Therapeutic Goods Order No. 80 - Child-Resistant Packaging Requirements for Medicines (27/08/2008)
Part 2Individual substances
Start here
Get a plain-English read of Part 2
Turn the raw legal text into a practical explanation grounded in Therapeutic Goods Order No. 80 - Child-Resistant Packaging Requirements for Medicines (27/08/2008).
Note The substances listed in this Part, when contained in a listed or registered medicine in the strength or pack size specified in this Part, result in the requirements of this Order applying to the medicine unless the medicine is exempted under section 7 or an exemption from compliance with this Order has been granted under section 14 and section 14A of the Act. Where a substance is shown but no strength or pack size is specified, the requirements of this Order apply to all strengths and pack sizes of medicines containing that substance.
Note: ALISKIREN.
AMBRISENTAN.
ANISE OIL, except:
(a) when packed in a container having a nominal capacity of 50 millilitres or less and fitted with a restricted flow insert; or
(b) in a preparation containing 50 per cent or less of anise oil, or a combination of anise oil and any other essential oil named in this Part.
ASPIRIN.
Azadirachta indica (Neem), in a preparation for human dermal use containing more than 1 per cent of cold pressed neem seed oil.
BASIL OIL, except:
(a) when packed in a container having a nominal capacity of 25 millilitres or less and fitted with a restricted flow insert; or
(b) in a preparation or oil containing 5 per cent or less of methyl chavicol.
BAY OIL, except:
(a) when packed in a container having a nominal capacity of 15 millilitres or less and fitted with a restricted flow insert; or
(b) in a preparation containing 25 per cent or less of bay oil, or a combination of bay oil and any other essential oil named in this Part.
BOSENTAN.
BROMHEXINE.
CAJUPUT OIL, except:
(a) when packed in a container having a nominal capacity of 15 millilitres or less and fitted with a restricted flow insert; or
(b) in a preparation containing 25 per cent or less of cajuput oil, or a combination of cajuput oil and any other essential oil named in this Part.
CAMPHORATED OIL.
CAMPHOR, except:
(a) in a liquid preparation containing 2.5 per cent or less of camphor;
(b) in an essential oil containing 10 per cent or less of camphor, packed in a container having a nominal capacity of 25 millilitres or less and fitted with a restricted flow insert;
(c) in an essential oil packed in a container having a nominal capacity of 15 millilitres or less and fitted with a restricted flow insert; or
(d) in rosemary oil, sage oil (Spanish), or lavandin oil as such.
Carapichea ipecacuanha (ipecacuanha).
CASSIA OIL, except in a preparation containing 2 per cent or less of cassia oil.
CHLORAL HYDRATE.
CILOSTAZOL.
CINEOLE, except:
(a) when packed in a container having a nominal capacity of 15 millilitres or less and fitted with a restricted flow insert;
(b) in a preparation or oil containing 25 per cent or less of cineole; or
(c) in rosemary oil or camphor oil (white).
CINNAMON BARK OIL, except in a preparation containing 2 per cent or less of cinnamon bark oil.
CINNAMON LEAF OIL, except:
(a) when packed in a container having a nominal capacity of 15 millilitres or less and fitted with a restricted flow insert; or
(b) in a preparation containing 25 per cent or less of cinnamon leaf oil, or a combination of cinnamon leaf oil and any other essential oil named in this Part.
CLONIDINE.
CLOVE OIL, except:
(a) when packed in a container having a nominal capacity of 15 millilitres or less and fitted with a restricted flow insert; or
(b) in a preparation containing 25 per cent or less of clove oil, or a combination of clove oil and any other essential oil named in this Part.
COLCHICINE.
Deferasirox.
Dextromethorphan.
ETHANOL, in a mouthwash preparation containing more than 3 grams of ethanol in a single pack.
EUCALYPTUS OIL, except:
(a) when packed in a container having a nominal capacity of 15 millilitres or less and fitted with a restricted flow insert; or
(b) in a preparation containing 25 per cent or less of eucalyptus oil, or a combination of eucalyptus oil and any other essential oil named in this Part.
FLUORIDE SALTS, in a pack containing the equivalent of more than 100 milligrams of elemental fluorine.
Guaiphenesin; GUAIFENESIN.
IRON COMPOUNDS, in a pack containing a total of more than 250 milligrams of elemental iron, except for divided preparations in which:
(a) the iron is compounded with one or more other active ingredients; and
(b) the amount of elemental iron per dosage unit is 5 milligrams or less.
However iron oxides that are present as an excipient, in either a divided preparation containing 10 milligrams or less of total iron oxides per dosage unit or an undivided preparation containing 1 per cent or less of total iron oxides, may be excluded from the calculation of elemental iron content.
Ivabradine.
Lanthanum.
Lenalidomide.
MARJORAM OIL, except:
(a) when packed in a container having a nominal capacity of 50 millilitres or less and fitted with a restricted flow insert, or
(b) in a preparation containing 50 per cent or less of marjoram oil, or a combination of marjoram oil and any other essential oil named in this Part.
MELALEUCA OIL, except:
(a) when packed in a container having a nominal capacity of 15 millilitres or less and fitted with a restricted flow insert; or
(b) in a preparation containing 25 per cent or less of melaleuca oil, or a combination of melaleuca oil and any other essential oil named in this Part.
METHYL SALICYLATE, in a liquid preparation containing 5 per cent or more of methyl salicylate.
MINOXIDIL, in a liquid preparation or a preparation for oral administration.
MOUTHWASH preparations — see ETHANOL.
NICOTINE.
NUTMEG OIL, except:
(a) when packed in a container having a nominal capacity of 25 millilitres or less and fitted with a restricted flow insert; or
(b) in a preparation containing 50 per cent or less of nutmeg oil, or a combination of nutmeg oil and any other essential oil named in this Part.
Oxymetazoline.
PARACETAMOL ‑ all solid dosage forms and liquid preparations.
PENNYROYAL OIL, except in a preparation containing 4 per cent or less of d‑pulegone.
Pentoxyverine.
PHENYLEPHRINE.
Pholcodine.
POLYGALA SENEGA (Senega).
POTASSIUM SALTS, in a pack containing a total of more than 4000 milligrams of elemental potassium, except:
(a) in a divided preparation in which the amount of elemental potassium per dosage unit is 40 milligrams to less; or
(b) when the potassium is present in the form of glucosamine sulfate potassium chloride complex.
PSEUDOEPHEDRINE.
RILUZOLE.
SAGE OIL DALMATIAN, except in a preparation containing 4 per cent or less of thujone.
SALBUTAMOL.
SASSAFRAS OIL, except in a preparation containing 1 per cent or less of safrole.
STAR ANISE OIL, except:
(a) when packed in a container having a nominal capacity of 50 millilitres or less and fitted with a restricted flow insert; or
(b) in a preparation containing 50 per cent or less of star anise oil, or a combination of star anise oil and any other essential oil named in this Part.
THEOPHYLLINE.
THYME OIL, except:
(a) when packed in a container having a nominal capacity of 25 millilitres or less and fitted with a restricted flow insert; or
(b) in a preparation containing 50 per cent or less of thyme oil, or a combination of thyme oil and any other essential oil named in this Part.
THYROXINE.
Varenicline.
WINTERGREEN OIL — see METHYL SALICYLATE.
XYLOMETAZOLINE.
Part Part 2 - Therapeutic Goods Order No. 80 - Child-Resistant Packaging Requirements for Medicines (27/08/2008) - Individual substances | Zoe