Export of medicines

Medicines must generally be registered or listed in the Australian Register of Therapeutic Goods (ARTG) before you can legally export them, unless the goods are the subject of an exemption, exclusion, approval or authority.

Medicines authorised for supply in Australia will already be in the ARTG and are permitted for export, provided you are either:

• the person in relation to whom the medicine is included in the ARTG

OR

• an agent authorised to act on behalf of the person in relation to whom the medicine is included in the ARTG.

For more information, refer to Export of medicines from Australia guidance.

• Grouping application form to add an export name to a registered product
  Use this form to add an export name to a medicine that is registered in the ARTG

Export Only medicines

The purpose of an Export Only medicine listing is to ensure that all products exported from Australia comply with standards that are similar to the standards applied to products supplied in Australia.

Export Only medicines must be listed in the ARTG (under section 26 of the Therapeutic Goods Act 1989) and cannot be supplied in Australia, including Australian duty free outlets.

For more information, refer to Export of medicines from Australia guidance.

• Notice that a certificate under subsection 26B(1) of the Therapeutic Goods Act 1989 is not required
  Mandatory form for all new Export Only medicine listing applications and grouping applications for existing Export Only medicine listings. This form provides notification to the Secretary of the Department of Health that a certificate under subsection 26B(1) is not required in relation to the application.

Export certification for medicines

To facilitate export, the TGA issues export certification for medicines that are registered or listed in the ARTG under section 58 of the Therapeutic Goods Act 1989.

If certification is required by the importing country, the TGA can issue a Certificate of Pharmaceutical Product (CPP) or a Certificate of Listed Product (CLP).

Certificate of Pharmaceutical Product (CPP)

The CPP is an internationally recognised certificate issued under the WHO Certification Scheme.

The CPP provides the regulatory status of a single pharmaceutical product.

The CPP is used by overseas authorities to verify information such as:

• product details including the name, formulation and dosage form
• compliance with Good Manufacturing Practice (GMP).

Certificate of Pharmaceutical Product (CPP) for an Export Only medicine

The CPP for an Export Only medicine is issued under the WHO Certification Scheme for a product that is listed as an Export Only medicine in the ARTG and is permitted to be exported from Australia. An Export Only medicine cannot be supplied in Australia.

Certificate of Listed Product (CLP)

The CLP is similar to a CPP, however it is not issued under the WHO Certification Scheme. A CLP can be issued for a single product listed as a complementary medicine in Australia, and it includes a comment specifying that the product is permitted for free sale (in that it can be legally supplied) in Australia.

The TGA understands that some products which are classified as therapeutic goods/medicines in Australia are regulated as health/dietary/food supplements in the importing country. As these products are regulated as medicines in Australia, they must be accompanied by TGA export certificates.  The CLP is widely accepted in international jurisdictions in place of a Certificate of Free Sale.

Specific CLP requirements for Vietnam

CLP requirements for products being exported to Vietnam and which are regulated as health/dietary/food supplements by the Vietnam Food Authority (VFA), will require the following:

• Inclusion of schedule 2 (manufacturing details) – please ensure you select this option during the application process and select the manufacturer of the dosage form for your product as a minimum
• Inclusion of a supporting Word document (see template at Attachment 2) stating a sponsor comment to be included in the CLP regarding the product category for Vietnam ‘health supplement/dietary/food supplement’.  This will be used to capture the requested sponsor comment in the CLP.

Please note that the TGA cannot advise on which product category should be listed on the CLP. It is up to the applicant to include the current comment/product category (as required by Vietnam) on what is acceptable or appropriate.

In circumstances where the product is not considered a medicine in Australia (i.e. not included in the ARTG), a Certificate of Free Sale can be obtained from the appropriate regulatory authority such as the Department of Agriculture, Water and the Environment (DAWE), - external site the Australian Chamber of Commerce and Industry (ACCI) - external site or other relevant agency depending on the nature of the product.

Please note: A Certificate of Free Sale issued by the TGA is ONLY available for medical devices and NOT listed/registered medicines.