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Database of TGA listed medicine compliance review results

18 December 2019

Important information about this database

Safety alerts

When serious safety or quality issues are identified with therapeutic goods, this information and any recommendations are posted immediately on the Safety information pages of the TGA website.

Listed medicines are included on the Australian Register of Therapeutic Goods (ARTG) without undergoing pre-market evaluation by TGA. This relies on them satisfying certain criteria to ensure they are low risk and the sponsor certifying that their medicine meets all of the requirements of the Therapeutic Goods Act 1989.

To monitor the safety, quality and efficacy of listed medicines and ensure they meet all requirements once they are on the market, each year the TGA conducts listed medicine compliance reviews on a proportion of those on the ARTG.

If during a compliance review, a medicine is found to not comply with regulatory requirements, the TGA will notify the sponsor and take action according to the risk posed by the medicine to the consumer. The sponsor may be required to resolve the identified issues (such as update their listing or medicine labels) to bring the listed medicine into compliance. In some cases, the medicine may be cancelled from the ARTG, meaning that it can no longer be lawfully supplied to the consumer. Sponsors may also respond with further information to refute conclusions derived during the compliance of their medicine.

This database makes information publically available about the results of TGA's compliance reviews of individual listed medicines. The information contained within the database will assist consumers to make an informed choice about whether a specific listed medicine is safe and does what it says it does, as well as what actions the consumer is recommended to take in response to the findings of the review.

Descriptions of identified issues are provided if they relate to the safety and efficacy of a medicine. Details about minor issues, such as those of an administrative nature, are not provided.

Publication of results only occurs once the compliance review has been concluded, after sponsor has had the opportunity to consider our findings and actions have been undertaken to address any identified issues.

Results are released quarterly.

More information about the publication of compliance review results and this database is provided for sponsors on the post-market compliance reviews web page.

Brief descriptions of the information presented in this database are included below.

ARTG ID: The unique identification code of a product included in the Australian Register of Therapeutic Goods (ARTG). The ARTG ID for listed medicines starts with an 'AUST' and is followed by an 'L' and a sequence of numbers. The ARTG number is displayed on a medicine/s main label.

Review outcome: Indicates whether the medicine is still permitted to be supplied following the compliance review due to whether it remains on the ARTG or not. This may include information on any corrective action taken by sponsors to address identified issues so that the medicine can continue to be included on the ARTG and supplied.

Is it safe to continue using this medicine?: This is indicated by a 'yes' or 'no', with specific directions provided as required.

What action should consumers take?: A summary of any recommended actions for consumers if they have taken or intend to take the medicine.

Sponsor: The sponsor of a product refers to the sponsor at the time the product was reviewed by the TGA. The current sponsor for the product may have changed in the time since the product was reviewed. The current sponsor of a listed medicine product is displayed in the ARTG.

How was this medicine selected for review?: A listed medicine may be selected randomly or be targeted for a review. Further information is provided at: Listed medicines compliance reviews.

Information reviewed: The information the TGA evaluated during the compliance review to determine whether the medicine met the relevant legal requirements. The type of information reviewed can include: the ARTG record of the medicine; labels; advertising; manufacturing documentation; scientific or traditional evidence supporting what the medicine claims to do; laboratory testing results. A compliance review can evaluate some or all of this information.

Issues related to safety: A summary of any issues identified during the compliance review that:

  • have the potential or are likely to affect consumer safety
  • are breaches of legal requirements that are in place to ensure the low-risk status of listed medicines, even if they are unlikely to pose a significant risk to consumer health and safety

Issues related to efficacy: A summary of any issues identified during the compliance review that may, or do, affect product efficacy (that the medicine does what it says it will do).

Actions taken during the review: A summary of the actions that the TGA and the sponsor took during the compliance review to address any issues identified by the TGA, for example: the TGA issuing a notice to the sponsor identifying issues with their medicine.

Cancellation effective date (if applicable): If a listed medicine is cancelled from the ARTG by the TGA following a compliance review, the date the medicine was no longer listed on the ARTG.

Date of review outcome/conclusion: The date the compliance review was closed by the TGA, which is after we consider a sponsor's submissions and any actions they took to rectify any identified issues.

Publication date: The date the compliance review information was published in the database.

Decision status (if applicable): If a listed medicine is cancelled from the ARTG by the TGA following a compliance review but this decision is later appealed and the decision to cancel is overturned.

For further information, please contact Complementary Medicines and OTC Medicines Branch via phone on 1800 020 653 or via email at complementary.medicines@health.gov.au.

Disclaimer about the release of information in this database

While reasonable care is taken to ensure that the information included in the database is an accurate record of the results and outcomes of TGA's listed medicines compliance reviews, the TGA does not guarantee or warrant the accuracy, reliability, completeness or currency of the information or its usefulness in achieving any purpose.

To the fullest extent permitted by law, including but not limited to section 61A of the Therapeutic Goods Act 1989, the TGA will not be liable for any loss, damage, cost or expense incurred in or arising by reason of any person relying on this information.

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Compliance review results

Well-Being

Date of review outcome: 16 Dec 2019

Publication date: Dec-19

ARTG ID: 234237

Review outcome:

Medicine continues to be permitted for supply

Is it safe to continue using this medicine?

Yes

What action should consumers take?

Consider whether the medicine is right for you given that the claims about maintenance or improvement of general well-being, increasing endurance, improving stamina, replenishing vital essence and invigorating qi were not substantiated.

Sponsor

Modere Australia Pty Ltd

How was this medicine selected for review?

Targeted

Information reviewed

Labels, Evidence, Manufacturing documentation, Website, ARTG Record

Issues related to safety

None

Issues related to efficacy

The sponsor did not hold sufficient evidence to support the advertised claims related to maintenance and improvement of general well-being, increasing endurance, improving stamina, replenishing vital essence and invigorating qi. The dosages and method of preparation of ingredients in the evidence provided were not relevant to the medicine. The populations described in the evidence were not relevant to the target population of the medicine. The evidence was not relevant to support indications based on a tradition of use in Traditional Chinese Medicine.

Actions taken during the review

TGA issued an educational letter to the sponsor. The sponsor was not required to respond but was expected to correct these issues.

Suppository for Hemorrhoid

Date of review outcome: 16 Dec 2019

Publication date: Dec-19

ARTG ID: 107592

Review outcome:

Medicine is no longer permitted to be supplied

Is it safe to continue using this medicine?

No, continued use is not recommended as its safety is not considered acceptable for a listed medicine

What action should consumers take?

Stop using this medicine immediately and seek advice from a healthcare practitioner

Sponsor

Shen Neng Herbal Medicines Group Pty Ltd

How was this medicine selected for review?

Targeted

Information reviewed

ARTG Record

Issues related to safety

The medicine contains a herbal ingredient (Datura stramonium) which is only allowed for use in listed medicines taken orally. However, this medicine is for rectal use. Additionally, the levels of this herbal ingredient are higher than that permitted for listed medicines. However, current data indicates that the amount of this ingredient contained in the medicine is unlikely to pose an immediate safety risk following rectal use.

Issues related to efficacy

The efficacy of the medicine was not assessed as part of this review

Actions taken during the review

TGA required the sponsor to correct the issues with the product. The sponsor cancelled their medicine and withdrew it from further supply.

Freely Moving

Date of review outcome: 16 Dec 2019

Publication date: Dec-19

ARTG ID: 282519

Review outcome:

Medicine continues to be permitted for supply

Is it safe to continue using this medicine?

Yes

What action should consumers take?

None

Sponsor

BlueSkyGreenEarth Herbs Pty Ltd

How was this medicine selected for review?

Random

Information reviewed

ARTG Record, Evidence, Labels, Manufacturing Documentation, Website

Issues related to safety

None

Issues related to efficacy

None

Actions taken during the review

TGA required the sponsor to correct the issues with the product. The sponsor responded with more information about their medicine and no further action was required.

Fertility Formula Female

Date of review outcome: 16 Dec 2019

Publication date: Dec-19

ARTG ID: 301937

Review outcome:

Medicine continues to be permitted for supply. Batches released from February 2020 must carry a correct vitamin B6 warning statement on the medicine label.

Is it safe to continue using this medicine?

Yes, if you follow the recommended action for consumers below

What action should consumers take?

Stop taking this medicine if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible, especially if you are taking multiple medicines containing vitamin B6.

Sponsor

Mygen Health Pty Ltd

How was this medicine selected for review?

Targeted

Information reviewed

Labels

Issues related to safety

The label had an incorrect version of the warning statement 'Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible. [Contains vitamin B6]', in that the statement 'Contains vitamin B6' was missing. These symptoms may be signs of nerve damage in some individuals as a result of vitamin B6 intake. It is important to help consumers link these symptoms to medicines containing vitamin B6, especially when taking medicines with multiple ingredients.

Issues related to efficacy

The efficacy of the medicine was not assessed as part of this review

Actions taken during the review

TGA required the sponsor to correct the issues with the product. The sponsor updated the label to include the correct warning statement.

Crystal Complexion Tablet

Date of review outcome: 16 Dec 2019

Publication date: Dec-19

ARTG ID: 279318

Review outcome:

Medicine is no longer permitted to be supplied

Is it safe to continue using this medicine?

Yes

What action should consumers take?

None

Sponsor

Sunpab Health Products Pty Ltd

How was this medicine selected for review?

Targeted

Information reviewed

Labels

Issues related to safety

None

Issues related to efficacy

The efficacy of the medicine was not assessed as part of this review

Actions taken during the review

TGA required the sponsor to correct the minor issues with the product. The sponsor cancelled their medicine and withdrew it from further supply.

After Workout

Date of review outcome: 12 Dec 2019

Publication date: Dec-19

ARTG ID: 235509

Review outcome:

Medicine continues to be permitted for supply. Batches released from 1 March 2020 must carry a corrected label.

Is it safe to continue using this medicine?

Yes

What action should consumers take?

None

Sponsor

Arbonne International LLC

How was this medicine selected for review?

Targeted

Information reviewed

Labels

Issues related to safety

None

Issues related to efficacy

The efficacy of the medicine was not assessed as part of this review

Actions taken during the review

TGA required the sponsor to correct the minor issues with the product. The sponsor updated the labels of the medicine to correct these issues.