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Tag Archives: Sponsor Responsibilities

Are you eCTD ready?

eCTD in Australia Following the successful eCTD pilot programme in 2014/2015, the TGA has published the final Australian eCTD specification (version 3.0) which is now mandatory for all dossiers submitted in eCTD format after 1 January 2016. This is an … Continue reading

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Release for supply – What every sponsor should know

What is release for supply? Every batch of medicine sold or supplied in Australia is required to have undergone a “release for supply” procedure. This applies to registered medicines, listed medicines as well as investigational medicinal products (phase 2 or … Continue reading

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