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 is used in the ‘application’ 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by the Minister on review under regulation 5M, of the Therapeutic Goods Regulations 1990 and the approval has not been withdrawn.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.
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.
cm-argcm-p4-110825.docx