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637 result(s) found, displaying 301 to 325
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/QWP/306970/2007
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/BWP/151897/2013
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/BWP/3354/1999 rev.1
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User guideThe Special Access Scheme (SAS) & Authorised Prescriber (AP) Online System (SAS & AP online system) is the preferred method of submission for AP applications.
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FormsUse this form to request certificates or certified copies of TGA licences and certificates.
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Compositional guidelinesCompositional guideline for 'DHA-rich oil derived from microalgae Schizochytrium sp.' permitted for use in listed medicines
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User guideThis 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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Compositional guidelinesCompositional Guideline for Bacillus subtilis strain NRRL B-67989 permitted for use in listed medicines.
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Compositional guidelinesCompositional Guideline for D-glucose, polymer with xylitol permitted for use in listed medicines.
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FormsSponsors must report every six months in relation to unapproved therapeutic goods supplied under the SAS and Authorised Prescriber (AP) schemes.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/BMWP/301636/2008 Rev. 1.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/QWP/396951/2006.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/118465/2012 Rev 1.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CPMP/EWP/1776/99 Rev. 1.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/QWP/1719/00 Rev 1.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/PhVWP/235910/2005 - rev.1.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CPMP/EWP/504/97 Rev 1.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/EWP/4937/03.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/273974/2005.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/EWP/1080/00 Rev. 1.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CHMP/EWP/4279/02.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/281371/2013.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/29947/2013/Rev. 4.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CPMP/555/95 Rev. 1.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CHMP/EWP/83561/2005.