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Tag Archives: Regulatory Affairs

Coronavirus (COVID-19): Information on medicines and medical devices supply in Australia

The Therapeutic Goods Administration (TGA) has consolidated all the COVID‑19 information on their website to assist manufacturers and suppliers with accessing the latest information about the special regulatory requirements for the supply of medicines and devices (including exemptions) in Australia … Continue reading

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Improved Consumer Medicine Information template

The TGA have now released implementation dates for the updated Consumer Medicine Information (CMI) template that was developed throughout 2019 to reduce complexity and improve readability. Newly registered medicines must use the new template from 1 January 2021, while previously … Continue reading

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No CE mark? No problem.

Changes to legislation have increased flexibility for Sponsors looking to market medical devices in Australia. Historically the TGA has only recognised EC certificates from European notified bodies or a TGA conformity assessment to support the inclusion of a Medical Device … Continue reading

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New ‘SmPC’ Format for the Australian Product Information

The TGA have published a new form for providing the product information (PI) which means more work for regulatory teams but an enhancement of the quality use of medicines for Australian patients.  The new form will be implemented over a … Continue reading

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NZ Regs Shake-up – what will become of medical devices?

The New Zealand Ministry of Health has announced that they are developing a new regime for the regulation of therapeutic products. Following the cessation of the Australia New Zealand Therapeutic Products Agency (ANZTPA), the New Zealand Ministry of Health is … Continue reading

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Commercial Eyes recruiting: Regulatory Affairs consultant positions

Due to ongoing demands in our Regulatory Affairs department, we are hiring Regulatory Affairs professionals with experience working with clinical registration. We are specifically looking for two (2) Regulatory Affairs Consultants: one (1) to be located in our Melbourne office … Continue reading

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