Therapeutic Goods and Other Drugs Amendment Regulation (No. 1) 1995 (Qld)

Queensland Subordinate Legislation 1995 No. 266 Health Act 1937 THERAPEUTIC GOODS AND OTHER DRUGS AMENDMENT REGULATION (No. 1) 1995 TABLE OF PROVISIONS Section Page 1 Short title . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 2 Regulation amended . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 3 Replacement of s 9 (Further labelling for cigarettes and tobacco) . . . . . . . 2 9 Further labelling requirements for tobacco . . . . . . . . . . . . . . . . . . . . 2 4 Replacement of s 14 (Prohibition on sale of therapeutic substances in certain packages) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 14 Packaging of certain therapeutic and other substances . . . . . . . . . . 3 5 Insertion of new schs 1 and 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 SCHEDULE 1 CLOSURES AND CONTAINERS SCHEDULE 2 PRESCRIBED SUBSTANCES

s1 2 s4 Therapeutic Goods and Other Drugs Amendment (No. 1) No. 266, 1995 ˙ Short title 1. This regulation may be cited as the Therapeutic Goods and Other Drugs Amendment Regulation (No. 1) 1995 . ˙ Regulation amended 2. This regulation amends the Therapeutic Goods and Other Drugs Regulation 1982 . ˙ Replacement of s 9 (Further labelling for cigarettes and tobacco) 3. Section 9— omit, insert— ˙ ‘ Further labelling requirements for tobacco ‘ 9.(1) This section applies to a retail package only as far as the Commonwealth regulation does not apply to the package. 1 ‘ (2) A retail package must be labelled in the way specified in the Commonwealth regulation, as if it were a package to which the Commonwealth regulation applied. ‘ (3) In this section— “Commonwealth regulation” means the Trade Practices (Consumer Product Information Standards)(Tobacco) Regulations (Cwlth). “retail package” has the meaning given by the Commonwealth regulation.’. ˙ Replacement of s 14 (Prohibition on sale of therapeutic substances in certain packages) 4. Section 14— 1 The Commonwealth regulation applies to a corporation, in trade or commerce, supplying goods that are intended to be used, or are of a kind likely to be used, by a consumer. See the Trade Practices Act 1974 (Cwlth), s 65D. This section provides for the same labelling requirements to apply to a package of tobacco under this regulation as apply to a package under the Commonwealth regulation.

s4 3 s4 Therapeutic Goods and Other Drugs Amendment (No. 1) No. 266, 1995 omit, insert— ˙ ‘ Packaging of certain therapeutic and other substances ‘ 14.(1) A person must not sell a prescribed substance unless it is packed— (a) in a reclosable container that has directions for opening and closing the container conspicuously marked or written on it or on a label securely attached to it; or (b) in a non-reclosable container. Maximum penalty—8 penalty units. ‘ (2) Subsection (1) does not apply to a prescribed substance— (a) in a container holding 500 solid dosage units or more; or (b) supplied to a person whom the doctor, dentist, veterinary surgeon or pharmacist prescribing or supplying the substance believes would suffer undue hardship if the person were required to open a container complying with this section; or (c) to be used by, or administered to, a patient in a hospital or nursing home. ‘ (3) In this section— “non-reclosable container” means a container that— (a) is in the form of a blister package or other sealed unit; and (b) is made from paper, film, plastic material, metal foil or another sheet or strip material, other than cellulose film or unlaminated paper; and (c) contains a single dosage unit, whether or not as part of a continuous series forming a strip or sheet of the same material. “prescribed substance” means— (a) a capsule, lozenge, pastille, suppository, tablet or similar discrete solid dosage unit, other than individually wrapped powders, containing— (i) a therapeutic or animal use substance mentioned in schedule 2, part 1; or

s5 4 s5 Therapeutic Goods and Other Drugs Amendment (No. 1) No. 266, 1995 (ii) an ester, salt or other derivative of a therapeutic or animal use substance mentioned in schedule 2, part 1; or (b) a liquid preparation containing a therapeutic or animal use substance mentioned in schedule 2, part 2. “reclosable container” means— (a) a container fitted with a closure mentioned in schedule 1, part 1; or (b) a container mentioned in schedule 1, part 2. “therapeutic or animal use substance” means— (a) a therapeutic substance; or (b) a substance for animal use that would be a therapeutic substance if it were for human use.’. ˙ Insertion of new schs 1 and 2 5. After section 27— insert— ‘ SCHEDULE 1 ‘ CLOSURES AND CONTAINERS section 14(3), definition “reclosable container” ‘ PART 1—CLOSURE Name of closure Australian registered trade mark Argus-Loc Yes Australian patent number None Approved Australian sizes distributor Australian manufacturer 28 33 38 mm ACI Plastics Imported Kingsway MOORABBIN 3189

s5 Clic-Loc No Clic-Loc No Easy Lok Yes Kerr CR-1 Yes Key No 5 Therapeutic Goods and Other Drugs Amendment (No. 1) s5 No. 266, 1995 477954 477954 467825 None 60320/80 Applied for 22 24 28 33 ACI Plastics Imported 38 mm Kingsway MOORABBIN 3189 24 28 33 38 mm GLASS-PAK Imported (Aust) Pty Ltd 349 Darebin Road THORNBURY 3071 28 and 38 mm RTTA Plastics Imported Marketing & Development Pty Ltd PO Box 443 CARINGBAH 2229 20 22 24 28 O R Cormack 20 24 28 30 33 30 33 Pty Ltd 38 mm 38 mm 13 Leeds manufactured Street by O R RHODES 2138 Cormack Pty Ltd 13 Leeds Street RHODES 2138 22 mm imported 28 mm only Van Leer Van Leer Australia Pty Australia Pty Ltd Plastics Ltd Plastics Division Cnr Division Cnr Ferndell Street Ferndell & Boundary Street & Road Boundary CHESTER Road HILL 2162 CHESTER HILL 2162

s5 Ring guard Yes Spotlock Yes Sunbeam No FG Willsafe Yes 6 Therapeutic Goods and Other Drugs Amendment (No. 1) s5 No. 266, 1995 449374 None 80696/82 Applied for 550878 20 22 24 28 O R Cormack 28 mm only 33 38 mm Pty Ltd manufactured 13 Leeds by O R Street Cormack Pty RHODES 2138 Ltd 13 Leeds Street RHODES 2138 Other sizes imported 28 mm only Madrega Pty Imported Ltd 139 Green’s Road DANDENONG 3175 28 mm only RTTA Plastics Imported Marketing & Development Pty Ltd PO Box 443 CARINGBAH 2229 24 28 33 38 mm Williamson Williamson & Ltd & Co Pty Co Pty Ltd Ltd 27 Anzac 27 Anzac Street Street GREENACRE GREENACRE 2190 2190 ‘ PART 2—RECLOSABLE CONTAINER Name of Australian Australian container registered patent trade mark number Loxon Yes 438899 Approved Australian sizes distributor Australian manufacturer 28 mm only Loxon Products J W S Plastics 30 Albert Parade Pty Ltd ASHFIELD 2131 15 Stanton Road SEVEN HILLS 2147

s5 Snap-safe Yes Snap-safe Yes Closure with Neta vial 7 Therapeutic Goods and Other Drugs Amendment (No. 1) s5 No. 266, 1995 PA33918/71 24 28 38 mm 462620 20 mm only OR Cormack Pty Closure– Ltd 13 Leeds imported Street RHODES Container 2138 manufactured by OR Cormack Pty Ltd 13 Leeds Street RHODES 2138 Closure–OR Closure– Cormack Pty Ltd imported 13 Leeds Street Vial– RHODES 2138 manufactured by Vial– Neta Moulders Neta Moulders 181 Burwood 181 Burwood Road Road HAWTHORN HAWTHORN 3122 3122 ‘ SCHEDULE 2 ‘ PRESCRIBED SUBSTANCES section 14(3), definition “prescribed substance” ‘ PART 1—SOLID DOSAGE UNIT 1. ANTIHISTAMINES, that is all substances the principal action of which is to antagonise the effects of histamine on H 1 receptors, in preparations where the antihistamine is the only therapeutically active substance, including— Antazoline Dexbrompheniramine Methdilazine Astemizole Dexchlorpheniramine Phenindamine Azatadine Dimenhydrinate Pheniramine

s5 8 s5 Therapeutic Goods and Other Drugs Amendment (No. 1) No. 266, 1995 Bamipine Dimethindene Phenyltoloxamine Bromodiphenhydramine Dimethothiazine Promethazine Brompheniramine Diphenhydramine Prothipendyl Buclizine Diphenidol Pyrathiazine Carbinoxamine Diphenylpyraline Pyroxamine Cetoxime Doxylamine Pyrrobutamine Chlorcyclizine Embramine Rotoxamine Chloropyrilene Halopyramine Thenalidine Chlorpheniramine Histapyrrodine Thenyldiamine Chlorphenoxamine Homochlorcyclizine Thiazinamium Cinnarizine Hydroxyzine Thonzylamine Clemastine Isothipendyl Tolpropamine Clemizole Mebhydrolin Trimeprazine Cycliramine Meclozine Trimethobenzamide Cyclizine Mepyramine Tripelennamine Cyproheptadine Methaphenilene Triprolidine Deproprine 2. TRICYCLIC ANTIDEPRESSANTS including— Amitriptyline Imipramine Monometacrine Amoxapine Intriptyline Nortriptyline Butriptyline Iprindole Noxiptyline Cidoxepin Ketipramine Octriptyline Clomipramine Lofepramine Opipramol Desipramine Loxapine Pirandamine Dibenzepin Maprotiline Prazepine Dothiepin Melitracen Protriptyline Doxepin Mezepine Tandamine

s5 9 s5 Therapeutic Goods and Other Drugs Amendment (No. 1) No. 266, 1995 Fantridone Mianserin Trimipramine 3. ASPIRIN 4. PARACETAMOL 5. SALICYLAMIDE 6. IRON COMPOUNDS, other than in preparations containing the equivalent of 5 mg or less of elemental iron in each solid dosage form 7. DIGITALIS GLYCOSIDES 8. QUININE 9. CHLOROQUINE 10. MONOAMINE OXIDASE INHIBITORS including— Iproniazid Phenelzine Isocarboxazid Tranylcypromine 11. ANTIARRHYTHMICS including— Amiodarone Mexiletine Bretylium Procainamide Disopyramide Quinidine Flecainide Verapamil 12. ANTICONVULSANTS including— Carbamazepine Phenytoin 13. GLUTETHIMIDE 14. ORPHENADRINE 15. LITHIUM CARBONATE 16. DIPHENOXYLATE HYDROCHLORIDE WITH ATROPINE SULPHATE 17. FLUORIDE SALTS, in packs containing the equivalent of more than 100 mg of elemental fluorine

s 5 10 s 5 Therapeutic Goods and Other Drugs Amendment (No. 1) No. 266, 1995 ‘ PART 2—LIQUID PREPARATIONS 18. PARACETAMOL, in preparations where paracetamol is the only therapeutically active substance, except in paediatric drops in packs containing not more than 2 g of paracetamol 19. METHYL SALICYLATE, in preparations containing more than 50% volume in volume of methyl salicylate, in a volume of 200 ml or less 20. EUCALYPTUS OIL, in preparations containing more than 50% volume in volume of eucalyptus oil, in a volume of 200 ml or less 21. DIGITALIS GLYCOSIDES 22. IRON, in preparations containing the equivalent of more than 250 mg of elemental iron in the total contents of the container 23. MELALEUCA OIL, in preparations containing more than 25% of cineole and in packs of 200 mL or less.’. ENDNOTES 1. Made by the Governor in Council on 14 September 1995. 2. Notified in the gazette on 15 September 1995. 3. Laid before the Legislative Assembly on . . . 4. The administering agency is the Department of Health. © State of Queensland 1995