Version history Version Description of change Author Effective date V4.0 The 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 Medicines March 2011 V4.1 Version 4.0 was transferred into the new TGA template. The content remained the same, but page numbers changed. This version was also labelled ‘Version 4.0’ Office of Parliamentary and Strategic Support May 2011 V4.2 A 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 Support August 2011 Trial
12. Product Specifications The product specification is a description of the product formulation, and the tests to be applied to batches of the product. The statement should contain (or make reference to): name of product; dosage form; product code; date of specification; revision or version number; name and signature of the appropriate company official; description of physical appearance; detail of physical tests performed (and limits) including total weight, weight variation, tests and limits, disintegration tests and limits; stage of manufacture; packaging type and closure; recommended storage conditions; recommended shelf-life; and details of the full formulation including all active and all excipient ingredients (including coatings and capsule ingredients). For every ingredient: give the Australian Approved Name (AAN); the quality standard and / or grade; state any overages used; the nominal (label claim) amount: Clearly identify whether the amount of substance is expressed in terms of the salt / complex, or base. If the label claim is not in the same terms, the amount in terms of the label statement should also be stated; and If the ingredient is herbal, the (Chapter 1, Section 3 – Herbal Substances) offers useful guidance. Include, for example, the botanical species, plant part and, if an extract, state the amount of the extract, the strength of the extract, and the equivalent amount of dried plant. The extracting solvent and diluting medium should also be described. Guidance on the identification of herbal materials and extracts is provided in the document titled Questions & Answers for the Identification of Herbal Materials and Extracts, available at <> on the TGA website; and If direct compression (DC) tableting materials are used, then, as with herbal extracts, describe the amount of DC material used, its equivalence to active substance, and describe the diluent.
Application An application made to TGA under the following sections of the Therapeutic Goods Act 1989 (note that where the Section / Regulation number is highlighted, the word ‘application’ is used in the legislation): Section 14 (exemption from compliance with a Standard); Section 19 and 41HB (special and experimental uses); and Section 23, 24, 25 and 26 (Registration or Listing) [Note that each application results in a single Registration or Listing or the inclusion of a separate and distinct product within a grouped Registration or Listing]; or Section 9C (request for copy of ARTG entry) Section 9D (request to vary information about an ARTG entry) Section 37 and 38 (manufacturer’s licence) Section 41EB (conformity assessment certificates) Section 58 (export certification) Section 61(6) (information from ARTG) Regulation 14 (transfer of goods Registered / Listed) Regulation 14A (reassignment of Registration / Listing numbers). (See also Submission.) Approval holder2 In relation to a restricted representation, means the person to whom notice of approval of the use of the restricted representation was given. (Regulation 6AA) Approval number1 The distinguishing number allocated to an approved advertisement by the Secretary Regulation 5J of the Therapeutic Goods Regulations 1990. (Section 42B) Approved advertisement1, 2 An advertisement is approved under regulation 5G, or taken to be approved by the Secretary under Sub regulation 5H(2), or approved by the Minister on review under regulation 5M, of the Therapeutic Goods Regulations 1990 and the approval has not been withdrawn. (Section 42B) Approved type3 A type that has been examined and approved by the Secretary under the type examination procedures. ARTG Australian Register of Therapeutic Goods. ARTG entry Refers to a separate and distinct product included in the ARTG, as described by the criteria in subsection 16(1) of the Therapeutic Goods Act 1989. Grouped products represent two or more ARTG entries under a single ARTG number.
ARTG purpose Relates to the basis for inclusion of the goods in the ARTG. Goods are included in the Register as a mechanism indicating approval for supply in Australia and / or approval for export from Australia. Goods Listed for export will have an ARTG purpose of ‘export’ only, all others will have a purpose of ‘supply’. ARTG status A term describes the Registration / Listing status of therapeutic goods in relation to their inclusion, or otherwise, in the ARTG. It includes Registered, Listed, cancelled by Secretary and cancelled by sponsor. ASMI2 The Australian Self-Medication Industry Incorporated (ABN 55 082 798 952). AUST L See Listing number. AUST R See Registration number. Australian Approved Name (AAN) for pharmaceutical substances A name for an ingredient, or a plant or other organism included in the formulation of a medicinal product, which is included in the list of Australian Approved Names for Pharmaceutical Substances published by the TGA. The list comprises three parts: AAN chemical substances list; AAN biological substances list; and AAN herbal substances list. (See TGA Approved Terminology for Drugs.) Australian Approved Names List2 The document entitled TGA Approved Terminology for Medicines (July 1999), as in force from time to time, published by the TGA. Note 1 The Australian Approved Names List includes: Australian Approved Names – Chemicals List; and Australian Approved Names – Biologicals List; and Australian Approved Names – Herbal Substances List. Note 2 The Australian Approved Names List may be published as part of a larger document; for example, the document entitled TGA Approved Terminology for Medicines. Australian legal unit of measurement3 Has the meaning given by the National Measurement Act 1960. Authorised delegate A delegate of the Secretary exercising a to decide whether to Register therapeutic goods. (Section 60A(8)) Authorised officer2 An officer of the Department, or of another Department or authority of the Commonwealth; or an officer of:
CTX Clinical Exemption scheme DNA deoxyribonucleic acid EC European Commission ECD electrochemical detection EEC European Economic Community EFTA European Free Trade Area ELF 3 Electronic Listing Facility – Version 3 EMEA European Medicines Agency (previously European Agency for the Evaluation of Medicinal Products) EPA Environmental Protection Agency (of the United States of America) EP European Pharmacopoeia (also known as PH. Eur.) EU European EudraLex The Governing Medicinal Products in the European Union FAO Food and Agriculture Organization (of the United Nations) FDA Food and Drug Administration (of the United States of America) FEMA Flavour and Extract Manufacturers Association (of the United States of America) FOI Freedom of Information FSANZ Food Standards Australia and New Zealand FSTA Food Science and Technology Abstracts GC gas chromatograph(y) GCP good clinical practice GLP good laboratory practice GM genetically modified GMO(s) genetically modified organism(s) GMP good manufacturing practice GRAS generally regarded as safe HACCP Hazard Analysis Critical Control Points HCN (Australian approved) Herbal Component Name HDL high-density lipoprotein HDPE high-density polyethylene HPLC high-performance liquid chromatography