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Posted 06 November 2012 | By Louise Zornoza,
Australia's Therapeutic Goods Administration (TGA) has reviewed the comments submitted on its Medicines Labeling and Packaging Review Consultation Paper, released in May 2012, and has identified six issues from the submitted comments that require further discussion with stakeholders:
As a result, TGA has formulated the following responses to the identified issues:
Need for labeling differences for Rx, OTC and Complementary Medicines It is now proposed that labeling requirements will be specific to the class of medicine and will reflect the level of risk associated with the product.Evidence To assist in the assessment of the evidence for proposed amendments, the TGA will publish on its website a brief annotated bibliography is being prepared analysing the current shortcomings of labelling and packaging, as well as potential solutions to the identified issues.Mandatory versus Voluntary The TGA will work with stakeholders to determine the best way to achieve the objectives of the review whilst ensuring that requirements are implementable and compliance can be achieved.Harmonization with other countries, including New Zealand The TGA, together with stakeholders, will investigate options for adopting and harmonizing better practice requirements from overseas regulators.Assessment of cost and ability of industry to implement TGA will work closely with industry to obtain verifiable information on the costs of particular labeling changes, and discussions held on whether there are any alternative labeling and packaging options that could achieve the same intent for a much lower cost.
Need for labeling differences for Rx, OTC and Complementary Medicines It is now proposed that labeling requirements will be specific to the class of medicine and will reflect the level of risk associated with the product.
Evidence To assist in the assessment of the evidence for proposed amendments, the TGA will publish on its website a brief annotated bibliography is being prepared analysing the current shortcomings of labelling and packaging, as well as potential solutions to the identified issues.
Mandatory versus Voluntary The TGA will work with stakeholders to determine the best way to achieve the objectives of the review whilst ensuring that requirements are implementable and compliance can be achieved.
Harmonization with other countries, including New Zealand The TGA, together with stakeholders, will investigate options for adopting and harmonizing better practice requirements from overseas regulators.
Assessment of cost and ability of industry to implement TGA will work closely with industry to obtain verifiable information on the costs of particular labeling changes, and discussions held on whether there are any alternative labeling and packaging options that could achieve the same intent for a much lower cost.
Tags: Latest News, australia, review
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