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- Prescription medicines (22)
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43 result(s) found, displaying 1 to 25
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/CVMP/QWP/17760/2009 Rev2
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FormsPrescription medicines Minor Variation E-form now available
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/CVMP/QWP/441071/2011 Rev. 2
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User guideThis user guide is for sponsors applying for a variation to the Australian Register of Therapeutic Goods (ARTG) entry of a medical device or IVD medical device.
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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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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1
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Reference materialGuidance on how to change sponsor details in PI and labels
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Reference materialExplanatory guide on the quality modules to be submitted for influenza vaccine registration, for manufacturers and sponsors.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/CVMP/QWP/63699/2014.
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User guideThis user guide describes how to change sponsor details in the Product Information (PI) and labels for prescription medicines
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/BWP/310834/2012 Rev. 1
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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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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. -
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/VWP/457259/2014
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Reference materialGuidance now includes advice on lodgement of provisional variation applications
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Reference materialGuidance for sponsors and applicants preparing applications and requests involving steps in the manufacture of medicines regulated as prescription medicines
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User guideWe have made templates for Product Information (PI) and Consumer Medicine Information (CMI) documents to assist sponsors lodging variation applications for solid-dose single ingredient paracetamol products affected by upcoming scheduling changes.
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Reference materialThis information is intended for sponsors applying to the TGA to enter a radiopharmaceutical in the Australian Register of Therapeutic Goods (ARTG).
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User guideThis form is used to include a new biological or vary an existing biological on the ARTG
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User guideThis document applies to all regulatory activities in electronic Common Technical Document (eCTD) format.
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Reference materialThe permitted indication reform has now commenced
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Reference material
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/PRAC/222346/2014
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Reference materialUpdated questions and answers