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TGA customer service standards

23 August 2017

The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health. The TGA's role is to enable the Australian public timely access to safe, high quality and effective therapeutic goods.

Therapeutic goods include medicines, medical devices and human blood, blood products and tissues.

As a regulator and Australian Public Service employees, we will ensure the information we provide is impartial and objective.

We are committed to the TGA's customer service standards (below) and will be helpful and provide information and guidelines in plain language.

Customer service standards

We comply with the Australian Public Service Values and Code of Conduct in all aspects of our business and value. This customer service charter sets out our commitment to the standards of service you can expect in your dealings with us, as well as what we can assist you with.

We will:

  • be helpful and treat you with courtesy
  • acknowledge your letters and emails within 5 working days and ensure that our responses to you are timely, relevant and easy to understand
  • where a full response cannot be provided within 5 working days, we will advise you when a response can be expected and keep you informed on progress if the issue is complex
  • respond to voice mail messages within two working days
  • identify ourselves to you on the telephone and in our letters and emails we will include contact details
  • provide you with background and reasons for adverse decisions
  • provide information and guidelines in plain language
  • respect your right to privacy and confidentiality - please refer to our privacy statement below.
What we can do What we cannot do
  • Identify and refer you to relevant guidance
  • Provide general advice and factual information *
  • Explain the process and procedure relating to regulation of therapeutic goods
  • Clarify existing guidance
  • Investigate and advise on system or application issues
  • Provide information about how to access regulatory affairs consultants who can provide you with more detailed/appropriate help.
  • Give definitive advice on specific issues relating to your particular circumstance, for example, appropriateness of indications, formulation, manufacturing or compliance
  • Offer interpretation of the legislation and its applicability to your circumstance
  • Provide detailed responses where guidance exists and has not been considered
  • Provide advice regarding your business decisions
  • Confirm that a business decision is appropriate and compliant with requirements

* Please note: Our responses contain general information given to you without prejudice; it is not binding on the TGA. The information provided does not constitute legal advice.

Privacy information

For general privacy information, see: Privacy.

The TGA collects personal information from you in order to respond to your enquiry. You are free to deal with the TGA anonymously or under a pseudonym, but doing so may in some circumstances mean we are unable to follow up on your enquiry.

Sometimes, people making enquiries give personal information about other people in their phone call or email to the TGA. We discourage you from giving us that kind of information unless it is absolutely necessary; but where you do provide us with such information, the TGA manages that information in accordance with the Privacy Act 1988.

Your role and providing feedback

When dealing with our staff we kindly ask that you be respectful and courteous.

In relation to an application you might have with the TGA, you can assist us by providing information required under the therapeutic goods legislation in a timely way and by ensuring its completeness and accuracy.

Please refer to our website for detailed information and guidance that may assist you with your enquiry or application. The SME Assist hub is also available on our website and is designed to help small and medium enterprises, and R&D groups developing new medicines and medical devices (including apps) understand their regulatory and legislative obligations with targeted tools and content.

Where the TGA has exceeded or not met expected standards according to the:

You can provide feedback, to assist us in our commitment to improving our service, to:

First Assistant Secretary
Regulatory Practice and Support Division
Therapeutic Goods Administration
PO Box 100

or contact the Customer Feedback/Complaints Service:

  • Telephone: 1800 020 653
  • Email:
  • Users who are deaf or have a hearing or speech impairment can call through the National Relay Service:
    • TTY or computer with modem users phone 1800 555 677 then ask for 1800 020 653
    • Speak and listen (speech to speech relay) users phone 1800 555 727 then ask for 1800 020 653

In accordance with our service standards feedback or complaints will either be answered or acknowledged within 5 working days.

Where feedback requires further investigation by the TGA, the acknowledgement will provide notification of this and associated timeframes for response.