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Collection content
114 result(s) found, displaying 51 to 60
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PageInformation about what to include in the Product Information (PI) and Consumer Medicine Information (CMI) for products included in the Black Triangle Scheme.
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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.
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PageInformation for applicants on how to request and prepare for pre-submission meetings.
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GuidanceGuidance on how the Poisons Standard is amended and the processes that underpin scheduling policy