Recent discussions with sponsors and industry associations indicate a good deal of uncertainty and misunderstanding about the legislative provisions and procedures applying to drug products that are produced solely for an overseas market. Some of the problems can be attributed to confusion between the two separate types of certificate that are issued by the TGA and their intended purpose.

Certificate of listing

The Therapeutic Goods Act 1989 requires that therapeutic goods that are imported, exported or manufactured for supply in Australia must be included in the Australian Register of Therapeutic Goods (ARTG). Those goods that are intended solely for export are accepted for "listing" in the ARTG subject to their compliance with basic quality and safety criteria. They are not required to be fully evaluated or to comply with Australian labelling and advertising standards. Products that would not be authorised for supply in Australia may still be listed for export subject to the recipient authority being informed of the circumstances and agreeing to accept the goods. A Certificate of Listing (for export only) is issued to sponsors whose product has been accepted for listing as evidence that the Act's requirements have been met. The Certificate of Listing is not designed as an international trade document.

Certificate of a Pharmaceutical Product

Where government documentation is required to facilitate overseas trade of therapeutic goods intended for human use, a Certificate of a Pharmaceutical Product (CPP) may be requested by the product's sponsor. Such certification may only be issued by the Commonwealth - States and Territories are expressly prohibited from doing so. The Commonwealth is a signatory to the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce and provides certification in the form required by that scheme. The certificates provide the recipient authority with statements concerning: the product's active ingredients, the licensing of the Australian manufacturers and their compliance with GMP, and the marketing status of the product in Australia. Explanatory information is added where necessary to assist acceptance in the foreign market. There is no legislative requirement for CPPs to be issued in all cases of export listing - sponsors need obtain one only if it is required by the overseas client.

The need for clarification of listing and certification procedures has been discussed with the Proprietary Medicines Association of Australia and it has been decided to develop and publish a guideline for exporters. In addition, the TGA is currently reviewing the wording of the Certificate of Listing - details will appear in the TGA News as they become available.