Facilities – GMP Clearance
Cosmetics – Ingredient Assessment
Cosmetics: NICNAS Notifications
Cosmetics: Advertising Compliance
Cosmetics: NICNAS Registration and Reporting
Generally called “complementary medicines,” listed medicines are a subset of therapeutic good in Australia that may only contain pre-approved, low risk ingredients and are limited to low-level health claims. Listed medicines include vitamins, minerals, amino acids, herbs, extracts and more.
In Australia, applications for listed medicines are not reviewed prior to the medicine’s inclusion on the ARTG, but applicants must attest that their product contains only pre-approved ingredients and makes low-level claims. Any therapeutic claims made for the product must be supported by evidence held by the company introducing the product. The benefit of using this approach is an extremely quick approval process and short time to market vital to the growth and stability of any company. The drawback of market authorization via the listed medicine route is the limitations on formula composition and marketing strategies. NHP Consulting can assemble evidence packages for health claim substantiation, and prepare/submit applications for listed medicines to the TGA. We can review promotional materials (labels, packaging, website, radio/TV advertisements) to ensure compliance with Australian advertising regulations (the Therapeutic Goods Advertising Code) and assemble dossiers for the evaluation of new complementary medicine substances (ie. approved ingredients) for listed medicines.
Registered medicines are those that are required to be sterile or contain ingredients or indications not permitted for listed medicines. This category typically encompasses both over-the-counter (OTC) and prescription products.
The Australian registered medicine category typically encompasses both over-the-counter (OTC) and prescription products. Registered medicines are not subject to the strict compositional and marketing limitations for listed medicines, but pre-marketing assessment of the safety, efficacy, and quality of the product is required before a registered medicine may be sold. NHP Consulting can prepare/submit applications for registered medicines to the TGA, including the assembly of evidence packages for health claim substantiation, safety and efficacy. We can also review promotional materials (labels, packaging, website, radio/TV advertisements) to ensure compliance with the Therapeutic Goods Advertising Code.
Homeopathic products of dilutions >1000 fold (4X) that do not contain human or animal material are exempt from ARTG and Good Manufacturing Processes (GMP) requirements. Homeopathic preparations greater than 4X (ie. all mother tinctures and 1X, 2X, and 3X homeopathic preparations) and those that contain human or animal material must be registered or listed on the ARTG (as above).
NHP Consulting can assess whether your homeopathic product requires registration or listing on the ARTG, and assemble evidence packages for health claim substantiation. We can prepare/submit applications for homeopathic products to the TGA, if necessary, as well as review promotional materials (labels, packaging, website, radio/TV advertisements) to ensure compliance with Australian regulations.
Australian medical devices are any item used for the diagnosis, prevention, monitoring, or treatment of a disease, injury, or disability, as well as items for control of contraception. The majority of medical devices require pre-market approval and registration on the ARTG before they can be sold in Australia.
Different regulations apply, depending on the type of device being registered (for example, condoms are regulated differently than MRI scanners), but all applicants must hold evidence their device is safe and effective for its intended purpose. There are seven categories depending on the risk classification of the device, and the classification drives the amount of evidence required during a submission to the TGA. We can help identify the risk classification of the medical device and help with the application process, including assembly of the evidence package to support the safety and efficacy of the device.
Facilities – GMP Clearance
Any site manufacturing a therapeutic good must be approved by the TGA as following Good Manufacturing Practice (GMP), before the therapeutic good manufactured at the site in question can be listed, registered, or sold in Australia.
Facilities manufacturing medical devices must hold a conformity assessment certificate from the TGA, and sites manufacturing listed or registered medicines must hold a License to Manufacture (Australia) or a GMP Clearance number (overseas sites). An overseas manufacturing site can be approved by the TGA via three methods.
- Mutual recognition agreement (MRA): The TGA accepts certification issued by the regulatory agencies of countries with which it has a MRA. The applicant must provide a certificate of GMP compliance. Assessment of the certificate is subject to a fee, and the process may be subject to additional charges depending on the level of involvement required by the TGA. A GMP Clearance number under a MRA should be issued within 15 working days. We can advise corrective actions to address any GMP deficiencies found by the regulatory agencies that may hinder the approval of the GMP certificate as well as assist with the TGA approval process.
- Compliance verification: If a country does not have an MRA with Australia, but they do have a memorandum of understanding or membership with the Pharmaceutical Inspection Co-operation Scheme (PIC/S), GMP clearance can be obtained via the compliance verification method. Applicants must submit an evidence package including a GMP inspection report and specific manufacturing documentation (a list of the regulatory inspections conducted within the past 3 years and a copy of the most recent inspection report; details of any regulatory actions in the past 3 years; site master file, quality manual or equivalent; GMP agreement between the sponsor and the manufacturer; list of products intended for supply in Australia; copy of the procedures for release for supply of products.) NHP Consulting has experts in GMP compliance and can help in each step along this process
- TGA on site audit. If neither of the two options above are possible for the manufacturing site in question, the site may be accredited by an on-site inspection by the TGA. We can provide assistance by participating in the audit and providing formal response and corrective actions for any deficiency found by the TGA. NHP Consulting can perform a paper audit of your manufacturing facility to identify aspects of non-compliance with GMP, and assist with TGA registration for Canadian sites through the MRA. We can oversee the compilation of evidence packages for GMP-clearance applications for foreign sites not covered under an MRA via the compliance verification method outlined above.
Cosmetics: Ingredient Assessment
Most ingredients used in Australian cosmetics are classed as industrial chemicals, and must be pre-approved by NICNAS before introduction to the Australian market.
NICNAS maintains a list (the Australian Inventory of Chemical Substances, AICS) of chemicals permitted for use in cosmetic products. Before selling a cosmetic in Australia, applicants must ensure that all ingredients in the formula are present on the AICS and that the product complies with any ingredient-specific restrictions mentioned on the AICS. Poison scheduling, quarantine, and other import issues may also apply. Only trained professionals should review and validate formulations, and NHP Consulting can assess the ingredients in your formula to identify any ingredients not currently approved for use in Australian cosmetics as well as highlight any specific conditions of use/sale required for your product.
In instances where a cosmetic contains one or more unapproved ingredients NICNAS must be notified before the product can be sold.
The presence of an unapproved ingredient does not necessarily preclude sale of a cosmetic in Australia, but NICNAS must be advised before sale commences. For unapproved ingredients, the applicant needs to either have the ingredient added to the approved list (AICS) or apply for any one of a number of NICNAS exemptions or permits that may apply. NHP Consulting can apply for additions, exemptions, and/or permits when required, which prevents delays to market.
Cosmetics: Advertising Compliance
All cosmetic labels and advertising must comply with Australian regulations.
All marketing material must company with Australian government regulations with respect to content, formatting, and claims. Only cosmetic-type claims can be made, and you must not make a claim that would be considered medical or therapeutic, since the product would then be classified as a medicine. NHP Consulting can review or prepare your product claims, and evaluate your product label, print advertisements, website, radio and television advertisements to identify aspects of non-compliance and prevent compliance actions.
Cosmetics: NICNAS Registration and Reporting
Companies selling cosmetics in Australia need to be registered with NICNAS and may need to submit annual reports of their activity.
All companies introducing cosmetics to the Australian market need to be registered with NICNAS before commencing business in Australia. If any product contains an ingredient subject to certain permits, exemptions, or certificates, the company is also required to provide an annual report to NICNAS. NHP Consulting can assist with NICNAS registration and annual reporting.
Food regulation in Australia involves all three levels of government, and the requirements differ depending on the location of the business as well as the nature of the foods being imported/sold. All foods are expected to comply with the Food Standards Code, which is administered by the bi-national government agency Food Standards Australia New Zealand (FSANZ).
Pre-market approval of food products is not required in Australia, but all companies involved in the handling/sale of food in Australia are responsible for ensuring the foods they manage are safe for human consumption. Depending on the level of risk of contamination, a formal food safety program may be required, and higher risk products may require personnel specifically designated to ensure food is handled safely. Most states require a registration or notification to the local council for businesses handling food. Specific imported foods, such as those containing milk or animal products, may be subject to requirements for import permits. Registration and annual maintenance fees for the registration of the food business apply. Due to the multi-level government involvement and complex nature of identifying and controlling high-risk foods, involving NHP Consulting from inception will ensure an expedited time to market in a compliant manner. NHP Consulting can assess the level of registration required for your food business in the state in which you wish to register, and assess the formulas of foods intended for import to identify any import permits required. We can review your label and marketing materials for compliance with the Food Standards Code, and evaluate the compliance of your formula with respect to FSANZ.