Frequently asked questions about exporting therapeutic goods

4 August 2015
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Export only products are required to be listed (not registered) on the ARTG before export. Broadly, they are expected to meet the same requirements as products listed for supply in Australia. They are assessed using the same criteria as listed products that are intended for supply in Australia. However, they are not required to comply with the labelling standards or advertising standards in force in Australia. Like other therapeutic products, an application fee is charged for listing an export only product on the ARTG.

If the medicine intended for export is currently available in Australian market, it would be already listed or registered on the ARTG. This medicine can be exported without further regulation, provided you are either the sponsor of the medicine or an agent of the sponsor.

If you are a sponsor and you want to export a medicine under a different name not already included in the product details on the ARTG, you can do this in either of two ways:

  • notifying the TGA of any 'export only' name(s) at the time of listing or registration of that medicine; or
  • if the medicine is already listed or registered, submit a 'grouping' application to the TGA. The grouping application is submitted electronically and it follows a review process similar to the review process required for a new application.

It is likely that you will still need to apply to the TGA for a certificate of pharmaceutical product (CPP) in order to satisfy the requirements of the importing country.

Paper based application forms are no longer accepted by the TGA Export Unit unless a genuine need is identified by a sponsor. Sponsors are required to apply for listing new medicines or obtaining certificates of pharmaceutical products through TGA on-line services, applying by submitting electronic applications.

If you are unable to use EEL for drafting and/or submitting an export application, please call 1800 092 788 and a paper application will be promptly mailed out to you.

Relatively minor changes to the export labels can be made by notifying to the TGA. These include changes to colour, font size, sponsor details, overseas distributor's details and some changes to wording of the label claims to account for cultural differences. The changes to the claims, however, must not compromise the claim itself and, must be consistent with the approved indications for the product in the ARTG. Additional safety warnings can also be added to the labels.

An export medicine label can be printed in languages other than English language, providing information on the label does not disagree with the draft label approved for the product at the time of listing. If a sponsor opts to use a foreign language label, he/she is required to submit an English translation of that label to the Export Unit for record purposes.

If a medicine is imported into Australia and it remains confined within the Customs territory at the air/sea port before it is exported, it doesn't require any export listing with the TGA. However, if the sponsor has shifted the medicine to their private storage facility or has repackaged it or has undertaken any other step of manufacturing on it, the medicine will require a new listing before its exportation.
You can use an overseas manufacturer to manufacture your export medicine. However, it is expected that the overseas manufacturer/s will have a level of GMP equivalent to licensed manufacturers in Australia. A valid Overseas Pre-clearance Certificate is required to be produced by sponsors at the time of listing of this product. This certificate can be obtained by applying to the TGA's Manufacturers Assessment Branch (MAB). For further information regarding Overseas Pre-clearance Certificate, please contact MAB on 02 6232 8708.

The exportation of human body fluids such as blood and blood products and urine is regulated under Regulation 8 of the Customs (Prohibited Exports) Regulations. Essentially these products may be exported without the need of a TGA issued permit if the container volume of each individual container is less than 50 mL. That is, the total shipment may have a volume of over 50 mL but as long as each individual container comprising the shipment is less than 50 mL in volume, there is no need to request a permit from the TGA in order to carry out the export. However, if the individual container volume does exceed 50 mL a permit to export is required. This permit can be obtained, free of charge, by applying to the TGA Export Medicines Unit. Further information in this regard and the relevant application form can be down-loaded from the TGA website.

For the exportation of human placenta, cremated body remains or a dead body for burial purposes there is no requirement to ask the TGA to issue an export permit as there is no permission to obtain in these situations. However, to enable the process of exportation to run smoothly, it is advised to check with the health authorities in your State regarding handling and storage requirements and also in the destination country to determine their requirements.

Effective from 12 June 2007, the export of human embryo no longer requires permission from the Attorney General's Department. That means embryos can now be exported from Australia as per the same rule as applicable to export of any other human tissue and/or fluid. This rule is covered under Customs (Prohibited Exports) Regulation 1958 Schedule 6 and infers that:

  1. If the immediate container that contains human embryos is of 50 mL or less volume, permit is not required by the TGA.
  2. If the container that contains human embryos exceeds 50 mL in volume, a permit will have to be obtained by the TGA Export Unit.

If a permit is required in your case, please download the relevant form from the TGA website and send it by fax to the TGA on 02 6232 8399.

If exportation of a medicine to a family member overseas is required, certain conditions must be met:

  1. The medicine to be exported must be on the Australian Register of Therapeutic Goods (ARTG), unless exempt.
  2. An Australian doctor's prescription accompanies the shipment
  3. The total quantity to be exported does not exceed 3 months continuous supply
  4. If the medicine is one on the Pharmaceutical Benefit Scheme (PBS) list it has been purchased on full payment and a Medicine Export Declaration Form, available from Medicare offices has been completed and also accompanies the shipment
  5. The Customs authorities of the importing country have been contacted to ensure compliance with local laws

If the medicine(s) to be sent comply with the above conditions it can be sent overseas.

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

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

The exportation of a medicine by a person, including pharmacists, pursuant to orders received from overseas 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 Act apply.

The exportation of a medicine by a person in response to orders received from overseas may also breach certain provisions of the National Health Act 1953, the Customs Act 1901 and other Commonwealth, State or Territory legislation.

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 using the form and guidelines at Import/export of unapproved therapeutic goods for experimental purposes.
No, the TGA Export Medicines Unit only regulates export of medicines for human use. If you wish to export or inquire about veterinary medicines, you should contact Australian Pesticides and Veterinary Medicines Authority on 02 6210 4700.
No, the TGA Export Medicines Unit only regulates export of medicines. If you wish to export a medical device or wish to have information in this regard, you should contact the TGA's Office of Devices Authorisation on 1800 141 144. Relevant information is also available at the TGA website at Medical devices regulation.