Products are categorised under 3 broad headings:

• Ethical pharmaceuticals (prescription medicines): These are either New Chemical Entities or Generic medicines. The Consultancy does not handle New Chemical Entities but can arrange for submissions to be done. REQUIRE REGISTRATION (AUST R)

• Over The Counter (OTC) medicines: These are controlled by the Poisons Regulations which limit sales outlets. REQUIRE REGISTRATION (AUST R)

• Complementary Medicines: These include specified herbal medicines, vitamins and minerals, amino acids, and a small range of other specially approved substances, sunscreens, Chinese medicines, Ayurvedic and homeopathic products. MOST REQUIRE LISTING (AUST L)

All medicines (therapeutic goods) must be manufactured in facilities which have an approved level of Good Manufacturing Practice (GMP) to the level of prescription medicines whether made in Australia or overseas. Overseas GMP must be pre-approved before submission.

To obtain approval to market all the ingredients must be acceptable to the Authorities, full details of the product formulation, specifications, dosage and claims must be submitted.

• For AUST R products data must be submitted to prove efficacy, safety and stability.
• For AUST L products the sponsor must hold proof of efficacy and stability but does not have to submit to the TGA
• Listing applications are computer generated but Registration applications are prepared in paper format.
• Listings take around 2 weeks from submission to final approval whereas Registrations take about 6 months for OTC and up to 2 years for ethicals.
• Fees are correspondingly much higher for Registration than Listing.
• The Consultancy maintains an up-to-date set of regulatory requirements, computer programs and application forms.

The Consultancy can prepare, submit and monitor the progress of Listings and Registrations of OTC and Generic products.