Australia differs from most countries in that products are classified as either Therapeutic or non-therapeutic. Most countries have an intermediate category of Dietary Supplements or similar name where products are manufactured in food class factories. To be approved in Australia products must be manufactured in plants that have GMP to prescription drug standard.

This poses problems for companies wishing to import from overseas since there are no exceptions granted.

There are two options – either the manufacturing facility must be inspected by an approved inspection service which can issue a certificate of approval – this includes Health Authorities from EU markets plus Canada, Scandinavia and The US FDA. For Devices the facilities must be CE marked.

• The GMPALS section of the TGA can visit a factory and inspect it and issue an approval.
• The alternative is to manufacture in Australia and there are a number of high quality companies who can provide this service.

If overseas manufacture is planned we must apply for a "pre-clearance" number for the manufacturing site.
The Consultancy can advise on the how to proceed, can co-ordinate with the TGA Canberra or can contact suitable local manufacturers.