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Regulatory

The Therapeutic Goods Act 1989 (The Act) applies to both the supply of therapeutic goods in Australia and the export of therapeutic goods from Australia. A key requirement of the legislation is that all complementary medicines, such as herbal, vitamin, mineral and nutritional supplements must be included in the Australian Register of Therapeutic Goods (ARTG), including those that are exported.

Our Regulatory Department, comprised of highly skilled and experienced professionals, offers clients ongoing counsel on regulatory planning to attain permits required in Australia and markets around the world. Our reputation and relationships allow us to provide strategic regulatory advice throughout the stages of your product’s lifecycle.

We have a proven track-record of listed and approved products registered with various health authorities around the world. With this breadth of experience and scientific knowledge, Vitex can facilitate all aspects of this process by providing the following specialist services to assist you in covering the criteria for regulatory compliance.

Our regulatory services include:

  • Advising eligibility of products and level of registration required
  • Australian regulatory compliance with the Therapeutic Goods Administration (TGA)
  • Evidence packages
  • Export certification
  • Label compliance
  • Maintenance of marketing licenses, permits and other compliance related activities through the life of a product
  • Preparation and submission of listing applications to the TGA
  • Preparation of product Registration Dossier packages
  • Regulatory compliance with international health authorities in all markets
  • Response to section 31, post market reviews