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Access to unapproved biologicals
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Accessing unapproved biologicals that are not on the Australian Register of Therapeutic Goods (ARTG)
GuidanceGuidance for people who want to access biologicals that are not included on the Australian Register of Therapeutic Goods (ARTG).
Applying for inclusion on the ARTG
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GuidanceAn outline of the regulatory process and a summary of the requirements to successfully submit a biologicals application.
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GuidanceGuidance to help determine whether products are separate and distinct biologicals that will need to be included as separate ARTG entries.
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GuidanceThis guidance outlines the information needed in your dossier for us to be able to effectively review your application for a biological therapeutic good.
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GuidanceGuidance on the stages of preparing and submitting an application for inclusion of a Class 2, 3 or 4 biological in the ARTG.
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Applying for a Class 1 biological to be added in the Australian Register of Therapeutic Goods (ARTG)
GuidanceGuidance for preparing and submitting an application for inclusion of a Class 1 biological on the ARTG. -
User guideThis form is used to include a new biological or vary an existing biological on the ARTG
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GuidanceRisk management plans for medicines and biologicals has been updated with new content, new Australia-Specific Annex and a new form.
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PageMedicines and other therapeutic goods must comply with applicable standards to be supplied in Australia.
Post-market responsibilities
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GuidanceGuidance for sponsors or suppliers of biologicals in Australia on their ongoing responsibilities after a product is included on the Australian Register. of Therapeutic Goods (ARTG).
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GuidanceThis guidance is for sponsors applying for a variation to the Australian Register of Therapeutic Goods (ARTG) entry of a biological
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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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GuidanceThis guidance is for all sponsors of products regulated as biologicals.
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PageInformation for sponsors conducting market actions for therapeutic goods in Australia.
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GuidanceGuidance about how to promote your business and service, without advertising biologicals to the public.
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GuidanceRelease on non-conforming biologicals is only permitted under prescribed circumstances and for an individual patient. Access to the request form and instructions are within the guidance document.