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General dossier requirements

27 July 2018

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Part A: Requirements for all dossiers

Although the formatting of dossiers of information will vary depending on the type of therapeutic good you are apply for, the following general requirements apply irrespective of the type of therapeutic good or the media you use to submit your dossier - that is, online, electronic or paper.

English

Make sure that either all information is in English and readable.

For information that is not in English, include both:

  • a copy of the information in the original language
  • a full translation of the information in English.

You are responsible for the accuracy of the translation.

If you need assistance, you can search for a qualified translator through the National Accreditation Authority for Translating and Interpreting (NAATI) website.

Acronyms and abbreviations

Make sure all acronyms and abbreviations are defined.

Fonts and readability

Make sure tables and images are large enough and of a style to be easily read, even after photocopying, scanning or printing and that any shading does not impair readability.

We recommend that text is no smaller than:

  • 12 point text
  • 10 point text within tables
  • 10 point text within footnotes.

Units of measurement

Use the Metric system.

Check that all the documents in your dossier refer to measurements in SI units or units generally accepted in clinical practice in Australia - for example, mmHg or French gauge.

The relevant standard for labels applies to the labels submitted as part of the dossier.

The Australian Measurement System from the National Measurement Institute.

Cross references (for medicines)

Refer to the module, volume, tab index and page number when cross referencing within your dossier - for example: see Module 3, 3.2.P.4.3 Method validation, p 23.

Responses to requests for information (RFI)

If we request additional information during the evaluation of your dossier, make sure your response also meets the general dossier requirements.

We can accept emails of up to a maximum 30MB if you are requested to respond via email.

Commercially confidential information

Information provided to us, whether as part of an application or otherwise, may be commercially confidential or personal in nature.

We will treat such information appropriately. For further information visit the following information published on our website:

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