Revised requirements for child-resistant packaging
Stakeholder consultation
7 January 2008
This consultation closed on 22 February 2008.
Comments from stakeholders are being sought on a proposed update to requirements for the child-resistant packaging (CRP) of medicines.
You are invited to provide input to this consultation process.
The closing date for comment is Friday 22 February 2008.
Background
Therapeutic Goods Order No. 65 Child-Resistant Packaging for Therapeutic Goods (TGO 65) <http://www.tga.gov.au/docs/html/tgo/tgo65.htm> specifies current Australian requirements for CRP for therapeutic goods.
TGO 65 was identified by the Therapeutic Goods Committee <http://www.tga.gov.au/docs/html/tgc.htm> (TGC - the expert committee established under regulation 34 of the Therapeutic Goods Regulations 1990 to advise the Minister on matters relating to standards for therapeutic goods) some time ago as having high priority for review in preparation for the proposed Australia New Zealand Therapeutic Products Authority (ANZTPA). This priority was based on the importance of CRP as an injury prevention strategy for children, the ongoing emergence of poisoning data and regular approval of new chemical entities and variants to existing products.
Considerable work was undertaken subsequently by an expert advisory committee to develop a draft Order for ANZTPA to specify CRP requirements for medicines. Stakeholder consultation on this draft ANZTPA Order, which was based in large part on TGO 65, was undertaken in April-May 2006.
Subsequent consideration of stakeholder responses resulted in a number of amendments to the draft ANZTPA Order <http://www.anztpa.org/consult/crp.htm> to improve clarity and remedy some unforeseen implications. Although it had been intended that the amended draft Order would be released to stakeholders, the postponement of establishment of ANZTPA prevented this from occurring.
The TGC noted this situation at its November 2007 meeting <http://www.tga.gov.au/docs/html/tgc/tgc31.htm#crp>, and recommended that, despite postponement of ANZTPA, there remained strong justification for updating CRP requirements for medicines in Australia. The Committee therefore recommended that a draft new Therapeutic Goods Order should be released for stakeholder consultation and, as far as is consistent with existing therapeutic goods legislation, the draft Order should include the same technical requirements and be applicable to the same medicines as identified in the draft ANZTPA Order.
Proposal
It is proposed that Therapeutic Goods Order No. 80 Child-Resistant Packaging Requirements for Medicines (TGO 80) will supersede TGO 65 as a standard made under section 10 of the Therapeutic Goods Act 1989.
TGO 80 (draft) incorporates a two year transition period, which would commence upon entry of TGO 80 onto the Federal Register of Legislative Instruments, for products to comply with the updated requirements.
Rather than incorporate Supplementary Notes, it is proposed that TGO 80 would be accompanied by a guidance document providing explanatory information and a series of questions and answers relating to the practical application of the Order.
Drafts of TGO 80 and the accompanying guidance document are now available for review by stakeholders.
Technical information
As well as changes to the list of substances requiring CRP, the main differences between TGO 65 and TGO 80 (draft) are:
- inclusion of information on:
- the objective of the Order;
- the role of CRP in reducing the incidence of accidental poisoning in children;
- the distinction between child-resistant and child-proof;
- the nature of considerations typically taken into account by the expert advisory committee in making recommendations on requirements for CRP, with six specific criteria identified; and
- the forms of packaging permitted by the Order;
- inclusion of some new product categories that are exempt from the requirements (e.g. spray presentations of liquid preparations subject to certain conditions; pastes, powders and gels for cleaning teeth);
- update to new editions of the referenced Australian, ISO and British Standards for reclosable packages;
- amendment to some terminology; and
- replacement of the Supplementary Notes section with a separate guidance document.
The requirements given in TGO 80 (draft) for non-reclosable forms of packaging remain unchanged from those of TGO 65. However the recommendation <http://www.tga.gov.au/docs/html/tgc/tgc31.htm#crp> that the TGA develop, in conjunction with industry and other stakeholders, a best practice guideline on non-reclosable packaging that will assist sponsors to improve the robustness of blister or foil strip packaging and thus further reduce the potential for the accidental poisoning of children should be noted. Stakeholders will be consulted separately on that work.
Consultation
Stakeholders are invited to provide comment on TGO 80 (draft) and its companion document Guidance on Therapeutic Goods Order No. 80 Child-Resistant Packaging Requirements for Medicines, also in draft.
Information that would assist in the assessment of the regulatory impact of the proposal to update requirements for CRP of medicines is also being sought as part of this consultation process.
Comments received in response to this consultation will be referred to the TGC for consideration.