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144 result(s) found, displaying 101 to 125
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Regulatory decision noticesThis instrument applies to an application to list a medicine under section 26 or 26A of the Act.
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Regulatory decision noticesThis instrument applies to an application to register a complementary medicine
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Regulatory decision noticesThis instrument applies to the online form titled Prescription Medicines Designation/Determination Application in the TGA's electronic lodgement facility, completed in accordance with the relevant instructions in that form.
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Regulatory decision noticesTherapeutic Goods (Provisional Determinations and Orphan Drug Designations-Extension) Approval of Application Form
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Regulatory decision noticess23 instruments supporting the new COR process have been updated.
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Regulatory decision noticesArrangement under subsection 7C(1) of the Therapeutic Goods Act 1989 for use of computer programs to make decisions under paragraph 61(2)(a)(iii) of the Act to release information from the Adverse Event Management System to the World Health Organization.
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Regulatory decision noticesArrangement under section 7C of the Therapeutic Goods Act 1989 for use of computer programs to make decisions.
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Regulatory decision noticesApproved manner for making an application under section 23 of the Therapeutic Goods Act 1989 in relation to the listing of export only medicine under section 26.
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Regulatory decision noticesRepeals 48 former notices made between 2005 and 2015 that are no longer required
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Regulatory decision noticesArrangement under section 7C(1) of the Therapeutic Goods Act 1889 for the use of computer program to make decisions in relation to the listing of medicines under section 26A and listing of kits for supply in Australia under section 26.
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Regulatory decision noticesApproved manner for making applications under section 23(1)(a) of the Therapeutic Goods Act 1889 in relation to the listing of medicines under section 26A and listing of kits for supply in Australia under section 26.
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Regulatory decision noticesMake a request under section 9D of the Therapeutic Goods Act 1989.
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Regulatory decision noticesApproval of the Therapeutic Goods
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Regulatory decision noticesApproval of the manner of making requests under subsection 9D(3) of the Therapeutic Goods Act 1989 to vary the entry in the Australian Register of Therapeutic Goods of registered therapeutic goods
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Media releases
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Regulatory decision noticesTherapeutic Goods Order No. 1 of 2010.
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Regulatory decision noticesThis Order may be cited as the Therapeutic Goods (Articles that are not Medical Devices) Order No. 2 of 2004.
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Regulatory decision noticesListing notice - fungal enzymes
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Regulatory decision noticesListing notice - curcumin
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Regulatory decision noticesListing notice - iron phosphate
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Regulatory decision noticesListing notice - Terminalia ferdinandiana (Kakadu plum)
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Regulatory decision noticesListing notice - sodium sulfate
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Regulatory decision noticesListing notice - cold-pressed neem (Azadirachta indica) seed oil
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Regulatory decision noticesListing notice - Trametes versicolor hyphae aqueous extract - powder
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Regulatory decision noticesListing notice - boric acid, borax, sodium perborate, borax pentahydrate, molybdenum trioxide, magnesium phosphate dibasic trihydrate