Influenza vaccines released for 2020 season

Source: Australian Department of Health

Six influenza vaccines are available in Australia in 2020. All of these vaccines are quadrivalent, which means they contain four strains of influenza.

To date, the Therapeutic Goods Administration (TGA) has released over 150 batches of influenza vaccine, consisting of over 12.2 million doses for supply in Australia for the 2020 season. This includes over 3.8 million for private supply, including through pharmacies, and over 8.4 million for Government-funded programs.

Every year, the TGA is responsible for reviewing the quality of all brands of the influenza vaccines released to the Australian market.

Despite the current COVID-19 pandemic, the TGA has not experienced any delay in processing influenza vaccines through the batch release program and has continued assessing the quality of the influenza vaccines for this season.

The Department of Health works closely with influenza vaccine manufacturers to ensure timely availability of influenza vaccines for all Australians, particularly those individuals identified at risk.

Vaccine manufacturers are responsible for prioritising vaccine supply to individual pharmacies and distributors.

To find out more about the 2020 flu vaccines, see 2020 seasonal influenza vaccines: Information for consumers and health professionals.

Gentamicin 40 mg/mL Injection (Hospira UK Limited)

Source: Australian Department of Health

Safety advisory – alternative product filling shortage may cause airway irritation if administered via inhalation

Consumers and health professionals are advised that Gentamicin 40 mg/ml Injection (Hospira UK Limited) may cause constriction or irritation to the airways if used as an inhalation to treat certain infections in the lungs, due to the presence of the preservatives, sodium metabisulfite, methyl hydroxybenzoate and propyl hydroxybenzoate.

Gentamicin 40 mg/ml Injection (Hospira UK Limited) is an unregistered product (sourced from overseas) that has been approved for use as an alternative product during the current shortage of Pfizer (Perth) Gentamicin 80 mg/2 mL (as sulfate) injection BP ampoule. This product is not expected to be available again until 30 April 2021.

In the meantime, the TGA has granted approval under Section 19A of the Therapeutic Goods Act 1989 to Pfizer Australia Pty Ltd to supply the alternative product, Gentamicin 40 mg/ml Injection (Hospira UK Limited), for the following indications:

Gentamicin 40mg/ml Injection (Hospira UK Limited) is approved for the treatment of infections due to susceptible organisms including Pseudomonas aeruginosa, and species of Proteus, Escherichia, Klebsiella, Enterobacter, Serratia and Staphylococcus (including strains resistant to other antibiotics such as penicillin). In vitro, gentamicin is also active against Salmonella and Shigella. Gentamicin may be used for the treatment of the following conditions when caused by susceptible organisms:

  • Bacteraemia
  • Respiratory tract infections
  • Urinary tract infections
  • Skin and skin structure infections
  • Burns
  • Sepsis

While Gentamicin 40 mg/ml Injection (Hospira UK Limited) is a suitable alternative in most situations, clinicians using this product for off-label use via inhalation may need to take the presence of preservatives into account and the possible effect they may have on a patient’s airways.

Although Pfizer (Perth) Gentamicin 80 mg/2 mL (as sulfate) injection BP ampoule has not been approved for use via inhalation and its Product Information references only intramuscular or intravenous use, the TGA is aware that there is some off-label use via inhalation.

Information for consumers

If you have any questions or concerns about this issue, talk to your health professional

Information for health professionals

During the shortage, health professionals who would have used Pfizer (Perth) Gentamicin 80 mg/2 mL (as sulfate) injection BP ampoule via inhalation for a patient may need to consider other products for the patient’s treatment.

If a preservative-free gentamicin product is required, health professionals may wish to request supply via the Special Access Scheme (SAS).

Pfizer Australia Pty Ltd can be contacted on 1800 675 229. Information about this Section 19A approval has been published in the TGA’s online Section 19A database.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA’s monitoring of these products.

The TGA cannot give advice about an individual’s medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.

Appointments to the Board of Taxation

Source: Australia Government Ministerial Statements

The Morrison Government has appointed Ms Rosheen Garnon as part-time Chair, and Mr Christopher Vanderkley as a part-time Member of the Board of Taxation for a three-year period from 25 March 2020.

The Board of Taxation is a non-statutory advisory body charged with improving the design of taxation laws and their operation by bringing together business and broader community perspectives.

Ms Garnon is an existing member of the Board. She brings a deep understanding of the business community and tax law from her roles on several boards and over 30 years’ experience in taxation, including as National Managing Partner for KPMG Australia’s Taxation Division and a member of the National Executive Committee of KPMG from 2009-2015.

Mr Chris Vanderkley has strong business taxation experience, with over 30 years’ corporate tax experience in the financial services sector. He held senior positions at GE Capital Asia Pacific, including as Chief Financial Officer, and is currently Special Counsel at PwC leading their tax transparency and tax governance practice.

The Government thanks Dr Julianne Jaques for her strong leadership of the Board’s work, as Acting Chair, after the sudden and sad passing of the late Michael Andrew AO.

Bioavailability, bioequivalence and biowaiver data summary forms

Source: Australian Department of Health

Summary of a bioavailability or bioequivalence study

This form should be used by prescription medicine, over-the-counter and registered complementary medicines sponsors to submit a summary of a bioavailability or bioequivalence study.

How to access a pdf or Word document

An alternative Bioequivalence Study Information Form is available to summarise each bioequivalence study. For more information, see Bioequivalence data summary templates below.

Bioequivalence data summary templates

The optional bioequivalence data summary templates are designed to help you prepare a submission for a new generic prescription medicine and ensure all the necessary information is provided at the time of application.

The templates are equivalent to similar templates used by comparable overseas regulators and our international collaborators in international regulatory forums.

Bioequivalence study summary template

This form could be used when you are submitting bioequivalence study data.

For guidance on completing this template, see Completing the Bioequivalence Study Information Form.

Biowaiver templates

Additional strength biowaiver template

This template could be used when bioequivalence study data has not been generated for all strength products and you are required to submit biowaiver data for these products.

Note: the additional strength biowaiver template currently is designed for systemically active immediate release oral dosage form.

Biopharmaceutics Classification System (BCS)-based biowaiver template

This template could be used when you are submitting BCS-based biowaiver data for all proposed strength products.

For guidance on completing the biowaiver templates, see Completing the biowaiver templates.

If you have any enquiry about templates, direct your queries to pcsinbox@health.gov.au.

49-2020 – Biosecurity officer redeployment

Source: Australia Government Statements – Agriculture

49-2020 – Biosecurity officer redeployment
Rohan.langeveld
Wed, 2020-04-01 14:22

Who does this notice affect? 

Third parties where the department undertakes regulatory work on premise 

What has changed?

The Department of Agriculture, Water and the Environment operates an integrated business model for its biosecurity operations.  This means that our biosecurity officers are cross skilled to undertake traveller, mail and cargo clearances at most ports.  Our biosecurity officers regularly move between ports, airports and third-party premises to conduct our regulatory work.  This model allows us to be efficient and flexible in the deployment of our workforce and to meet the variability in industry demands.

Given the drop off in the number of international traveller arrivals, the department will be moving more staff out of the airport environment into other parts of our biosecurity operations.  This is not a new process, but some ports and third-party premises will see some new faces around as we manage volumes and work demands. 

The department has taken several measures to ensure the safety of our staff as well as external stakeholders.  

The Department of Health has advised the risk for staff working at airports remains low.  A number of biosecurity officers have been tested for COVID-19 where they have either had flu like symptoms or have been in contact with a confirmed case.  All biosecurity officers that are suspected of being infected are placed on paid leave whilst they await test results.  To date, no biosecurity officers have tested positive for COVID-19. 

The department has conducted extensive training and briefings with operational staff to ensure that they are well equipped to do their job and minimise the risk of transmission. Staff are supplied with their own personal protective equipment if and when they are required to wear it. 

All biosecurity operations staff are in regular contact with their supervisors about their health and have been advised to not attend work if they are feeling unwell. 

Further information

Importers are encouraged to check our website regularly or subscribe to our mailing list for up to date information.

Wednesday,1 April 2020

Accessing official Coronavirus advice

Source: Australian Department of Prime Minister and Cabinet

Key to Australia’s effective management of the Coronavirus COVID-19 pandemic is providing accurate, timely information to Australians. www.Australia.gov.au is your trusted source of government information. A one-stop shop for advice, www.Australia.gov.au is regularly updated to give you the latest Coronavirus news and announcements from government agencies across Australia, including:

  • New regulations Australians must comply with such as quarantine and restricted social gatherings.
  • Financial support and assistance packages for individuals, households, families, businesses, employees and communities.
  • Health and prevention measures to slow the spread of COVID-19.
  • How to seek medical assistance remotely and in person, accessing GP consultations and scripts.
  • Guidance on self-isolation and social distancing.
  • Mental health support and wellbeing resources.
  • Advice specific to vulnerable groups such as NDIS participants, the elderly and Indigenous Australians.
  • Travel restrictions.

 Right now, it can be hard to know where to find trusted advice. www.Australia.gov.au puts you on the right path by linking to official information, support and services across all Australian government websites, as well as state and territory resources. Mobile users can download the Government’s Coronavirus Australia app in the Apple App Store or Google Play, and receive updates on the go by joining the Government’s official WhatsApp channel on iOS or Android.

Visit www.Australia.gov.au to keep up-to-date on the Government’s advice and support to help you through the Coronavirus COVID-19 epidemic.

Wednesday, 01 April 2020

Source: Australian Department of Prime Minister and Cabinet

Key to Australia’s effective management of the Coronavirus COVID-19 pandemic is providing accurate, timely information to Australians. www.Australia.gov.au is your trusted source of government information. A one-stop shop for advice, www.Australia.gov.au is regularly updated to give you the latest Coronavirus news and announcements from government agencies across Australia, including:

  • New regulations Australians must comply with such as quarantine and restricted social gatherings.
  • Financial support and assistance packages for individuals, households, families, businesses, employees and communities.
  • Health and prevention measures to slow the spread of COVID-19.
  • How to seek medical assistance remotely and in person, accessing GP consultations and scripts.
  • Guidance on self-isolation and social distancing.
  • Mental health support and wellbeing resources.
  • Advice specific to vulnerable groups such as NDIS participants, the elderly and Indigenous Australians.
  • Travel restrictions.

 Right now, it can be hard to know where to find trusted advice. www.Australia.gov.au puts you on the right path by linking to official information, support and services across all Australian government websites, as well as state and territory resources. Mobile users can download the Government’s Coronavirus Australia app in the Apple App Store or Google Play, and receive updates on the go by joining the Government’s official WhatsApp channel on iOS or Android.

Visit www.Australia.gov.au to keep up-to-date on the Government’s advice and support to help you through the Coronavirus COVID-19 epidemic.

Dwelling approvals rise in February (Media Release)

Source: Australian Bureau of Statistics 2

1 April 2020

MEDIA RELEASE
Embargoed 11:30am (AEDT)

Dwelling approvals rise in February

The number of dwellings approved rose 1.0 per cent in February, in trend terms, according to data released by the Australian Bureau of Statistics (ABS) today.

“The rise was driven by private sector dwellings excluding houses, which rose 1.6 per cent, in trend terms,” said Daniel Rossi, Director of Construction Statistics at the ABS. “A significant rise in the number of apartments approved in February has offset the weakness recorded in January. Private sector houses also rose 0.6 per cent”.

Across the states and territories, dwelling approvals rose in Victoria (3.9 per cent) and Queensland (0.4 per cent). Falls were recorded in the Australian Capital Territory (7.7 per cent), Northern Territory (5.3 per cent), South Australia (2.6 per cent), Western Australia (2.0 per cent) and New South Wales (0.1 per cent), in trend terms, while Tasmania was flat.

Approvals for private sector houses increased in Western Australia (1.0 per cent), Victoria (0.9 per cent), Queensland (0.6 per cent) and New South Wales (0.2 per cent), in trend terms, while South Australia was flat.

The seasonally adjusted estimate for total dwellings approved rose 19.9 per cent in February, driven by a 61.7 per cent increase in private dwellings excluding houses. This was largely due to strength in approvals for apartments in Victoria, which came off a low base in January.

The value of total building approved rose 0.6 per cent in February, in trend terms, and has risen for three months. The value of residential building rose 0.9 per cent, while non-residential building increased 0.1 per cent.

Further information is available in Building Approvals, Australia (cat no. 8731.0).

Media note:

  • When reporting ABS data, the Australian Bureau of Statistics (or ABS) must be attributed as the source.
  • For media requests and interviews, contact the ABS Communications Section on 1300 175 070 (8.30am – 5pm Mon-Fri).
  • Subscribe to our email notification service and receive media releases or products sent to you on release.

Remotely piloted aircraft registration and accreditation – further assistance for industry

Source: Australian Civil Aviation Safety Authority

On 24 March 2020, CASA announced a suite of measures to alleviate pressure on Australian RPA operators while ensuring the ongoing safety of aviation.

COVID-19 is expected to continue to disrupt business and operations for some time, so we are putting in place further measures to assist the RPAS industry.

Drone registration for commercial operators and excluded category operators was scheduled to commence on 1 April 2020 in line with legislation that was passed in July 2019.

The government has agreed to defer mandatory drone registration and accreditation until 30 September 2020.

Recreational drone registration and accreditation is still expected to commence in 2022.

Subscribe to our mailing list for further updates on drone registration and accreditation.

Regards

Shane Carmody
Chief Executive Officer and Director of Aviation Safety

2021 RAAF Heritage Awards announced

Source: Australia Department of Defence

The RAAF Heritage Awards is a literature competition designed to enhance the records of the Air Force and foster interest in its history and heritage.

In a break from previous years, the 2021 round will seek entries that highlight areas of the Air Force’s history, which have not been thoroughly covered in the past.

The focus will be on Cold War activities and Southeast Asia Treaty Organization involvement, United Nations commitments, and post-war transitions as a period of force regeneration and force rebalance.