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    Importing to Australia

    What do I need to import goods to Australia?

    You don’t need a license to import to Australia in general, however some products may require special licenses. See http://www.customs.gov.au/site/page.cfm?u=4369 for information on prohibited or restricted goods.

    Goods Classification

    The first thing
    According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
    you need to do is classify your goods correctly so that the appropriate duties and tariffs (if any) apply.

    Not sure how to classify your goods?

    Customs provides a tariff advice service for importers who are unsure as to the correct classification or concession for their merchandise. To take advantage of this service l
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    odge an application with Customs along with supporting evidence. You can apply for a tarif concession on imported goods that do no compete in the market place with goods of Australian manufacture.

    You are ultimately responsible for classifying goods correctly as well as all other Customs documentation –even if they were
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    prepared by a Broker, Freight Forwarder or Service Provider. It is recommended that you check over all documents before they are given to customs and retain copies. Talk to your Broker of Freight Forwarder if there are any errors.

    You also need to account for any surplus goods, promotional materials and samples.

    All
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    customs documentation must be retained for 5 years.

    For more information on your responsibilities and where you can find help, see http://www.customs.gov.au/site/page.cfm?u=4271

    What happens at customs?

    Customs may decide to inspect your goods or they may waive the inspection. You do not need to submit commercial docu
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    mentation, but you do need to to keep all the relevant commercial documents for 5 years after that time.

    If you have an Australian Business Number(ABN) you will need to supply it to Customs when formally entering goods . Importers need to be registered for GST purposes and have an ABN in order to claim input tax credits
    ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
    or access the GST deferral scheme.

    Duties and Tariffs – How much will they cost?

    Duties and Tariffs are based on the classification code of the goods, valuation and country of origin. Valuation of imported goods can be complex and importers are urged to seek advice from a customs broker or to contact a Customs Informati
    easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
    on Centre

    You can find Tariff information at http://www.customs.gov.au/site/page.cfm?u=4273.

    Where do I go for help?

    Contact the Customs Information and Support Centre on 1300 363 263 or send an email to information@customs.gov.au

    Customs Australia http://www.customs.gov.au/site/page.cfm?u=4226

    Business Australia h
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ttp://www.business.gov.au

    General Guide to Importing to Australia http://www.sd.qld.gov.au/dsdweb/docs-bin/v2/small_bus/SD1351_ImportProductsNo22.pdf

    Importing to New Zealand

    What am I responsible for?

    You are responsible for:


    • Making an accurate and correct entry
    • Paying all Customs charges
    and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
    Keeping all commercial documents for 7 years and providing to Customs if necessary
    • Compliance with legislative requirements

    Classification of Goods

    The correct classification of goods is the most complex part of importing, and for this reason, many people choose to use Customs brokers to worry about it for
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    them!

    The classification code which best fits your merchandise will determine the tariffs and duties you have to pay. You are ultimately responsible for choosing the correct classification code.

    Whether you complete this process yourself, or receive help from a broker or Customs, you will need to provide the following
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    information:


    • purchase invoice
    • manufacturer’s costings
    • freight and insurance costs
    • product sample
    • catalogues or brochures
    • evidence of origin
    • proof of payment.

    For some items you will also need:


    • An airway bill or bill of lading.
    • Invoi
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ces.
    • Packing lists
    • Insurance certificates.

    Importers may also need to contact shipping companies, airlines or freight forwarders for advice on their requirements, operating hours and/or location of the goods.

    Who can help me Classify goods?

    For first time importers, Customs run training programs whi
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ch you can attend. Email cbaff@clear.net.nz to find out more.

    For successive imports, you will be expected to complete the entry yourself or use a Customs broker or agent, or freight forwarder. All import entries must be completed electronically using the appropriate software or over the Internet http://www.cusweb.co.n
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    z.

    Remember that you are responsible for the accuracy of the customs documents - even when they are completed by a broker or agent - so it’s important to check all details.

    Where do I find a Customs broker?

    Customs brokers and freight forwarders are listed in New Zealand business directories under those headings. A lis
    t?

    As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
    t of those affiliated to CBAFF is also available at www.cbaff.org.nz

    How much will I have to pay in Tariffs and Duties?

    Tariffs and duties are determined by the classification of your goods, the country of origin, and preference toward some countries as per trade agreements. Where duty is expressed as a percentage rate
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    , it is calculated on the Customs value of the goods.

    See: http://www.customs.govt.nz/importers/Commercial+Importers/Duties+and+Levies.htm for more information.

    GST

    GST (Goods and Services tax) of 12.5% applies to almost everything imported to New Zealand.

    GST is payable on the sum of following amounts:


    * the Cus
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    toms value of the goods


    * any import duty, anti-dumping and countervailing duties, ALAC or HERA levies payable (see above)


    * the freight and insurance costs of transporting the goods to New Zealand.

    Import Entry Transaction Fee

    An Import Entry Transaction Fee of $25.38 (GST inclusive) is payable on every comme
    .

    As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
    rcial import entry and import declaration for goods with a duty and GST liability of $50 or more.

    How do I pay fees?

    There are three payment options:


    * Cash


    * Deferred payment — only available to importers who are holders of a deferred account


    * Broker deferred — available on the request of an agent who h
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    olds a broker deferred account. It is not available to an importer who holds a deferred account.For more information see:

    NZ Customs http://www.customs.govt.nz/importers/

    NZ Government http://www.govt.nz/record?recordid=2599

    Ministry of Economic Development http://www.med.govt.nz/templates/StandardSummary____22.aspx


    tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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