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195 result(s) found, displaying 51 to 75
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Regulatory decision noticesFind out about how GMP clearances for manufacturing sites in Bulgaria can now be assessed via the Mutual Recognition Agreement (MRA) pathway.
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Regulatory decision noticesInformation about GMP clearances issued via the MRA Pathway that expire on 31 December 2023 as well as information on the ongoing use of the GMP clearance questionnaire.
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Regulatory decision noticesWe've granted a labelling exemption for the COVID-19 Vaccine, Pfizer (raxtozinameran), under the current Poisons Standard.
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Regulatory decision noticesFind out how listed medicine ingredients, and requirements for their use, have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2023.
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Regulatory decision noticesArrangement under subsection 7C(1) of the Therapeutic Goods Act 1989
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Regulatory decision noticesThis instrument is made under subregulation 10JD(4) of the Therapeutic Goods Regulations 1990.
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Regulatory decision noticesFind out how listed medicine ingredients, and requirements for their use, have been updated in the latest Therapeutic Goods (Permissible Ingredients) Determination.
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Regulatory decision noticesThe TGA has provisionally approved Pfizer’s bivalent COVID-19 vaccine, tozinameran and riltozinameran (COMIRNATY Original/Omicron BA.1) for use as a booster dose in adults 18 years and over.
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Regulatory decision noticesArrangement under subsection 7C(1) of the Therapeutic Goods Act 1989
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Regulatory decision noticesArrangement under subsection 7C(1) of the Therapeutic Goods Act 1989
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Regulatory decision noticesDelays in processing timeframes of applications to extend GMP Clearances.
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Regulatory decision noticesListed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2023.
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Regulatory decision noticesMore applications for Good Manufacturing Practice (GMP) clearances can now be assessed under the TGA’s MRA pathway.
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Regulatory decision noticesListed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2023.
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Regulatory decision noticesThis instrument is made under section 39 of the current Poisons Standard.
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Regulatory decision noticesThis labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.
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Regulatory decision noticesThe TGA has issued a direction notice to a Melbourne-based individual to cease advertising of all nicotine vaping products.
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Regulatory decision noticesThis instrument is made under subsection 26BD(3) of the Therapeutic Goods Act 1989.
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Therapeutic Goods (Biologicals-Application Form for Priority Applicant Determinations) Approval 2022
Regulatory decision noticesApproval of the Therapeutic Goods (Biologicals—Application Form for Priority Applicant Determinations) -
Regulatory decision noticesListed medicine ingredients and requirements are updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 5) 2022.
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Regulatory decision noticesArrangement 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
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Regulatory decision noticesThis instrument is the Therapeutic Goods (Poisons Standard) (COVID-19 Vaccine - Pfizer) (Tozinameran and Riltozinameran) Labelling Exemption 2022.
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Regulatory decision noticesThe TGA has issued a direction notice to MDNE Enterprises Pty Ltd to cease promoting the use and supply of nicotine vaping products to the Australian public.
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Regulatory decision noticesThis instrument is the Therapeutic Goods (Poisons Standard) (COVID-19 Vaccine - Moderna) (Elasomeran and Imelasomeran) Labelling Exemption 2022.
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Regulatory decision noticesThe TGA has provisionally approved Moderna's bivalent COVID-19 vaccine, elasomeran/imelasomeran (SPIKEVAX Bivalent Original/Omicron) for use as a booster dose in adults 18 years and over.