Research

 

What is involved in Listing a Product on the Australian Register of Therapeutic Goods?

To list a product on the Australian Register of Therapeutic Goods is a costly and complex process. But at Body Science we are dedicated to supplying our customers with quality, safe and efficacious products. We put the compliance of our products with relevant industry guidelines and legislative requirements as our number one priority.

Paramount to the successful listing of a product on the Australian Register of Therapeutic Goods is the compliance of your product with the code of Good Manufacturing Practice (GMP).

  • Products must be manufactured in a GMP compliant manufacturing laboratory.
  • Detailed and technical product specifications must be prepared, clearly specifying all requirements of raw materials to be used and applicable release limits.
  • All raw materials must be tested for quality, purity and identity prior to approval for use in production.
  • Manufacturing procedures must comply with technical standard operating procedures, internal and external auditing, and there must be thorough validation of manufacturing and testing procedures prior to the product being approved for manufacture.
  • All documentation relating to raw materials, formulation details and manufacturing and testing methods must be prepared, checked and approved prior to product listing.
  • Body Science keeps copies of all relevant documentation in product listing files

There are also requirements regarding the claims that can be made regarding listed medicines. The Therapeutic Goods Administration (TGA) has guidelines detailing levels and kinds of evidence required to be held by sponsors of Listed Medicines to support product indications and claims. The Therapeutic Goods Act 1989 requires that at the time of Listing, sponsors must certify that they hold evidence to support any claim made relating to the medicine. All indications and claims made about therapeutic goods must be capable of substantiation – that is, evidence held by sponsors must demonstrate that the indications and claims are true, valid and not misleading.

The Body Science reference library has in excess of 300 scientific references on file, which provide the TGA, and our customers, with the guarantee that all claims we make regarding our products and what they will do for you are true, valid and not misleading. Whilst the listing process is a costly and complex process, we wouldn’t place our products on the market without checking and double-checking that they comply with all relevant industry guidelines and legislative requirements. This give us the confidence that we are supplying only safe and efficacious products of the highest quality, and you, the consumer, the confidence that when you take a Body Science product you are taking a quality product and you will see results!

Why do Body Science List products on the Australian Register of Therapeutic Goods?

The answer is simple. To give you, the consumer, confidence that the products you are taking are safe, efficacious and manufactured to the highest standards.

  • Does the formulation contain quality ingredients?
  • Does the formula contain therapeutic doses of the ingredients for maximum results?
  • Does the formula contain everything it claims to contain?
  • Is it manufactured using quality manufacturing standards?

You can be confident that the answer to all of these important questions is YES when you take a Body Science product. Our products are manufactured in GMP (Good Manufacturing Practice) compliant facilities. Taking products made to GMP specifications ensures the safety, efficacy and quality of the product. Products are manufactured according to detailed and technical standard operating procedures, internal and external auditing, and thorough validation of manufacturing and testing procedures. This ensures product quality, efficacy, safety, purity, identity and compliance with regulatory requirements and standards in Australia.

So you can be confident when you take a Body Science Product that it will be a quality and efficacious product, containing everything listed on the label – you will see results!