This article applies to selling in: Australia

OTC medicines approval requirements

Amazon limits the addition of new sellers in certain categories to ensure a high level of quality so that customers are able to buy with confidence from all Amazon sellers. In order to sell Over-the-Counter (OTC) medicines, you will have to meet the requirements listed below. While our site-wide selling guidelines still apply, please bear the additional requirements for this category in mind.

Seller requirements

  • You must be registered as a seller on Professional Selling on the Amazon program.
  • You must have an inventory of more than one product in this category.
  • You must have a return delivery address in the local country or provide free delivery.
  • You must be able to provide local language support for customer service in the marketplace in which the sale is intended.
  • Your own company website is not required, but it is helpful to use it for review during the application process.
  • You must provide acceptable documentation (for example, valid invoices) and other information that we request about the products that you intend to sell.
  • You must be able to provide a copy of the ARTG certificate or summary for each product that you wish to sell

Product requirements

  • The products that you sell must be new.
  • All products must be intended for sale within Australia and comply with all laws and regulations of Australia.
  • For each product, a valid barcode (product identifier) registered and associated with the product is required.
  • All products offered for sale on an Amazon website must (as a minimum) be labelled in English.
  • All products must have an ARTG number (where required by the Australian law)
  • Ingredients for all over-the-counter (OTC) medicines and dietary supplements must be listed in the inventory file template. Additionally, images of ingredients and or nutritional facts listed on product packaging should be uploaded as secondary product images on product detail pages.

Important: Important: Within Australia, no seller is permitted to list any of the following products for sale: (i) prescription-only medicines, (ii) pharmacist-only medicines or (iii) pharmacy-only medicines.

Next steps

If you are able to meet all of the requirements listed above, click Request Approval during the product setup process. By clicking the button, you are confirming that you have reviewed the requirements above and that you want to apply to sell in the Health & Personal Care category. We will contact you to request for additional required information after you have submitted your request to sell.

Related links

TGA Legislation Basics

Forms for OTC Medicines Approval in Australia

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