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889 result(s) found, displaying 676 to 700
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Reference materialSearch the Code Tables for codes needed to apply for good manufacturing practice (GMP) clearance.
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Reference materialThis document will assist applicants completing the Bioequivalence Study Information Form (BSIF) for inclusion in an application for a new prescription generic medicine.
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Reference materialThis document will assist applicants completing biowaiver templates for inclusion in an application for a new prescription generic medicine.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/BPWP/572810/2013.
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Reference materialRegistered over-the-counter medicine application levels
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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. -
FormsComplete this form when submitting a new DMF to TGA, or when updating an existing DMF already held by the TGA.
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Reference materialThe TGA will be initiating targeted compliance reviews of selected listed medicines to evaluate evidence held to support indications related to exercise performance.
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Reference materialThese historical guidelines describe the information to be supplied for the registration or listing of disinfectants and sterilants in the Australian Register of Therapeutic Goods (ARTG).
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FormsA list of TGA forms for prescription medicine sponsors.
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Reference materialThis guidance is for both licenced manufacturers and community pharmacists involved in the manufacture of compounded medicines or dose administration aids (DAAs).
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Reference materialThis document reflects the evidence supporting the use of medicinal cannabis in nausea and vomiting and the recommendations of the Nausea and Vomiting Working Group
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Reference materialThe Department of Health has developed a series of guidance documents to assist health professionals who choose to prescribe medicinal cannabis in Australia under current access schemes
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Reference materialThis brochure provides a broad overview of the current evidence to support using medicinal cannabis
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Reference materialThis document reflects the evidence supporting the use of medicinal cannabis in treating chronic pain and the recommendations of the Chronic Pain Working Group
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Reference materialThis document reflects the evidence supporting the use of medicinal cannabis in treating epilepsy in particular patient groups and the recommendations of the Epilepsy Working Group
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Reference materialThis document reflects the evidence supporting the use of medicinal cannabis in treating symptoms of MS
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Guidance for the use of medicinal cannabis in the treatment of palliative care patients in Australia
Reference materialThis document reflects the evidence supporting the use of medicinal cannabis in palliative care patients and the recommendations of the Palliative Care Working Group -
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CHMP/EWP/4713/03.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/BMWP/118264/2007 Rev. 1.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/BPWP/94033/2007 rev. 2