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Exporting therapeutic goods from Australia: Frequently asked questions

7 May 2020

The TGA will accept electronic submissions of schedules to accompany the Certificate of Pharmaceutical Product (CPP) and Certificate of Listed Product (CLP).

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Medicines

General export information

To export a medicine on a commercial scale, you must be the sponsor of that medicine or an authorised agent acting on behalf of the sponsor.

A person must not export a medicine that is not listed or registered in the Australian Register of Therapeutic Goods (ARTG) to that person, unless the medicine is subject to an exemption, approval or authorisation under the Therapeutic Goods Act 1989.

The exportation of a medicine by a person, including a pharmacist, may breach section 19B and/or contravene section 19D of the Act in cases where the exported medicine is not listed or registered in relation to that person, the medicine is not an exempt good and none of the exemptions, approvals or authorisation under sections 18A, 19 or 19A of the Therapeutic Goods Act 1989 apply.

Therapeutic goods are broadly defined as products for use in humans in connection with:

  • preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury
  • influencing, inhibiting or modifying a physiological process
  • testing the susceptibility of persons to a disease or ailment
  • influencing, controlling or preventing conception
  • testing for pregnancy
  • the replacement or modification of parts of the anatomy

Therapeutic goods can comprise a broad range of things, such as bandages, pregnancy testing kits, herbal remedies, tissue grafts and paracetamol. A tool has been prepared to help you identify if your product may be a therapeutic good.

Moisturisers, facial cleansers, dental bleaches and whiteners and sunscreens with an SPF of more than 4 but less than 15, are generally regulated as cosmetic products and fall out of the scope of the TGA. For more information about the regulation of these products contact the National Industrial Chemicals Notification and Assessment Scheme (NICNAS).

A medicine currently available for sale in the Australian market will be in the ARTG and can be exported without further regulation; provided that:

  • you are the sponsor of the medicine or an authorised agent acting on behalf of the sponsor
  • the medicine is unchanged prior to export

Export only products must be listed in the ARTG before export is commenced. Only the sponsor of a medicine, or an authorised agent acting on behalf of the sponsor, can apply for an export only listing to allow the export of the medicine from Australia.

Products listed as export only products cannot be supplied in Australia.

If a medicine is imported into Australia and it remains confined by Customs' at the air/sea port before it is exported, it doesn't require an export only listing in the ARTG. However, if the sponsor chooses to hold the medicine in a private storage facility within Australia prior to export the medicine will be required to be listed in the ARTG as an export only medicine before exportation. In this instance, a step of manufacture must be performed by an Australian based manufacturer prior to export listing.

If you are a sponsor, or an authorised agent acting on behalf of the sponsor, and you want to export a medicine under a different name than the ARTG entry, you need to:

  • notify the TGA of any proposed 'export only' names in the application to either list or register the medicine in the ARTG; or
  • submit a grouping application to the TGA to add the 'export only' name to the medicine if the medicine is already listed or registered.

You need to meet certain conditions to export therapeutic goods overseas for non-commercial use:

  1. The goods must not be for commercial supply, must not contain a substance prohibited under the Customs Act 1901 and must not be for use in a clinical trial in humans.
  2. The goods to be exported must be on the Australian Register of Therapeutic Goods (ARTG), unless exempt from this requirement.
  3. The total quantity to be exported does not exceed 3 months continuous supply.
  4. An Australian doctor's prescription must accompany the shipment if this is registered as a prescription medicine in Australia.
  5. You must keep all goods in original packaging. In the case of prescription medicines, the label on the packaging must show where the medicine was dispensed, for whom the medicine was prescribed and how much was paid for the medicine.
  6. You should contact the embassy or high commission of the destination country to ensure the goods are legally able to enter your proposed destination.

If a medicine is covered by the Pharmaceutical Benefits Scheme (PBS), see Travelling overseas with a PBS medicine to ensure you are fulfilling any PBS requirements.

The TGA only regulates the export of therapeutic goods for human use. If you wish to export veterinary medicines, you should contact Australian Pesticides and Veterinary Medicines Authority (APVMA).

Applications for export only medicines

All steps of manufacture must meet requirements equivalent to Australian regulatory guidelines for the specific medicine type. Export Only medicines must be manufactured in accordance with Good Manufacturing Practice (GMP) as outlined in the Manufacturing principles for medicinal products.

Mandatory requirements for Export Only medicines:

  • Australian manufacturers must have a current manufacturing licence issued by the TGA
  • overseas manufacturers must have a current GMP clearance issued by the TGA in the name of the sponsor

One or more steps of manufacture must take place in Australia for all Export Only medicines (Item 1, Schedule 4 of the Therapeutic Goods Regulations 1990). The step(s) of manufacture must align with the manufacturing licence. This includes medicines imported into Australia and held by the sponsor prior to export, refer to Importing therapeutic goods for export purposes.

Your application will be rejected if you do not meet the manufacturing requirements.

New export only medicine application: The intended change creates a separate and distinct good, as defined under section 16(1) of the Therapeutic Goods Act 1989; therefore a unique (new) AUST L number will be issued. A fee for listing a new product is payable.

Grouping export only application: The intended change is permitted under the Groups order currently in force, therefore certain restrictions and conditions are applied to the application. A grouping application is only appropriate when the goods are intended to replace the currently supplied goods. The existing AUST L number is maintained. A fee equivalent to the listing of a new product is payable.

Variation to an existing export only listing: The intended change creates a minor change to an existing product's details. The current AUST L number is maintained. An application fee is payable.

Notification to an existing export only listing: The intended change creates a very minor change to the product's details that do not change the ARTG record. The current AUST L number is maintained. An application fee is not payable.

Changes to export only listings

Type of change New application Grouping Variation Notification
Change in dosage form New application
Addition or deletion of an active ingredient New application
Change in the amount of an active ingredient New application
Change in type of container (e.g. finished product to bulk product) New application
Change in dosage form New application
Change in the amount of an excipient Grouping
Change to product name Grouping
Addition or deletion of an export only name Grouping
Addition of therapeutic indications Grouping
Directions for use Grouping
Addition or deletion of fragrance, flavour or colouring Grouping
Change in Shelf life Variation
Change in source of animal ingredient Variation
Change in manufacturer Variation
Change of wording of indications (intent must remain the same) Notification
Removal of some or all indications Notification
Addition or deletion of pack size Notification
Change to Product Information (not reviewed by the TGA - must be already approved by the importing health authority) Notification

Specific changes to product label

Change to product label Variation Notification
Change to dosing instructions Variation
Change to font/colour/layout Notification
Addition or deletion of country specific warning Notification
Change to distributor details Notification
Marketing authorisation number Notification
Language Notification

Specific changes to product specification

Change to product specifications Variation Notification
A less restrictive limit within an already given range Variation
Addition of tests other than 'Appearance' or 'Identification' Variation
A more restrictive limit within an already given range Notification
Removal of country specific tests Notification
Addition of tests regarding 'Appearance' or 'Identification' Notification

The Exports Team at the TGA aims to process applications within thirty (30) business days, starting from when the completed application is received by the Exports Team. The application fee must be paid before processing commences.

The costs associated with an export only listing can be found in the Schedule of fees and charges on the TGA website. The cost for a grouping application is the same as that of a new listing application.

Certificate of Pharmaceutical Product (CPP) and Certificate of Listed Product (CLP)

The Certificate of Pharmaceutical Product (CPP) is modelled on the WHO scheme on the quality of pharmaceutical products moving in international commerce. The Certificate of Listed Product (CLP) has a similar layout but is not formally issued under the WHO scheme.

  • Certificate of Pharmaceutical Product (CPP) is based on the World Health Organization (WHO) scheme on the quality of pharmaceutical products moving in international commerce. The CPP is issued on an internationally harmonised template to provide assurance to countries participating in the scheme about the quality of the pharmaceutical product.
    • This certificate has the following TGA comment for a registered medicine: This product has been evaluated and approved by the TGA and is permitted to be supplied in Australia.
    • This certificate has the following TGA comment for a listed medicine: This product has been approved by the TGA and is permitted to be supplied in Australia.
  • Certificate of Pharmaceutical Product (CPP) for an Export Only Medicine is similar to a CPP, but used for products that are listed as 'export only' medicines and are not available for supply in Australia.
    • This certificate has the following TGA comment: This product has been listed on the Australian Register of Therapeutic Goods as an export only medicine.
  • Certificate of Listed Product (CLP) is similar to a CPP, but used for products regulated as medicines in Australia that have a different regulatory status in other countries, such as herbal products, vitamins and minerals regulated as foods or dietary products overseas. A CLP is only provided for listed medicines.
    • This certificate has the following TGA comment: This product has been approved by the TGA and is permitted for free sale (in that it can be legally supplied) in Australia.

Sponsors may provide additional schedules to include with their Certificate of Pharmaceutical Product (CPP) or Certificate of Listed Product (CLP) application as requested by the country of import. The schedules must be submitted via post as A4, single sided documents. Each page of the schedule should be numbered.

All information included with the CPP and CLP applications must be verifiable against the ARTG.

Only the following may be included as a schedule to accompany the certificate:

  • formulation details
  • manufacturing details
  • product label that has been approved by the TGA
  • Product Information (PI) that has been approved by the TGA
  • Consumer Medicine Information (CMI) that has been approved by the TGA
  • shelf life that has been approved by the TGA

Requirement for hard copies of schedules

Some importing health authorities require a declaration and an original signature of the sponsor on the sponsor provided schedules. Due to this, the TGA requires all schedules supplied by the sponsor to contain a declaration and an original signature to assist with the requirements of the importing country. If you wish to submit an additional schedule to accompany your CPP or CLP, you will be required to post these to the exports team at the following address:

Therapeutic Goods Administration
Attn: Exports
PO Box 100
Woden ACT 2606
Australia

The declaration that accompanies a sponsor provided schedule should state:

I, your name, on behalf of your company's name declare the information provided in this schedule is current and correct.

This should be signed and dated by the sponsor or an authorised agent acting on behalf of the sponsor.

The TGA recommends that if you are including your own copy of the schedules, that they are posted early in this process to avoid delay of processing of your application.

The Exports Team at the TGA aims to process applications within fifteen (15) business days starting from when the completed application is received by the Exports team. The application fee must be paid before processing commences.

The costs associated with a Certificate of Pharmaceutical Product (CPP) and Certificate of Listed Product (CLP) can be found in the Schedule of fees and charges on the TGA website.

Medical devices

Certificates of free sale and export certificates

When exporting medical devices to other countries, sponsors may be asked by the importing country to supply a certificate of free sale or an export certificate. Certificates of free sale and export certificates are documents supplied by the TGA outlining that the relevant medical device(s) are included in the ARTG and are either able to be freely supplied and sold within Australia or are able to be exported from Australia.

To apply for a certificate of free sale you need to have a current Australian Register of Therapeutic Goods (ARTG) inclusion for your products that allows them to be supplied and sold within Australia, unless they are exempt from this requirement.

To apply for an export certificate you need to have a current export only ARTG inclusion for your products, unless they are exempt from this requirement.

Further information can be found in Certificates of free sale and export certificates for medical devices.

The following information is included on the certificate:

  • Australian Register of Therapeutic Goods (ARTG) number(s)
  • device description based on the Global Medical Device Nomenclature (GMDN) code(s)
  • GMDN code(s) for your medical device
  • the medical device class
  • the sponsor's name and address as it appears in the ARTG inclusion
  • the primary manufacturer's name and address as it appears in the ARTG inclusion

Instead of listing individual ARTG numbers on the application form, you may include the statement: Refer to Schedule.

Further information that the importing country requires to be included in your certificate can be provided via a schedule accompanying your application form.

You may or may not need to provide a schedule with your certificate depending on the information required by the country of import. If additional information is required, you will need to provide that information in a schedule accompanying your application form, in an accessible electronic document (preferably a Microsoft Word document) on your company's letterhead.

Schedules should include information limited to the following:

While your schedule may not include all of this information, it should not include any fields other than those listed.

Sponsors and authorised agents acting on their behalf must ensure that the information provided in an application to the TGA is consistent with their TGA Business Services (TBS) client details and their Australian Register of Therapeutic Goods (ARTG) records.

Any inconsistencies in information currently in the ARTG or TBS client details must be rectified before making an application, or the TGA will not be able to process the application.

In these circumstances, a refund of the application fee is not provided.

The Application for certificate of free sale or export certificate for a medical device is available on the TGA website.

Ensure that you provide:

  • the completed application form
  • any necessary schedules that you would like attached to your certificate
  • a completed credit card authorisation form

Email your completed application and any required documents to accountsrec@health.gov.au.

Your certificate can be supplied either electronically or by post. Indicate your preference on your application. If you elect to have hard copies sent to you, you are able to request up to five (5) copies. If you are requesting hard copies, please indicate on your application form how many copies you require.

The TGA aims to process applications within ten (10) business days starting from when the completed application is received by the Exports Team. The application fee must be paid before processing commences.

The costs associated with a certificate of free sale (CFS) or export Certificate can be found in the Schedule of fees and charges on the TGA website.

Human substances

If you are exporting human body fluids, organs and other tissues, you:

  • do not need a TGA export permit if the volume of each individual container is 50 mL or less (even if the total volume of a shipment exceeds 50 mL)
  • need a TGA export permit when the volume of a container exceeds 50 mL.

If you are exporting substances derived from human blood, such as immunoglobulins or blood factors, you need a TGA permit regardless of the volume.

Further information can be found in Export of human substances.

You do not need a TGA export permit to export human breast milk. We suggest that you contact your state or territory department of health regarding their requirements for handling and storage.

You do not need a TGA export permit to export human placenta. We suggest that you contact your state or territory department of health regarding their requirements for handling and storage.

Unapproved therapeutic goods

The export of unapproved therapeutic goods for experimental purposes in humans requires approval in writing from the TGA. Applicants can submit an application under section 19(1)(b) or 32CK(1) or 41HB(1) of the Therapeutic Goods Act 1989. Import/export of unapproved therapeutic goods for experimental purposes provides further information.