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Understand the Medicines Safety Update for June 2023 - Information for health professionals and consumers.

To help sponsors and manufacturers transition to new manufacturer evidence.

Information about the TGA's safety monitoring of COVID-19 vaccines.

The TGA has issued three infringement notices totalling $39,960 to Queensland-based company Pracmed Healthcare Pty Ltd for alleged unlawful advertising of complementary medicines.

The TGA has issued 38 infringement notices totalling $588,840 to four Sydney-based entities for allegedly importing 22 consignments containing a total of 379,600 nicotine vaping products.

The TGA has issued 5 infringement notices to Affinity Corp Australia Pty Ltd for the alleged unlawful advertising of medicinal cannabis products.

Check the labels of all medicines and medical devices, including those you buy without a doctor’s prescription.

Medicines Safety Update - Information for health professionals

These international recognition routes, which have been facilitated by existing international partnerships such as those developed through the Access Consortium and Project Orbis, are part of a new international recognition framework for medicines that is specific to the UK following their exit from the European Union.

Influenza vaccines can change from year to year as new strains of influenza virus appear. This is one reason vaccination against influenza is given every year.

Information about the TGA's safety monitoring of COVID-19 vaccines.

Want to know what’s in your medicines? The obvious place to start is with the medicine’s label, but there may be more to it.

A warning about anticoagulant-related nephropathy (ARN) has been added to the Product Information (PI) for all oral anticoagulants.

The TGA has approved applications submitted by Australian Red Cross Lifeblood (Lifeblood) to remove most of the sexual activity ineligibility criteria for plasma donors used for fractionated products only. Lifeblood refers to this approach as ‘the plasma pathway’.

Transition period for accepting ISO 13485 ends 26 May 2023.

It is alleged that the individual attempted to import six different types of nicotine vaping products (prescription medicines). The unapproved nicotine vaping products were intercepted by the Australian Border Force and have been seized and will be destroyed under advice from the TGA.

Arrangement under subsection 7C(1) of the Therapeutic Goods Act 1989

Arrangement under subsection 7C(1) of the Therapeutic Goods Act 1989

Information about the TGA's safety monitoring of COVID-19 vaccines.

Delays in processing timeframes of applications to extend GMP Clearances.

The Prescribing Medicines in Pregnancy database has now been updated.

The TGA has issued 5 infringement notices to 3 health practitioners for the alleged unlawful importation of unregistered prescription-only medicines.

New warnings for baricitinib, tofacitinib and upadacitinib follow a TGA review of a randomised safety trial called the ORAL Surveillance Study.

The TGA has updated the Australian Regulatory Guidelines for Sunscreens (ARGS) to align with the data requirements for all ingredients proposed to be included in the Therapeutic Goods (Permissible Ingredients) Determination

The TGA will recognise the extended transition for the European Union Medical Device Regulation (EU MDR).