481-490 of 669 results
Assessment of biosimilars - Is Australia leading, following or going its own way?
The ongoing lack of certainty about what is required to obtain biosimilar registration in Australia extends to three key issues - Comparability is the new product sufficiently similar to permit it to rely on the reference products safety and efficacy data Extrapolation for which of the indications ...
ASIC announces fintech licensing exemptions
As part of its implementation of the regulatory sandbox for fintech companies ASIC is providing relief for certain fintech businesses from the obligation to hold an Australian financial services or Australian credit licence Relief may be available for up to 12 months and may be useful to businesses ...
ACCC's Enforcement and Compliance priorities for 2017
Criminal cartels unfair contract terms consumer guarantees and the health construction and agriculture sectors are some of the ACCCs key enforcement and compliance priorities for 2017 ACCC Chairman Rod Sims released the ACCCs 2017 Compliance and Enforcement Policy on Friday 24 February 2017 ...
Mandatory data breach notification scheme passed
The Federal Parliament has today passed the Privacy Amendment Notifiable Data Breaches Bill 2016 which will amend the Privacy Act 1988 Cth to introduce a mandatory data breach notification scheme ...
Australia releases model for implementing the Nagoya Protocol
The Federal Government has released a model for the implementation of the Nagoya Protocol that will have major implications for those who use genetic resources and associated traditional knowledge for biodiscovery Partner Sarah Matheson and Lawyer Julieane Bull provide an overview of changes ...
The ramifications of a Facebook rant
The Full Court of the Federal Court recently handed down its decisions on an appeal that highlights the dangers of making unsubstantiated social media comments Partner Miriam Stiel and Lawyer Tracy Lu report on a long-running dispute where the court found personal Facebook posts constituted ...
Allens insights: Implementation of Australia's PCEHR system reviewed
At the end of 2013 the Federal Minister for Health announced a panel review into Australias Personally Controlled Electronic Health Record PCEHR system to consider implementation and uptake issues The subsequent report made public in May 2014 puts forward 38 recommendations to address the issues ...
Food Law Bulletin
we look at the ACCCs current enforcement activities on credence claims in food labelling the development of a national information standard for the contentious area of free-range eggs in light of the industrys failure to selfregulate a Federal Court decision that provides some welcome clarification ...
The ending point for 'starting point'
The Full Federal Court has published its much-anticipated judgment in the AstraZeneca v Apotex appeal A bench of five judges heard the appeal in contrast to the usual three judges in order to be able to clarify or overrule if appropriate an earlier Full Court decision relating to the correct test ...
Privacy Commissioner reports on Department of Immigration and Border Protection's data breach
The Australian Privacy Commissioner has released a report into the Department of Immigration and Border Protection having breached the privacy of asylum seekers in February 2014 Partner Michael Pattison and Associate Priyanka Nair report on the Commissioners findings and the lessons for all ...