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79 result(s) found, displaying 1 to 25
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BlogWhile we encourage health practitioners to prescribe approved therapeutic goods where possible, unapproved therapeutic goods can be accessed in limited circumstances.
In making these joint decisions to use an unapproved therapeutic good, your doctor is required to inform you of the potential benefits and risks. -
NewsWe will be initiating targeted compliance reviews of selected listed medicines that are required to display a warning statement
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Compliance undertakingsWe have accepted a court-enforceable undertaking from Your Solution Compounding Pharmacy Pty Ltd, regarding advertising of prescription-only compounded medicines for weight-loss.
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Media releasesWe have accepted a court-enforceable undertaking from Your Solution Compounding Pharmacy Pty Ltd, regarding advertising of prescription-only compounded medicines for weight-loss.
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NoticesUpdate on the progress in reducing the backlog of GMP Clearance Compliance Verification (CV) applications.
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NoticesListed medicines indications and requirements for their use have been updated in the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025.
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NoticesListed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2025, which commenced on 1 March 2025
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NoticesThis consent is given under sections 14 and 14A of the Therapeutic Goods Act 1989.
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Safety updatesTCMs sold in Australia are carefully regulated to ensure safety and quality.
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NoticesMRA GMP clearances that are expiring on 31 December 2024 will be automatically extended.
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BlogIf your business sells or advertises paracetamol, then you need to be aware of the new rules around pack sizes that commence on 1 February 2025.
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NoticesThis instrument is made under section 39 of the current Poisons Standard.
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NoticesThis instrument is made under section 39 of the current Poisons Standard.
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NoticesWe are providing a 12-month period of labelling exemptions for signal words for certain Pharmacy medicine and Pharmacist Only medicine products.
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Safety updatesHealth professionals and consumers are advised that the oral antihistamine promethazine hydrochloride, sold as Phenergan and other generic brands, should not be used in children under 6 years of age.
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NoticesFind out how listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 3) which commenced on 27 September 2024.
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Media releasesThe TGA reminds businesses and media outlets that it is unlawful to publicly advertise prescription-only medicines, including prescription-only weight loss medicines.
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NoticesInformation for manufacturers and sponsors regarding a new method for GMP inspections that will be used from 1 July 2024 and the extended validity of TGA issued GMP Certificates.
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Media releasesAmendments to the Therapeutic Goods Regulations 1990 (Schedule 5, item 6) have been made resulting in compounded GLP-1 RA products no longer being able to be compounded by pharmacists and supplied to patients.
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NoticesFind out how listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2024, which commenced on 14 June 2024.
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NoticesThis instrument is the Therapeutic Goods (Poisons Standard) (Benzylpenicillin—Seqirus) Approval 2024.
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BlogSome online health clinics are advertising and selling compounded medicines. However, it is important to know that compounded products are not identical to TGA approved products.
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NewsWe will adopt the 2021 Sunscreen Standard into therapeutic goods legislation. If you're a manufacturer or sponsor, find out what this means for you.
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NewsThe Assessed listed medicine evidence guidelines have been updated, based on feedback, to aid sponsors in preparing their product applications.
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NoticesFind out how listed medicine ingredients, and requirements for their use, have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2024.
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