a of medicine listing’ is generated for downloading by the sponsor; and ‘Certificate a of listing’ letter is generated and sent to the sponsor by the TGA. ‘Conditions The product details will usually be viewable on the eBS website the day after the information has been written to the ARTG. Diagram 1 the process for listing a medicine on the ARTG via the ELF. via Diagram 1: The process for listing a medicine on the ARTG ELF Product variation Following the inclusion of a product as a listed medicine on the ARTG, sponsors may need to update certain product details. Changes in manufacturer, changes in product ingredients or developing marketing strategies may require amendment of the product details of a medicine included listed on the ARTG. Where the intended change does not create another product altogether i.e. a and ‘separate distinct’ therapeutic good (see below), there are provisions in the legislation for certain details to be amended in a medicines’ ARTG entry. However, if the intended change would create a and distinct’ good sponsors are required to submit a new application to ‘separate list the goods and a new AUST L number will be issued (unless the two medicines are eligible for under the Therapeutic Goods (Groups) Order- see Therapeutic ‘grouping’ ‘The Goods (Groups) Order’ below). Changes that result in and distinct’ goods ‘separate Section 16 (1A) of the Act outlines those criteria which make listed medicines (other than only’ medicines) and distinct’ from other therapeutic goods. ‘export ‘separate (1A) Medicines that are listable goods (other than export only medicines) are taken to be separate and distinct from other therapeutic goods if the medicines have: (a) different active ingredients; or (b) different quantities of active ingredients; or (c) a different dosage form; or (d) such other different characteristics as the regulations prescribe; In relation to 16 (1A) (d) of the Act, characteristics’ for listed medicines (other ‘different than only’ medicines) are provided in Regulation 11: ‘export (a) a different name; or (b) different indications; or (c) a different excipient; or (d) for medicines that contain any restricted ingredients: (i) a different quantity of a restricted ingredient that is an excipient; or (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine a different concentration of the restricted ingredient; or —
a ‘Certificate of medicine listing’ is generated for downloading by the sponsor; and a ‘Conditions of listing’ letter is generated and sent to the sponsor by the TGA. The product details will usually be viewable on the eBS website the day after the information has been written to the ARTG. Diagram 1 the process for listing a medicine on the ARTG via the ELF. Diagram 1: The process for listing a medicine on the ARTG via ELF Product variation Following the inclusion of a product as a listed medicine on the ARTG, sponsors may need to update certain product details. Changes in manufacturer, changes in product ingredients or developing marketing strategies may require amendment of the product details of a medicine included listed on the ARTG. Where the intended change does not create another product altogether i.e. a ‘separate and distinct’ therapeutic good (see below), there are provisions in the legislation for certain details to be amended in a medicines’ ARTG entry. However, if the intended change would create a ‘separate and distinct’ good sponsors are required to submit a new application to list the goods and a new AUST L number will be issued (unless the two medicines are eligible for ‘grouping’ under the Therapeutic Goods (Groups) Order- see ‘The Therapeutic Goods (Groups) Order’ below). Changes that result in ‘separate and distinct’ goods Section 16 (1A) of the Act outlines those criteria which make listed medicines (other than ‘export only’ medicines) ‘separate and distinct’ from other therapeutic goods. (1A) Medicines that are listable goods (other than export only medicines) are taken to be separate and distinct from other therapeutic goods if the medicines have: (a) different active ingredients; or (b) different quantities of active ingredients; or (c) a different dosage form; or (d) such other different characteristics as the regulations prescribe; In relation to 16 (1A) (d) of the Act, ‘different characteristics’ for listed medicines (other than ‘export only’ medicines) are provided in Regulation 11: (a) a different name; or (b) different indications; or (c) a different excipient; or (d) for medicines that contain any restricted ingredients: (i) a different quantity of a restricted ingredient that is an excipient; or (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine — a different concentration of the restricted ingredient; or
consult-cm-argcm-partb-130121-1.docx