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biotechnology.gov.au
Biotechnology Australia works to ensure implementation of the National Biotechnology Strategy, which provides a framework for capturing the benefits of biotechnology development for Australia.
business.gov.au
Simple and convenient access to all the government information, transactions and services you need to plan, start and run your business.

Explanatory Guide
  1. As you move through the BioRegs Online web-tool, you will be asked a series of up to 17 questions about your biotechnology product or project.
  2. The series of questions and answers (Q&A) in a pathway session should take no more than 10-20 minutes to complete.
  3. The specific questions presented to you will depend on your answers to previous questions. The answers may be Yes/No, single choice or multiple choice.
  4. The web-tool is designed to identify the relevant regulations and business development information for your particular biotechnology product. The questions are framed with the expectation that you have a reasonably clear understanding of the nature of your biotechnology product and how it will be developed and used.
  5. Using this tool in no way commits you to a course of action or regulatory process. If you are unsure about how to answer a particular question, you can conduct several pathway sessions choosing alternative answers, to see which pathway and package of information appear to best suit your needs.
  6. As you answer each question, relevant information about your regulatory and business development requirements is progressively assembled in the background.
  7. The progress of the questions and your answers is displayed in the right hand side panel on each page. If you wish to go back and select a different answer to a previous question, you will need to re-answer all subsequent questions from that point onwards.
  8. For most questions, you can find more information about the meaning of the question and the terminology by clicking on "More Information" below the question.
  9. If your product has more than one application (eg it could be a human therapeutic or a functional food), you should conduct separate pathway sessions for each application, as the regulatory requirements will be different in each case.
  10. It is not possible to stop part-way through a pathway session and return to complete it at a later time. Once you have closed out of the BioRegs Online web-tool, your pathway information is not retained.
  11. On completion of a pathway Q&A session, you will be presented with a comprehensive package of regulatory and business development requirements and information, customised to suit your particular product. You may view, print, save or email this information as a PDF file.

    12. Please note that this information is based on your responses to the web-tool questions and should not be relied upon for business or compliance decision making – you should confirm your regulatory requirements with the relevant agencies and/or qualified professional advisers.
  12. If you wish to report any problems, queries or feedback about the web-tool, you may contact Biotechnology Australia by completing the e-mail form on the final page of the pathway. Any enquiries of a regulatory nature should be directed to the relevant government agency using the hyperlinks on the website or e-mail links found in the regulatory information packages.


    13. For further important information about this website and the web-tool, please refer to the Copyright, Disclaimer and Privacy statements, see below.

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