Listed complementary medicine compliance reviews
- Cancellations from the ARTG following compliance review
- Australian regulatory guidelines for complementary medicines (ARGCM)
- Complementary medicines reforms
- Publishing outcomes of listing compliance reviews
- Complementary medicines - compliance reviews 2013
- Complementary medicines - compliance reviews outcomes 2014
Process for listing medicines
Listed medicines are low risk medicines and are included on the Australian Register of Therapeutic Goods (ARTG) through an electronic application and validation process.
Refer to Overview of listed complementary medicines for information on the regulatory framework for listed medicines.
At the time of submitting an application for a listed medicine, the sponsor certifies that their medicine meets all of the requirements of section 26A of the Therapeutic Goods Act 1989.
Listed medicines are not evaluated by the TGA before they are included on the ARTG. However, we review a proportion to check their compliance against relevant regulatory requirements.
How we select medicines for a compliance review
A complementary medicine may be subject to any number of compliance reviews while it remains on the ARTG. Medicines may be randomly selected or targeted for a review.
Random compliance reviews
A proportion of newly listed medicines are randomly selected for review by a computer, based on a mathematical model.
Targeted compliance reviews
Listed complementary medicines with potential non-compliance issues may be selected for a targeted review. Potential non-compliance issues may come to our attention from:
- External sources, such as: consumers, media, industry, health care professionals, other regulatory agencies.
- Internal sources, such as: screening of recently listed medicines on the ARTG; previous compliance reviews; internal referrals.
Risk framework for compliance reviews
Approximately 1600 new complementary medicines are listed on the ARTG each year. As we cannot review all listed complementary medicines, we use a risk management approach to prioritise issues and direct our resources to provide the greatest benefit for the Australian public. We give priority to issues that:
- may result in immediate or potential health risk to consumers
- could significantly mislead the Australian public, particularly where there is a health impact
- are likely to become widespread if we do not intervene
- are of national or international significance
- involve a new or emerging issue of concern
- are the subject of public or media scrutiny and concern
- could lead to a loss of stakeholder confidence in the TGA or in therapeutic goods.
Priority may also be given to products that have been relisted after a cancellation (either initiated by a sponsor or by us) or where the characteristics or risk of the medicine are of concern.
Information we may request in a compliance review
Information we may request for a random compliance review
For a random compliance review, we usually request the following information from the sponsor, under the provisions of section 31(2) of the Act:
- labels for the product as it is supplied in Australia
- finished product specifications
- a certificate of analysis for the last released batch
- manufacturing formula including a list of all ingredients and their quantities
- a summary of the evidence held by the sponsor that supports the indications and claims made in relation to the product (detailed evidence may be requested if required)
- if applicable, information relating to Transmissible Spongiform Encephalopathy.
Information we may request for a targeted compliance review
We may conduct a targeted review based upon information:
- included on the ARTG for the medicine
- provided in a complaint or referral, if appropriate
- from other sources.
We may also request information from the sponsor, under the provisions of section 31(2) of the Act, such as:
- the same information requested for the purposes of a random review
- raw material specifications and certificates of analysis
- methodology and results of a specific test
- copies of permits and/or licences allowing the importation of the medicine if it contains substances that are prohibited imports for the purposes of the Customs Act 1901
- promotional and advertising material
- detailed evidence to support the indications and claims made in relation to the product.
What we assess in a compliance review
During a compliance review, we assess the information for the medicine against the relevant legislative requirements, including the Act, the Therapeutic Goods Regulations 1990, the Therapeutic Goods Advertising Code, Therapeutic Goods Orders, conditions of listing and other relevant/applicable legislative documents.
We may also view websites for the purpose of considering whether advertising for the product complies with the Therapeutic Goods Advertising Code.
Possible outcomes of a compliance review
A compliance review will result in one of the following outcomes.
No compliance breaches identified for the selected listing requirements
If no compliance breaches are identified, the review is finalised and the medicine remains on the ARTG.
Compliance breaches identified for the selected listing requirements
If compliance breaches are identified, there are a number of regulatory actions we can take- refer to Regulatory action taken for non-compliant medicines.
Compliance status unable to be determined
A compliance status may be unable to be determined, for reasons such as: the medicine was cancelled by the sponsor before assessment commenced; the medicine was cancelled by us due to non-payment of fees by the sponsor; or the medicine was not yet manufactured.
During any stage of a product undergoing a compliance review, the sponsor can request the medicine be cancelled from the ARTG. If this medicine is subsequently relisted, a targeted review may be undertaken according to our prioritisation strategy.
Possible regulatory action for a non-compliant medicine
Where a breach of a legislative requirement is found there are a number of regulatory actions we can take, such as:
- Issue a proposal to cancel notice under subsection 30(3) of the Act. If this occurs, under the Act, the sponsor must be given a reasonable opportunity to address the non-compliance issues. The following outcomes may result:
- the sponsor satisfactorily addresses all non-compliance issues
- the sponsor requests the TGA to cancel the medicine from the ARTG
- we may cancel the medicine (pursuant to subsection 30(2) of the Act) if the sponsor does not satisfactorily address all non- compliance issues.
- Cancellation of the product from the ARTG. Under subsections 30(1), 30(1A) or 30(1C) of the Act, the Secretary may cancel the medicine without a proposal to cancel notice being issued, where:
- there is an imminent risk of death, serious illness or serious injury
- the medicine is not 'eligible for listing', for example, because it contains ingredients not permitted in listed medicines
- the manufacturing of the goods in Australia has not been done by a person with a manufacturing licence
- the medicine contains substances that are prohibited imports under the Customs Act 1901
- the sponsor failed to provide the required information within 20 working days after requested to do so.
- Suspension of the product from the ARTG under section 29D of the Act.
- Recall the product from the market place.
If a medicine is cancelled from the ARTG
If a medicine is cancelled from the ARTG, it cannot be legally imported, exported, manufactured or supplied for use in Australia.
It is an offence under the Act for a person to:
- import, supply or manufacture in Australia therapeutic goods that are not on the ARTG, unless the goods are exempt from being included in the ARTG (s.19B)
- publish or broadcast an advertisement about therapeutic goods that are not on the ARTG (s.42DL(1)(g)) or to publish an advertisement in a newspaper or magazine or broadcast on radio or on free-to-air television that has not been approved by the Secretary where such an approval is required (s.42C).
As an alternative to criminal prosecution as outlined above, civil penalties are payable by the sponsor of therapeutic goods for importing, supplying or manufacturing therapeutic goods that are not on the ARTG unless the goods are exempt from being included in the ARTG (s.19D).
It may also be an offence under the law of some States to supply therapeutic goods that are not included in the ARTG.
Review of a TGA decision
Some decisions made by us during a compliance review of a listed medicine can be reviewed. These include a decision to:
- request information or documents (subsection 31(2) of the Act)
- impose additional conditions of listing (section 28 of the Act)
- suspend a product from the ARTG (section 29D of the Act)
- cancel a product from the ARTG (section 30 of the Act)
- recover (recall) a product (section 30(EA) of the Act).
Any person whose interests are affected by such a decision can ask for an internal review by a delegate of the Minister/Parliamentary Secretary and an Administrative Appeals Tribunal review - refer to Mechanism for review of decisions made under the Act.
Publication of compliance activities and review outcomes
Since 2012 we have published the following information on compliance activities:
- Details of medicines that have been cancelled by the TGA from the ARTG following a compliance review - refer to Complementary medicines: Cancellations from the ARTG.
- Yearly statistics on compliance review activity undertaken, including information about the number and types of reviews and outcomes - refer to:
For further information contact the Complementary Medicines Branch.