Invitation to comment
The TGA sought feedback on a proposal to publish the names of excipient ingredients used in therapeutic goods in the public view of the Australian Register for Therapeutic Goods (ARTG).
We are responding to consumer frustrations that they cannot easily access this information through existing mechanisms. By making this information available in the public ARTG view, which is available on the TGA website, we hope to help consumers make more informed and safer choices about their medicines.
Consultation document
Timetable
Document released for consultation on Thursday, 29 August 2019.
Interested parties should respond by close of business Thursday, 10 October 2019.
Feedback will be released following consideration of submissions. (See 'What will happen').
About the consultation
To make safe and informed choices, people need access to information about the ingredients in their therapeutic goods. It is also important to have this information to identify when specific ingredients may have contributed to an adverse reaction.
Some information about the ingredients in therapeutic goods is available to consumers in public documents. Alternatively, consumers must contact the company responsible for the goods or make a request for specific ingredient information from the TGA. Consumers have expressed frustrations that these mechanisms do not provide easy access to information about excipient (or ‘inactive’) ingredients in all medicines.
In response, we are consulting on options for making this information available online in the public summaries of goods on the ARTG.
Submissions
You may address any, or all, of the questions posed in the consultation paper.
Submissions can be provided along with any supporting evidence against all, or any, of the options provided in the consultation paper.
We are specifically interested in what impact (health, safety or commercial) displaying the names of excipient ingredients would have on you. If the proposals in the paper are implemented, we are also interested to know if any organisations are willing to collaborate with us to help raise consumer awareness about the availability of this information.
What will happen
All submissions and survey responses will be placed on this website unless marked confidential or indicated otherwise in the form (see Privacy information).
We will review all input received and provide feedback on outcomes through both the TGA and Health consultation websites.
Privacy information
- We collect your personal information in this submission in order to:
- contact you if we need to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.
- help provide context about your submission (e.g. to determine whether you are an individual or a director of a company or representing an interest group).
- Seek feedback about how the consultation was undertaken.
- Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.
- More information on consultations and privacy is included in the submission form and on our website.