New laws for autologous human cell and tissue products

On 1 July 2018, changes to the regulation of human cells and tissues were introduced which affect several biologicals[1] and blood products, especially those intended for autologous application – many of which were previously exempt from the therapeutic goods regime. The affected biologicals, often referred to as ‘stem cell treatments’, are subject to additional manufacturing,
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A New Code for Therapeutic Goods Advertising

Several reforms to the advertising framework for therapeutic goods have commenced. Among these, a new Therapeutic Goods Advertising Code has been introduced. The new Code seeks to simplify the minimum standards for all medicine and medical device advertisements which are directed at the public. Importantly, however, despite expectations that the new Code would commence on
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The What’s What of the Therapeutic Goods Advertising Reforms

21 June 2018 Media coverage of the advertising reforms for therapeutic goods appears to have precipitated strong reaction to the enhanced sanctions and penalties which have been introduced to manage non-compliance. Several other advertising reforms to be implemented shortly which are intended to streamline the requirements for medicines and medical devices and will give the
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Persistence pays off – NSW steps up to improve access to medicinal cannabis

NSW Health has removed the red tape that was delaying and blocking patient access to medicinal cannabis therapies in NSW. Access for one of our pro bono clients was authorised late last week, confirming that the new streamlined process is now operational. Now it is up to the remaining States and Territories to follow NSW
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Sceptics’ forum on proposed advertising reforms for therapeutic goods a sham

Complementary medicine sceptics attended a forum last Wednesday to voice their concerns about proposed changes to the regulation of OTC and complementary medicine advertisements in Australia. With the TGA and representative industry bodies noticeably absent from the forum, it seems that its purpose was to broadcast an anti-complementary medicines agenda without canvassing the substantive issues
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Exports approved but what about Australian patients?

Federal Minister for Health, Greg Hunt, recently announced that medicinal cannabis products manufactured in Australia will be legalised for export so that Australia can compete in the global market. However, substantial hurdles continue to stifle domestic access to medicinal cannabis, such that an international export agenda has the potential to further disadvantage Australian patients. Partner,
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Initial Report from WHO supports removal of restrictions on CBD

The World Health Organisation’s Expert Committee on Drug Dependence has published its initial report on the international controls which should be applied to cannabidiol (CBD) and concluded that current information does not justify scheduling of CBD. Partner, Dr Teresa Nicoletti and Law Graduate, Helaena Short, discuss. Background to the Report Historically, cannabis has never been
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Hemp foods available for lawful sale in Australia next week

Foods made from low-THC hemp seeds and hemp seed oil are permitted for sale from 12 November 2017 in Australia. However, it remains unclear as to who may lawfully cultivate, manufacture and produce such food products. Partner, Dr Teresa Nicoletti and Law Graduates Helaena Short and Sarah Martin, discuss. Background For several decades, Cannabis sativa
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Private Greens Bill wins Majority Vote in the Senate

The Greens’ Medicinal Cannabis Legislation Amendment (Importation and Manufacture) Bill 2017 attempts to put an end to the government’s last ditch-efforts to stifle access to medicinal cannabis for terminally ill patients. Partner, Dr Teresa Nicoletti and Law Graduates, Helaena Short and Sarah Martin, discuss. Yesterday, the Senate majority voted in favour of the Medicinal Cannabis
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The Senate sees Sense: Terminally ill patients may receive expedited access to medicinal cannabis

New votes by the One Nation Party in a surprise re-hearing of Senator Richard Di Natale’s medicinal cannabis motion mean that terminally ill patients may be able to access medicinal cannabis via Category A of the SAS once again. Partner, Dr Teresa Nicoletti and Paralegal, Helaena Short, discuss. Earlier this year Senator Richard Di Natale
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One Nation and the Xenophon Team prioritise political interests at the expense of terminally ill patients

A motion moved by Richard Di Natale of the Greens to disallow legislation which blocks immediate access to medicinal cannabis by terminally ill patients was recently voted down in the Senate due to unexpected votes by One Nation and the Nick Xenophon Team. Paralegal, Helaena Short and Partner, Dr Teresa Nicoletti discuss. In February this
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Voluntary Euthanasia in New South Wales: Draft legislation to be considered in 2017

Prompted by the draft Voluntary Assisted Dying Bill 2017 (NSW), New South Wales is preparing to tackle growing community demands for end-of-life legislation in the coming months. Partner, Dr Teresa Nicoletti and Paralegal, Helaena Short discuss. A draft of the Voluntary Assisted Dying Bill 2017 (NSW) (Bill) was recently released for public consultation by a
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Hemp-based foods to be legalised in Australia

Ministers have approved a decision by the food regulator to permit the sale in Australia of foods made from low-THC hemp seeds and hemp seed oil – however, other legal hurdles remain. Partner, Dr Teresa Nicoletti discusses. The Australian and New Zealand ministers responsible for food regulation have approved a recommendation from Food Standards Australia
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Hope for Hemp Industry Stakeholders – final decision on the scheduling of cannabis deferred

Fervent advocacy by Mills Oakley partner, Dr Teresa Nicoletti, has stalled a final decision on the scheduling of cannabis and tetrahydrocannabinols, to allow more careful consideration and consultation. Partner, Dr Teresa Nicoletti; and Paralegal, Helaena Short discuss. A notice published on the Therapeutic Goods Administration (TGA) website yesterday announced that the Secretary of the Commonwealth
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Access to medicinal cannabis – how terminally ill patients are missing out

Terminally ill patients continue to be denied access to essential medicines despite positive developments in the medicinal cannabis framework in Australia. Partner, Dr Teresa Nicoletti and Paralegal, Helaena Short discuss. Bold claims have been made in the Daily Telegraph this morning that terminally ill patients will be given the “green light” to access medicinal cannabis
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