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.

4726 result(s) found, displaying 4376 to 4400

Swisse Ultiboost High Strength Deep Sea Krill Oil, Swisse Wellness Pty Ltd, CON-240

21 February 2018

Section 14 consent

Consent to while noncompliant with standards.
Swisse Ultiboost Super Strength Deep Sea Krill Oil, Swisse Wellness Pty Ltd, CON-240

21 February 2018

Section 14 consent

Consent to while noncompliant with standards.
Pandemic Influenza Vaccine H5N1 BAXTER (whole virion, vero cell derived, inactivated) suspension for injection 0.5 ml dose syringe, AU Pharma Pty Ltd, CON-246

30 January 2018

Section 14 consent

Consent to while noncompliant with standards.
Pandemic Influenza Vaccine H5N1 BAXTER (whole virion, vero cell derived, inactivated) suspension for injection 0.5 ml dose vial, AU Pharma Pty Ltd, CON-246

30 January 2018

Section 14 consent

Consent to while noncompliant with standards.
MENVEO meningococcal (Groups A, C, W-135 and Y) oligosaccharide CRM197 conjugate vaccine, GlaxoSmithKline Australia Pty Ltd, CON-238

21 December 2017

Section 14 consent

Consent to while noncompliant with standards.
PULMICORT Respules budesonide 0.125 mg/mL nebuliser suspension, AstraZeneca Pty Ltd, CON-239

21 December 2017

Section 14 consent

Consent to while noncompliant with standards.
PULMICORT Respules budesonide 0.125 mg/mL suspension for inhalation ampoule, AstraZeneca Pty Ltd, CON-239

21 December 2017

Section 14 consent

Consent to while noncompliant with standards.
PULMICORT Respules budesonide 0.25 mg/mL suspension for inhalation ampoule, AstraZeneca Pty Ltd, CON-239

21 December 2017

Section 14 consent

Consent to while noncompliant with standards.
PULMICORT Respules budesonide 0.5 mg/mL suspension for inhalation ampoule, AstraZeneca Pty Ltd, CON-239

21 December 2017

Section 14 consent

Consent to while noncompliant with standards.
MEN'S REGAINE EXTRA STRENGTH FOAM (new formula) minoxidil 5% w/w aerosol can, Johnson Johnson Pacific Pty Ltd, CON-237

18 December 2017

Section 14 consent

Consent to while noncompliant with standards.
WOMEN'S REGAINE minoxidil 5% w/w spray aerosol can, Johnson Johnson Pacific Pty Ltd, CON-237

18 December 2017

Section 14 consent

Consent to while noncompliant with standards.
LATANOPROST SANDOZ latanoprost 50 micrograms/mL eye drop solution bottle, Sandoz Pty Ltd, CON-235

15 December 2017

Section 14 consent

Consent to while noncompliant with standards.
DILATREND carvedilol 12.5 mg tablet blister pack, Pharmaco Australia Ltd, CON-234

14 December 2017

Section 14 consent

Consent to while noncompliant with standards.
DILATREND carvedilol 25 mg tablet blister pack, Pharmaco Australia Ltd, CON-234

14 December 2017

Section 14 consent

Consent to while noncompliant with standards.
DILATREND carvedilol 6.25 mg tablet blister pack, Pharmaco Australia Ltd, CON-234

14 December 2017

Section 14 consent

Consent to while noncompliant with standards.
CREON 10,000 capsule bottle (reformulation), Mylan Health Pty Ltd, CON-233

11 December 2017

Section 14 consent

Consent to while noncompliant with standards.
CREON 25,000 pancreatic extract 300 mg capsule bottle, Mylan Health Pty Ltd, CON-233

11 December 2017

Section 14 consent

Consent to while noncompliant with standards.
CREON 40,000 pancreatic extract 400 mg capsules of enteric-coated minimicropsheres bottle, Mylan Health Pty Ltd, CON-233

11 December 2017

Section 14 consent

Consent to while noncompliant with standards.
CREON MICRO pancreatic extract 20 g enteric coated granules bottle, Mylan Health Pty Ltd, CON-233

11 December 2017

Section 14 consent

Consent to while noncompliant with standards.
ENOXAPARIN WINTHROP enoxaparin sodium 100 mg/1 mL injection syringe, Sanofi'“Aventis Australia Pty Ltd, CON-232

28 November 2017

Section 14 consent

Consent to while noncompliant with standards.
ENOXAPARIN WINTHROP enoxaparin sodium 60 mg/0.6 mL injection syringe, Sanofi'“Aventis Australia Pty Ltd, CON-232

28 November 2017

Section 14 consent

Consent to while noncompliant with standards.
ENOXAPARIN WINTHROP enoxaparin sodium 80 mg/0.8 mL injection syringe, Sanofi'“Aventis Australia Pty Ltd, CON-232

28 November 2017

Section 14 consent

Consent to while noncompliant with standards.
AGRYLIN anagrelide hydrochloride 0.5 mg capsule bottle, Shire Australia Pty Limited, CON-231

23 November 2017

Section 14 consent

Consent to while noncompliant with standards.
CINRYZE C1 esterase inhibitor 500 units powder for solution for injection vial with diluent vial, Shire Australia Pty Limited, CON-231

23 November 2017

Section 14 consent

Consent to while noncompliant with standards.
FIRAZYR icatibant (as acetate) 30 mg/3 mL injection pre-filled syringe, Shire Australia Pty Limited, CON-231

23 November 2017

Section 14 consent

Consent to while noncompliant with standards.

Sub menu

Section 14 consents

Filter results

Therapeutic good type

Decision date

Swisse Ultiboost High Strength Deep Sea Krill Oil, Swisse Wellness Pty Ltd, CON-240

Swisse Ultiboost Super Strength Deep Sea Krill Oil, Swisse Wellness Pty Ltd, CON-240

Pandemic Influenza Vaccine H5N1 BAXTER (whole virion, vero cell derived, inactivated) suspension for injection 0.5 ml dose syringe, AU Pharma Pty Ltd, CON-246

Pandemic Influenza Vaccine H5N1 BAXTER (whole virion, vero cell derived, inactivated) suspension for injection 0.5 ml dose vial, AU Pharma Pty Ltd, CON-246

MENVEO meningococcal (Groups A, C, W-135 and Y) oligosaccharide CRM197 conjugate vaccine, GlaxoSmithKline Australia Pty Ltd, CON-238

PULMICORT Respules budesonide 0.125 mg/mL nebuliser suspension, AstraZeneca Pty Ltd, CON-239

PULMICORT Respules budesonide 0.125 mg/mL suspension for inhalation ampoule, AstraZeneca Pty Ltd, CON-239

PULMICORT Respules budesonide 0.25 mg/mL suspension for inhalation ampoule, AstraZeneca Pty Ltd, CON-239

PULMICORT Respules budesonide 0.5 mg/mL suspension for inhalation ampoule, AstraZeneca Pty Ltd, CON-239

MEN'S REGAINE EXTRA STRENGTH FOAM (new formula) minoxidil 5% w/w aerosol can, Johnson Johnson Pacific Pty Ltd, CON-237

WOMEN'S REGAINE minoxidil 5% w/w spray aerosol can, Johnson Johnson Pacific Pty Ltd, CON-237

LATANOPROST SANDOZ latanoprost 50 micrograms/mL eye drop solution bottle, Sandoz Pty Ltd, CON-235

DILATREND carvedilol 12.5 mg tablet blister pack, Pharmaco Australia Ltd, CON-234

DILATREND carvedilol 25 mg tablet blister pack, Pharmaco Australia Ltd, CON-234

DILATREND carvedilol 6.25 mg tablet blister pack, Pharmaco Australia Ltd, CON-234

CREON 10,000 capsule bottle (reformulation), Mylan Health Pty Ltd, CON-233

CREON 25,000 pancreatic extract 300 mg capsule bottle, Mylan Health Pty Ltd, CON-233

CREON 40,000 pancreatic extract 400 mg capsules of enteric-coated minimicropsheres bottle, Mylan Health Pty Ltd, CON-233

CREON MICRO pancreatic extract 20 g enteric coated granules bottle, Mylan Health Pty Ltd, CON-233

ENOXAPARIN WINTHROP enoxaparin sodium 100 mg/1 mL injection syringe, Sanofi'“Aventis Australia Pty Ltd, CON-232

ENOXAPARIN WINTHROP enoxaparin sodium 60 mg/0.6 mL injection syringe, Sanofi'“Aventis Australia Pty Ltd, CON-232

ENOXAPARIN WINTHROP enoxaparin sodium 80 mg/0.8 mL injection syringe, Sanofi'“Aventis Australia Pty Ltd, CON-232

AGRYLIN anagrelide hydrochloride 0.5 mg capsule bottle, Shire Australia Pty Limited, CON-231

CINRYZE C1 esterase inhibitor 500 units powder for solution for injection vial with diluent vial, Shire Australia Pty Limited, CON-231

FIRAZYR icatibant (as acetate) 30 mg/3 mL injection pre-filled syringe, Shire Australia Pty Limited, CON-231

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