THERAPEUTIC GOODS REGULATIONS (AMENDMENT) 1991 NO. 84 THERAPEUTIC GOODS REGULATIONS (AMENDMENT) 1991 NO. 84 - TABLE OF PROVISIONS 1. Commencement 2. Amendment 3. Regulation 12 (Exempt goods) 4. Regulation 24 (Authorised officer-powers and duties) 5. Regulation 45 (Waiver or reduction of fees) 6. Part 7 (Fees and costs) 7. New regulation 45A 8. Regulation 46 (Release of information) 9. Regulation 48 (Review of decisions) 10. Schedule 3 (Therapeutic goods required to be included in the part of the Register for registered goods) 11. Schedule 4 (Therapeutic goods required to be included in the part of the Register for listed goods) 12. Schedule 5 (Therapeutic goods exempt from the operation of Part 3 of the Act) 13. New schedule 5A (Therapeutic goods exempt from the operation of Part 3 of the Act subject to conditions) 14. Schedule 7 (Therapeutic goods exempt from the operation of Part 4 of the Act unless supplied as pharmaceutical benefits) 15. Schedule 9 (Fees) 1991 No. 84 THERAPEUTIC GOODS REGULATIONS (AMENDMENT) - REG 1 1. Commencement 1.1 Regulations 3.1, 5.2, 7.1, 10.2, 11.1, 12.2, 12.4, 13.1 and 14.1 are taken to have commenced on 15 February 1991. 1991 No. 84 THERAPEUTIC GOODS REGULATIONS (AMENDMENT) - REG 2 2. Amendment 2.1 The Therapeutic Goods Regulations are amended as set out in these Regulations. 1991 No. 84 THERAPEUTIC GOODS REGULATIONS (AMENDMENT) - REG 3 3. Regulation 12 (Exempt goods) 3.1 After subregulation 12 (1), insert: "(1A) For the purposes of subsection 18 (1) of the Act, the therapeutic goods or classes of therapeutic goods specified in an item in column 2 of Schedule 5A are exempt from the operation of Part 3 of the Act subject to compliance with the relevant conditions specified in column 3 of that Schedule.". 1991 No. 84 THERAPEUTIC GOODS REGULATIONS (AMENDMENT) - REG 4 4. Regulation 24 (Authorised officer-powers and duties) 4.1 Paragraph 24 (1) (a): After "licence holder", insert "or wholesaler". 1991 No. 84 THERAPEUTIC GOODS REGULATIONS (AMENDMENT) - REG 5 5. Regulation 45 (Waiver or reduction of fees) 5.1 Paragraph 45 (2) (a): After "ingredient", insert "or are therapeutic devices". 5.2 Subregulation 45 (3): Omit "payable in relation to the entry of therapeutic goods in the Register", substitute "that are payable in relation to therapeutic goods". 1991 No. 84 THERAPEUTIC GOODS REGULATIONS (AMENDMENT) - REG 6 6. Part 7 (Fees and costs) 6.1 Heading: Omit the heading, substitute "FEES, COSTS AND CHARGES". 1991 No. 84 THERAPEUTIC GOODS REGULATIONS (AMENDMENT) - REG 7 7. New regulation 45A 7.1 After regulation 45, insert in Part 7: Charges reduced where annual turnover is not more than $50,000 "45A. If the wholesale turnover of therapeutic goods of a person who is required to hold a licence under Part 4 of the Act is not more than $50,000 in a financial year, the annual charge payable by the person for a licence that is in force at any time during that financial year is half of the amount otherwise payable under subregulation 3 (2) of the Therapeutic Goods (Charges) Regulations in respect of that licence.". 1991 No. 84 THERAPEUTIC GOODS REGULATIONS (AMENDMENT) - REG 8 8. Regulation 46 (Release of information) 8.1 Subparagraph 46 (2) (e) (ii): Omit "Poisons Schedule", substitute "Poisons Standard". 1991 No. 84 THERAPEUTIC GOODS REGULATIONS (AMENDMENT) - REG 9 9. Regulation 48 (Review of decisions) 9.1 After subregulation (1), insert: "(1A) The Minister may, by signed instrument, delegate to an officer of the Department all or any of the Minister's powers and functions under this Regulation other than the power of delegation.". 1991 No. 84 THERAPEUTIC GOODS REGULATIONS (AMENDMENT) - REG 10 10. Schedule 3 (Therapeutic goods required to be included in the part of the Register for registered goods) 10.1 Item 3, paragraph (c): Before "accessories", insert "implantable". 10.2 Item 3, paragraph (g): Omit the paragraph, substitute: "(g) devices of human or animal origin, other than devices for use on or in the body of a person, that: (i) are manufactured using animal-derived fats, waxes or varnishes; or (ii) are used externally; or (iii) contain wax and are used internally; or (iv) incorporate heparin, unless heparin is being delivered as a drug; or (v) are sutures conforming to a standard determined under Part 2 of the Act; or (vi) are made from sintered hydroxyapatite." 1991 No. 84 THERAPEUTIC GOODS REGULATIONS (AMENDMENT) - REG 11 11. Schedule 4 (Therapeutic goods required to be included in the part of the Register for listed goods) 11.1 Part 3: After "Magnesium sulfate", insert "Manganese amino acid chelate as a source of manganese". 11.2 Part 4 (item relating to Acorus calamus): Omit ", Blue flag". 11.3 Part 4: Add at the end: "(NOTE: As to preparations containing a herbal substance derived from a herb not approved in Australia for therapeutic use in humans, see Schedule 3, item 2.)". 1991 No. 84 THERAPEUTIC GOODS REGULATIONS (AMENDMENT) - REG 12 12. Schedule 5 (Therapeutic goods exempt from the operation of Part 3 of the Act) 12.1 Heading: Omit "Regulation 12", substitute "Subregulation 12 (1)". 12.2 Item 5: Omit the item. 12.3 Item 7, paragraph (c): Omit the paragraph, substitute: "(c) non-implantable, non-powered diagnostic tools that: (i) are not supplied in a sterile state; and (ii) are not intended to monitor a physiological process; and (iii) are not referred to in paragraph (b)". 12.4 Item 10: Omit the item. 12.5 Item 11: Omit the item, substitute: "11 therapeutic goods: (a) in relation to the importation of which a permission, licence or declaration under regulation 5A, 5B or 5C of the Customs (Pro-hibited Imports) Regulations granted or made before the commencement of the Act is in force; and (b) which are supplied in Australia for use in humans not more than 6 months after the commencement of the Act". 1991 No. 84 THERAPEUTIC GOODS REGULATIONS (AMENDMENT) - REG 13 13. New schedule 5A (Therapeutic goods exempt from the operation of Part 3 of the Act subject to conditions) 13.1 After Schedule 5, insert: "SCHEDULE 5A Subregulation 12(1A) THERAPEUTIC GOODS EXEMPT FROM THE OPERATION OF PART 3 OF THE ACT SUBJECT TO CONDITIONS Column 1 Column 2 Column 3 Item No. Therapeutic goods Conditions 1 Goods imported into (a) the sponsor must: Australia that are (i) keep records relating to the held under the source and supply of those goods; and direct control of the (ii) if requested by the Secretary, supply sponsor pending: those records to the Secretary; and (a) approval for (b) if the goods are the subject of an registration or approval under subsections 19(1) of the listing; or Act, the supply of those goods must be (b) approval under in accordance with that approval subsection 19 (1) of the Act 2 Japanese encephalitis the vaccine must be: vaccine (a) imported by the undertaking known as Commonwealth Serum Laboratories for supply to Fairfield Hospital in the State of Victoria; and (b) supplied to that Hospital for use in patients who have given adequately adequately informed consent to the proposed treatment before it is commenced, being patients who: (i) are to be resident for more than 12 months in an area in which Japanese encephalitis is endemic; or (ii) make, or are to make, repeated short trips to areas in which Japanese encephalitis is endemic; encephalitis is endemic; or (iii) intend to visit rural areas in which there is an epidemic of Japanese encephalitis; and (c) approved for administration to each patient by, or at the direction of, the Director of Medical Services at that hospital: and (d) prescribed by a medical practitioner working at the hospital who is not the person who approved its administration to the patient to whom it is administered." 13.2 Add at the end: "3 Rherapeutic goods used (a) before starting to use the goods, the used solely for the sponsor must notify the Secretary in experimental purposes in writing, in accordance with a form in humans approved by the Secretary, that he or she intend to undertake a clinical trial using specified goods; and (b) the notification must be accompanied by the notification fee referred to in item 14 of Schedule 9; and (c) the goods must be approved for this purpose by the Chairperson of the Ethics Committee responsible for the hospital or institution in which the trial is to be undertaken; and (d) that Ethics Committee must be constituted and operate in accordance with the current guidelines of the National Health and Medical Research Council; and (e) the Secretary must not, at any time: (i) have become aware that to undertake or continue the trial would be contrary to the public interest; and (ii) have directed that the trial not be undertaken or be stopped, as appropriate in the circumstances of the case". 1991 No. 84 THERAPEUTIC GOODS REGULATIONS (AMENDMENT) - REG 14 14. Schedule 7 (Therapeutic goods exempt from the operation of Part 4 of the Act unless supplied as pharmaceutical benefits) 14.1 Item 3: Omit the item, substitute: "3 components for therapeutic devices". 1991 No. 84 THERAPEUTIC GOODS REGULATIONS (AMENDMENT) - REG 15 15. Schedule 9 (Fees) 15.1 Item 2, subparagraph (d) (i): Omit "ingredient(s)", substitute "ingredient or are therapeutic devices". 15.2 Item 12: After "modification to", insert ", or variation of, the written information relating to". 15.3 Add at the end: "14 notification fee referred to in item 3 of Schedule 5A $ 60". - NOTES 1991 No. 84*1* THERAPEUTIC GOODS REGULATIONS*2* (AMENDMENT) *1*Notified in the Commonwealth of Australia Gazette on 30 April 1991. *2*Statutory Rules 1990 No. 394.