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889 result(s) found, displaying 501 to 525
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Reference materialLearn how prescription medicines are regulated in Australia
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Reference materialCertain folate substances presented as foods or dietary management products have been declared therapeutic goods
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Reference materialQuestions and answers about the Medical device Incident Reporting and Investigation Scheme
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Reference materialTGA Laboratory testing - Contamination of ranitidine medicines with the nitrosamine NDMA
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User guideElectronic data interchange for ICSR submission using the E2B R2 format
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Reference materialAdditional Q&A's on use of market authorisation evidence from overseas regulatory bodies for medical devices
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User guideA how to fill in a device incident report
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Reference materialAdvisory Committee on Medicines Scheduling to consider upscheduling of modified release paracetamol to 'Pharmacist Only'
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Compositional guidelinesCompositional guideline for 'Streptococcus salivarius M18' permitted for use in listed medicines
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Reference materialIn addition to the legislated requirements, there are other features of leaflet and card design that can be very helpful for patients
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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 materialIf you are considering a cosmetic injection, use this information to carefully research both the products and the health practitioners involved.
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Compositional guidelinesCompositional guideline for 'Calcified Lithothamnion species' permitted for use in listed medicines
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Compositional guidelinesCompositional guideline for 'Resveratrol' permitted for use in listed medicines
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Reference materialThings to keep in mind when you see the ‘TGA assessed’ symbol or statement
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Reference materialThe TGA has published a list of FAQs on issues raised by industry in relation to permitted indications
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Reference materialRisk management plans for medicines and biologicals has been updated with new content, new Australia-Specific Annex and a new form
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User guideUser guide on the Adverse Event Management System (AEMS) for health professionals.
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Reference materialImportant information about potential impact of regulation changes that came in force on 1 July 2018
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Reference materialEffective 1 October 2018 TGA has made a new determination which excludes certain goods from the operation of the Act
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Reference materialGuidance on colourings in medicines for topical and oral use
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FormsChecklist to assist in a priority review designation application