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623 result(s) found, displaying 601 to 623
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User guideUpdated information for registered users of the Australian Adverse Drug Reaction Reporting System
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Reference materialThis section informs advertisers, including manufacturers, pharmacists and health professionals, of their responsibilities when advertising therapeutic goods.
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Reference materialGuidance on how the Poisons Standard is amended and details of the processes that underpin the scheduling policy
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Reference materials23 instruments supporting the new COR process have been updated.
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Compositional guidelinesCompositional guideline for 'Refined Buglossoides arvensis seed oil' permitted for use in listed medicines.
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Reference materialThe ARGLMRCM presents guidance in separate documents to facilitate timely updates.
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User guideThe OTC Dossier Documents Matrix (the 'matrix') provides a summary of which documents are required for each application level (N1, N2, N3, N4, N5, C1, C2, C3 or C4)
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Reference materialQuestions and answers about the Medical device Incident Reporting and Investigation Scheme
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Reference materialHow to demonstrate that IVF solutions comply with the Essential Principles for safety and performance.
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Reference materialSerious Scarcity Substitution Instruments (SSSIs) allow community pharmacists to substitute specific medicines without prior approval from the prescriber so long as the permitted circumstances within the SSSI are met.
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Reference materialInformation on the types of search results for the System for Australian Recall Actions (SARA) database
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Reference materialNew clinician information sheets on opioid analgesic tapering.
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Reference materialThe NeeS specification is an interim arrangement as applicants plan the move to full eCTD
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Reference materialQuestions and answers from the information webinars held on 8 and 9 October 2020
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Reference materialHow to apply for a permit to export human substances under the Customs (Prohibited Exports) Regulations 1958.
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Reference materialDossier requirements for literature based submissions
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User guideQuestions and answers about submitting an application for approval to use a restricted representation.
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Reference materialFind out when you should use a literature-based submissions (LBS) for your application.
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Reference materialThis brochure provides a broad overview of the current evidence to support using medicinal cannabis
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Reference materialSpecial Access Scheme - portal updates
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Reference materialThis guidance explains part 6 of the Code, which outlines requirements for using endorsements and testimonials in advertisements about therapeutic goods.
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FormsFind out how the free trade agreement affects your application to include a product on the Australian Register of Therapeutic Goods.