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Section 14 consents
Database of consents to import, supply or export therapeutic goods that do not comply with standards
Medicines and other therapeutic goods must comply with applicable standards to be supplied in Australia.
Under the Therapeutic Goods Act 1989 prior consent must be given under sections 14 and 14A of the Act to the import, export or supply of therapeutic goods that do not comply with an applicable standard. The Secretary can impose conditions on the consent under section 15 of the Act.
The records below include information about these decisions, and any subsequent review of such decisions. All records below which relate to a single consent decision will have the same consent number.
Information about decisions made before 29 January 2016 are on the Federal Register of Legislation website.
For guidance on applying for consent see Consent to import, supply or export therapeutic goods that do not comply with standards - information for industry
In July 2020, TGA created a special consent process for prescription medicine manufacturers experiencing difficulties in introducing new TGO91 labels into their manufacturing process due to COVID-19. These decisions are displayed in a separate database: Database of consents for prescription medicines that do not comply with TGO 91 labelling due to COVID-19.
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4782 result(s) found, displaying 1 to 25
- Section 14 consentMedtronic Australasia Pty Ltd, from CON-1010, Musculoskeletal Tissue - Bone, morsellised, demineralised - L - Grafton DBM Flex - Medtronic Australasia Pty Ltd - Implant - PouchApproved for Import and supply while noncompliant with standards. The consent is effective from the 21 September 2022 until 21 December 2022.
- Section 14 consentMedtronic Australasia Pty Ltd, from CON-1010, Musculoskeletal Tissue - Bone, morsellised, demineralised - L - Grafton Plus DBM Paste - Medtronic Australasia Pty Ltd - Implant - SyringeApproved for Import and supply while noncompliant with standards. The consent is effective from the 21 September 2022 until 21 December 2022.
- Section 14 consentMedtronic Australasia Pty Ltd, from CON-1010, Musculoskeletal Tissue - Bone, morsellised, demineralised - L - Grafton DBM Matrix - Medtronic Australasia Pty Ltd - Implant - PouchApproved for Import and supply while noncompliant with standards. The consent is effective from the 21 September 2022 until 21 December 2022.
- Section 14 consentAustralian Nuclear Science and Technology Organisation T/A ANSTO, from CON-1011, Sodium iodide(131I) 200 MBq/mL Therapy Solution oral liquid BP vialApproved for Supply and export while noncompliant with standards. This consent is effective from 26 September 2022 until 31 December 2022.
- Section 14 consentAustralian Nuclear Science and Technology Organisation T/A ANSTO, from CON-1011, AUSTRALIAN RADIOISOTOPES Sodium Iodide (I-131) 50 - 6000 MBq Therapy Capsule vialApproved for Supply and export while noncompliant with standards. This consent is effective from 26 September 2022 until 31 December 2022.
- Section 14 consentAustralian Nuclear Science and Technology Organisation T/A ANSTO, from CON-1011, Sodium iodide(131I) 2000 MBq/mL Therapy Solution oral liquid BP vialApproved for Supply and export while noncompliant with standards. This consent is effective from 26 September 2022 until 31 December 2022.
- Section 14 consentViatris Pty Ltd, from CON-1012, VIAGRA sildenafil (as citrate) 50 mg tablet blister packApproved for Import and supply while noncompliant with standards. The consent is effective from 30 September 2022 until 30 September 2024 for import and supply of the affected batch.
- Section 14 consentMedtronic Australasia Pty Ltd, from CON-1013, Musculoskeletal Tissue - Bone, morsellised, demineralised - L - Grafton DBM Orthoblend - Implant - Jar/CanApproved for Import and supply while noncompliant with standards. The consent is effective from 21 September 2022 until 21 December 2022.
- Section 14 consentMedtronic Australasia Pty Ltd, from CON-1013, Musculoskeletal Tissue - Bone, morsellised, demineralised - L - Grafton DBM Flex - Implant - PouchApproved for Import and supply while noncompliant with standards. The consent is effective from 21 September 2022 until 21 December 2022.
- Section 14 consentMedtronic Australasia Pty Ltd, from CON-1013, Musculoskeletal Tissue - Bone, morsellised, demineralised - L - Grafton Plus DBM Paste - Implant - SyringeApproved for Import and supply while noncompliant with standards. The consent is effective from 21 September 2022 until 21 December 2022.
- Section 14 consentMedtronic Australasia Pty Ltd, from CON-1013, Musculoskeletal Tissue - Bone, morsellised, demineralised - L - Grafton DBM Matrix - Implant - PouchApproved for Import and supply while noncompliant with standards. The consent is effective from 21 September 2022 until 21 December 2022.
- Section 14 consentViatris Pty Ltd, from CON-1014, CILICAINE VK phenoxymethylpenicillin (as potassium) 250 mg capsule blister packApproved for Import and supply while noncompliant with standards. The consent is effective from 11 October 2022 until 11 October 2023.
- Section 14 consentJuno Pharmaceuticals Pty Ltd, from CON-1015, TIROFIBAN JUNO tirofiban (as hydrochloride) 12.5 mg/50 mL Concentrated Injection for infusion VialApproved for Supply while noncompliant with standards. The consent is effective from 13 October 2022 until 30 June 2023.
- Section 14 consentMerck Healthcare Pty Ltd, from CON-1016, TEPMETKO tepotinib 225 mg (as hydrochloride monohydrate) tablet blister packApproved for Import and supply while noncompliant with standards. The consent is effective for all relevant batches released from 13 October 2022 until 29 September 2023.
- Section 14 consentModerna Australia Pty Ltd, from CON-1017, SPIKEVAX BIVALENT ORIGINAL/OMICRON (elasomeran and imelasomeran) COVID-19 VACCINE 0.1 mg/mL suspension for injection vialApproved for Import and supply while noncompliant with standards. The consent is effective from 18 October 2022 until 29 August 2024
- Section 14 consentBayer Australia Ltd, from CON-1018, ULTRAVIST 370 iopromide 153.77 g/200 mL injection bottleApproved for Import and supply while noncompliant with standards. The consent is effective for all batches of the products released for supply from 20 October 2022 until 20 October 2024.
- Section 14 consentBayer Australia Ltd, from CON-1018, ULTRAVIST 150 iopromide 62.34 g/200 mL injection bottleApproved for Import and supply while noncompliant with standards. The consent is effective for all batches of the products released for supply from 20 October 2022 until 20 October 2024.
- Section 14 consentAustralian Red Cross Lifeblood, from CON-384,Approved for Supply while noncompliant with standards. The consent has no end date however it will become ineffective when the transition period ends.
- Section 14 consentAustralian Red Cross Lifeblood, from CON-385,Approved for Supply while noncompliant with standards. The consent is effective from 23 March 2020 until the conditions no longer remain true.
- Section 14 consentAustralian Red Cross Lifeblood, from CON-386,Approved for Supply while noncompliant with standards. The consent is effective from 23 March 2020 until the following conditions no longer remain true.
- Section 14 consentAustralian Red Cross Lifeblood, from CON-387,Approved for Supply while noncompliant with standards. The consent is effective from 23 March 2020 until the conditions no longer remain true.
- Section 14 consentAustralian Red Cross Lifeblood, from CON-390,Approved for Supply while noncompliant with standards. The consent is effective from 23 March 2020 until the conditions no longer remain true.
- Section 14 consentAustralian Red Cross Lifeblood, from CON-391,Approved for Supply while noncompliant with standards. The consent is effective from 23 March 2020 until the conditions no longer remain true.
- Section 14 consentiNova Pharmaceuticals (Australia) Pty Ltd, from CON-508,Approved for Supply while noncompliant with standards. The consent is effective from the 23 July 2020 until 30 November 2020
- Section 14 consentAustralian Red Cross Lifeblood, from CON-520,Approved for Supply while noncompliant with standards. This consent is effective from the 28 July 2020 until further information is submitted to the Therapeutic Goods Administration (TGA) for review.