CUSTOMS (PROHIBITED IMPORTS) REGULATIONS (AMENDMENT) 1991 NO. 23 CUSTOMS (PROHIBITED IMPORTS) REGULATIONS (AMENDMENT) 1991 NO. 23 - TABLE OF PROVISIONS 1. Commencement 2. Amendment 3. Regulation 2 (Interpretation) 4. Regulation 5 (Importation of drugs) 5. Regulation 5A (Importation of therapeutic substances) 6. Regulation 5B (Licensed importers) 7. Regulation 5C (Designated therapeutic substances) 8. Regulation 5D (Conditions of licences under regulation 5B) 9. Regulation 5E (Disposal of designated therapeutic substances) 10. Regulation 5F (Reasons for refusal to be given) 11. Regulation 5G (Appeals) 12. Regulation 5H (Importation of various certain goods) 13. New regulation 5HA 14. Schedule 8 (Goods the importation of which is prohibited except with the permission of the Secretary of the Department of Community Services and Health or of an authorised officer) 15. Further amendments 16. Transitional 1991 No. 23 CUSTOMS (PROHIBITED IMPORTS) REGULATIONS (AMENDMENT) - REG 1 1. Commencement 1.1 These Regulations, other than subregulation 14.3, commence on the day of commencement of the Therapeutic Goods Act 1989. 1991 No. 23 CUSTOMS (PROHIBITED IMPORTS) REGULATIONS (AMENDMENT) - REG 2 2. Amendment 2.1 The Customs (Prohibited Imports) Regulations are amended as set out in the Regulations. 1991 No. 23 CUSTOMS (PROHIBITED IMPORTS) REGULATIONS (AMENDMENT) - REG 3 3. Regulation 2 (Interpretation) 3.1 Subregulation 2 (2): Omit "purpose of regulations 5A to 5G (inclusive) of these Regulations:", substitute "purposes of regulations 5A and 5F:". 1991 No. 23 CUSTOMS (PROHIBITED IMPORTS) REGULATIONS (AMENDMENT) - REG 4 4. Regulation 5 (Importation of drugs) 4.1 Subregulation 5 (18A): Omit the subregulation, substitute: "(18A) Where the Secretary of the Department of Community Services and Health or an authorised person makes a decision: (a) not to grant under subregulation (5) a licence to import drugs, or a permission to import a drug; or (b) to grant under subregulation (13) a permission, to import a drug, that specifies: (i) a condition or requirement to be complied with; or (ii) a time at which a condition or requirement specified in the permission is to be complied with; or (c) not to specify under subregulation (15) a period, other than the period specified in a permission, as the period during which the importation of a drug may be effected; or (d) to revoke under subregulation (17) a licence to import drugs; or (e) to revoke under subregulation (18) a permission to import a drug; the Secretary of the Department of Community Services and Health or the authorised person, as the case requires, must give to the applicant or the holder of the licence or the holder of the permission, as the case requires, notice in writing setting out the decision as soon as practicable after the making of the decision."; 4.2 Subregulation 5 (20): Insert the following definition: " `authorised person' means a person authorised in writing by the Secretary of the Department of Community Services and Health to be an authorised person for the purposes of this regulation;". 1991 No. 23 CUSTOMS (PROHIBITED IMPORTS) REGULATIONS (AMENDMENT) - REG 5 5. Regulation 5A (Importation of therapeutic substances) 5.1 Subregulation 5A (1): Omit the subregulation, substitute: "(1) The importation into Australia of a therapeutic substance that is an antibiotic substance, other than a substance: (a) that is for the personal use of a passenger, or a relative of a passenger on a ship or an aircraft; and (b) that is brought to Australia on that ship or aircraft; and (c) the amount of which does not exceed 3 months' supply for a person at the maximum dosage recommended by the manufacturer of the substance; is prohibited unless a permission in writing to import the substance has been granted by the Secretary of the Department of Community Services and Health or an authorised person."; 5.2 Subregulation 5A (2): Omit the subregulation. 5.3 Subregulation 5A (3): Omit the subregulation. 5.4 Subregulation 5A (4): Omit "or under subregulation (3)". 5.5 Subregulation 5A (5): Omit "authorized officer" (wherever occurring), substitute "authorised officer". 5.6 Subregulation 5A (6): Omit the subregulation, substitute: "(6) Where: (a) a permission granted under subregulation (1) is subject to a condition to be complied with by a person; and (b) the person fails to comply with the condition; then the Secretary of the Department of Community Services and Health may revoke the permission whether or not the person is charged with an offence under subsection 50 (4) of the Act in respect of the failure to comply with the condition or requirement."; 5.7 Subregulation 5A (7): Omit the subregulation. 5.8 Subregulation 5A (8): Insert the following definition: " `authorised officer' means an officer authorised in writing by the Secretary the Department of Community Services and Health to be an authorised officer for the purposes of subregulation (5);". 1991 No. 23 CUSTOMS (PROHIBITED IMPORTS) REGULATIONS (AMENDMENT) - REG 6 6. Regulation 5B (Licensed importers) 6.1 Omit the regulation. 1991 No. 23 CUSTOMS (PROHIBITED IMPORTS) REGULATIONS (AMENDMENT) - REG 7 7. Regulation 5C (Designated therapeutic substances) 7.1 Omit the regulation. 1991 No. 23 CUSTOMS (PROHIBITED IMPORTS) REGULATIONS (AMENDMENT) - REG 8 8. Regulation 5D (Conditions of licences under regulation 5B) 8.1 Omit the regulation. 1991 No. 23 CUSTOMS (PROHIBITED IMPORTS) REGULATIONS (AMENDMENT) - REG 9 9. Regulation 5E (Disposal of designated therapeutic substances) 9.1 Omit the regulation. 1991 No. 23 CUSTOMS (PROHIBITED IMPORTS) REGULATIONS (AMENDMENT) - REG 10 10. Regulation 5F (Reasons for refusal to be given) 10.1 Paragraph 5F (1) (b): Omit the paragraph, substitute: "(b) revokes under subregulation 5A (6) a permission;". 10.2 Paragraphs 5F (1) (c), (d), (e) and (f): Omit the paragraphs. 10.3 Subregulation 5F (2): Omit the subregulation. 10.4 Subregulation 5F (3): Omit "or (3)". 10.5 Subregulation 5F (4): Omit the subregulation. 1991 No. 23 CUSTOMS (PROHIBITED IMPORTS) REGULATIONS (AMENDMENT) - REG 11 11. Regulation 5G (Appeals) 11.1 Omit the regulation. 1991 No. 23 CUSTOMS (PROHIBITED IMPORTS) REGULATIONS (AMENDMENT) - REG 12 12. Regulation 5H (Importation of various certain goods) 12.1 Add at the end: "(4) Where: (a) a permission granted under subregulation (2) is subject to a condition to be complied with by a person; and (b) the person fails to comply with the condition; then the Secretary of the Department of Community Services and Health may revoke the permission whether or not the person is charged with an offence under subsection 50 (4) of the Act in respect of the failure to comply with the condition.". 1991 No. 23 CUSTOMS (PROHIBITED IMPORTS) REGULATIONS (AMENDMENT) - REG 13 13. New regulation 5HA 13.1 After regulation 5H, insert: Review of decisions "5HA. (1) In this regulation: `decision' has the same meaning as in the Administrative Appeals Tribunal Act 1975; `initial decision' means a decision: (a) of the Secretary of the Department of Community Services and Health, or an authorised person, under subregulation 5 (5), (13), (15), (17) or (18) or 5A (1), (4) or (6); or (b) of the Secretary of the Department of Community Services and Health, or an authorised officer, under subregulation 5H (2) or (4); `Minister' means the Minister of State for Community Services and Health. "(2) A person whose interests are affected by an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person's notice. "(3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may: (a) confirm the initial decision; or (b) revoke the initial decision; or (c) revoke the initial decision and make a decision in substitution for that decision. "(4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision. "(5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating: (a) the result of the reconsideration; and (b) that the applicant may, except where subsection 28 (4) of Administrative Appeals Tribunal Act 1975 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Appeals Tribunal for review of that decision. "(6) If written notice of the making of an initial decision is given to a person whose interests are affected by the decision, the notice is to include a statement to the effect that a person whose interests are affected by the decision may: (a) seek a reconsideration of the decision under this regulation; and (b) subject to the Administrative Appeals Tribunal Act 1975, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Appeals Tribunal for review of that decision. "(7) Any failure to comply with the requirements of subregulation (5) or (6) relation to a decision does not affect the validity of the decision. "(8) An application may be made to the Administrative Appeals Tribunal for review of a decision under subregulation (3).". 1991 No. 23 CUSTOMS (PROHIBITED IMPORTS) REGULATIONS (AMENDMENT) - REG 14 14. Schedule 8 (Goods the importation of which is prohibited except with the permission of the Secretary of the Department of Community Services and Health or of an authorised officer) 14.1 After item 3: Insert: "3A Anabolic or androgenic substances or natural or synthetic growth hormones.". 14.2 Items 8B, 11AA, 11A, 11B and 11C: Omit the items. 14.3 After item 12A: Insert: "12AA Laetrile and preparations containing laetrile.". 14.4 Item 13: Omit ", tobacco habit". 14.5 Item 13A: Omit the item. 1991 No. 23 CUSTOMS (PROHIBITED IMPORTS) REGULATIONS (AMENDMENT) - REG 15 15. Further amendments 15.1 In the following provisions, after "Secretary of the Department of Community Services and Health" (wherever occurring or as otherwise specified), insert "or an authorised person": Subparagraph 5 (1) (a) (i); Subparagraph 5 (1) (a) (ii); Subregulation 5 (5); Subregulation 5 (6) (first occurring); Subregulation 5 (7) (first occurring); Paragraph 5 (9) (f); Paragraph 5 (9) (h) (first occurring); Subregulation 5 (10) (first occurring); Subparagraph 5 (12) (a); Subregulation 5 (15) (last occurring); Subregulation 5 (16); Subregulation 5 (17); Subregulation 5 (18). 15.2 In the following provisions, after "Secretary of the Department of Community Services and Health" (wherever occurring or as otherwise specified), insert "or authorised person": Subregulation 5 (6) (last occurring); Paragraph 5 (7) (a); Paragraph 5 (10) (a). 1991 No. 23 CUSTOMS (PROHIBITED IMPORTS) REGULATIONS (AMENDMENT) - REG 16 16. Transitional 16.1 Despite the amendment of regulation 5 of the Customs (Prohibited Imports) Regulations by these Regulations, that regulation as in force immediately before the commencement of these Regulations continues to apply in relation to a decision of the Secretary of the Department of Community Services and Health referred to subregulation 5 (18A) made before the commencement of these Regulations as if these Regulations had not been made. 16.2 Despite the amendment of regulation 5D of the Customs (Prohibited Imports) Regulations by these Regulations, that regulation as in force immediately before the commencement of these Regulations continues to apply during the period: (a) commencing on the date of commencement of these Regulations; and (b) ending on the expiration of 6 months after that date; in relation to a licence granted under regulation 5B of the Customs (Prohibited Imports) Regulations before the commencement of these Regulations as if these Regulations had not been made. 16.3 Despite the amendment of regulation 5E of the Customs (Prohibited Imports) Regulations by these Regulations, that regulation as in force immediately before the commencement of these Regulations continues to apply during the period: (a) commencing on the date of commencement of these Regulations; and (b) ending on the expiration of 6 months after that date; in relation to a person to whom that regulation applied immediately before the commencement of these Regulations as if these Regulations had not been made. - NOTES 1991 No. 23*1* CUSTOMS (PROHIBITED IMPORTS) REGULATIONS*2* (AMENDMENT) *1* Notified in the Commonwealth of Australia Gazette on 27 February 1991. *2* Statutory Rules 1956 No. 90 as amended by 1958 Nos. 6 and 67; 1959 Nos. 17, 31, and 93; 1960 No. 22; 1961 No. 117; 1962 No. 82; 1963 No. 26; 1964 Nos. 25 and 39; 1965 Nos. 81, 91, 135, 167 and 190; 1966 No. 95; 1967 Nos. 41, 58, 114 and 178; 1968 Nos. 100, 141 and 161; 1969 Nos. 2, 7, 10, 39, 43 and 218; 1970 Nos. 8, 72, 105 and 194; 1972 No. 97; 1973 Nos. 5, 6, 42, 43, 89, 93, 162, 175, 217, 227, 228 and 262; 1974 Nos. 123 and 249; 1975 Nos. 58, 62, 121, 172 and 183; 1976 Nos. 98, 159, 186 and 291; 1977 Nos. 18, 23, 24, 59, 67 and 162; 1978 No. 276; 1979 Nos. 145, 155 and 280; 1980 Nos. 71, 78, 150, 211, 368, 376, 380 and 382; 1981 Nos. 29, 71, 176, 309, 369 and 383 and Act No. 75, 1981; 1982 Nos. 44, 80, 102, 170, 236 and 252; 1983 No. 331; 1984 Nos. 55, 64, 102, 128, 260, 261, 317 and 318; 1985 Nos. 26, 96, 139, 160, 305 and 377; 1986 Nos. 180, 307, 342, 354, 362 and 385; 1987 Nos. 37, 98, 101, 320 and 321; 1988 Nos. 64, 136, 177, 326, 327, 374 and 375; 1989 Nos. 60 and 379; 1990 Nos. 39, 191, 265, 324, 460 and 467.