Part C: Formatting your dossier
This guidance on formatting your dossier needs to be used in conjunction with the Part A: Requirements for all dossiers.
The formatting requirements differ depending on the type of therapeutic good and you need to follow the specific guidance for:
- Complementary medicines
- Over-the-counter medicines
- Prescription medicines
- Biologicals
- Medical devices
- Conformity assessment
Complementary medicines
Registered and assessed listed medicines
Prepare your dossier and submit electronically either using online submissions (preferred) or electronic media delivery.
The actual content of the dossier will vary according to the application category. Applicants are encouraged to organise each document in the CTD dossier within folders that correspond to the CTD modules appropriate to the application. Alternatively, applicants can supply a dossier that meets the following minimum requirements:
- CTD headings (combination of module number and module name).
- Single PDF document for each module.
- Text searchable and either bookmarked or hyperlinked PDFs (generated from electronic source documents and not from scanned material).
CTD headings can be found at: Common Technical Document (CTD).
New ingredients for use in listed medicines
We encourage you to present your dossier consistent with CTD format.
Related information and guidance
- Information required for evaluation of a new complementary medicine
- Assessed listed medicines evidence guidelines
Over-the-counter medicines
Prepare your dossier using CTD and submit electronically either using online submissions (preferred) or electronic media delivery. Paper submissions are not accepted.
Folders
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Organise each document in the CTD dossier within 'folders' that correspond to the CTD modules appropriate to the application.
We recommend you format your electronic dossier to be consistent with either:
- International Conference on Harmonisation (ICH) eCTD specification and AU Module 1 specifications (pdf,725kb)
- Non-eCTD electronic submission (NeeS)
For module 1
We recommend you follow CTD Module 1.
For modules 2, 3, 4 and 5
We recommend folder names detailed in Appendix 3 to the ICH eCTD Specification.
Currently, we will accept other formats provided they follow the modular CTD structure and the guidelines below.
A sample empty eCTD folder structure is available to download from eCTD Specification and Related Files. This may be a useful indicator of the folder structure for modules 2-5 (ignoring the folder "util" which is eCTD specific).
You can use it as a starting point to establish a folder structure for an electronic dossier. You would need to delete unused folders - see 'Not applicable' content in Part B.
Table of contents
The main table of contents should be located in the top-level folder - see Figure 6.
Figure 6 - An example
folder structure for
locating the table of
contents
The table(s) of contents should have hyperlinks that navigate to the individual files (documents) in the dossier.
The hyperlinks can direct either to the individual files or via individual 'module TOCs' as set out in the NeeS format.
Files (documents)
Files, or documents, included in an OTC dossier should be in (PDF) and generally be no larger than 100 megabytes (MB).
File names
File, or document, names should follow the ICH naming conventions.
The ICH file names are designed to be as short as possible while still corresponding to subordinate CTD titles and headings. That is, file names should be meaningful and be indicative of the position of the document within the CTD structure.
For modules 2, 3, 4 and 5, recommended file names are set out in Appendix 4 to the ICH eCTD Specification.
Prescription medicines
Prepare your electronic submission using either:
- eCTD
- NeeS
We will contact you if there are any issues with uploading an electronic sequence.
Biologicals
Class-specific requirements and dossier structure for biologicals applications are outlined in Dossier requirements for Class 2, 3 and 4 biologicals.
Medical devices and IVDs
If you have been advised that your application has been selected for audit and requested to provide information, we suggest collating the information, and submit using either
- The IMDRF format
- The table of contents structure (for medical devices)
- Standard Technical Documentation (STED) for IVDs (see guidance on application audit technical file review for IVD medical device applications).
Table of contents structure- medical devices
If you are not using IMDRF format, structure the table of contents, for information requested in relation to an application audit for ARTG inclusion, in the following way:
Table of contents
- Covering letter
Device information
- Manufacturer's declaration of conformity
- Manufacturer's certification/ declaration of conformity for systems and procedure packs and/or explanation how the kind of device is covered under the scope of the certificate (if required)
- Copy of the product labels
- Pictorial images of the device
- Packaging - inner and outer packaging
- Instructions for use
- Product, user or operator manual
- Advertising material including brochures, extracts from web pages
- Technical documentation describing mechanism of action of the device (if required)
Additional information for level 2 application audits
- Clinical evidence
- Risk management report
Additional information for devices that sterilise/ disinfect
- Efficacy and performance data for devices intended to disinfect/ sterilise other medical device.
Any other information we may request in the selection notice
Conformity assessments
We will accept your dossiers submitted in the following IMDRF formatprovided that the document contains the requested information:
- Non-In Vitro Diagnostic Device Market Authorization Table of Contents
- Vitro Diagnostic Medical Device Market Authorization Table of Contents