Understanding the constraints of operating in a regulated marketplace can be the difference between product success or failure in Australia.
The regulatory requirements for these sectors are complex, and constantly changing. Ensuring that your business and products comply with the regulatory requirements of government agencies such as The Therapeutic Goods Administration (TGA), NationalIndustrial Chemicals Notification and Assessment Scheme (NICNAS), and the Australian Quarantine and Inspection Service (AQIS) can be challenging.
This is where an experienced regulatory consultant can provide a value added service to your business.
The ingredients in a product, the claims made, and how a product is presented may all contribute to determining if your product is regulated as a therapeutic good.
Understanding how these regulatory controls impact on your product is critical to be able to position your product to maximize your business objectives.
Products that sit on or near the boundary between medicines, medical devices, cosmetics or foods can be challenging for businesses to determine how to proceed.
Knowledge of the regulatory requirements is critical to provide advice on the most business appropriate pathway for your product.
Medical devices must be included on the TGA’s Australian Register of Therapeutic Goods (ARTG).
The level of pre-market regulatory submission required is determined by the inherent risk associated with the medical device. The complexity, duration & cost of the application is dependent upon the type of device, its classification, and if it has already undergone Conformity Assessment in the EU ( CE Mark).
We can conduct a product review, and advise on the appropriate TGA evaluation pathway, and the information requirements for your product.
Once product classification is confirmed, we can review documentation or assist in preparing and submitting applications to TGA.
Most OTC medicines will require product registration, which requires pre-market evaluation of a product dossier by TGA.
Lower risk consumer medicines, such as complementary medicines (herbs, vitamins, nutritional/dietary supplements, homeopathic medicines) and sunscreens are regulated as listed medicines.
Listed medicines do not undergo the same level of pre-market evaluation by TGA, but can only contain certain low risk ingredients; must be manufactured under GMP conditions, and make claims for health maintenance/enhancement, or non serious , self limiting conditions. The sponsor must certify that the product meets all the legislative requirements.
We can conduct a product review, and advise on the appropriate TGA evaluation pathway, and the information requirements for your product. Once product classification is confirmed, we can assist in preparing and submitting applications to TGA.
Over the lifecycle of your product, there are likely to be variations required to the product. We can advise on the regulatory consequences of any proposed changes, prepare and lodge targeted submissions.
Specific advice projects for existing products are available, including:
- Labelling reviews
- Advertising & claim reviews
Cosmetic products do not require pre-market evaluation before supply, however the Company must comply with the Cosmetic regulatory requirements of the Australian Competition and Consumer Commission (ACCC) and the Cosmetic Standard of the Industrial Chemicals (Notification and Assessment) Act 1989.
We can review product formulas for compliance with the Cosmetic regulations including:
- Australian Inventory of Chemical Substances ingredient assessment
- Labelling and claims reviews
- NICNAS liaison for Company registrations & new chemical introductions
- Review of poisons scheduling restrictions
- AQIS ingredient reviews
Whether your product is a cosmetic, medicine, or medical device there is legislation detailing the information that must be included on your label.
We can review your label and provide advice to ensure it is compliant, and assist you in wording label claims to avoid any unintended regulatory action.
Making changes to product packaging and labelling is expensive so it is important that packaging is compliant before you proceed to market your product.
Advertising & claim reviews
There is no more keenly contested area of regulatory compliance than product claims and advertising. Negotiating product claims that are compliant and that also meet the strategic direction for your product is a key area of our consulting business.
We review and provide advice on advertising claims and substantiation material, to achieve the combination of regulatory compliance and strategic direction.
We can liaise with relevant approval bodies, such as ASMI (Australian Self Medication Industry), CHC (Complementary Healthcare Council) and CAD (Commercials Advice at Free TV) to gain advertising approval where required.
Provide advice, and assist in resolving advertising complaints through the possible options of :
- Company to Company dispute resolution,
- Industry Code of Practice Complaints Processes, or
- Complaints Resolution Panel.
Scheduling of ingredients directly impacts consumer accessibility to products that contain the ingredient. Ingredients contained in medicines, medical devices, cosmetics and personal care products can be affected. The Advisory Committee on Medicines Scheduling (ACMS) and Advisory Committee of Chemical Scheduling (ACCS) recommend appropriate classification of substances based on risk, which can impact on distribution, labelling, storage & handling and packaging.
Changes to ingredient classification are subject to public consultation. We can flag to you when ingredients in your products are subject to changes to enable you to respond, or we can assist in the preparation of submissions.