Tell us about your search experience on the TGA website - complete our short survey
COVID-19 (Coronavirus) update - impact on Freedom of Information requests
The Therapeutic Goods Administration (TGA) is actively processing FOI requests and is aiming to finalise all requests as quickly as possible. However, the TGA is experiencing a significant call on resources to manage Australia's response. This is having an impact on our ability to process requests.
During this period, we may require additional time to process your request and seek your agreement to an extension of time, or seek this agreement from the Office of the Australian Information Commissioner. We encourage all applicants to use self-service, administrative access schemes (obtaining information outside of the FOI Act) or access information on our website where possible.
The Freedom of Information Act 1982 (FOI Act) gives you the right to:
- ask for access to copies of documents (except exempt documents) we hold
- ask for information we hold about you to be changed or annotated if it is incomplete, out of date, incorrect or misleading; and
- seek a review of our decision not to allow you access to a document or not to amend your personal record.
You can ask to access any document that we hold. We can refuse access to some documents, or parts of documents, that are exempt under the FOI Act. Exempt documents may include those containing material obtained in confidence, material that is commercial-in-confidence, material that may unreasonably adversely affect the business, commercial or financial affairs of a third party, or other matters set out in the FOI Act.
FOI Disclosure Log
Documents provided in response to an FOI request will be included in our FOI Disclosure Log. However, personal information and information about the business, commercial, financial or professional affairs of a person will be deleted from the documents if publication of that information would be unreasonable.
Documents available outside the FOI Act
You should check the information we have published under the Information Publication Scheme and FOI Disclosure Log to see if the information you are seeking is already available.
Recently the TGA provided a response to members of the public that were interested in accessing information regarding the safety and efficacy of the COVID-19 vaccines.
How to make a request
Your request must:
- be in writing
- state that the request is an application for the purposes of the FOI Act
- provide sufficient information about the document(s) you seek to allow us to process your request, e.g. the type of document or what product it relates to; and
- provide a method by which we can reply, for example an email or postal address.
How to access a pdf or Word document
To assist you with making an FOI request, you may wish to download and complete the form.
This form is available in pdf and Microsoft Word formats. The pdf form can be filled in and saved to your computer using Adobe Reader version 7 or later or any version of Adobe Acrobat Standard or Professional. If you have an earlier version of Adobe Reader you can fill in the form on-screen and print it out but you will not be able to save the completed form.
- Request for access to documents under the Freedom of Information Act 1982 (Cth) form (pdf,139kb)
- Request for access to documents under the Freedom of Information Act 1982 (Cth) form (docx,123kb)
You can send your request either:
| By post | Therapeutic Goods Administration Department of Health PO Box 100 WODEN ACT 2606 Australia |
|---|---|
| By email | tga.foi@health.gov.au |
If you ask a third party to make an FOI request on your behalf, you need to provide a written authority to send copies of documents to that person, or to allow that person to inspect copies of relevant documents, on your behalf.
If you require more information, please contact the FOI Coordinator by emailing tga.foi@health.gov.au or calling the Therapeutic Goods Administration on 1800 020 653 or 02 6289 4630.
Fees and charges
There is no application fee for an FOI request.
There are no processing charges if you request access to documents containing only your personal information. However, processing charges may apply to other requests. The most common charges are:
| Activity item | Charge |
|---|---|
| Search and retrieval: time we spend searching for or retrieving a document | $15.00 per hour |
| Decision making: time spent in deciding to grant or refuse a request, including examining documents, consulting with other parties, making deletions or notifying any interim or final decision on the request |
First five hours: Nil Subsequent hours: $20 per hour |
| Electronic production: retrieving and collating stored on a computer or on like equipment | An amount not exceeding the actual cost incurred in producing the copy |
| Transcript: preparing a transcript from a sound recording, shorthand or similar medium | $4.40 per page of transcript |
| Photocopy: a photocopy of a written document | $0.10 per page |
| Other copies: a copy of a written document other than a photocopy | $4.40 per page |
| Inspection: supervision by an agency officer of the applicant's inspection of documents or hearing or viewing an audio or visual recording | $6.25 per half hour (or part thereof) |
| Delivery: posting or delivering a copy of a document at the applicant's request | Cost of postage or delivery |
Further information regarding charges can be found on the Office of the Australian Information Commissioner (OAIC) website.
If we decide to impose a charge, we will give you a written estimate and the basis of our calculation. Where an estimate is less than $25, we may ask you to pay the amount in full. Where the estimated charge is between $25 and $100, we may ask you to pay a deposit of $20, or where the estimated charge exceeds $100, we may ask you to pay a 25% deposit before we process your request.
You can ask for the charge to be waived or reduced for any reason, including financial hardship or on the grounds of public interest. If you do so, you should explain your reasons and you may need to provide some evidence.
If we decide to impose a charge, you will be required to pay the full charge (less any deposit) before you are given access to the documents.
What you can expect from us
We will tell you within 14 days that we have received your request and we will provide you with the expected timeframes for processing your request. If we decide to impose charges, we will provide you with an estimate of the amount of the charge (based on the charges set out above). The processing of your request will be suspended until the deposit is paid.
We have thirty (30) calendar days to make a decision on your request. However, the 30 days may be extended to allow for the time taken for:
- you to pay a deposit that we ask you to pay;
- us to consider any request from you that a charge should be reduced or waived;
- us to undertake any third party consultation that may be required (this may be up to 30 days);
- additional processing time that you agree to (we may request an extension of up to 30 days if your request is complex); and/or
- additional processing time that is approved by the Office of the Australian Information Commissioner for a request that is complex or voluminous.
If you disagree with our decision
When we have made a decision about your FOI request, we will send you a letter explaining our decision and your review and appeal rights.
You can ask for the following decisions to be reviewed:
- a decision to refuse to give you access to all or part of a document or if we defer giving you access
- a decision to impose a charge
- a decision to refuse to change or annotate information about you that you claim is incomplete, incorrect, out of date or misleading.
A third party who disagrees with our decision to give you documents that contain information about them can also ask for a review of our decision about that information.
Internal review
You can request that we reconsider our decision through an internal review. The request must be made in writing and should set out the reasons why you are seeking review, i.e. why you do not agree with the decision. An internal review will be conducted by another officer in our agency. We will advise you of our new decision within 30 days of receiving your request.
Information Commissioner review
You can ask the Australian Information Commissioner to review our original decision or our decision on internal review within 60 days of the date of decision (or 30 days after you are notified if you are an affected third party). The Information Commissioner can affirm or vary the decision or substitute a new decision. The Information Commissioner may decide not to conduct a review in certain circumstances.
Lodging a complaint
If you are unhappy with the way we have handled your request, you can submit a complaint to the Office of the Australian Information Commissioner who may investigate our actions. The Commonwealth Ombudsman can also investigate complaints about our actions. However, the Commonwealth Ombudsman and the Information Commissioner will consult to avoid the same matter being investigated twice.
More information regarding reviews and complaints is available on the OAIC website.
More information
The OAIC website provides useful information about the FOI process, publications and resources.
If you require more information, please contact the FOI Coordinator by emailing tga.foi@health.gov.au or calling the Therapeutic Goods Administration on 1800 020 653 or 02 6289 4630.