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ARTICLE · 21 OCTOBER 2020

The TGA early notice scheme for patentees: Not yet safe or effective

Corrs Chambers Westgarth
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The proposed approach does not provide transparency as to which patents are relevant to particular therapeutic products.

AustraliaIntellectual Property
David Fixler
David Fixler
Brian Fisher
Brian Fisher
Kate Hay
Kate Hay
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Earlier this year, we reported on proposals by Australia's Therapeutic Goods Administration (TGA) to: 

  • release certain information about applications for the registration of new medicines shortly after preliminary assessment; and 

  • require generic or biosimilar pharmaceutical companies to notify innovator companies when making applications to register generic or biosimilar pharmaceutical products.

On 9 October 2020, the TGA announced that the Federal Government has given approval for both measures to be implemented. The first measure (publication of new medicines) will commence from January 2021. Legislative changes to implement the second measure (the notice scheme for generic / biosimilar companies) will be introduced to Parliament in “late 2020”. The TGA has previously indicated that the second measure would be implemented in “early 2021”.

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