Tag archives: Australia

Australia: Improvements for GMP clearance

By on August 18, 2017 Posted in International

Australia’s therapeutic goods regulator, the Therapeutic Goods Administration (TGA) has announced that it is planning improvements around Good Manufacturing Practice (GMP) clearance. As part of this, the TGA will be publishing an updated revision of the GMP clearance guidance document, and redesigning the current GMP Clearance application e-forms. GMP clearance is required for all medicines … Continue reading

Marketing class actions: a new frontier for medical products

By Toby Biddle (AU) and Helen Macpherson (AU) on June 5, 2017 Posted in International

A new type of product claim is emerging in the Australian class action market; one which has been part of the US class action landscape for many years. Unlike previous product class actions where the safety of the product was typically in issue, the new product claims focus on statements/ representations made in the marketing … Continue reading

Mandatory kilojoule labeling – Victoria, Australia

By on May 18, 2017 Posted in FDA & Food Safety, International

The Victorian Government has introduced the requirement that all major Victorian food outlets and supermarket chains must display kilojoule contents on their menus. The Food (Kilojoule Labelling Scheme and Other Matters) Amendment Act 2016 will, from May 2018, require large chain food businesses and large chain supermarkets to display: the average kilojoule content of standardised, … Continue reading

Australia – Gene Technology Regulator commences review into Gene Technology Regulations

By Rohan Sridhar (AU) on November 15, 2016 Posted in International

The Australian Gene Technology Regulator has commenced a technical review of the Gene Technology Regulations (Regulations), which underpin the regulation of a range of gene technologies and genetically modified organisms. The review is aiming to ‘provide clarity about whether organisms developed using a range of new technologies are subject to regulation’ and to ‘ensure that … Continue reading

Australia: Regulator considers permitting the sale of food derived from low THC hemp seeds

By Bernard O'Shea (AU) and Rohan Sridhar (AU) on August 22, 2016 Posted in FDA & Food Safety

Food Standards Australia New Zealand (FSANZ) is calling for submissions in response to its draft variation of the Food Standards Code that would permit the sale of foods derived from low tetrahydrocannbinol (THC) hemp. The proposal follows a request by the Australia and New Zealand Ministerial Forum on Food Regulation (Forum) for FSANZ to consider … Continue reading

Australia trials “Health Care Homes”, a new model of primary health care

By Rohan Sridhar (AU) on August 15, 2016 Posted in International

Australia is set to trial a new model of primary health care based on the successful “Health Care Homes” programs in Canada and the United States. Australia’s version of the Health Care Homes scheme was proposed in broad terms in December 2015 by the Primary Health Care Advisory Group, in its Better Outcomes for People … Continue reading

Australia: Review of pharmaceutical reimbursement rules

By Bernard O'Shea (AU) and Rohan Sridhar (AU) on May 24, 2016 Posted in International

Background On 25 April 2015, the Minister for Health announced a review of the Guidelines (Guidelines) for Preparing Submissions to the Pharmaceutical Benefits Advisory Committee (PBAC), the body that recommends which products should be reimbursed by Government, and for how much. The Minister said the review sought to ensure that the PBAC Guidelines are “consistent … Continue reading

Australia – nicotine and therapeutic goods

By Bernard O'Shea (AU) and Rohan Sridhar (AU) on May 11, 2016 Posted in FDA & Food Safety

A recent Australian case (http://www.austlii.edu.au/au/cases/cth/FCA/2016/394.html) has touched on the tricky area of nicotine containing products, this time in the guise of product known as the Voke Inhalator, which contained 0.43mg of nicotine in a pressurised inhalation can. The supplier of the product was seeking to register the product as an OTC product, but our regulator, … Continue reading

TPP and biologics – a battleground in Australian elections

By Bernard O'Shea (AU) and Rohan Sridhar (AU) on May 10, 2016 Posted in FDA & Food Safety

The Australian Labor Party has flagged the data exclusivity provisions of the Trans Pacific Partnership Agreement (TPP) as a major issue ahead of our now confirmed July date for an Australian election.… Continue reading

Times, they are a-changin’ – new country of origin food labeling system effective 1 July 2016

By Frances Drummond (AU) and Alyson Poole (AU) on May 6, 2016 Posted in FDA & Food Safety

Summary From 1 July 2016, new country of origin labeling requirements will become a reality in Australia, with a new food labeling system commencing under the Australian Consumer Law. The implementation of the new system will have a two year transition period. From 1 July 2018, the new system will be mandatory and something which … Continue reading

Australia – States and territories agree to country of origin food labelling reforms

By on April 20, 2016 Posted in FDA & Food Safety

Australia’s country of origin labelling system for food products is to be overhauled following agreement by State and Territory Ministers for Consumer Affairs. Food offered for retail sale in Australia will be required to be labelled more clearly to inform consumers of the product’s origins.… Continue reading

Australian TGA on cyber security

By Bernard O'Shea (AU) on April 4, 2016 Posted in FDA & Food Safety

In a timely note, the March 2016 edition of the Medical Devices Safety Update, put out by the Australian Therapeutic Goods Administration, highlights medical device cyber security as a key issue. Interestingly, this comes shortly after the release by the FDA of its draft guidance in relation to “Post Market Management of Cyber Security in … Continue reading

Australia – ehealth amendments

By on January 5, 2016 Posted in International

As part of the Australian Government’s digital health agenda, the Health Legislation Amendment (eHealth) Act 2015 (the Act) has recently been assented to. The personally controlled electronic health record (PCEHR) system was launched in July 2012. eHealth records are an online summary of an individuals’ health information. The individual controls what is included in the … Continue reading

Updates to low THC hemp food in Australia

By Rohan Sridhar (AU) on January 5, 2016 Posted in FDA & Food Safety

As previously noted, low tetrahydrocannabinol (THC) hemp for human consumption in Australia has been mooted as a potential basis of inexpensive food and expanded sales capability for farmers who currently grow hemp for industrial purposes. This has been particularly sought after in Tasmania where the majority of industrial hemp is currently grown.… Continue reading

Australia – New twist in the battle between the Commonwealth and originator pharma

By Bernard O'Shea (AU) and Rohan Sridhar (AU) on September 1, 2015 Posted in International

What it means: The Commonwealth’s desire to pursue damages pursuant to the usual undertaking seems firmly entrenched. Pharmaceutical patent holders need to consider this prior to commencing infringement actions. The Commonwealth seems to be guarded regarding the potential success of its two initial claims against originators. The Commonwealth of Australia’s ongoing battle with originator pharma … Continue reading

Australia – Inquiry into Intellectual Property Arrangements

By on September 1, 2015 Posted in International

The Australian Federal Treasurer, Joe Hockey, recently announced that there will be an inquiry into Australia’s intellectual property arrangements. The inquiry, to be conducted by the Productivity Commission, the Australian Government’s independent research and advisory body, will examine the balance between promoting competition and protecting intellectual property in Australia, taking into account our international trade … Continue reading

Push for industrial hemp for human consumption in Australia grows

By on August 26, 2015 Posted in FDA & Food Safety

State and Federal Tasmanian Members of Parliament have stepped up the pressure on the Federal Government to allow production of industrial hemp for human consumption. In Australia, the National Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) includes the genus Cannabis as a ‘Prohibited Substance’, except as processed hemp fibre containing 0.1 per … Continue reading

FSANZ calls for submissions on GM soybean

By Bernard O'Shea (AU) on August 3, 2015 Posted in FDA & Food Safety

Food Safety Australia New Zealand (FSANZ) has opened submissions into a request by Monsanto Australia (Monsanto) to market (but not cultivate) food based on a genetically modified soybean line, MON-87751. MON-87751 has been genetically engineered to express two proteins, which provide protection from feeding damage caused by particular insects. The GM soybean would be cultivated … Continue reading

Australian Government begins second awareness campaign for Health Star Rating

By Bernard O'Shea (AU) on July 31, 2015 Posted in FDA & Food Safety

The Australian Government has begun further awareness raising for its multi-million dollar Health Star Rating (Health Star) system. The Health Star system aims to aid in the education of Australians regarding their food choices, through a complicated 5 star rating system. The Health Star system awards points to foods based on their protein, fibre and … Continue reading

Australian – Stock and Pet Food Regulation

By Bernard O'Shea (AU) on July 31, 2015 Posted in FDA & Food Safety

The Australian Government recently made substantial amendments to the Agricultural and Veterinary Chemicals Code Regulations 1995 (Agvet Code Regulations)[1]. These amendments were intended to reduce the impacts of regulation on low risk stock food and pet foods, and are estimated to save $7.8 million per year in regulatory costs. The Government has now released a … Continue reading

Australian Parliament introduces food import and export bills

By Bernard O'Shea (AU) on July 30, 2015 Posted in FDA & Food Safety

The Australian Parliament has recently introduced two suites of bills, relating to charges for the import of food into, and export of food out of, Australia. The Export Charges (Collection) Bill 2015, Export Charges (Imposition – General) Bill 2015, Export Charges (Imposition – Excise) Bill 2015 and Export Charges (Imposition – Customs) Bill 2015 (collectively … Continue reading

As Germany clamps down on health sector corruption, is Australia next?

By on July 30, 2015 Posted in International

Corrupt pharmacists, physiotherapists, doctors and care workers could face up to five years imprisonment if found guilty of corruption or bribery, according to a new law being introduced by the German government. This week, German Chancellor Angela Merkel’s Cabinet signed off on the anti-corruption plan presented by the German Justice Minister. Some commentators say that … Continue reading

Australia – new country of origin food labelling regime

By Bernard O'Shea (AU) on July 29, 2015 Posted in FDA & Food Safety

In a surprise announcement, Australian Prime Minister Tony Abbot announced on 21 July 2015 the new labelling regime, earlier than expected. This announcement follows a large public survey on the issue of country of origin food labelling, which had almost 18,000 responses. In a press conference, along with the Hon. Ian Macfarlane, Minister for Industry … Continue reading

Nutrition content and health claims

By on June 2, 2015 Posted in FDA & Food Safety

The Australia New Zealand Food Standards Code (the Code) sets out Food Standards that are legislative instruments under the Legislative Instruments Act 2003. A new Standard to regulate nutrition content claims and health claims on food labels and in advertisements became law on 18 January 2013 (Standard 1.2.7) (the Standard). The Standard sets out conditions … Continue reading