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General dossier requirements

27 July 2018

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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

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.

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

How to access a pdf document

*Large file warning: Attempting to open large files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open it from there.

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:

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
Figure 6 - Example folder structure with table of contents located in top level

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

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

  1. Covering letter
Device information
  1. Manufacturer's declaration of conformity
  2. 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)
  3. Copy of the product labels
  4. Pictorial images of the device
  5. Packaging - inner and outer packaging
  6. Instructions for use
  7. Product, user or operator manual
  8. Advertising material including brochures, extracts from web pages
  9. Technical documentation describing mechanism of action of the device (if required)
Additional information for level 2 application audits
  1. Clinical evidence
  2. Risk management report
Additional information for devices that sterilise/ disinfect
  1. 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

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