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What's new
83 result(s) found, displaying 76 to 83
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PageInformation for sponsors and manufacturers on assessing the risk of potential nitrosamine contamination in listed medicines.
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PageYou can access unapproved therapeutic goods in certain circumstances. Find out who can apply, what you can access and what to do before you apply.
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GuidanceGuidance for medical practitioners, Human Research Ethics Committees, specialist colleges and sponsors of 'unapproved' therapeutic goods.
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PageInformation about current processing times, workload, priorities, and key messages for GMP Clearance applications.
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GuidanceGuidance on testing of disinfectants and sterilants so they meet quality, safety and efficacy requirements specified in Therapeutic Goods Order 104.
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PageModule 1 is the section that contains administrative information about your electronic Common Technical Document (eCTD) submission specific to Australia.
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Australian public assessment report (AusPar)Plaque psoriasis Uteknix is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
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PageLearn about how vapes for smoking cessation and nicotine dependence are regulated, and the requirements for dispensing and supplying vapes.