Commercialisation of healthcare in Australia: overview

A Q&A guide to the commercialisation of healthcare in Australia.

This Q&A provides an overview of the regulatory framework for the commercialisation of medical products in Australia. It covers the key requirements for manufacturing, advertising and selling drugs, medical devices, biological products and natural health products.

To compare answers across multiple jurisdictions, visit the commercialisation of healthcare Country Q&A tool.

This Q&A is part of the Commercialisation of Healthcare Global Guide. For a full list of jurisdictional Q&As visit www.practicallaw.com/healthcare-guide.

Contents

Regulatory overview

1. What is the regulatory framework for medical products?

Any medicinal product for which therapeutic claims are made must be listed or registered in the Australian Register of Therapeutic Goods (ARTG) before it can be lawfully supplied in Australia.

Legislation

The Therapeutic Goods Act 1989 (TG Act) provides a framework governing the process by which therapeutic goods are controlled and monitored in Australia, to ensure that Australian consumers receive access to therapeutic goods that are safe, effective and of a high quality.

Regulatory authorities

The Therapeutic Goods Administration (TGA) is part of the Australian Federal Government's Department of Health and Ageing and is responsible for regulating therapeutic goods.

The TGA evaluates therapeutic goods before they are marketed and monitors products once they are on the market. It also assesses the suitability of medicines and medical devices for export from Australia, and regulates manufacturers of therapeutic goods to ensure that they meet acceptable standards of manufacturing quality.

For more information on the Therapeutic Goods Administration, see box: The regulatory authorities.

Private parties

Private entities (other than sponsor companies that apply for the listing or registration of therapeutic products on the ARTG) are not involved in the regulatory process for the approval of medicinal products supplied in Australia.

 
2. What types of medical products are regulated?

Therapeutic goods are broadly defined in the Therapeutic Goods Act 1989 (TG Act) as products for use in humans in connection with:

  • Preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury.

  • Influencing, inhibiting or modifying a physiological process.

  • Testing the susceptibility of persons to a disease or aliment.

  • Influencing, controlling or preventing conception.

  • Testing for pregnancy.

Some products that technically meet the definition of a therapeutic good can be declared to not be a therapeutic good under section 7 of the TG Act. Conversely, some products that do not meet the definition of a therapeutic good can be declared as therapeutic goods, allowing the Therapeutic Goods Administration (TGA) to regulate them.

The distinction between a therapeutic product and a food or cosmetic product is not always clear-cut. A product's principal use is a primary consideration when determining whether it is a food or medicine. In each case, if therapeutic claims are made in marketing or labelling material, despite the product being commonly accepted as a food or cosmetic product, it is likely that the product will be regulated under the TG Act.

The TGA regulates a wide range of goods, including:

  • Medical devices.

  • Complementary medicines.

  • Over-the-counter (OTC) medicines.

  • Prescription medicines.

  • Blood and tissues.

  • In vitro diagnostic devices and other therapeutic goods.

A medicine is defined by the TG Act as including medicinal products that are represented to achieve, or are likely to achieve, their principal intended action by pharmacological, chemical, immunological or metabolic means, in or on the body of a human or animal.

 

Drugs

3. What are the general requirements for a drug to be manufactured, advertised and sold?

Manufacturing

Manufacturers must comply with the Therapeutic Goods Act 1989 (TG Act) and demonstrate, during a factory audit, compliance with manufacturing principles, including the relevant codes of good manufacturing practice (GMP). The Therapeutic Goods (Manufacturing Principles) Determination 1 of 2013 requires therapeutic goods to be manufactured in compliance with the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (15 January 2009, published by the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme).

Overseas manufacturers must provide evidence that their product is manufactured to an acceptable standard before it can be included on the Australian Register of Therapeutic Goods (ARTG). Where there is no acceptable evidence of GMP, the Therapeutic Goods Administration (TGA) inspects the manufacturing sites in the country where the product is manufactured.

The regulatory requirements for products manufactured overseas for supply in Australia are regularly updated (see Guidance on the GMP Clearance of Overseas Medicine Manufacturers, 17th edition, 16 May 2011). Medicinal products that are included in ARTG are entered as either registered or listed goods, depending on their ingredients and intended purpose. Most prescription products are subject to registration requirements that are more comprehensive than those for listed products.

Advertising

The advertising of prescription products directly to consumers is prohibited.

Advertisements for medicinal products must comply with:

  • The TG Act.

  • The Australian Consumer Law.

  • Other applicable state and territory legislation.

  • The Therapeutic Goods Advertising Code 2007.

Other industry codes of conduct are relevant, such as the Medicines Australia Code of Conduct and the Generics Medicines Australia Code of Conduct.

Sale

All prescription products must be registered on the ARTG. This requires a sponsor to apply to the TGA, and provide data supporting the quality, safety and efficacy of the product for its intended use. The Australian Regulatory Guidelines for Prescription Medicines (updated on 28 January 2015) assists sponsors in the preparation of applications to register new prescription medicines for human therapeutic use.

 
4. Are there different requirements for patented and generic drugs?

All prescription products, whether patented or not, must be registered or listed on the Australian Register of Therapeutic Goods (ARTG) to be marketed in Australia.

Medicines that come within the definition of "essentially similar" to a previously registered medicinal product (and, in particular, generic versions of an existing pharmaceutical product) are exempt from the requirement to provide data based on clinical trials. Instead, the sponsor of a generic pharmaceutical product must provide the Therapeutic Goods Administration (TGA) with bioequivalence data derived from bioequivalence and bioavailability studies. The generic product is considered bioequivalent if it contains the same amount of the active ingredient in the same dosage form and the rate of absorption of the active is essentially the same as the already registered product (that is, registered on the ARTG).

An applicant seeking to include therapeutic goods on the ARTG must provide one of two alternative certificates for patents before listing or registering those goods on the ARTG:

  • A certificate to the effect that the applicant, acting in good faith, believes on reasonable grounds that it is not marketing, and it does not propose to market, the therapeutic goods in a manner or circumstances that would infringe a valid claim of a patent that has been granted for the goods.

  • A certificate to the effect that a patent has been granted for the goods, that the applicant proposes to market the goods before the end of the term of the patent and the applicant has notified the patentee of the application for registration or listing of the goods.

Only applicants that must submit safety or efficacy data for the goods as part of the process of applying for registration or listing on the ARTG must provide a certificate.

 
5. What authority is responsible for regulating the manufacture, advertising and sale of drugs?

The Therapeutic Goods Administration (TGA) regulates and controls the manufacture, advertising and sale of drugs in Australia.

However, for advertising therapeutic goods and medicines, additional control is given to the Australian Competition and Consumer Commission (ACCC). The ACCC has an overarching power to control advertising in accordance with the Australian Consumer Law, which prohibits any advertisement (including for therapeutic goods and medicines) that is misleading and deceptive. The Australian Consumer Law also gives private parties the ability to commence proceedings to, for example, prevent competitors from engaging in advertising and marketing activity that is misleading and deceptive.

For more information on the Therapeutic Goods Administration, see box: The regulatory authorities.

 
6. Are there fewer or different requirements for drugs that have already been licensed/approved in another jurisdiction?

The requirements to obtain registration or listing on the Australian Register of Therapeutic Goods (ARTG) are the same regardless of whether the drug has been licensed or approved in another jurisdiction. However, a sponsor can make a category 2 application to the Therapeutic Goods Administration (TGA) to register or list a therapeutic drug by relying on the evaluation reports from two acceptable countries where a similar application has been approved. Acceptable countries for the purpose of providing an evaluation report are:

  • Canada.

  • Sweden.

  • The Netherlands.

  • The UK.

  • The US.

The two overseas evaluation reports must be independent reports. The formulation, directions for use and indications for the medicine in the dossier must be identical to those evaluated and approved for marketing in the two countries from which the evaluation reports are provided.

 
7. Is it possible to sell drugs to or buy drugs from other jurisdictions?

Therapeutic goods can be imported from foreign countries into Australia for supply in Australia. However, these products must be registered or listed on the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in Australia. Consequently, these imported products must comply with all of the relevant requirements not only regarding the active pharmaceutical ingredient but also regarding the packaging and labelling requirements for these products.

Therapeutic goods can also be exported from Australia to foreign countries. Even goods that are intended for export must be included in the ARTG. Medicines that are only intended for export must be listed (but not registered) on the ARTG before export. Those medicines must:

  • Be safe for their intended purpose of use.

  • Be manufactured under good manufacturing practice (GMP).

  • Meet any standards applicable under the Therapeutic Goods Act 1989 (TG Act).

  • Not be of an unacceptable presentation.

If the goods intended for export are already available in Australia, then they are included on the ARTG and can be exported without further regulation, provided that the party responsible for export is either the sponsor or the agent of the sponsor. Following listing or registration on the ARTG, the sponsor can apply to the Therapeutic Goods Administration (TGA) for an export certificate to be issued for the product.

From 25 August 2015, Australian medicine producers can manufacture in Australia patented pharmaceuticals for export to countries experiencing a health crisis under a compulsory licence granted by the Federal Court of Australia.

 
8. Is it permitted to advertise drugs to consumers? Are there restrictions on advertising?

Only non-prescription medicines (over-the-counter and non-prescription complementary medicines) can be advertised directly to consumers (see Question 3). Prescription medicines can only be advertised to health professionals.

Disease education campaigns are permitted (section 13.7, Medicines Australia Code of Conduct). The focus of these campaigns must be on the particular medical condition and its recognition rather than treatment options. However, this does not mean that treatment options that form part of an education campaign are forbidden provided there is no encouragement to seek prescription of a prescription-only product.

 

Medical devices

9. What are the general requirements for a medical device to be manufactured, advertised and sold?

The majority of medical devices must be included in the Australian Register of Therapeutic Goods (ARTG) before being made available for sale. A comprehensive guide to the regulation of medical devices is included in the regulatory guidelines for medical devices (version 1.1, May 2011) issued by the Therapeutic Goods Administration (TGA) and available on the website of the TGA (www.tga.com.au).

Manufacturing

The Australian medical device regulatory regime has the following features:

  • A classification scheme based on the level of risk.

  • Compliance with a set of essential principles to ensure that safe, effective and quality medical devices are supplied.

  • Implementation of conformity assessment procedures to demonstrate compliance with the essential principles.

  • Recognition of international medical device reference standards to ensure compliance with the essential principles.

  • Implementation of regulatory controls for manufacturing processes.

  • Inclusion on the ARTG.

  • Implementation of post-market surveillance systems, adverse event reporting programmes and vigilance activities.

For a medical device to be included on the ARTG, the following criteria must be met:

  • The product must be a medical device.

  • The device must have an intended purpose.

  • The device must be correctly classified.

  • There must be evidence demonstrating that the device complies with the applicable essential principles.

  • There must be evidence of selection of an appropriate conformity assessment procedure and the rationale for the use of the conformity assessment procedure must be substantiated.

  • Any advertising for the device must comply with all legal requirements.

  • The device must not contain any prohibited imports.

The Therapeutic Goods Act 1989 (TG Act) defines a medical device as any instrument, apparatus, appliance, material or other article (whether used alone or in combination, and including the software necessary for its proper application), intended by the person under whose name it is to be supplied, to be used for human beings for the purpose of one or more of the following:

  • Diagnosis, prevention, monitoring, treatment or alleviation of a disease.

  • Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap.

  • Investigation, replacement or modification of the anatomy or of a physiological process.

  • Control of conception.

A medical device does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but can be assisted in its function by such means, or an accessory to the device.

Medical devices are classified into five classes, based on the level of risk in the intended purpose of the device.

The Therapeutic Goods (Medical Devices) Regulations 2002 defines "intended purpose" as the the purpose for which the manufacture of the device intends it to be used, as stated in:

  • The information provided with the device.

  • The instructions for use of the device.

  • Any advertising material applying to the device.

The essential principles are set out as guiding requirements that specify characteristics to assist the manufacturer in producing safe, quality and effective medical devices. The essential principles are divided into two sections:

  • Part I: general principles including:

    • use of medical devices not to compromise health and safety;

    • design and construction of medical devices to conform with safety principles;

    • medical devices suitable for intended purpose;

    • long-term safety;

    • medical devices not to be adversely affected by transport or storage; and

    • benefits of medical devices to outweigh any side effects.

  • Part II: principles about design and construction including:

    • chemical, physical and biological properties;

    • infection and microbial contamination;

    • construction and environmental properties;

    • medical devices with a measuring function;

    • protection against radiation;

    • medical devices connected to or equipped with an energy source;

    • information to be provided with medical devices; and

    • clinical evidence.

A conformity assessment certificate issued by the TGA and a declaration of conformity made by the manufacturer form the basis of a manufacturer's application to supply medical devices. The declaration of conformity is a statement by a manufacturer that it:

  • Complies with the essential principles.

  • Has been classified according to the classification rule.

  • Complies with the conformity assessment procedures selected.

Advertising

See Question 3, Advertising.

Sale

For a medical device to be included in the ARTG, the TGA must be satisfied that there is appropriate evidence on the perceived risks of the device to support its safe and effective use, and that an appropriate system is in place for monitoring the ongoing performance and safety of the device.

If a person intends to supply a device that is identical to a device that is already in the ARTG, an application to include the device in the ARTG must still be made to the TGA if both devices are made by the same manufacturer. This is because the ARTG is not only a record of the devices that can be supplied in Australia but is also a record of all the sponsors that are legally responsible for the medical devices on the market.

 
10. What authority is responsible for regulating the manufacture, advertising and sale of medical devices?

The Therapeutic Goods Administration (TGA) regulates and controls the manufacture, advertising and sale of medical devices.

The advertising of medical devices is also subject to the controls imposed under the Australian Consumer Law (see Question 3, Advertising).

For more information on the TGA see box: The regulatory authorities.

 
11. Are there fewer or different requirements for medical devices that have already been licensed/approved in another jurisdiction?

Australia has a mutual recognition agreement with the EU. This means that the conformity assessment certificate that is awarded by the Therapeutic Goods Administration (TGA) is recognised by the EU, and vice versa for the CE certification.

Australia has agreements with certain other countries, including:

  • Canada.

  • Switzerland.

  • Singapore.

These are steps towards mutual recognition of conformity assessment requirements.

 
12. Is it possible to sell devices to or buy devices from other jurisdictions?

Medical devices imported from a foreign country into Australia must either comply with the regulatory requirements (see Question 9) or fall within a relevant exemption category.

Sponsors wishing to export medical devices from Australia must comply with the requirements set out in the Therapeutic Goods Act 1989 (TG Act) and the Therapeutic Goods (Medical Devices) Regulations 2002.

Before a sponsor can export a medical device from Australia, the device must either be:

  • Included in the Australian Register of Therapeutic Goods (ARTG) for supply in Australia.

  • Included in the ARTG as an export-only medical device.

  • Exempt under item 1.2, part 1, schedule 4 of the Therapeutic Goods (Medical Devices) Regulations 2002.

 
13. Is it permitted to advertise medical devices to consumers? Are there restrictions on advertising?

In theory, medical devices can be advertised to consumers (if they are not prescription-only products), although this is not common. The Therapeutic Goods Advertising Code 2007 applies to all advertisements for medical devices directed to consumers.

Advertising medical devices is also subject to the additional control of the Australian Competition and Consumer Commission (ACCC) which controls compliance with the Australian Consumer Law.

The Medical Technology Industry Code of Practice, 8th edition (2012) requires members of the Medical Technology Association of Australia to comply with the Code in relation to advertisements directed exclusively to healthcare professionals and those with responsibility for purchasing medical devices. All claims made in respect of such medical devices must be truthful, valid and not misleading.

 

Biological products

14. What are the general requirements for a biological product to be manufactured, advertised and sold?

The Biologicals Regulatory Framework came into effect on 31 May 2011, amending the Therapeutic Goods Act 1989 (TG Act). The framework must be read in conjunction with the Australian regulatory guidelines for biologicals (version 1.0, June 2011) available on the website of the Therapeutic Goods Administration's (TGA) (www.tga.gov.au). The Biologicals Regulatory Framework allows for four classes of biological products based on the risk posed by the products, which are related to both:

  • The methods used to prepare and process the products during their manufacture.

  • Whether their intended use is the same as their usual biological function.

Where required, the approval of a biological product can be given by the Advisory Committee on Biologicals. Approval of genetically modified biological products is overseen by the Gene Technology Regulator.

A biological product is an item made from, or containing, human cells or human tissues that is used for one of the following purposes:

  • Treat or prevent disease or injury.

  • Diagnose a condition of a person.

  • Alter the physiological processes of a person.

  • Test the susceptibility of a person to disease.

  • Replace or modify a person's body parts.

An item can also be classified as a biological product by the Secretary of Health. The following biological products are currently included in the regulatory framework:

  • Human tissue therapy products.

  • Processed human tissues.

  • Human cellular therapy products.

  • Immunotherapy products containing human cells.

  • Genetically modified human cellular products.

Blood and blood components are not biological products for the purpose of the TG Act as they are regulated as medicines.

The four classes of biological products are:

  • Class 1. Biological products declared as such.

  • Class 2. Biological products that are:

    • both processed using only one or more of the actions of minimal manipulation and are for homologous use; or

    • declared in accordance with the regulations as class 2 biological products.

  • Class 3. Biological products that are:

    • processed using a method in addition to any of the actions of minimal manipulation and in a way that does not change an inherent biochemical, physiological or immunological property; or

    • declared as class 3 biological products.

  • Class 4. Biological products that are:

    • processed using a method in addition to any of the actions of minimal manipulation and in a way that changes an inherent biochemical, physiological or immunological property; or

    • declared as class 4 biological products.

Class 1 and 2 biological products are regarded as low risk, class 3 biological products as medium risk and class 4 biological products as high risk.

To be included on the Australian Register of Therapeutic Goods (ARTG) for supply in Australia, sponsors of class 1 biological products must submit a statement of compliance with the mandatory standards. The TGA reviews the statement of compliance but does not need to further evaluate the product before it is included on the ARTG. Manufacturers of class 1 biological products do not need a manufacturing licence.

To be included on the ARTG for supply in Australia, class 2 biological products must be evaluated by the TGA for their compliance with relevant standards. To be included on the ARTG for supply in Australia, class 3 biological products must be evaluated by the TGA for safety, quality and efficacy. This evaluation is based on the information supplied to the TGA in the product dossier.

To be included on the ARTG for supply in Australia, class 4 biological products require additional supporting data and must be evaluated by the TGA for safety, efficacy and quality as for class 3, but with further assessment and analysis of the supporting data.

Manufacturing

Biological products are subject to current good manufacturing practice (cGMP). The cGMP sets out the manufacturing and quality system requirements for biological products and operates in conjunction with the product standards.

Advertising

As biological products are intended for human therapeutic use they are subject to the same advertising regulation as pharmaceuticals (see Question 3, Advertising).

Sale

Biological products for human therapeutic use must be registered with the ARTG before they can be supplied in Australia.

 
15. What authority is responsible for regulating the manufacture, advertising and sale of biological products?

The Therapeutic Goods Administration (TGA) regulates and controls the manufacture, advertising and sale of biological products in Australia. When a biological product proposed for inclusion on the Australian Register of Therapeutic Goods (ARTG) is, or contains, a genetically modified product or organism, the TGA must notify the Office of the Gene Technology Regulator and request advice on the application.

The advertising of biological products is also subject to the control of the Australian Competition and Consumer Commission (ACCC). The ACCC has an overarching power to control advertising consistently with the Australian Consumer Law, which prohibits any advertisement, including for therapeutic goods and medicines, that is misleading and deceptive. The Australian Consumer Law also gives private parties the ability to commence proceedings to, for example, prevent competitors from engaging in advertising and marketing activity that is misleading and deceptive.

For more information on the TGA and the Office of the Gene Technology Regulator see box: The regulatory authorities.

 
16. Are there fewer or different requirements for biological products that have already been licensed/approved in another jurisdiction?

The Australian Regulatory Guidelines for Biologicals 2011 make no express provision for any abbreviated evaluation process for a biological product that has been licensed or approved in a foreign country.

However, it is likely that such licensing or approval would be a factor raised with the Therapeutic Goods Administration (TGA) during the course of the evaluation of the biologic application in Australia.

 
17. Is it possible to sell biological products to or buy biological devices from other jurisdictions?

Biological products imported into Australia must comply with the Regulatory Guidelines for Biologicals 2011 (see Question 16).

Biological products that are intended for export only are classified using the same rules as for the other classes of biological products. The pre-market evaluation process for classes 3 and 4 export-only biological products is the same as for class 2 biological products that are intended for domestic supply.

 
18. Is it permitted to advertise biological products to consumers? Are there restrictions on advertising?

Biological products are subject to the same advertising requirements as other therapeutic goods (see Questions 3, Advertising and 8).

 

Natural health products

19. Is there a category for natural health products (including, for example, traditional medicines, homeopathic medicines, supplements, vitamins and minerals)?

The Therapeutic Goods Act 1989 (TG Act) contains provisions on natural health products. If therapeutic claims are made for these products, they are regarded as therapeutic goods for the purposes of the TG Act. Otherwise, they are treated as "complementary medicines".

 
20. What are the general requirements for natural health products to be manufactured, advertised and sold?

Manufacturing

For most complementary medicines, licensing or evidence of good manufacturing practice (GMP) is not required for the manufacturer of the active ingredient. This means that the active ingredient can be sourced from any suitable manufacturer without the approval of the Therapeutic Goods Administration (TGA).

Australia ensures that complementary medicines are manufactured safely and contain only approved ingredients by means of the deployment of the two-tiered system described below (see below, Sale). Manufacturers must comply with GMP standards.

Advertising

Where advertisements about listed complementary medicines make unjustified or misleading claims, consumers or healthcare professionals can lodge a complaint under the Therapeutic Goods Advertising Code. A variety of bodies also handle complaints various voluntary codes of practice such as the Complementary Healthcare Council of Australia.

Sale

Australia has a risk-based approach to complementary medicines, with a two-tiered system for the regulation of such products, as follows:

  • Lower risk medicines can be listed on the Australian Register of Therapeutic Goods (ARTG).

  • Higher risk medicines must be registered on the ARTG.

Some complementary medicines are exempt from the requirement to be included on the ARTG, such as certain preparations of homeopathic medicines. The current requirements for the regulation of complementary medicines are reflected in the Australian Regulatory Guidelines for Complementary Medicines available on the website of the TGA (www.tga.gov.au). Sponsors of complementary medicines can apply for the registration of products containing otherwise listable substances that are for indications outside those allowed for listable products. The TGA has compiled a list of diseases, disorders and conditions (registrable diseases list) for which indications or claims can be made only after an evaluation of the evidence by the TGA before approval of the product and inclusion on the ARTG.

The evaluation of an application for registration of a complementary medicine includes:

  • An assessment of the safety, quality and efficacy of the product.

  • An assessment of the safety and quality of any new substances that are in the product.

To be eligible as a listed complementary medicine on the ARTG for supply in Australia, the following the product must contain only ingredients that can be approved for use in listed complementary medicines and that make only general or medium level indications, as defined in the guidelines for levels, and there must be evidence to support indications and claims.

Some medicines do not need to be either registered or listed in the ARTG as the result of a specific exemption or determination. These include:

  • Medicines that are dispensed or extemporaneously compounded for a particular person for therapeutic application to the person.

  • Certain homeopathic preparations.

  • Certain shampoos for the treatment or prevention of dandruff.

 
21. What authority is responsible for regulating the manufacture, advertising and sale of natural health products?

The Therapeutic Goods Administration (TGA) is responsible for the regulation of natural health products.

For more information on the TGA, see box: The regulatory authorities.

 
22. Are there fewer or different requirements for natural health products that have already been licensed/approved in another jurisdiction?

In deciding on allowing the manufacture of complementary medicines, the Therapeutic Goods Administration (TGA) takes into account whether the sponsor has confirmed conformity for the product as follows:

  • By the European Commission for the EU or an authority in the European Free Trade Area (EFTA).

  • For a non-EC or non-EFTA confirmation, if a step in the manufacture of a product has been carried out in a country declared by the minister under the Therapeutic Goods Act 1989 (TG Act) to be covered by a non-EC or EFTA mutual recognition agreement.

  • For a non-EC or non-EFTA confirmation, where an acceptable form of evidence from the relevant overseas authority establishes that the manufacturer of the product is of an acceptable standard.

 
23. Is it possible to sell natural health products to or buy natural health products from other jurisdictions and/or electronically?

Products available on international websites are not regulated by the Therapeutic Goods Administration (TGA).

There is no restriction on the personal importation of complementary medicines into Australia that do not make therapeutic claims.

Under the personal importation scheme, an individual can import a three-month supply (at the maximum dose recommended by the manufacturer) of unapproved therapeutic goods in any one importation without approval by the TGA provided that the following conditions are satisfied:

  • The goods are for the individual's own treatment or the treatment of that person's immediate family.

  • The person does not supply the medicine to any other person.

  • The medicine is kept in its original packaging.

  • The goods are not restricted under the Australian Customs Laws.

  • The total quantity of the goods imported within a 12-month period does not exceed 15 months' supply.

 
24. Is it permitted to advertise natural health products to consumers? Are there restrictions on advertising?

If the complementary medicines are not prescription products, they can be advertised directly to consumers. The advertising of therapeutic goods in Australia is subject to the advertising requirements of the Therapeutic Goods Act 1989 (TG Act), which adopts the Therapeutic Goods Advertising Code and supporting regulations, and the provisions of the Australian Consumer Law.

The Complementary Health Care Council of Australia has also published a Code of Practice for the marketing of complementary healthcare and health food products (www.cmaustralia.org.au). The current version is dated September 2013.

 

Reform

25. Are there any plans to reform the rules on the development, manufacture, advertising and sale of medical products?

In October 2014 an Expert Panel Review of Medicines and Medical Devices Regulation (Review) was announced by the then Minister for Health. The Expert Panel subsequently delivered two reports that assessed the regulatory framework for medicines and medical devices in Australia and made fifty-eight recommendations for reform.

On 15 September 2016, the Australian Government published its response to the Review. The proposed programme of reform involves:

  • Increasing the use of overseas assessments with comparable regulators, while maintaining the authority of Australian regulatory decisions.

  • Increasing flexibility in pre-market assessment processes for medicines and medical devices, including expedited and provisional approvals, and allowing the operation of commercial assessment bodies in Australia for medical device assessments.

  • Taking a risk-based approach to variations in medicines and medical devices, and also to access to products not listed in the Australian Register of Therapeutic Goods.

  • Enhancing post-market monitoring and improving integration of administrative arrangements relating to pre and post-market processes for subsidy and other purposes.

  • Simplifying processes by which advertising a therapeutic product to the public is regulated.

  • Working across government departments to consider the introduction of innovation incentives to improve the competitiveness of the Australian complementary medicine industry, and increasing the information available to consumers.

  • Conducting further reviews of the Scheduling Policy Framework for substances, in consultation with states and territories, and of the appropriateness of the application of the therapeutic goods regime to low-risk products.

The recommendations will be implemented in stages over the course of the next three years.

The Australian Government's detailed response to the Review can be accessed at www.tga.gov.au/sites/default/files/australian-government-response-mmdr-2016.pdf.

 

The regulatory authorities

Therapeutic Goods Administration (TGA)

W www.tga.gov.au

Principal responsibilities. The TGA regulates the supply, import, export, manufacturing and advertising of therapeutic goods. The TGA also monitors and evaluates the safety and efficacy of therapeutic products. The TGA does not regulate veterinary products, food, cosmetics or chemicals.

Office of the Gene Technology Regulator

W www.ogtr.gov.au

Principal responsibilities. The Office of the Gene Technology Regulator is responsible for administering the Gene Technology Act 2000 and the corresponding state and territory laws.



Online resources

Therapeutic Goods Act 1989 (TG Act)

W www.comlaw.gov.au/Series/C2004AO3952

Description. The text of the TG Act is available on the ComLaw website maintained by the Australian Federal Government. The website contains the most complete and up-to-date collection of Australian Commonwealth legislation.



Contributor profile

Wayne Condon, Partner

Griffith Hack Lawyers

T +61 3 9243 8344
F +61 3 9243 8333
E wayne.condon@griffithhack.com.au
W www.griffithhack.com.au

Professional qualifications. Australia and New Zealand, lawyer

Areas of practice. Life sciences; intellectual property; regulatory law; competition law.

Recent transactions

  • Advising a global pharmaceutical company on data protection and privacy law compliance issues in Australia.
  • Advising a global biological products manufacturer on marketing approval requirements for a proposed biological drug launch in Australia.

Languages. English

Professional associations/memberships. International Bar Association (IBA); Australian Bar Association (ABA); Law Council of Australia.

Publications. "Pharmaceutical, Biotechnology and Chemical Inventions: World Protection and Exploitation", Oxford University Press, 2011 (contributing author).


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