GMP Clearance for Complementary Products

 Even for low-risk complementary medicine products, GMP (Good Manufacturing Practice) clearance is required. Complementary medicines (often known as ?traditional? or ?alternative? medicines) include vitamin, mineral, herbal, aromatherapy and homoeopathic products. These medicines may be either listed or registered, depending on their ingredients and the claims made.

GMP (Good Manufacturing Practice) encompasses a set of principles and procedures that when followed helps to ensure that therapeutic goods are of high quality – in particular, there is a quality process during manufacture which ensures consistency of product within the declared composition specification. The key objective of GMP is to ensure safety, quality and efficacy of the therapeutic goods sold in Australia. All steps of manufacture are required to be GMP compliant unless exempt.

The Therapeutic Goods Administration (TGA) has the authority to issue GMP clearance to sponsors of a complementary medicine. The AUST L or AUST R number on a medicine package shows it is authorised by the TGA and it is on the Australian Register of Therapeutic Goods (ARTG). GMP is required if the product is to be registered or listed or the manufacturing process recorded on the ARTG.

A common query relates to the acceptability of overseas manufacture, particularly where it can be demonstrated that the overseas manufacturer complies with GMP practices.