Section 6: Programs for the Provision of Registered Medicines at No Cost or Reduced Cost

Companies may offer programs for the provision of a registered medicine at no cost or reduced cost. These programs must be only for the purpose of enhancing patient access or enabling prescribers to gain experience with the product to improve patient care.

1. Companies may supply Starter packs at no cost or trade packs at no cost or reduced cost.
2. Companies must be aware of jurisdictional and individual institutional requirements for the supply, management and distribution of prescription products.
3. Programs must be reasonable and withstand public scrutiny with regard to the amount of stock, duration of program and any other relevant aspects of the program.

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6.1 Product Starter Packs

1. Starter Pack definition and labelling requirements are specified under the current Therapeutic Goods Order.
2. Companies should ensure that they are kept informed of any changes in Commonwealth and State laws concerning the supply of starter packs. A summary of this information can be found in the Code Tool Kit.
3. Starter packs of products must be stored and supplied consistent with related product labelling.
4. Starter packs of products may only be supplied by representatives employed by the holder of a manufacturer’s licence or wholesale dealer’s licence or by authorised Company representatives.
5. A written request from a healthcare professional to receive starter packs, including the name and address of person supplied and the name, strength and quantity of the starter packs supplied, must be submitted prior to supply.  
6. A record of delivery, including the quantity and nature of starter packs, should be kept for a minimum of two years by the Company.