The Therapeutics Goods Act 1989 (The Act) requires that all therapeutic goods that are imported or manufactured for supply in Australia be included in the Australian Register of Therapeutic Goods (ARTG).
In Australia, Complementary Medicines, such as herbal, vitamin, mineral and nutritional supplements, as well as sunscreens are classified as therapeutic goods and are included under listed medicines on the ARTG and as such, sponsors are required at the time of submitting an application, to certify that the medicine meets certain criteria for ingredients, dosage form, evidence, indications, side effects and warning statements.
Advanced Wellness Regulatory Solutions can facilitate all aspects of this process by providing the following specialist services to assist you in covering all of the criteria for listing.
Services include:
- Ingredient and product specification reviews
- Product Formulation
- Evidence packages and therapeutic indications
- Preparation and submission of listing applications to the Therapeutic Goods Administration (TGA)
- Label development and reviews
- Advertising reviews
- GMP Preclearance
- Response to section 31, post market reviews
- PI notifications
- Liaising with the TGA
- Stability advice and protocol development
Advertising Complementary Medicines
The Act also requires that all advertisements for therapeutic goods, including but not limited to labeling, print, broadcast and mainstream media comply with theTherapeutic Goods Advertising Code (TGAC).
Most types of advertising materials require approval by appropriate government bodies prior to print or broadcast. Regulatory solutions can assist you with compliant advertising copy and scripts or review advertisements and promotional material in accordance with the appropriate regulations before approval, saving you time during the approval process.
Product manuals, technical articles and newsletters are an important part of the marketing of a new product, or the ongoing marketing of an existing product or product range. We can provide information that is technically accurate, and that reads easily and effectively. It is important to be aware that product-specific information must also comply with the TGAC, and we can assist you in meeting these regulations.