidance to reflect new amendments made to the regulations.
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Reference materialUpdated guidance to reflect new amendments made to the regulations.
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FormsPrescription medicines Minor Variation E-form now available
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Reference materialThis page contains practical guidance to assist medical and nurse practitioners with prescribing therapeutic vapes for smoking cessation or the management of nicotine dependence.
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Reference materialGuidance for medical devices manufacturers on how we conduct Quality Management System (QMS) audits, roles and responsibilities for audits, aspects of conformity assessment certification and post-audit activities.
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FormsFind out what process to follow if a product is manufactured using a human embryo or a human embryonic stem cell, or any material sourced from such an embryo or stem cell.
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FormsUse these forms to apply for a permit to export human substances from Australia
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Reference materialHow to apply for a permit to export human substances under the Customs (Prohibited Exports) Regulations 1958.
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User guideThis user guide is for sponsors wanting to submit GMP clearance application by the TGA Business services (TBS) portal.
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Reference materialHow we regulate sunscreens as listed or registered medicines in the Australian Register of Therapeutic Goods.
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User guideThis user guide outlines how sponsors can access and use the Adverse Event Management System (AEMS) web portal.
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FormsThis checklist may help you to meet your responsibility for ensuring your advertising complies with the advertising legislative requirements.
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Reference materialBatch release testing of biological medicines (excluding vaccines) is no longer required.
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Reference materialLearn how we manage medical device adverse event reports.
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Reference materialThe guidelines provide information on the import, export and supply of medical devices within Australia.
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Reference materialThis guidance describes options for the removal of the Product Information (PI) as an insert from a medicine package while still complying with the labelling order.
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Reference materialTo enable timely distribution of COVID-19 vaccines, international labels are being used during the initial global rollout, including in Australia.