Frequently Asked Questions
What is the TGA?
The Therapeutic Goods Administration (TGA) is the regulatory body for therapeutic goods (including medicines, medical devices, gene technology, and blood products) in Australia.
It is a Division of the Australian Department of Health established under the Therapeutic Goods Act 1989. The TGA is responsible for conducting assessment and monitoring activities to ensure that therapeutic goods available in Australia are of an acceptable standard and that access to therapeutic advances is in a timely manner.
What is the benefit of working with a TGA approved contract manufacturer?
Companies who are TGA licensed are subject to strict operating procedures and testing protocols to ensure public safety is assured in the products they manufacture. Given the high level of regulation affecting the manner in which TGA licensed companies operate, product quality standards are of the upmost importance.
Working with a TGA licensed manufacturer such as Ross Cosmetics provides confidence that procedures are closely followed to deliver a high quality outcome for you as the client.
What is the difference between a TGA Licensed and Registered product?
TGA licensed products are subject to a lower level of regulation than Registered products. Licensed products are registered with TGA utilising a validated formulation. If using a pre-existing formulation the process is straight forward, and provision of a licence number (Aust-L) will take approximately one week from application. An example would be a client who wished to move manufacturers of a sunscreen. Ross Cosmetics has validated sunscreen formulations registered with TGA, and the process would be to register your brand name as using the Ross provided formulation.
Registering (or moving manufacture of a) TGA Registered product (Aust-R) is more time consuming given a higher level of regulatory compliance is required. Batch and manufacturing procedure validation are required for submission to the TGA, as is formula stability data. If a client is moving manufacture of an Aust-R product and has this data from their existing supplier, the process is more streamlined. If a product is being produced for the first time and requires this full validation process the timeline is more extensive.
What is involved in moving the manufacture of a therapeutic product to a new contract manufacturer?
The requirements depend on the nature of the product. If it is a licenced product (Aust-L) such as a sunscreen, the process is quite simple. Ross Cosmetics can assist in the registration of your brand name utilising one of Ross’ TGA validated formulations. Securement of an Aust-L for inclusion on packaging is required, which can be achieved within a week of registration.
A registered (Aust-R) product is a little more involved, however Ross Cosmetics are experts in managing this process, and can support you in managing the TGA engagement to streamline this process for you. If stability and assay data is available from your current manufacturer, the process is quite straight forward assuming your formula has met all TGA validation requirements and can be manufactured using Ross Cosmetics’ TGA approved manufacturing procedures.
Please contact us to discuss your requirements and our team of experts will be happy to assist you.
Does Ross Cosmetics produce pharmaceuticals?
Ross Cosmetics is licensed by the TGA to manufacture topical therapeutic products, which are manufactured in a site regulated to the same level as companies who produce ingestible medicines. Ross Cosmetics however is not licenced to produce ingestible medicines.
Does Ross Cosmetics work to a Minimum Order Quantity?
Yes. The nature of our operation and TGA batch size validations restricts us from supporting small volume clients. We encourage you to contact us to discuss your needs to see if we can be of assistance to you.
How long does it take to manufacture and deliver my product?
Every case is different, depending on what product is required, what materials are used, where it is to be shipped to etc. For non-therapeutics our standard leadtime is 16-20 weeks from provision of order and finished artwork. This can vary, and our team will work with you to deliver to your needs in the fastest timeframe possible.
Registered therapeutic products will take longer to produce again depending on the requirement. This is due to the extensive validation process required to produce a registered therapeutic product.