This first section provides an overview of the requirements for including complementary medicines as Listed goods. Detailed guidance is provided in the following sections: . Eligibility for including Listed complementary medicines on the ARTG – . The Listing Process – . The Electronic Listing Facility Version 3 (ELF 3) – – . Quality – . Safety and efficacy – . Labelling and presentation – . Post market review – . Product changes – . requirements. – 1.1 Background The (the Act) requires that therapeutic trial that are imported or manufactured for supply in Australia be included in the ARTG, unless they are specifically exempted from this requirement by Schedule 5 of the (the Regulations). It is an offence under the Act to import, export, manufacture or supply non-exempt goods that have not been entered in the ARTG. Medicines may be either or in the ARTG, depending on their ingredients or the ‘Listed’ ‘Registered’ intended purpose of their use. Schedules 3 and 4 of the Regulations outline those goods that must be Listed or Registered. Medicinal products submitted for inclusion in the ARTG for Listed goods are made eligible on the basis of an application made via the (ELF 3). Sponsors of Listed medicines provide certain product information and a formal declaration that all the requirements, as set out in subsection 26A(2) of the Act, have been met. of this part of the Guidelines is designed to help sponsors determine whether their medicinal products are eligible for Listing and whether or not they comply with all the Listing requirements. Eligibility for including Listed complementary medicines on the ARTG This section details the criteria used to determine the eligibility of a product for inclusion in the Australian Register of Therapeutic Goods (ARTG) as a Listed complementary medicine. This section is divided into the following subsections:
This first section provides an overview of the requirements for including complementary medicines as Listed goods. Detailed guidance is provided in the following sections: . – Eligibility for including Listed complementary medicines on the ARTG . – The Listing Process . – The Electronic Listing Facility – Version 3 (ELF 3) . – Quality . – Safety and efficacy . – Labelling and presentation . – Post market review . – Product changes . – requirements. 1.1 Background The (the Act) requires that therapeutic that are imported or manufactured for supply in Australia be included in the ARTG, unless they are specifically exempted from this requirement by Schedule 5 of the (the Regulations). It is an offence under the Act to import, export, manufacture or supply non-exempt goods that have not been entered in the ARTG. Medicines may be either ‘Listed’ or ‘Registered’ in the ARTG, depending on their ingredients or the intended purpose of their use. Schedules 3 and 4 of the Regulations outline those goods that must be Listed or Registered. Medicinal products submitted for inclusion in the ARTG for Listed goods are made eligible on the basis of an application made via the (ELF 3). Sponsors of Listed medicines provide certain product information and a formal declaration that all the requirements, as set out in subsection 26A(2) of the Act, have been met. of this part of the Guidelines is designed to help sponsors determine whether their medicinal products are eligible for Listing and whether or not they comply with all the Listing requirements. Eligibility for including Listed complementary medicines on the ARTG This section details the criteria used to determine the eligibility of a product for inclusion in the Australian Register of Therapeutic Goods (ARTG) as a Listed complementary medicine. This section is divided into the following subsections: trial
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