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ARGOM: Guidelines on electronic OTC dossiers
V1.0, April 2013
This guidance has been updated and this webpage will be archived on 1 March 2016.
Please go to OTC dossier documents matrix for the updated guidance which you can commence using.
Australian regulatory guideline for over-the-counter medicines
The introduction of electronic dossiers for OTC medicine submissions is subject to staged implementation.
The requirements of these guidelines will come into effect in April 2014.
Until April 2014, the TGA will continue to accept a 'soft copy' of the paper dossier (i.e. an electronic 'scan' of the paper copy, on CD DVD or data stick).
While the requirements of these guidelines will come into effect in April 2014, sponsors are encouraged to start to follow them wherever possible.
Details of the staged implementation will be regularly updated on the TGA website.
Structure and format
This guideline is to be read in conjunction with the Guidelines on the pre-market application and evaluation process for OTC medicines.
The intention of this guidance is to ensure that electronic dossiers submitted to the TGA in support of applications to register or vary OTC medicines can be clearly identified with the associated application, uploaded to the TGA records management system, and readily accessed and navigated as necessary for evaluation of the submission.
The dossier should follow the modular structure of the Common Technical Document (CTD).
- Each document in the dossier should be organised within electronic 'folders' that correspond to the CTD modules that are appropriate to the application.
- Guidance on the placement of documents within the CTD structure for particular application types is provided in the OTC dossier documents matrix.
You may use the non-eCTD electronic submission (NeeS) format or the ICH eCTD format if you have the ability to do this, but other formats can be used provided they follow the modular CTD structure and guidelines below.
Document and folder naming
Application dossiers should use the folder names recommended in the OTC dossier documents matrix.
For compatibility with TGA systems, please make the document and folder names as short as possible while still being meaningful (abbreviations are encouraged so long as the meaning is clear). The standardised abbreviated folder names in the ICH eCTD guideline, such as those in the screenshot in Figure 1, are useful for keeping the total path lengths short.
For module 3, the OTC dossier documents matrix references the ICH eCTD guideline for the recommended folder names. However, for the majority of OTC submissions, it will not be necessary to use all of the module 3 electronic folders that are listed in the ICH guideline.
For example, for a Category N3 application, the structure indicated in the screenshot in Figure 1 could be used. This structure includes only the 'top-level' module 3 folders 3.2.P.1, 3.2.P.2, 3.2.P.3, 3.2.P.4, 3.2.P.5, 3.2.P.6, 3.2.P.7 and 3.2.P.8.
For a simpler application such Category C2 for an extension of shelf life, the structure might be as follows:
Figure 2: Screenshot representation of a suggested folder structure of module 3 that might be used for a simple application for extension of shelf life
The TGA will not generally require these folders to be split into any of the subordinate level CTD folders, such as 3.2.P.1.1, etc (although you may do so if you wish). However, the documents and headings within the folders should follow the subordinate CTD titles and headings that are applicable.
Any relevant subordinate CTD headings that are used within a document should be bookmarked.
Similarly truncated folder structures may also be applicable to modules 4 and 5, where these are included in an OTC application.
The documents included in an OTC electronic dossier should be in portable document format (PDF). PDF documents need to meet the following key requirements.
- Documents need to be able to be read with Adobe Acrobat Reader version X (10).
- Documents should not be protected.
- Fonts that are not supported by Microsoft Word should not be used in the PDF document.
- Dossiers should contain the maximum amount of text searchable content. Therefore, with limited exceptions, PDF documents should be generated from electronic source documents and not from scanned material. Some exceptions include original certificates of analysis, signed letters of authorisation, etc. See TGA NeeS guidance for further guidance on text searchable documents.
- Documents should be bookmarked to assist with navigation.
- Hyperlinks should be used for cross-referenced information.
It is preferred that you do not provide empty folders, or folders that only contain a document stating 'not applicable'. Where data or information is not required or not relevant for a specific module, the folder should be omitted. However, if dossiers are already in CTD format when you receive them the TGA will not insist that empty folders be removed.
To avoid doubt as to whether a folder has been intentionally or accidentally omitted (or is intentionally empty), it is recommended that you write 'not applicable' against the relevant module(s) in the table of contents.
However, be aware that, if data or information would normally be expected in accordance with relevant guidelines, a justification should be provided if the data or information is not included.
Navigation of the dossier should be based on electronic tables of contents, bookmarks, and hyperlinks.
Tables of contents and hyperlinks
Tables of contents should be provided in PDF format, and be hyperlinked to the individual documents. All documents lodged should be referenced from the hyperlinked tables of contents.
For the majority of OTC applications it is acceptable to have only one table of contents (in the module 1.1 folder) referring directly to all documents in the dossier. However, for larger applications (e.g. applications containing two or more Modules in addition to Module 1), the main table of contents should be hyperlinked to individual tables of contents in each module, which are then further hyperlinked to the documents within the respective module.
All PDF documents should be appropriately bookmarked to ensure that evaluators can navigate directly to individual sections. Good bookmarking practices are suggested as follows:
- Bookmarks should be organised like a table of contents.
- Documents of ten pages or more should be bookmarked unless they have no internal structure (e.g. a single data listing).
- Sections, subsections, tables, figures and appendices should all be bookmarked.
- The number of bookmark levels should generally be limited to three.
- Bookmark names should be concise.
For example, the bookmarks in module 3.2.P.5 would typically correspond to the subordinate CTD headings; and might look like Figure 3 below.
Responses to TGA requests for information
A response to a TGA request for information (RFI) should consist of a cover letter containing the sponsor's response to each issue, together with any amended or supplementary documents that are required (e.g. amended labels, finished product specifications, etc.).
Electronic documents that are provided with a response to a RFI should be organised in a modular CTD structure that follows the same basic principles as the initial electronic submission, described above. The structure will typically be very simple.
Currently the electronic copy of the dossier should be provided on CD ROM, CD-R, DVD-R or 'data stick'.
The CDs/DVDs/data sticks should be packed adequately to prevent damage. The physical security of the submission dossier during transportation is the responsibility of the sponsor.
Prior to accepting the electronic dossier, it will be checked by the TGA for viruses, and for compatibility with TGA systems.
Labelling of CDs/DVDs
Each CD or DVD should include the following label information:
- TGA application number(s)
- sponsor's name
- product name(s)
- number of CDs/DVDs per full set and an indication of the place of the individual CD/DVD within the set [for example, 1(3), 2(3), 3(3)].
TGA eBusiness Services (eBS)
It is intended that the eBS will be upgraded to allow the electronic dossier to be attached to the electronic application in the near future. Further information will be provided on the TGA website when this occurs.
The sponsor is responsible for ensuring the electronic application dossier does not contain any viruses.
As soon as the TGA receives the dossier, a virus check will be performed. If a virus is detected, it may constitute grounds for considering the application unacceptable. Therefore, you should perform a virus scan on the CD/DVD/data stick with an up-to-date virus checker prior to submission.
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