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
provide assurance of the safety of complementary medicines through a risk-based program of post market monitoring and surveillance; provide consumer confidence in the safety and quality of complementary medicines; and ensure industry compliance with regulatory standards and guidelines for complementary medicines. The measures required to meet the objectives include: targeted and random audits of Listed medicines; monitoring of suspected adverse reactions; targeted and random laboratory testing of medicines and ingredients; targeted and random surveillance in the market place; an effective, responsive and timely recalls procedure; audit of Good Manufacturing Practice (GMP); an effective co-regulatory approach to control advertising; and These measures provide timely identification and appropriate regulatory responses to problems associated with the formulation, manufacture, labelling and advertising of medicines. 8.2 Listing Compliance Section of the Office of Complementary Medicines The Listing Compliance Section (LCS) operates in the following functional areas: monitoring of medicines Listed on the ARTG through the Version 3 (ELF 3); investigation of medicines where a potential problem has been identified; safety and efficacy reviews; regulatory action; and administration and business processes. 8.2.1 Post-market monitoring of ELF 3 Following Listing of medicines on the ARTG, a proportion of them will undergo a random or targeted, desk-based post market review. Reviews are performed at one or other of three levels. The information required for review at each level will include, but not be restricted to: Level 1 Review Information available on ELF 3 to be reviewed: claims and indications; ingredients; current GMP certification for nominated manufacturers; and sponsor self-certification and Office of Scientific Evaluation (OSE) pre-clearance documentation for ingredients of animal origin. The following information may need to be supplied by the sponsor, under the provisions of Section 31(2) of the (the Act), within the time period stated in the Section 31 letter: a summary of the of evidence that support the indications claimed for the medicine (bibliography); the claimed shelf life of the medicine; specifications for the final medicine; and