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

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

The Prescribing Medicines in Pregnancy database has now been updated.

Delays in processing timeframes of applications to extend GMP Clearances.

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

From 1 June 2023, prescribing of oral ivermectin for ‘off-label’ uses will no longer be limited to specialists such as dermatologists, gastroenterologists and infectious diseases specialists.

Listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2023.

The TGA has issued nine infringement notices to three companies and two associated individuals for the alleged unlawful importation of nicotine vaping products.

Essential Principle 7 now mentions nanomaterials explicitly (see EP 7.7).

From 22 March 2023 changes to the Therapeutic Goods Act 1989 will help alleviate the effects of medicine shortages on patients.

Provisional registration of Tecentriq (atezolizumab) for the treatment in mTNBC will lapse on 22 March 2023.

More applications for Good Manufacturing Practice (GMP) clearances can now be assessed under the TGA’s MRA pathway.

The TGA is aware of several scams targeting consumers seeking semaglutide (Ozempic). Consumers are strongly advised not to use products unless they have come from a trusted source.

This instrument is made under section 39 of the current Poisons Standard.

This labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.

From 1 July this year, medicines containing the psychedelic substances psilocybin and MDMA can be prescribed by specifically authorised psychiatrists for the treatment of certain mental health conditions.

Current antibiotics shortages in Australia include amoxicillin, amoxicillin/clavulanic acid, cefalexin, metronidazole and trimethoprim.

The Generic Medicines Work-Sharing Initiative has updated its Operational Procedures document and Expression Of Interest form.

Approval of the Therapeutic Goods (Biologicals—Application Form for Priority Applicant Determinations)

A warning to social media influencers and advertisers not to advertise this prescription medicine.

Arrangement under subsection 7C(1) of the Therapeutic Goods Act 1989 for use of computer programs to make decisions under sections 61(3)(a), 61(5AA), and 61(5AB) of the Act

The Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey is now open until 18 December 2022 for medicine sponsors to complete.

JSHealth Vitamins Pty Ltd fined for alleged unlawful advertising

The TGA approved Moderna Australia’s application to transition its COVID-19 vaccine, SPIKEVAX (elasomeran), from provisional to full registration.

TGA has released over 95 batches of influenza vaccine, consisting of over 16.8 million doses, for supply in Australia for the 2022 influenza season.