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PRODUCT REGULATIONS


Recent Health Regulation Developments in Response to COVID-19

The outbreak of the COVID-19 pandemic has led to a dramatic increase in the promotion and sale of various products which may be used to combat the virus. By shifting to manufacture, advertise and supply products such as hand sanitiser and disinfectants, companies must comply to the regulatory framework for therapeutic goods.

It is essential for MedCart suppliers are aware of, and comply with, any regulations that apply to them, and are aware of the specific requirements that relate to COVID-19-related products. If a product is listed as TGA approved a MedCart supplier/retailer, it must provide evidence of the approval prior to listing the product for sale. If you have purchased a product and have any questions or concerns about its validity, please contact us.



Role of the Therapeutic Goods Regulatory Regime

The Therapeutic Goods Administration (TGA) is the authority responsible for regulating therapeutic goods, such as medicines (including vaccines and complementary medicines) and medical devices. Therapeutic goods, including all products about which therapeutic use claims are made, are in most cases required to be entered in the Australian Register of Therapeutic Goods (ARTG) before they can be imported into, supplied or manufactured in, or exported from, Australia. Examples of therapeutic use claims include claims that a product can:

  • Prevent, diagnose, cure or alleviate a disease or injury;

  • Influence a physiological process in a person; or

  • Test the susceptibility of a person to a disease or ailment.

In addition, representations about therapeutic goods that refer to a serious form of disease, condition, ailment or defect, are characterised as 'restricted representations'. TGA approval is required before any restricted representation can be made in an advertisement about a therapeutic good.


Any claim about the treatment of or protection against COVID-19 requires express TGA approval before it can be made.


Before approving a restricted representation, the TGA will likely require evidence to support the claim (for example, results of clinical trials).


Advertising of COVID-19 related products

A supplier must comply with the strict requirements under the Therapeutic Goods Act 1989, Therapeutic Goods Regulations 1990 and Therapeutic Goods Advertising Code (No. 2) 2018 (Therapeutic Goods Advertising Code) when advertising therapeutic goods. If a supplier makes a claim about a product that relates to the cure or alleviation of a disease, it may be considered therapeutic in nature and subject to the therapeutic goods regulatory regime.

For example, while a claim that a hand sanitiser 'kills 99.9% of germs' would likely not constitute a therapeutic use claim, an additional claim that the sanitiser has a health benefit, such as alleviating symptoms of a disease, would render it a therapeutic good.

The therapeutic goods legislation provides for a range of criminal offences (including up to five years' imprisonment) and civil penalties (including up to $1.05 million for an individual or $10.5 million for a company) as consequences of a breach.



Product Regulations

Hand sanitisers and disinfectants – regulatory requirements

The outbreak of the COVID-19 pandemic has led to a dramatic rise in the sale of hand sanitiser and disinfectant products which consumers are using to quell the spread of germs and bacteria. Certain hand sanitisers and disinfectants are regulated as therapeutic goods and, importantly, the TGA has recently made various determinations to clarify suppliers' obligations in relation to the sale and advertising of these products.

Hand sanitisers

The TGA's guidance states that hand sanitisers fall into one of three classes for regulatory purposes – general consumer products, which are not regulated by the TGA, therapeutic goods, which are, and products with one of two specific formulations, which are excluded from regulation for the duration of the COVID-19 pandemic. Hand sanitisers are general consumer products (and therefore classified as 'cosmetics') if:

  • They are for personal or domestic use and not used in a health care setting;
  • Any claims are limited to general low level activity against bacteria and germs (e.g. 'kills 99.9% of germs');
  • They have no claims against viruses; and
  • They contain only low-risk ingredients.

These cosmetics are regulated under the National Industrial Notification and Assessment Scheme rather than by the TGA.

By contrast, antibacterial hand hygiene products that claim to kill specific organisms (such as viruses) and/or that are to be used in clinics or hospitals are therapeutic goods and must be entered in the ARTG. Claims that are permitted to be made on the labels of these products include 'antiseptic hand wash/rub' and 'hygienic hand wash/rub'.

On 28 March 2020, in an attempt to enable the urgent and continued supply of hand sanitiser in Australia, the Federal Minister for Health made an Excluded Goods Determination excluding specific hand sanitiser formulations from TGA regulation. To fall within the scope of this exclusion, a hand sanitiser must contain particular ingredients in particular quantities, comply with manufacturing regulations, and comply with advertising and labelling conditions.

Importantly, regardless of whether a hand sanitiser is covered under the Excluded Goods Determination, a person cannot make a claim that a product can be used to prevent or treat COVID-19 without express TGA approval.



Disinfectants

In light of the coronavirus outbreak, there is significant interest from potential suppliers of disinfectants. Certain disinfectants are 'therapeutic goods' and must be entered in the ARTG, depending on the intended purpose of the disinfectant and what claim/s are made about it. Under the therapeutic goods regime, hospital grade or household/commercial grade disinfectants that make 'specific claims' (such as claims that the product kills, or is active against, viruses) and that are:

  • not intended for use internally or on skin;
  • not intended for use on a medical device; and
  • intended for use on hard or soft surfaces (for example curtains, floors, bench tops), must be entered in the ARTG prior to supply in Australia.

Disinfectants of the kind described above that do not make 'specific claims' are exempt from inclusion in the ARTG, but must still meet other regulatory requirements for exempt disinfectants as set out in the therapeutic goods legislation. Further, under the therapeutic goods regime:

  • liquids, sprays, wipes and aerosols that are intended to be used on medical devices; and
  • other cleaners intended to be used on medical devices and that do not make disinfectant or sterilant claims, are regulated as medical devices and must be entered in the ARTG.

Otherwise, general cleaners and sanitisers that do not make disinfectant claims are not regulated by the TGA. Read more about the regulation of disinfectants under the TGA.




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