Export of medicines for commercial supply
Introduction
Generally speaking, therapeutic goods, which are intended to be exported from Australia for commercial supply, must first be included in the Australian Register of Therapeutic Goods (ARTG) in the name of the sponsor of the goods. There may be some exemptions contained in Schedule 5 of the Therapeutic Goods Regulations 1990 but they relate mainly to non-commercial exports.
"Sponsor" in this case means a person who exports, or arranges the exportation of, the goods from Australia, but does not include a person who exports the goods or arranges the exportation of the goods on behalf of another person who, at the time of the exportation, is a resident of Australia or is carrying on business in Australia.
In plain English, this generally means that intending exporters of such goods have two options:
- act as the sponsor of the goods and submit an application to include the goods in the ARTG prior to export; or
- arrange the exportation of the goods on behalf of the sponsor who already has the medicine included in the ARTG.
Clearly, both options require the support of the original Australian product sponsor. Note that the product then authorised to be exported under these arrangements would need to be identical to that which is included in the ARTG in the name of the original product sponsor (eg product name, container type, indications, dosage, etc).
In the case of medicines intended for sale overseas, a key issue for commercial suppliers is whether the goods are:
- intended exclusively for export; or
- intended for supply in Australia as well as export: The medicines listed or registered on the ARTG or exempt for listing on the ARTG can also be exported.
This distinction is dealt with in more detail later in this information.
Medicines solely for the purpose of export
Medicines intended solely for the purpose of export are required to be listed (not registered) on the ARTG before export is commenced. Broadly, these medicines must:
- be safe for their intended purpose of use;
- be manufactured under GMP;
- meet any standards applicable under Section 10 of the Therapeutic Goods Act; and
- not be of an unacceptable presentation.
Sponsors requiring to list export products on the ARTG can opt to list their products either under Section 26 or Section 26A of the Therapeutic Goods Act 1989. The products listed under Section 26 are referred to as Export-only products and the products listed under Section 26A are termed as Solely for Export products. The two types of products do not differ from each other in the quality and safety criterion required by the TGA and are so named only to distinguish between the assessment pathways of the two product types. Both type of products are exclusively for export purpose and can not be supplied within Australia including Duty Free outlets.
There is a small difference in terms of the fees requirement of export-only and solely for export products. While same application fee is charged for both types of products, export medicines listed under Section 26A incur an annual maintenance fee whereas there is no annual fee for maintaining product listings that are listed under Section 26 on the ARTG.
Relatively minor changes to the export product labels can be made by notifying to the TGA. These include colour, font size, sponsor details, overseas distributor's details and some changes to the wordings of the label claims to account for cultural differences. The changes to the claims, however, must be consistent with the approved indications for the product in the ARTG. Further, safety warnings can also be added.
The export labels can be printed in languages other than English, providing information on the label does not disagree with the draft label approved for the product at the time of listing. An English translation of the foreign label is required to be submitted to the Export Unit for record purposes.
If an export product is manufactured overseas, it is expected that the overseas manufacturer/s will have an equivalent level of GMP compared to licensed manufacturers in Australia. A valid Overseas Pre-clearance Certificate is required to be produced by sponsors at the time of listing of the product. This certificate can be obtained by applying to the TGA's Manufacturers Assessment Branch (MAB). For further information regarding Overseas Preclearance Certificate, please contact MAB on 02 6232 8708.
Obviously, the requirements of governments overseas will vary greatly with regard to registration of medicines. These requirements should be thoroughly checked by the sponsor of the goods before applying for approval as the TGA cannot give advice on the policies of other countries. However, if you do have difficulties in accessing overseas markets due to export certification concerns you should contact the TGA. This will assist in identifying foreign regulatory agencies, which we need to focus on in promoting the strength of the Australian regulatory system.
Exporters should also check that they meet any State or Federal laws regarding the procurement and storage of medicines (eg. State poisons legislation), and other relevant legislation such as Trademarks, Patents, Wildlife Protection, Customs and Quarantine.
Special requirements exist for the export of drugs such as narcotics, psychotropics, or their precursors. These are listed in the various schedules of the Customs (Prohibited Exports) Regulations. You can also refer to the personal export information <http://www.tga.gov.au/impexp/personal.htm>.
Applications for listing export medicines are currently lodged electronically using the Export Electronic Lodgement (EEL) System <http://www.tga.gov.au/online/eel.htm> which is part of the TGA's eBusiness Services. Both S26 and S26A online application forms can be accessed by accessing TGA eBusiness Services homepage <https://www.ebs.tga.gov.au> or via the TGA Internet homepage <http://www.tga.gov.au/>. Once on the TGA eBusiness Services homepage select 'Secure login' to create either an S26 or S26A New Listing application, or a Variation to a current ARTG Export listing application.
Please note that paper based applications for New Listings or Variations are no longer accepted unless a sponsor identifies a genuine need to the TGA. For sponsors 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 to you.
Safety approval process
Many countries which are importing medicines from Australian exporters look to our system of certification and regulation as an indication that the products involved have been assessed for safety or quality. This may be particularly relevant in countries where resources do not permit a dedicated effort to fully assess every medicine that enters the country.
Where the TGA has serious concerns about the safety of a product, we may seek a statement from the regulatory authorities in the importing country to confirm that they do not object to the listing of the product in the Australian Register of Therapeutic Goods (ARTG).
If it is necessary to do this, about 30 working days will be added to the application processing time.
The procedure involves the TGA sending a letter to the authority involved and requesting whether the importing country is willing to accept the product. When consent is granted, the product is listed in the ARTG. The limited situations where the Safety Approval Process would be used are outlined in the TGA Policy for the export of medicines from Australia <http://www.tga.gov.au/docs/html/export/exppol.htm>.
Where there are no serious safety concerns but some other specific concerns about the export product need be communicated to the country of import, the TGA may adopt the Export Advisory Procedure. In this procedure, the TGA communicates with the importing country via conditions of listing which may be imposed on the supply of the product or as a statement in the export certificate. Further details about this procedure are available in the TGA Policy for the export of medicines from Australia <http://www.tga.gov.au/docs/html/export/exppol.htm>.
Medicines solely for the purpose of export - administrative procedure
The process of listing of products solely for the purpose of export takes approximately 30 working days for completion from the time TGA receives an export listing application, unless the Safety Approval Process is required. The application for listing is submitted electronically through the TGA eBusiness Services website. Once the fee has been processed by the TGA's Financial Services Group, the Export Unit reviews the application for eligibility. After the review has been completed and the application is considered eligible, the data on the application is entered onto the ARTG and a Certificate of Medicine Listing for Export Only is issued for the product.
The Certificate of Medicine Listing should not be confused with an Export Certificate. Whereas an export (medicine) listing certificate is issued to the sponsor of an export medicine after the medicine has been successfully reviewed and entered on the ARTG, an Export Certificate is issued under WHO Certification Scheme. This certificate is issued for a medicine that has already been listed/registered on the ARTG or it is exempt from the requirement of listing or registering on the ARTG. The purpose of the export certificate is to assist overseas health authorities in determining the quality and safety of the medicine that is intended to be exported to their country from Australia.
Medicines for export which are also supplied in Australia
If the goods for export are already available in Australia, they will be on the ARTG, and you can export them without further regulation, provided that you are either the sponsor or the agent of the sponsor.
If you are a sponsor and you want to export a product under a different name, you can do this in either of two ways:
- notifying us of any 'export only' names at the time of listing or registration; or
- through a 'grouping' application for products already on the ARTG. The grouping application is submitted electronically and it follows a review process similar to the review process required for a new application.
Export certification
Following listing or registration in the ARTG, a sponsor may apply to the TGA for an Export Certificate to be issued for the product. The application for an Export Certificate is required to be submitted electronically using TGA's eBusiness Services <https:/www.ebs.tga.gov.au> in a manner similar to the electronic lodgement of Export Listing applications.
To access the Certificate menu, please click on the Export Medicines link on the left hand side of the screen and after logging on, select Export Certificates. Once an application for certification has been received by the TGA Export Unit, it takes 15 working days for its complete review and issuing of the certificate.
In the event that the lodgement of Export Certificate applications using EEL is not possible, please call 1800 092 788 and a paper application form will be promptly delivered via post.
WHO Certification Scheme (CPPs)
Australia is a participant in the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce. This scheme is intended to ensure the quality and safety of medicines which are ultimately sold in countries other than those where they were manufactured.
The TGA, as part of its responsibilities under the WHO Certification Scheme, issues Certificates of a Pharmaceutical Product (CPP) to commercial exporters.
The CPP identifies whether a product can be sold in Australia, or if it is limited to export only. Where it is limited to export, the sponsor may nominate a standard comment to be included which explains why the product is not marketed in Australia. TGA comments may also be included as the CPP is recognised as an effective tool for TGA to communicate with international regulators.
The CPP also assures overseas regulators and importers that the manufacturer is subject to Good Manufacturing Practice (GMP) inspections at regular intervals. In addition, the CPP contains product details such as formulation.
As already mentioned the CPP is not the same as a Certificate of Medicine Listing for Export Only Product. The CPP is an internationally recognised document verifying the status of a product after the product has been listed or registered on the ARTG. As such it is used by overseas regulators and importers as a way of knowing that the product is produced under a comprehensive system of quality assurance including a national system of licensing and conformity with GMP.
Certificate of Listed Product
Complementary healthcare products such as herbals, vitamins and minerals are regulated as foods or dietary supplements in many countries. However, in Australia they are generally regulated as listed complementary medicines. This can cause difficulties where overseas regulators request Certificates of Free Sale to be provided. Products, which are regulated as medicines in Australia, cannot be issued Certificates of Free Sale as they need to meet certain legislative requirements before they can be legally supplied. Instead of a Certificate of Free Sale, a Certificate of Listed Product may be requested for listed medicines, which have been approved for supply in Australia. This certificate is not issued under the WHO Scheme but does contain most of the information included in a CPP.
Certificate of Exempt Product
Some products such as certain sunscreens (below SPF 4), shampoos and deodorants are considered to be therapeutic goods but are exempt from the requirement to be included in the ARTG or to be manufactured under GMP (refer Schedule 5 and Schedule 7 to the Therapeutic Goods Regulations 1990). Sponsors may request the TGA to issue a Certificate of Exempt Product for these products.
General information and updates regarding export
Sponsors can receive general information and updates regarding the use of the Export Electronic Lodgement System by clicking on Export News while on the TGA eBusiness Services website <https:/www.ebs.tga.gov.au> or by ringing the EEL Help line on 1800 092 788.