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Collection content
116 result(s) found, displaying 51 to 60
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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.
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GuidanceGuidance on submitting an effective prescription medicines application.
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GuidanceGuidance on the process and regulatory requirements to register prescription medicines.
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PageImportant information on the Database of TGA Laboratory testing results.
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GuidanceThis guidance is for sponsors and manufacturers supplying medicines in Australia that are serialised or have data matrix codes.
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GuidanceGuidance on obligations during provisional registration period, process for applying for extension of provisional registration and transition to full registration.
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GuidanceThis guidance explains the administrative and prescribing (dossier) information you need to support the registration or variation of a prescription medicine.