In Australia complementary medicines (CMs) are regulated similarly to OTC products.

Complementary healthcare products may be either registered or listed in the Australian Register of Therapeutic Goods (ARTG), depending on their composition and intended use.

Listed medicines are considered to be of lower risk than registered medicines, often containing well-known ingredients, often with a long history of safe usage.

Manufacturers of therapeutic goods in Australia, whether supplying local or export markets, are required to comply with the Code of GMP.

Sphere's application of GMP ensures that our products meet or exceed the requirements for supply to markets where pharmaceutical standard GMP is the benchmark for manufacturing processes.

Any therapeutic product sold in or exported from Australia receives a unique identity number which is registered on the ARTG.

By dealing with Sphere as their contract manufacturer, sponsors of products can be confident that their products can be manufactured, packed and released for supply to the market, all from one facility in minimal time and in compliance with regulatory requirements.

Whilst Sphere is not a regulatory consulting business, our regulatory and technical staff is well versed in the Australian and a number of overseas regulatory environments.

We can assist on matters relating to:

• Labeling requirements
• Formulation limitations from a regulatory perspective
• Ingredient selection

Sphere staff are active members of various industry committees, which ensures that the information provided is both current and qualified. 
Sphere recommends that sponsors obtain independent regulatory advice specific to their products and markets.

Contact Sphere Healthcare customer service for further information.