Consultation: Child-resistant packaging requirements for medicines
For Consultation: Proposed Amendments to Therapeutic Goods Order No. 80 Child-Resistant Packaging Requirements for Medicines (TGO 80) (pdf,147kb)
Invitation to comment
TGA is seeking comments from interested parties on a number of proposed amendments to Schedule 1 to Therapeutic Goods Order No. 80 Child-Resistant Packaging Requirements for Medicines <http://www.tga.gov.au/legis/tgo/tgo80.htm> (TGO 80).
These amendments to Schedule 1 to TGO 80 would update the list of substances which, if present in a medicine, require the medicine to have child-resistant packaging (CRP).
Through the consultation process the TGA hopes to receive feedback that will help ensure that TGO 80 remains a useful tool in assisting in the prevention of accidental poisoning of children.
Timetable
Document released for consultation on 8 February 2010.
Interested parties should respond by close of business 19 March 2010.
Feedback will be released following consideration of submissions by the Therapeutic Goods Committee (TGC) (see 'What will happen').
About the consultation
This consultation is a key component of the annual review of Schedule 1 to TGO 80.
The purpose of this annual review is to:
- identify any new medicines that may warrant CRP, and
- to consider any new information on those substances already included in Schedule 1 which may be relevant to the requirement for CRP.
The objective of the proposed amendments to TGO 80 is to ensure that Schedule 1 to TGO 80 continues to reflect currently approved medicines and an appropriate risk management approach to the identification of substances warranting CRP, based on the criteria for CRP described in the introduction to TGO 80.
These criteria relate not only to the toxicity of substances and reports of poisoning incidents in young children, but also patterns of availability in the community and any special needs of patients who regularly need access to medicines containing those substances.
Content of submissions
Submissions may address any, or all, of the proposed amendments to TGO 80 and other identified issues.
Submissions relating to particular substances should address the criteria specified in the "Introduction" to TGO 80.
In addition, your submission might include:
- relevant supporting information such as toxicity data, evidence and/ or examples to support the views expressed; and
- relevant information concerning the impact of proposed changes on affected parties, including information on the number of products affected, the availability of suitable child-resistant packaging, costs of process changes associated with packaging revisions, and the time necessary to implement packaging changes.
How to respond
All submissions should be accompanied by a coversheet.
Submissions must include full personal or organisational contact details (including address, telephone number and email).
Sponsors should also complete and return the Impact Assessment Checklist.
Electronic submissions are preferred and should be emailed to standards@tga.gov.au .
Please include "TGO 80" in the subject line of the email.
Alternatively, hard copy submissions may be mailed to:
The Project Officer
TGO 80 Consultation 2010
Office of Laboratories & Scientific Services
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606 Australia
What will happen
Submissions will be acknowledged.
Submissions will be provided to the TGC for consideration in their formulation of advice to the Minister for Health and Ageing on any recommended amendments to TGO 80.
Feedback will be provided to respondents through the publication on the TGA's Internet site of the TGC meeting report, which will include any recommendations for amendment to TGO 80.
Respondents should not assume however that recommendations made by the TGC will reflect the final decision of the Minister relating to any amendment to TGO 80.
Confidentiality
All submissions received will be placed on the TGA's Internet site, unless marked confidential. Any confidential material contained within your submission should be provided under a separate cover and clearly marked "IN CONFIDENCE". Reasons for a claim to confidentiality must be included in the space provided on the TGA submission coversheet.
For submission made by individuals, all personal details, other than your name, will be removed from your submission before it is published on the TGA's Internet site.
In addition, a list of parties making submissions will be published. If you do not wish to be identified with your submission you must specifically request this in the space provided on the submission coversheet.
More information
Any questions relating to submissions should be directed to the Project Officer, by email at standards@tga.gov.au or by telephone to 02 6232 8661.
Downloads
How to access a pdf or Word document
- Consultation document: Proposed Amendments to Therapeutic Goods Order No. 80 Child-Resistant Packaging Requirements for Medicines (TGO 80) (pdf,147kb)
- Therapeutic Goods Order No. 80 Child-Resistant Packaging for Medicines (pdf,186kb)
- Submission coversheet (Word,67kb)
- Impact Assessment Checklist for sponsors (Word,63kb)