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Dossier requirements for Class 2, 3 and 4 biologicals
Australian Regulatory Guidelines for Biologicals (ARGB)
This guidance outlines the information needed in your dossier for us to be able to effectively review your application for a biological therapeutic good.
The kind and form of information that must accompany an application for entry in the ARTG are defined in a legislative instrument under subsections 32DDA (9) and (10) of the Therapeutic Goods Act 1989.
Format of biologicals dossier
Information on the format of your dossier is covered in the following sections:
- General dossier requirements which provides:
- general information for all therapeutic goods dossiers
- submission details for both electronic and hard copy dossiers
- Dossier structure provides an outline of the sections within the dossier for both:
Content of biologicals dossier
Information on the content you need to include in your dossier is covered in:
- Technical requirements
- you need to address all sections in the dossier structure that apply to your class of biological
- justify why a particular section does not apply to your biological.
Guidance on applicable standards
Your dossier needs to demonstrate compliance with applicable standards, including product-specific orders. To assist you when compiling your dossier we suggested you consider our recommendations detailed in:
- Guidance on TGO 87 - Standards for Labeling
- Guidance on TGO 88 - Standards for donor selection, testing and minimising infectious disease transmission via therapeutic goods that are human blood and blood components, human tissues and human cellular therapy products
- guidance on the applicable standards which indicate where specific clauses are to be documented in your dossier.
International reference and guidance documents
We have provided information on national and international reference and guidance documents to assist you with specific aspects of your application. Such references are not intended to introduce any requirements additional to the applicable standards.
The information contained within your dossier:
- must demonstrate compliance with all relevant product-specific and default standards (if applicable)
- is to be formatted according to the headings listed under Dossier structure
- is to address all headings listed in the dossier structure
- is to address and justify if a particular section of the dossier does not apply to your biological
- is to include evidence of manufacturer's licence or clearance.
We have outlined the type of content we expect you to address in each section to provide us sufficient information to evaluate your submission. We recognise that due to the diversity of biologicals, not all sections outlined may apply to all applications.
If you have questions or need clarification about the dossier requirements please contact us.
We recommend you request a pre-submission meeting to facilitate the compiling and subsequent submission of your dossier.
If there are any questions, or if clarification is required in relation to this guidance on the dossier requirements for a biological, please contact us.