ARGCM Part II: Listed Complementary Medicines

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ARGCM Part II: Listed Complementary Medicines

Therapeutic Goods Administration

Australian Guidelines for Complementary Medicines (ARGCM)Part II: Listed Complementary Medicines

Version 4.2, August 2011

About the Therapeutic Goods Administration (TGA)The TGA is a division of the Australian Government Department of Health and Ageing, and is responsible for regulating medicines and medical devices.The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary.The work of the TGA is based on applying scientific and clinical expertise to decision-making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices.The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices. The TGA investigates reports received by it to determine any necessary regulatory action.To report a problem with a medicine or medical device, please see the information on the TGA website.

Therapeutic Goods Administration

Copyright Commonwealth of Australia 2011

This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any process without prior written permission from the Commonwealth. Requests and inquiries concerning reproduction and rights should be addressed to the Commonwealth Copyright Administration, Attorney Generals Department, National Circuit, Barton ACT 2600 or posted at

Australian Guidelines for Complementary Medicines , Part IIV4.2 August 2011Page 2 of 76

Version historyVersionDescription of changeAuthorEffective date

V4.0The ARGCM was amended to take into account the TGA restructure of July 2010. Some editorial changes were made, such as corrections of typographic errors.Office of Complementary MedicinesMarch 2011

V4.1Version 4.0 was transferred into the new TGA template. The content remained the same, but page numbers changed. This version was also labelled Version 4.0Office of Parliamentary and Strategic SupportMay 2011

V4.2A version history table was added. The version was labelled as Version 4.2. Changes were also made to capitalisation of titles.Office of Parliamentary and Strategic SupportAugust 2011

Therapeutic Goods Administration

Therapeutic Goods Administration

Document title, Part #, Section # - Section titleV1.0 October 2010Page 15 of 76

Australian Guidelines for Complementary Medicines, Part IIV4.2 August 2011Page 7 of 76

Contents1.Overview81.1Background82.Eligibility for including Listed complementary medicines on the ARTG92.1General criteria for Listed complementary medicines92.2Ingredients approved for use in Listed complementary medicines112.2.1Approved active ingredients112.3Assessing the status of herbal ingredients for use in Listed medicines112.3.1Determining Status as a Listed Substance112.3.2Definition of a herbal substance122.3.3Schedule 4 to the Regulations122.3.4Herbal ingredients that are not permitted for use in Listed medicines132.4Assessing the status of non-herbal substances132.5Assessing the status of excipient ingredients132.5.1Excipients other than topical excipients132.5.2Topical excipients143.The Listing process163.1Flow chart163.2Listed medicine application lodgement and validation via ELF3183.3Payment processing183.4Listing and operations section processing183.5Random post market review process183.6Fee structure193.6.1New Listed medicine application193.6.2Product variation194.The Electronic Listing Facility Version 3 (ELF3)204.1Overview of the ELF system204.1.2Gaining access to ELF3204.1.3ELF3 User Guide214.1.4Security of operations214.1.5Accessing the ELF3 system214.1.6Validation system within ELF 3214.1.7Sponsor certifications under Section 26A of the Act225.Quality265.1Active ingredient complementary medicine substance265.1.1Manufacture of the active ingredient275.1.2Compositional information275.1.3Control of active substance specifications275.2Finished product305.2.1Description and composition of the product305.2.2Product development305.2.3Formulation305.2.4Manufacture of the finished product355.2.5Control of excipients - specifications365.2.6Control of active ingredient - specifications375.2.7Control of the finished product specifications385.2.8Batch certificates of analysis415.2.9Container415.2.10Finished product stability426.Safety and efficacy516.1Safety516.1.1Introduction516.1.2Ingredients of animal and human origin516.1.3Pre-clearance application for animal-derived ingredients516.2Efficacy526.2.1Introduction526.2.2Guidelines for levels and kinds of evidence to support indications and claims526.2.3Post-Market Requirements Efficacy547.Labelling and presentation557.1Labelling557.1.1Statement of ingredients567.1.2Directions for use and dosage577.1.3Distinctiveness of labels577.1.4Reference to other products577.1.5Logos and symbols577.1.6Sugars in medicinal products577.1.7Negative disclosure statements587.1.8Language on labels587.1.9Internet addresses587.2Unacceptable presentation587.3Ingredient names on labels598.Post market review618.1Background618.2Listing Compliance Section of the Office of Complementary Medicines628.2.1Post-market monitoring of ELF3628.3Medicine investigation638.4Specific safety and efficacy reviews638.5Regulatory action638.6Laboratory testing program638.7Good Manufacturing Practice (GMP) audits648.8The Regulatory Compliance Unit648.9Problem reporting and recall648.9.1Recalls648.9.2Adverse reaction reporting649.Product changes679.1About this guidance679.2Notes for sponsors689.2.1Identifying missing information in your ARTG product record689.2.2Adding indications for grandfathered products689.2.3Single event changes689.3Does the change make the goods separate and distinct699.4Groups Order summary699.4.1Name change699.4.2Different export name699.4.3Different indications709.4.4Different directions for use709.4.5Different quantity of excipient that is a restricted ingredient709.4.6Removal or addition of a fragrance, flavour, printing ink or colour709.4.7Different composition of proprietary excipient709.5Types of changes709.5.1New:709.5.2Group / Grouping:719.5.3Vary / Variation:719.5.4Correction of ARTG Record:719.6Terminology used to describe the changes719.6.1Change:719.6.2Update addition:719.6.3Update deletion:719.6.4Addition:719.6.5Deletion:719.7Changes tables7110 Other requirements7310.1Conditions of Listing7310.1.1Section 28 of the Therapeutic Goods Act 19897310.1.2Statutory conditions of Listing7310.1.3Additional conditions of Listing7410.1.4Substances with conditions of Listing surrounding their use7510.2Endangered species75

1. OverviewThe purpose of this part of the Guidelines is to help sponsors seeking to include complementary medicines on the Australian Register of Therapeutic Goods (ARTG) as Listed medicines. The regulatory requirements for the Registration of complementary medicines are discussed in PartI of the Guidelines, and for complementary medicine substances in PartIII.This first section provides an overview of the requirements for including complementary medicines as Listed goods. Detailed guidance is provided in the following sections:Section 2. Eligibility for including Listed complementary medicines on the ARTGSection 3. The Listing ProcessSection 4. The Electronic Listing Facility Version 3 (ELF 3)Section 5. QualitySection 6. Safety and efficacySection 7. Labelling and presentationSection 8. Post market reviewSection 9. Product changesSection 10. Other requirements.

1.1BackgroundThe Therapeutic Goods Act 1989 (the Act) requires that therapeutic goods 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 Therapeutic Goods Regulations 1990 (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 Electronic Listing Facility Version 3 (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. Section 2 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.

Australian Guidelines for Complementary Medicines,Part II , Section 1 OverviewV4.2 August 2011Page 8 of 76

2. Eligibility for including Listed complementary medicines on the ARTGThis 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:2.1. General criteria for Listed complementary medicines2.2. Ingredients approved for use in Listed complementary medicines2.3. Assessing the status of herbal ingredients for use in Listed medicines2.4. Assessing the status of non-herbal substances2.5. Assessing the status of excipient ingredients.2.1General criteria for Listed complementary medicinesTo be eligible as a Listed complementary medicine in the ARTG for supply in Australia, the product must contain only ingredients that may been approved for use in Listed compl