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Collection content
114 result(s) found, displaying 41 to 50
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GuidanceGuidance on how to request early scientific advice on a biowaiver justification.
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GuidanceGuidance on how we make use of assessments from comparable overseas regulators (CORs).
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GuidanceGuidance on how to meet child-resistant packaging requirements in the Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017 (TGO 95).
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GuidanceGuidance for sponsors on the eligibility criteria for reduced application and evaluation fees for major variation applications for prescription medicines.
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GuidanceGuidance for sponsors of antibiotics on collecting and providing pre- and post-market information about antibiotic resistance.
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PageUpdate about the transitionary arrangements for reformatting Product Information, including accessing a fee waiver.
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PageExplanatory guide on the quality modules to be submitted for influenza vaccine registration, for manufacturers and sponsors.
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GuidanceGuidance explaining types of variations, for registered medicines and biologicals, that can be submitted as notifications due to being very low risk.
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GuidanceGuidance on the mandatory reporting scheme for medicine shortages and permanent discontinuations, and our approach to compliance.
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PageSearch the Code Tables for codes needed to apply for good manufacturing practice (GMP) clearance.