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Developments in the Australian medicinal cannabis industry

There have been significant developments in the Australian medicinal cannabis industry with the Turnbull Government now permitting the export of Australian manufactured medicinal cannabis products. This, in conjunction with...more

Advertising of unapproved therapeutic goods may soon be permitted

Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 and Therapeutic Goods (Charges) Amendment Bill 2017 (collectively, the Bills) propose to bring significant changes to the Therapeutic Goods Act 1989 (the TG Act) and...more

Australia aligns with the European medical device regulatory framework

In July 2017, the TGA sought comments from interested parties to further align Australian and European medical device regulatory requirements to - - up-classify surgical mesh from Class IIb (medium to high risk) to...more

TGA response: Changes to accessing unapproved therapeutic goods through the Authorised Prescriber (AP) and Special Access Schemes...

In March 2017, the TGA invited responses to the public consultation paper, ‘Changes to accessing unapproved therapeutic goods through the Authorised Prescriber (AP) and Special Access Schemes (SAS)’. The TGA responded on 9...more

Industrial Chemicals Bill 2017: Recent Developments - Nearly all ingredients in cosmetic products are regulated as industrial...

Nearly all ingredients in cosmetic products are regulated as industrial chemicals under the Industrial Chemicals (Notification and Assessment) Act 1989 (Cth) (the IC(NA) Act)....more

A not so special leave – Mercanti v Mercanti [2017] HCA 1

The High Court has recently dismissed an application for special leave to appeal the Western Australian Court of Appeal’s decision in Mercanti v Mercanti [2016] WASCA 206, in respect of a case involving amendments to a family...more

High expectations for medicinal cannabis in Australia

Recognition of the potential therapeutic benefits of medicinal cannabis for a range of debilitating health conditions has been growing for several years. Recent legislative amendments open the door for the cultivation and...more

Permitted indications reform: Draft list of permitted indications released by the Therapeutic Goods Administration

On 5 July 2017, the Therapeutic Goods Administration (TGA) released a draft list of permitted indications and evidence qualifiers which it proposes be used by listed medicine sponsors to enter product indications in the...more

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