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Section 14 consents
Search 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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You can narrow down the results using the filters.
Therapeutic good type
- Prescription medicines (1524)
- Listed complementary medicines (952)
- Over-the-counter medicines (254)
- Blood, tissues, and biologicals (212)
- Other therapeutic goods non-approved (87)
- Registered complementary medicines (51)
- Other therapeutic goods registered (4)
- Other therapeutic goods listed (2)
- Listed Medicines (1)
Decision date
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Section 14 consentConsent to Supply while noncompliant with standards. The consent is effective from 15 October 2021 until 30 May 2022.
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Section 14 consentConsent to Supply while noncompliant with standards. The consent is effective from 15 October 2021 until 30 May 2022.
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Section 14 consentConsent to Import and supply while noncompliant with standards. The consent is effective from the 15th October 2021 until 17 August 2023.
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Section 14 consentConsent to Import and supply while noncompliant with standards. The consent is effective from 14 October 2021 until 13 October 2022.
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Section 14 consentConsent to Supply while noncompliant with standards. The consent is effective from the 6 October 2021 until 7 October 2022.
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Section 14 consentConsent to Import and supply while noncompliant with standards. The consent is effective for batch number C2000129 of the product from 27 September 2021 until 27 September 2026, or until the batch is depleted, whichever is sooner.
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CARDIZEM CD diltiazem hydrochloride 360 mg capsule bottle, Sanofi-Aventis Australia Pty Ltd, CON-871
Section 14 consentConsent to Import and supply while noncompliant with standards. The consent is effective from the 24 September 2021 until 30 April 2022 -
Section 14 consentConsent to Import and supply while noncompliant with standards. The consent is effective from the 24 September 2021 until 30 April 2022
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Section 14 consentConsent to Import and supply while noncompliant with standards. The consent is effective for all batches of the products released from 24 September 2021 until 31 October 2023.
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Section 14 consentConsent to Import and supply while noncompliant with standards. The consent is effective for all batches of the products released from 24 September 2021 until 31 October 2023.
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Section 14 consentConsent to Import and supply while noncompliant with standards. The consent is effective from the 24 September 2021 until 30 April 2022
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Section 14 consentConsent to Import and supply while noncompliant with standards. The consent is effective from 16 September 2021 until supply of the affected clinical trial labelled batches 1163406, 1164929, 1163292, 1163279, 1162729, 1163299, 1164608, and 1164287 is exhausted.
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Section 14 consentConsent to Supply while noncompliant with standards. The consent is effective from 16 September 2021 until 31 July 2023.
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Section 14 consentConsent to Supply while noncompliant with standards. The consent is effective from 14 September 2021 until 31 October 2021.
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Section 14 consentConsent to Import and supply while noncompliant with standards.
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Section 14 consentConsent to Import and supply while noncompliant with standards. The consent is effective from 10 September 2021 until 10 September 2023.
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Section 14 consentConsent to Import and supply while noncompliant with standards. The consent is effective from 9 September 2021 until 23 July 2022.
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Section 14 consentConsent to Supply while noncompliant with standards. The consent is effective from 2 September 2021 until 1 September 2022.
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Section 14 consentConsent to Supply while noncompliant with standards. The consent is effective from 2 September 2021 until 1 September 2022.
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Section 14 consentConsent to Supply while noncompliant with standards. The consent is effective from 2 September 2021 until 1 September 2022.
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Section 14 consentConsent to Supply while noncompliant with standards. The consent is effective from 2 September 2021 until 1 September 2022.
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Section 14 consentConsent to Supply while noncompliant with standards. The consent is effective from 2 September 2021 until 1 September 2022.
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Section 14 consentConsent to Supply while noncompliant with standards. The consent is effective from 2 September 2021 until 1 September 2022.
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Section 14 consentConsent to Supply while noncompliant with standards. The consent is effective from 2 September 2021 until 1 September 2022.
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Section 14 consentConsent to Supply while noncompliant with standards. The consent is effective from 2 September 2021 until 1 September 2022.