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ARGOM Appendix 2: Guidelines on quality aspects of OTC applications

Version 1.1

30 May 2014

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8. Finished product container

Details of the container type and material(s) must be provided; as well as details of specifications applied to the container components.

For plastic and rubber packaging components, evidence should be provided that the components comply with the relevant BP/Ph. Eur. and/or USP/NF requirements for polymeric materials used in packaging of medicines, or are approved for use with foodstuffs.

The sponsor should ensure that the container closure system complies with the requirements of the TGO 80 Child-Resistant Packaging Requirements for Medicines, where applicable. Where the TGO 80 applies to the product, the sponsor should provide details of the container closure system and an assurance that it complies with the TGO 80.

Although the Code of Practice for the Tamper-Evident Packaging (TEP) of Therapeutic Goods (Ed 1 June 2003) is currently under review, voluntary compliance is recommended by the TGA.

8.1 Measuring devices or other dose delivery devices

Some measuring devices or dose delivering devices may require a separate listing on the ARTG, sponsors should refer to the Australian Regulatory Guidelines for Medical Devices (ARGMD) for further guidance.

All submissions should include details of any measuring device or other dose delivery device that is intended to be supplied with an OTC medicine. The submission should include a copy of the specifications for the measuring device. If the design, composition and performance of the device is not clearly described in the submitted specifications, it may be necessary to submit drawings or a sample of the measuring device for evaluation.

Calibrations on measuring devices should be exclusively in metric units and allow all the doses shown on the labels to be measured accurately.

The ability of the device to deliver the correct dose accurately and reproducibly must be ensured. In particular, the BP/Ph. Eur. Appendix XII C. Consistency of Formulated Preparations includes a test and requirement for Uniformity of Weight (Mass) of Delivered Doses from Multidose Containers (Ph. Eur. monograph 2.9.27). Where this requirement applies, it is sufficient that the sponsor provide an assurance that the proposed measuring device complies with the requirements of this test.

Note: Sponsors intending to supply measuring devices with the product should also consult the current versions of the Australian Standards AS 2224.2 and AS 2224.1 for plastic and glass medicine measures, respectively. These Australian Standards provide guidance on materials, design, dimensions, construction, markings and performance attributes of medicine devices. These Standards are not mandatory requirements in this context; however, if the device does comply with all or part of the relevant Standard, it will facilitate the evaluation if this is stated.

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