{"id":"F2008L03428","name":"Therapeutic Goods Order No. 80 - Child-Resistant Packaging Requirements for Medicines (27/08/2008)","slug":"therapeutic-goods-order-no-80-child-resistant-packaging-requirements-for-medicines-27-08-2008","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"repealed","isInForce":false,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":120460,"registerId":"commonwealth-F2008L03428-current","compilationNumber":null,"startDate":"2026-04-03","status":"Repealed","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"part","heading":"Name of Order","content":"# 1 Name of Order\n\nThis Order is Therapeutic Goods Order No. 80 Child-Resistant Packaging Requirements for Medicines.","sortOrder":0},{"sectionNumber":"2","sectionType":"part","heading":"Commencement","content":"# 2 Commencement\n\nThis Order commences on the day after the day it is registered on the Federal Register of Legislative Instruments.","sortOrder":1},{"sectionNumber":"3","sectionType":"part","heading":"Transition","content":"# 3 Transition\n\n(a) Up to and including 31 August 2010, each medicine to which this Order applies must comply with either this Order or Therapeutic Goods Order No. 65 Child-Resistant Packaging for Therapeutic Goods.\n\n(b) On and from 1 September 2010, each medicine to which this Order applies must comply with this Order.","sortOrder":2},{"sectionNumber":"4","sectionType":"part","heading":"Introduction","content":"# 4 Introduction\n\n(1) The objective of this Order is to set particular requirements for the packaging of medicines that may present a significant risk of toxicity to children if accidentally ingested. These requirements relate to child‑resistant packaging — that is, packaging that is designed to be resistant to opening by young children.\n\n(2) Child‑resistant packaging is not child‑proof. While it has an important role in reducing the incidence and public health burden of accidental poisoning in children and the associated morbidity and mortality, it provides only one safeguard in that it delays the time taken by a child to open a package and access multiple units, thereby increasing the probability of adult intervention before the contents are fully accessible and can be ingested.\n\n(3) Compliance of packaging with the national or international Standards for child‑resistance referred to in this Order only establishes a packaging system as child‑resistant, not child‑proof.\n\n(4) The criteria used by the committee advising on requirements for child‑resistant packaging are:\n\n(a) the toxicity of the substance contained in the medicine, and risk of harm if it is accidentally ingested by a young child; and\n\n(b) the extent and patterns of availability in the community of medicines containing the substance; and\n\n(c) the number and type of incidents reported to Poisons Information Centres and other relevant organisations involving accidental ingestion of medicines containing the substance; and\n\n(d) the consequences of these incidents (hospital admission or other treatment, serious injury, or death), including the difficulty or complexity of treatment; and\n\n(e) any special needs of patients who regularly need access to medicines containing the substances, such as older persons or people with a disability; and\n\n(f) the technical feasibility and practicality of child‑resistant packaging for medicines containing the substance, taking into account the usual dosage form and presentation; and\n\n(g) other such matters as the committee thinks fit.\n\n(5) A substance will, in general, be considered to be sufficiently toxic to warrant child‑resistant packaging if the amount contained in a maximum prescription quantity (for example under the Pharmaceutical Benefits Scheme) or the largest retail pack quantity, is likely to produce significant harm (i.e. a requirement for hospital treatment, or death) in a child of 11 kg (i.e. a typical weight of an 18 month old child, representative of the age group in which accidental poisoning is most common).\n\n(6) While the criteria set out in subsection 4(4) and the guideline set out in subsection 4(5) relate to toxicity only from ingestion, if a medicine presents a hazard in terms of potential to cause serious harm to young children through inadvertent contact with the eyes, the skin or mucous membranes, then these medicines will also be considered for child‑resistant packaging.\n\n(7) None of the criteria set out in subsection 4(4) are intended to be considered in isolation and recommendations for child‑resistant packaging are made on balance. Consideration of all of the criteria permits the objective assessment of the risk/benefit balance although emphasis will be given to public health and safety.\n\n(8) The criteria do recognise that child-resistant packaging can present difficulties for older persons and those with a disability. This also is recognised in each of the Standards for child‑resistance referred to in this Order, which include protocols for testing not only with young children but also with adults who are between 50 and 70 years of age.\n\n(9) The forms of packaging permitted by this Order may be either reclosable or non‑reclosable. Requirements for reclosable child‑resistant packages are performance‑based and rely on compliance with at least one of a range of specified national or international Standards, together with a small number of other requirements.\n\n(10) At this time, requirements of this Order for non‑reclosable packages such as blister or foil strips do not involve performance testing, but instead are based on design and specified materials of construction. These requirements reflect the general requirements of Australian Standard AS 1928‑2001 Child‑resistant packages.\n\n(11) While non-reclosable packaging has been accepted to date as providing a child‑barrier, it is intended that a best practice guideline on this form of packaging will be developed in order to help sponsors improve the robustness and effectiveness of blister or foil strip packaging in order to further reduce the potential for accidental childhood poisoning from medicines packaged in this way.","sortOrder":3},{"sectionNumber":"5","sectionType":"part","heading":"Interpretation","content":"# 5 Interpretation\n\n(1) In this Order:\n\nAct means the Therapeutic Goods Act 1989, as amended from time to time;\n\n> blister means a package in which:\n\n> (a) one or more dosage units are enclosed in pockets between a pre‑formed tray with individual pockets and a lidding material which may be flat or shaped; and\n\n> (b) the dosage units can only be extracted from one pocket at a time; and\n\n> (c) the material of the tray is usually different from that of the lid; and\n\n> (d) the material of the tray or lid must be cut, torn or peeled open in order to access the contents of individual pockets.\n\n> bulk medicine pack means a pack intended to be broken down and repackaged by a pharmacist to allow individual courses of treatment to be dispensed to a patient.\n\n> child‑resistant packaging means packaging that is designed or constructed to be difficult for young children to open, or gain access to the contents, within a reasonable time but is not unduly difficult for adults to use properly.\n\n> Note Child-resistant packaging does not mean packaging that is impossible for young children to open, or obtain the contents of, within a reasonable time. Child-resistant is not synonymous with child-proof.\n\n> closure means the part of a reclosable package that keeps the package closed.\n\n> Note A closure may be separately identifiable or an integral component of a package.\n\n> container has meaning given in subsection 3(1) of the Act.\n\n> export only medicine has the meaning given in subsection 3(1) of the Act.\n\n> homoeopathic preparation has the meaning given in regulation 2 of the regulations.\n\n> indications has the meaning given in subsection 3(1) of the Act.\n\n> label means a display of printed information on, or securely affixed to, the container, any intermediate packaging and any primary pack containing the medicine.\n\n> listed medicine means a medicine that is included in the Part of the Register for goods known as listed goods.\n\n> medicine has the meaning given in subsection 3(1) of the Act.\n\n> non‑reclosable package means a package that, having been opened, is not capable of being reclosed to its original state.\n\n> packaging means the components that together immediately contain and protect the dosage form of a medicine.\n\n> Note The components that immediately contain and protect the dosage form include containers, closures and closure systems, and closure liners. Packaging may be either reclosable or non-reclosable.\n\n> primary pack has the meaning given in subsection 3(1) of the Act.\n\n> reclosable package means a package that, once opened, can be reclosed to its original state.\n\n> Register has the meaning given in subsection 3(1) of the Act.\n\n> registered medicine means a medicine that is included in the part of the Register for goods known as registered goods.\n\n> regulations means the Therapeutic Goods Regulations 1990.\n\n> restricted flow insert means a restriction that:\n\n(a) is fitted or moulded into the neck of a container; and\n\n(b) cannot readily be removed from the container by manual force; and\n\n(c) limits the delivery of the contents to drops each of which is not more than 200 microlitres.\n\n> Secretary has the meaning given in subsection 3(1) of the Act.\n\n> sponsor has the meaning given in subsection 3(1) of the Act.\n\n> Standard means any of the national or international Standards referred to in section 9.\n\n> strip means packaging in which:\n\n> (a) one or more dosage units are enclosed individually in a continuous strip made by bonding two layers of material together so that the dosage units are separated and protected; and\n\n> (b) the dosage units can only be extracted from one pocket at a time; and\n\n> (c) each layer of material may be similar or different; and\n\n> (d) the material must be cut or torn in order to access the contents.\n\n> young children means children within the age groups specified in the protocols given in the Standards referred to in section 9 for the testing of child‑resistance.\n\n> Note The age range specified in the protocols given in the Standards referred to in section 9 for the testing of child-resistance is 42 to 51 months inclusive.","sortOrder":4},{"sectionNumber":"6","sectionType":"part","heading":"Application","content":"# 6 Application\n\n(1) This Order applies to each medicine for human use that is supplied by a sponsor and that is:\n\n(a) a registered medicine that contains a substance, or a salt, ester or other derivative of a substance, that belongs to a class of substance specified in Part 1 of Schedule 1; or\n\n(b) a listed or registered medicine that contains a substance, or a salt, ester or other derivative of a substance, specified in Part 2 of Schedule 1 in the strength or pack size specified in Part 2 to Schedule 1; or\n\n(c) any other medicine that is labelled or packaged in a way that states or implies to a consumer or purchaser that the product, as presented, is child‑resistant.\n\n(2) However, this Order does not apply to a medicine that is exempted under section 7 or in relation to which an exemption from compliance with this Order has been granted by the Secretary in accordance with section 14 and 14A of the Act.","sortOrder":5},{"sectionNumber":"7","sectionType":"part","heading":"Exemptions","content":"# 7 Exemptions\n\nThis Order does not apply to a medicine that is:\n\n(a) in a container intended only as a bulk medicine pack and that is clearly labelled ‘For dispensing only’ and ‘This pack not to be supplied to a patient’ or words to that effect; or\n\n(b) intended to be administered by injection; or\n\n(c) a solid or semi‑solid (excluding solid dosage forms) preparation intended for application to the skin or mucous membrane, including transdermal patches; or\n\n(d) a liquid or semi‑solid preparation intended for application to the eye, ear or mucous membrane, and supplied in a container that:\n\n(i) has a nominal capacity of not more than 20 millilitres; or\n\n(ii) is fitted with a restricted flow insert; or\n\n(e) an individually wrapped powder; or\n\n(f) a medicine containing only homoeopathic preparations; or\n\n(g) a liquid preparation in spray presentation if:\n\n(i) the delivery device is engaged into the container in such a way that prevents it from being readily removed; and\n\n(ii) direct suction through the delivery device results in delivery of no more than one dosage unit; and\n\n(iii) actuation of the spray device is ergonomically difficult for young children to accomplish; or\n\n(h) a paste, powder or gel for the cleaning of teeth; or\n\n(i) a starting material used in the manufacture of medicines except when pre‑packaged for supply for other therapeutic purposes or formulated as a dosage form; or\n\n(j) not at its final stage of manufacture; or\n\n(k) to be used by, or administered to, a patient for treatment in a public hospital, private hospital, nursing home, dental hospital or dental surgery; or\n\n(l) an export‑only medicine.","sortOrder":6},{"sectionNumber":"8","sectionType":"part","heading":"General requirements","content":"# 8 General requirements\n\n(1) The requirements of this Order apply in addition to any other packaging requirements that may be applied to medicines under the Act or regulations.\n\n(2) The packaging for a medicine to which this Order applies must:\n\n(a) remain fit for its purpose until the expiry date of the medicine; and\n\n(b) retain its child‑resistant properties for the expected number of openings and closings necessary to fully use the contents.\n\n(3) Performance of the child‑resistant feature must not be adversely affected by the contents of the package.\n\n(4) Sight, unusual strength or unusual dexterity must not be required to access the contents of the package or, in the case of a reclosable package, to re‑engage the child‑resistant feature.","sortOrder":7},{"sectionNumber":"9","sectionType":"part","heading":"Reclosable packages","content":"# 9 Reclosable packages\n\n(1) If a medicine to which this Order applies is in a reclosable package, the package must comply with at least one of the following Standards:\n\n(a) The International Standards Organisation Standard ISO 8317:2003 entitled Child‑resistant packaging — Requirements and testing procedures for reclosable packages (as amended by Technical corrigendum issued January 2005: ISO 8317:2003/Cor 1:2005 : Child‑resistant packaging — Requirements and testing procedures for reclosable packages — Technical Corrigendum 1);\n\n(b) The British Standards Institution Standard BS EN ISO 8317:2004 entitled Child‑resistant packaging. Requirements and testing procedures for reclosable packages;\n\n(c) The Canadian Standards Association Standard CSA Z76.1‑99 entitled Reclosable Child‑Resistant Packages;\\]\n\n(d) The United States Code of Federal Regulations, Title 16, Part 1700 Section \\[1700.\\]15, entitled Poison prevention packaging standards and Title 16, Part 1700, Section \\[1700.\\]20, entitled Testing procedure for special packaging, as in effect at the date of this Order;\n\n(e) The Australian Standard AS 1928-2007 entitled Child-resistant packaging- Requirements and testing procedures for reclosable packages (ISO 8317:2003, MOD).\n\n(2) If a medicine to which this Order applies is in a reclosable package that complies with a Standard mentioned in subsection 9(1), the sponsor of the medicine must hold evidence of the compliance. The evidence may consist of:\n\n(a) a certificate (or an appropriately authorised copy of a certificate) from a test agency, attesting that the package complies with a relevant Standard, expressed in a way that makes it beyond doubt that the certification in fact refers to the package specified by the sponsor, together with a statement of the protocol used to demonstrate child‑resistance and, if requested, evidence of the test agency’s standing; or\n\n(b) if the package is not certified as mentioned in paragraph (a), information proving compliance with a relevant Standard, expressed in a way that makes it beyond doubt that the information in fact refers to the package specified by the sponsor, together with a statement of the protocol used to demonstrate child‑resistance; or\n\n(c) information demonstrating that the package as specified by the sponsor has been established previously as complying with a relevant Standard.\n\n(3) In addition to the requirements mentioned in subsections 9(1) and 9(2), if a medicine to which this Order applies is in a reclosable package, the sponsor must hold evidence demonstrating that the requirements of subsections 8(2) and 8(3) are met.\n\n(4) If a change in specifications for a reclosable package occurs, the sponsor must hold additional evidence demonstrating that the child‑resistant properties of the package and operation of the closure have not been adversely affected.\n\n(5) In addition to the requirements mentioned in subsections 9(1), 9(2), 9(3), and 9(4), if a medicine to which this Order applies is in a reclosable package, the sponsor must hold information on:\n\n(a) the types and sizes of container of immediate relevance to the sponsor’s range of medicines to which a specified closure may be applied; and\n\n(b) the suitability of the package for the type of medicine; and\n\n(c) the correct application of the closure to the container after filling and engagement of the child‑resistant mechanism, as appropriate to the particular packaging system; and\n\n(d) the quality control tests applied to demonstrate that production lots of the package components are of consistent and satisfactory quality and appropriate for use.\n\n(6) If a medicine to which this Order applies is in a reclosable package, adequate directions for opening and effectively reclosing the package must be:\n\n(a) conspicuously marked or written on the package or on a label securely affixed or attached to the package; and\n\n(b) written in English or clearly demonstrated in graphics.\n\n(7) If a medicine to which this Order applies is packaged together with a separate dropper or applicator that is reasonably expected to replace the original closure on the medicine once the product is in use, then that configuration also must comply with the requirements of this Order.","sortOrder":8},{"sectionNumber":"10","sectionType":"part","heading":"Non‑reclosable packages","content":"# 10 Non‑reclosable packages\n\n(1) Subject to subsection 10(2), if a medicine to which this Order applies is in a non‑reclosable package, the package must be in the form of a blister or other sealed unit formed from paper, film, plastic material, metal foil or other sheet or strip material, or a combination of these materials in which a single dosage unit is enclosed, whether as part of a continuous series comprising a strip or sheet of the same material or not.\n\n(2) A non‑reclosable package referred to in subsection 10(1) must not be formed from cellulose film or unlaminated paper.","sortOrder":9},{"sectionNumber":"Schedule 1 Medicines to which this Order","sectionType":"part","heading":"Schedule 1 Medicines to which this Order applies","content":"# \nSchedule 1 Medicines to which this Order applies\n\n(section 6)","sortOrder":10},{"sectionNumber":"Part 1","sectionType":"part","heading":"Classes of substance","content":"## Part 1 Classes of substance\n\n> Note 1 Column 1 lists the classes of substance that, when included in a registered medicine, result in the requirements of this Order applying to the medicine irrespective of indications, unless the medicine is exempted under section 7 or an exemption from compliance with this Order has been granted under section 14 and 14A of the Act.\n\n> Note 2 Class names reflect the Anatomical Therapeutic Chemical (ATC) classification system of the World Health Organization Collaborating Centre for Drug Statistics Methodology (http://www.whocc.no/atcddd/). Classes shown include any substance included under the given ATC classification, unless the substance is specifically exempted from this Order.\n\n> Note 3 Columns 2 and 3 provide examples of substances classified as falling within each of the named classes. These lists are not exhaustive. When a new substance that is covered by a class set out below is used in medicine, the Schedule will apply to that substance.\n\n```html\n

Class

Examples of substances included in class

ACE INHIBITORS

Captopril

Enalapril

Fosinopril

Lisinopril

Perindopril

Quinapril

Ramipril

Trandolapril

ANAESTHETICS, LOCAL

Amethocaine

Articaine

Benzocaine

Bupivacaine

Cinchocaine

Levobupivacaine

Lignocaine

Mepivacaine

Oxybuprocaine

Procaine

Ropivacaine

ANGIOTENSIN II ANTAGONISTS

Candesartan

Eprosartan

Irbesartan

Losartan

Olmesartan

Telmisartan

Valsartan

ANTIARRHYTHMICS

Amiodarone

Bretylium tosilate

Disopyramide

Dofetilide

Esmolol

Flecainide

Ibutilide

Lignocaine

Mexiletine

Procainamide

Quinidine

Sotalol

Verapamil

ANTICHOLINERGICS

Atropine

Benzhexol

Benztropine

Biperiden

Cyclopentolate

Glycopyrrolate

Homatropine

Orphenadrine

Oxybutamine

Pilocarpine

Procyclidine

Solifenacin

Tolterodine

Tropicamide

ANTI‑DEMENTIA DRUGS

Donepezil

Galantamine

Memantine

Rivastigmine

ANTIDEPRESSANTS

Amitriptyline

Citalopram

Clomipramine

Desipramine

Desvenlafaxine

Dothiepin

Doxepin

Duloxetine

Escitalopram

Fluoxetine

Fluvoxamine

Imipramine

Mianserin

Mirtazapine

Moclobemide

Nefazodone

Nortriptyline

Paroxetine

Protriptyline

Reboxetine

Sertraline

Trazodone

Trimipramine

Venlafaxine

ANTIEMETICS AND ANTINAUSEANTS

Aprepitant

Dimenhydrinate

Dolasetron

Domperidone

Granisetron

Hyoscine

Metoclopramide

Ondansetron

Tropisetron

ANTIEPILEPTICS

Carbamazepine

Clonazepam

Ethosuximide

Gabapentin

Lacosamide

Lamotrigine

Levetiracetam

Methylphenobarbitone

Oxcarbazepine

Phenobarbitone

Phenytoin

Pregabalin

Primidone

Sodium valproate

Sulthiame

Tiagabine

Topiramate

Valproic acid

Vigabatrin

Zonisamide

ANTIHISTAMINES

Antazoline

Astemizole

Azatadine

Azelastine

Brompheniramine

Cetirizine

Chlorpheniramine

Clemizole

Cyproheptadine

Desloratadine

Dexchlorpheniramine

Dimenhydrinate

Diphenhydramine

Doxylamine

Fexofenadine

Hydroxyzine

Ketotifen

Levocabastine

Levocetirazine

Loratadine

Meclozine

Mepyramine

Mequitazine

Methdilazine

Pheniramine

Promethazine

Terfenadine

Thiethylperazine

Trimeprazine

Triprolidine

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON‑STEROIDS

Benzydamine

Bufexamac

Celecoxib

Diclofenac

Etoricoxib

Flurbiprofen

Ibuprofen

Indomethacin

Ketoprofen

Ketorolac

Lumiracoxib

Mefenamic acid

Meloxicam

Nabumetone

Naproxen

Parecoxib

Phenylbutazone

Piroxicam

Sulindac

Tiaprofenic acid

Valdecoxib

ANTIMALARIALS, except doxycycline.

Artemether

Atovaquone

Chloroquine

Hydroxychloroquine

Lumefantrine

Mefloquine

Primaquine

Proguanil

Pyrimethamine

Quinine

Sulfadoxine

ANTINEOPLASTIC AGENTS

Altretamine

Arsenic trioxide

Bevacizumab

Bleomycin

Busulfan

Capecitabine

Carboplatin

Carmustine

Cetuximab

Chlorambucil

Cisplatin

Cladribine

Cyclophosphamide

Cytarabine

Dacarbazine

Dactinomycin

Dasatinib

Daunorubicin

Docetaxel

Doxorubicin

Epirubicin

Erlotinib

Estramustine

Etoposide

Fludarabine

Fluorouracil

Fotemustine

Gefitinib

Gemcitabine

Hydroxyurea

Idarubicin

Ifosfamide

Imatinib

Irinotecan

Lapatinib

Levamisole

Lomustine

Melphalan

Mercaptopurine

Methotrexate

Methyl aminolevulinate

Mitomycin

Mitotane

Mitoxantrone

Nilotinib

Paclitaxel

Pemetrexed

Procarbazine

Raltitrexed

Rituximab

Sorafenib

Sunitinib

Tegafur

Temozolomide

Teniposide

Thioguanine

Thiotepa

Topotecan

Trastuzumab

Tretinoin

Verteporfin

Vinblastine

Vincristine

Vindesine

Vinorelbine

ANTI‑PARKINSON DRUGS

Amantadine

Apomorphine

Benzhexol

Benztropine

Biperiden

Bromocriptine

Cabergoline

Entacapone

Levodopa

Orphenadrine

Pergolide

Pramipexole

Procyclidine

Ropinirole

Rotigotine

Selegiline

ANTIPSYCHOTICS

Amisulpride

Aripiprazole

Chlorpromazine

Clozapine

Droperidol

Flupenthixol

Fluphenazine

Haloperidol

Lithium carbonate

Methyltrimeprazine

Olanzapine

Paliperidone

Pericyazine

Perphenazine

Pimozide

Prochlorperazine

Promazine

Promethazine

Quetiapine

Risperidone

Sulpiride

Tetrabenazine

Thioridazine

Trifluoperazine

Trimeprazine

Ziprasidone

Zuclopenthixol

ANTITHROMBOTIC AGENTS

Clopidogrel

Dabigatran

Dipyridamole

Phenindione

Prasugrel

Rivaroxaban

Ticlopidine

Warfarin

BENZODIAZEPINE DERIVATIVES and BENZODIAZEPINE RELATED DRUGS

Alprazolam

Bromazepam

Clobazam

Clonazepam

Diazepam

Flunitrazepam

Lorazepam

Lormetazepam

Midazolam

Nitrazepam

Oxazepam

Potassium clorazepate

Temazepam

Triazolam

Zaleplon

Zolpidem

Zopiclone

BETA BLOCKING AGENTS

Acebutolol

Atenolol

Betaxolol

Bisoprolol

Carvedilol

Celiprolol

Esmolol

Labetalol

Levobunolol

Metoprolol

Nadolol

Nebivolol

Oxprenolol

Pindolol

Propranolol

Sotalol

Timolol

CALCIUM CHANNEL BLOCKERS

Amlodipine

Diltiazem

Felodipine

Isradipine

Lercanidipine

Nifedipine

Nimodipine

Perhexiline

Verapamil

CARDIAC GLYCOSIDES

Digitalis lanata

Digitalis purpurea

Digoxin

CENTRALLY ACTING SYMPATHOMIMETICS

Atomoxetine

Dexamphetamine

Methylphenidate

Modafinil

DIURETICS

Amiloride

Bendrofluazide

Chlorothiazide

Chlorthalidone

Ethacrynic acid

Frusemide

Hydrochlorothiazide

Hydroflumethiazide

Indapamide

Spironolactone

Triamterene

ERGOT ALKALOIDS

Dihydroergotamine

Ergotamine

Methysergide

MONOAMINE OXIDASE INHIBITORS

Moclobemide

Phenelzine

Tranylcypromine

OPIOIDS

Alfentanil

Buprenorphine

Butorphanol

Codeine

Dextromoramide

Dextropropoxyphene

Dihydrocodeine

Diphenoxylate

Fentanyl

Hydromorphone

Loperamide

Methadone

Morphine

Opium

Oxycodone

Papaver somniferum

Pentazocine

Pethidine

Remifentanyl

Tramadol

ORAL BLOOD GLUCOSE LOWERING AGENTS

Acarbose

Chlorpropamide

Glibenclamide

Gliclazide

Glimepiride

Glipizide

Metformin

Miglitol

Nateglinide

Pioglitazone

Repaglinide

Rosiglitazone

Sitagliptin

Tolazamide

Tolbutamide

\n```","sortOrder":11},{"sectionNumber":"Part 2","sectionType":"part","heading":"Individual substances","content":"## Part 2 Individual substances\n\n> 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.\n\n> Note: ALISKIREN.\n\n AMBRISENTAN.\n ANISE OIL, except:\n\n(a) when packed in a container having a nominal capacity of 50 millilitres or less and fitted with a restricted flow insert; or\n\n(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.\n\n ASPIRIN.\n Azadirachta indica (Neem), in a preparation for human dermal use containing more than 1 per cent of cold pressed neem seed oil.\n BASIL OIL, except:\n\n(a) when packed in a container having a nominal capacity of 25 millilitres or less and fitted with a restricted flow insert; or\n\n(b) in a preparation or oil containing 5 per cent or less of methyl chavicol.\n\n BAY OIL, except:\n\n(a) when packed in a container having a nominal capacity of 15 millilitres or less and fitted with a restricted flow insert; or\n\n(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.\n\n BOSENTAN.\n BROMHEXINE.\n CAJUPUT OIL, except:\n\n(a) when packed in a container having a nominal capacity of 15 millilitres or less and fitted with a restricted flow insert; or\n\n(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.\n\n CAMPHORATED OIL.\n CAMPHOR, except:\n\n(a) in a liquid preparation containing 2.5 per cent or less of camphor;\n\n(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;\n\n(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\n\n(d) in rosemary oil, sage oil (Spanish), or lavandin oil as such.\n\n Carapichea ipecacuanha (ipecacuanha).\n CASSIA OIL, except in a preparation containing 2 per cent or less of cassia oil.\n CHLORAL HYDRATE.\n CILOSTAZOL.\n CINEOLE, except:\n\n(a) when packed in a container having a nominal capacity of 15 millilitres or less and fitted with a restricted flow insert;\n\n(b) in a preparation or oil containing 25 per cent or less of cineole; or\n\n(c) in rosemary oil or camphor oil (white).\n\n CINNAMON BARK OIL, except in a preparation containing 2 per cent or less of cinnamon bark oil.\n CINNAMON LEAF OIL, except:\n\n(a) when packed in a container having a nominal capacity of 15 millilitres or less and fitted with a restricted flow insert; or\n\n(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.\n\n CLONIDINE.\n CLOVE OIL, except:\n\n(a) when packed in a container having a nominal capacity of 15 millilitres or less and fitted with a restricted flow insert; or\n\n(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.\n\n COLCHICINE.\n Deferasirox.\n Dextromethorphan.\n ETHANOL, in a mouthwash preparation containing more than 3 grams of ethanol in a single pack.\n EUCALYPTUS OIL, except:\n\n(a) when packed in a container having a nominal capacity of 15 millilitres or less and fitted with a restricted flow insert; or\n\n(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.\n\n FLUORIDE SALTS, in a pack containing the equivalent of more than 100 milligrams of elemental fluorine.\n Guaiphenesin; GUAIFENESIN.\n IRON COMPOUNDS, in a pack containing a total of more than 250 milligrams of elemental iron, except for divided preparations in which:\n (a) the iron is compounded with one or more other active ingredients; and\n (b) the amount of elemental iron per dosage unit is 5 milligrams or less.\n 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.\n Ivabradine.\n Lanthanum.\n Lenalidomide.\n MARJORAM OIL, except:\n\n(a) when packed in a container having a nominal capacity of 50 millilitres or less and fitted with a restricted flow insert, or\n\n(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.\n\n MELALEUCA OIL, except:\n\n(a) when packed in a container having a nominal capacity of 15 millilitres or less and fitted with a restricted flow insert; or\n\n(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.\n\n METHYL SALICYLATE, in a liquid preparation containing 5 per cent or more of methyl salicylate.\n MINOXIDIL, in a liquid preparation or a preparation for oral administration.\n MOUTHWASH preparations — see ETHANOL.\n NICOTINE.\n NUTMEG OIL, except:\n\n(a) when packed in a container having a nominal capacity of 25 millilitres or less and fitted with a restricted flow insert; or\n\n(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.\n\n Oxymetazoline.\n PARACETAMOL ‑ all solid dosage forms and liquid preparations.\n PENNYROYAL OIL, except in a preparation containing 4 per cent or less of d‑pulegone.\n Pentoxyverine.\n PHENYLEPHRINE.\n Pholcodine.\n POLYGALA SENEGA (Senega).\n POTASSIUM SALTS, in a pack containing a total of more than 4000 milligrams of elemental potassium, except:\n\n(a) in a divided preparation in which the amount of elemental potassium per dosage unit is 40 milligrams to less; or\n\n(b) when the potassium is present in the form of glucosamine sulfate potassium chloride complex.\n\n PSEUDOEPHEDRINE.\n RILUZOLE.\n SAGE OIL DALMATIAN, except in a preparation containing 4 per cent or less of thujone.\n SALBUTAMOL.\n SASSAFRAS OIL, except in a preparation containing 1 per cent or less of safrole.\n STAR ANISE OIL, except:\n\n(a) when packed in a container having a nominal capacity of 50 millilitres or less and fitted with a restricted flow insert; or\n\n(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.\n\n THEOPHYLLINE.\n THYME OIL, except:\n\n(a) when packed in a container having a nominal capacity of 25 millilitres or less and fitted with a restricted flow insert; or\n\n(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.\n\n THYROXINE.\n Varenicline.\n WINTERGREEN OIL — see METHYL SALICYLATE.\n XYLOMETAZOLINE.","sortOrder":12},{"sectionNumber":"Part 3","sectionType":"part","heading":"Alphabetical listing of entries","content":"## Part 3 Alphabetical listing of entries\n\n> Note This Part is included for information only.\n\nAcarbose (Oral Blood Glucose Lowering Agents).\n\nACE INHIBITORS.\n\nAcebutolol (Beta Blocking Agents).\n\nAlfentanil (Opioids).\n\nAliskiren.\n\nAlprazolam (Benzodiazepine Derivatives).\n\nAltretamine (Antineoplastic Agents).\n\nAmantadine (Anti‑Parkinson Drugs).\n\nAmbrisentan.\n\nAmethocaine (Anaesthetics, Local)\n\nAmiloride (Diuretics).\n\nAmiodarone (Antiarrhythmics).\n\nAmisulpride (Antipsychotics).\n\nAmitriptyline (Antidepressants).\n\nAmlodipine (Calcium Channel Blockers).\n\nANAESTHETICS, LOCAL.\n\nANGIOTENSIN II ANTAGONISTS.\n\nAnise oil, except:\n\n(a) when packed in a container having a nominal capacity of 50 millilitres or less and fitted with a restricted flow insert; or\n\n(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 Part 2.\n\nAntazoline (Antihistamines).\n\nANTIARRHYTHMICS.\n\nANTICHOLINERGICS.\n\nANTI‑DEMENTIA DRUGS.\n\nANTIDEPRESSANTS.\n\nANTIEMETICS AND ANTINAUSEANTS.\n\nANTIEPILEPTICS.\n\nANTIHISTAMINES.\n\nANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON‑STEROIDS.\n\nANTIMALARIALS, except doxycycline.\n\nANTINEOPLASTIC AGENTS.\n\nANTI‑PARKINSON DRUGS.\n\nANTIPSYCHOTICS.\n\nANTITHROMBOTIC AGENTS.\n\nApomorphine (Anti‑Parkinson Drugs).\n\nAprepitant (Antiemetics and Antinauseants).\n\nAripiprazole (Antipsychotics).\n\nArsenic trioxide (Antineoplastic Agents).\n\nArtemether (Antimalarials).\n\nArticaine (Anaesthetics, Local).\n\nAspirin.\n\nAstemizole (Antihistamines).\n\nAtenolol (Beta Blocking Agents).\n\nAtomoxetine (Centrally Acting Sympathomimetics).\n\nAtovaquone (Antimalarials).\n\nAtropine (Anticholinergics).\n\nAzadirachta indica (Neem), in a preparation for human dermal use containing more than 1 per cent of cold pressed neem seed oil.\n\nAzatadine (Antihistamines).\n\nAzelastine (Antihistamines).\n\nBasil oil, except:\n\n(a) when packed in a container having a nominal capacity of 25 millilitres or less and fitted with a restricted flow insert; or\n\n(b) in a preparation or oil containing 5 per cent or less of methyl chavicol.\n\nBay oil, except:\n\n(a) when packed in a container having a nominal capacity of 15 millilitres or less and fitted with a restricted flow insert; or\n\n(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 Part 2.\n\nBendrofluazide (Diuretics).\n\nBenzhexol (Anticholinergics; also Anti-Parkinson Drugs).\n\nBenztropine (Anticholinergics; also Anti-Parkinson Drugs).\n\nBenzocaine (Anaesthetics, Local).\n\nBENZODIAZEPINE DERIVATIVES.\n\nBENZODIAZEPINE RELATED DRUGS.\n\nBenzydamine (Antiinflammatory and Antirheumatic Products, Non‑Steroids).\n\nBETA BLOCKING AGENTS.\n\nBetaxolol (Beta Blocking Agents).\n\nBevacizumab (Antineoplastic Agents).\n\nBiperiden (Anticholinergics; also Anti-Parkinson Drugs).\n\nBisoprolol (Beta Blocking Agents).\n\nBleomycin (Antineoplastic Agents).\n\nBosentan.\n\nBretylium tosilate (Antiarrhythmics).\n\nBromazepam (Benzodiazepine Derivatives).\n\nBromhexine.\n\nBromocriptine (Anti‑Parkinson Drugs).\n\nBrompheniramine (Antihistamines).\n\nBufexamac (Antiinflammatory and Antirheumatic Products, Non‑Steroids).\n\nBupivacaine (Anaesthetics, Local).\n\nBuprenorphine (Opioids).\n\nBusulfan (Antineoplastic Agents).\n\nButorphanol (Opioids).\n\nCabergoline (Anti‑Parkinson Drugs).\n\nCajuput oil, except:\n\n(a) when packed in a container having a nominal capacity of 15 millilitres or less and fitted with a restricted flow insert; or\n\n(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 Part 2.\n\nCALCIUM CHANNEL BLOCKERS.\n\nCamphorated oil.\n\nCamphor, except:\n\n(a) in a liquid preparations containing 2.5 per cent or less of camphor;\n\n(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;\n\n(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\n\n(d) in rosemary oil, sage oil (Spanish), or lavandin oil as such.\n\nCandesartan (Angiotensin II Antagonists).\n\nCapecitabine (Antineoplastic Agents).\n\nCaptopril (ACE Inhibitors).\n\nCarapichea ipecacuanha (Ipecacuanha).\n\nCarbamazepine (Antiepileptics).\n\nCarboplatin (Antineoplastic Agents).\n\nCARDIAC GLYCOSIDES.\n\nCarmustine (Antineoplastic Agents).\n\nCarvedilol (Beta Blocking Agents).\n\nCassia oil, except in a preparation containing 2 per cent or less of cassia oil.\n\nCelecoxib (Antiinflammatory and Antirheumatic Products, Non‑Steroids).\n\nCeliprolol (Beta Blocking Agents).\n\nCENTRALLY ACTING SYMPATHOMIMETICS.\n\nCetirizine (Antihistamines).\n\nCetuximab (Antineoplastic Agents).\n\nChloral hydrate.\n\nChlorambucil (Antineoplastic Agents).\n\nChloroquine (Antimalarials).\n\nChlorothiazide (Diuretics).\n\nChlorpheniramine (Antihistamines)\n\nChlorpromazine (Antipsychotics).\n\nChlorpropamide (Oral Blood Glucose Lowering Agents).\n\nChlorthalidone (Diuretics).\n\nCilostazol.\n\nCinchocaine (Anaesthetics, Local).\n\nCineole, except:\n\n(a) when packed in a container having a nominal capacity of 15 millilitres or less and fitted with a restricted flow insert;\n\n(b) in a preparation or oil containing 25 per cent or less of cineole; or\n\n(c) in rosemary oil or camphor oil (white).\n\nCinnamon bark oil, except in a preparation containing 2 per cent or less of cinnamon bark oil.\n\nCinnamon leaf oil, except:\n\n(a) when packed in a container having a nominal capacity of 15 millilitres or less and fitted with a restricted flow insert; or\n\n(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 Part 2.\n\nCisplatin (Antineoplastic Agents).\n\nCitalopram (Antidepressants).\n\nCladribine (Antineoplastic Agents).\n\nClemizole (Antihistamines).\n\nClobazam (Benzodiazepine Derivatives).\n\nClomipramine (Antidepressants).\n\nClonazepam (Antiepileptics; also Benzodiazepine Derivatives).\n\nClonidine.\n\nClopidogrel (Antithrombotic Agents).\n\nClove oil, except:\n\n(a) when packed in a container having a nominal capacity of 15 millilitres or less and fitted with a restricted flow insert;\n\n(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 Part 2.\n\nClozapine (Antipsychotics).\n\nCodeine (Opioids).\n\nColchicine.\n\nCyclopentolate (Anticholinergics).\n\nCyclophosphamide (Antineoplastic Agents).\n\nCyproheptadine (Antihistamines).\n\nCytarabine (Antineoplastic Agents).\n\nDabigatran (Antithrombotic Agents).\n\nDacarbazine (Antineoplastic Agents).\n\nDactinomycin (Antineoplastic Agents).\n\nDasatinib (Antineoplastic Agents).\n\nDaunorubicin (Antineoplastic Agents).\n\nDeferasirox.\n\nDesipramine (Antidepressants).\n\nDesloratadine (Antihistamines).\n\nDesvenlafaxine (Antidepressants).\n\nDexamphetamine (Centrally Acting Sympathomimetics).\n\nDexchlorpheniramine (Antihistamines).\n\nDextromethorphan.\n\nDextromoramide (Opioids).\n\nDextropropoxyphene (Opioids).\n\nDiazepam (Benzodiazepine Derivatives).\n\nDiclofenac (Antiinflammatory and Antirheumatic Products, Non‑Steroids).\n\nDigitalis lanata (Cardiac Glycosides).\n\nDigitalis purpurea (Cardiac Glycosides).\n\nDigoxin (Cardiac Glycosides).\n\nDihydrocodeine (Opioids).\n\nDihydroergotamine (Ergot Alkaloids).\n\nDiltiazem (Calcium Channel Blockers).\n\nDimenhydrinate (Antiemetics and Antinauseants; also Antihistamines).\n\nDiphenhydramine (Antihistamines).\n\nDiphenoxylate (Opioids).\n\nDipyridamole (Antithrombotic Agents).\n\nDisopyramide (Antiarrhythmics).\n\nDIURETICS.\n\nDocetaxel (Antineoplastic Agents).\n\nDofetilide (Antiarrhythmics).\n\nDolasetron (Antiemetics and Antinauseants).\n\nDomperidone (Antiemetics and Antinauseants).\n\nDonepezil (Anti‑Dementia Drugs).\n\nDothiepin (Antidepressants)\n\nDoxepin (Antidepressants).\n\nDoxorubicin (Antineoplastic Agents).\n\nDoxylamine (Antihistamines).\n\nDroperidol (Antipsychotics).\n\nDuloxetine (Antidepressants).\n\nEnalapril (ACE Inhibitors).\n\nEntacapone (Anti‑Parkinson Drugs).\n\nEpirubicin (Antineoplastic Agents).\n\nEprosartan (Angiotensin II Antagonists).\n\nERGOT ALKALOIDS.\n\nErgotamine (Ergot Alkaloids).\n\nErlotinib (Antineoplastic Agents).\n\nEscitalopram (Antidepressants).\n\nEsmolol (Antiarrhythmics; also Beta Blocking Agents).\n\nEstramustine (Antineoplastic Agents).\n\nEthacrynic acid (Diuretics).\n\nEthanol, in mouthwash preparations containing more than 3 grams of ethanol in a single pack.\n\nEthosuximide (Antiepileptics).\n\nEtoposide (Antineoplastic Agents).\n\nEtoricoxib (Antiinflammatory and Antirheumatic Products, Non‑Steroids).\n\nEucalyptus oil, except:\n\n(a) when packed in a container having a nominal capacity of 15 millilitres or less and fitted with a restricted flow insert; or\n\n(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 Part 2.\n\nFelodipine (Calcium Channel Blockers).\n\nFentanyl (Opioids).\n\nFexofenadine (Antihistamines).\n\nFlecainide (Antiarrhythmics).\n\nFludarabine (Antineoplastic Agents).\n\nFlunitrazepam (Benzodiazepine Derivatives).\n\nFluoride salts, in a pack containing the equivalent of more than 100 milligrams of elemental fluorine.\n\nFluorouracil (Antineoplastic Agents).\n\nFluoxetine (Antidepressants).\n\nFlupenthixol (Antipsychotics).\n\nFluphenazine (Antipsychotics).\n\nFlurbiprofen (Antiinflammatory and Antirheumatic Products, Non‑Steroids).\n\nFluvoxamine (Antidepressants).\n\nFosinopril (ACE Inhibitors).\n\nFotemustine (Antineoplastic Agents).\n\nFrusemide (Diuretics).\n\nGabapentin (Antiepileptics).\n\nGalantamine (Anti‑Dementia Drugs).\n\nGefitinib (Antineoplastic Agents).\n\nGemcitabine (Antineoplastic Agents).\n\nGlibenclamide (Oral Blood Glucose Lowering Agents).\n\nGliclazide (Oral Blood Glucose Lowering Agents).\n\nGlimepiride (Oral Blood Glucose Lowering Agents).\n\nGlipizide (Oral Blood Glucose Lowering Agents).\n\nGlycopyrrolate (Anticholinergics).\n\nGranisetron (Antiemetics and Antinauseants).\n\nGuaiphenesin; Guaifenesin.\n\nHaloperidol (Antipsychotics).\n\nHomatropine (Anticholinergics).\n\nHydrochlorothiazide (Diuretics).\n\nHydroflumethiazide (Diuretics).\n\nHydromorphone (Opioids).\n\nHydroxychloroquine (Antimalarials).\n\nHydroxyurea (Antineoplastic Agents).\n\nHydroxyzine (Antihistamines).\n\nHyoscine (Antiemetics and Antinauseants).\n\nIbuprofen (Antiinflammatory and Antirheumatic Products, Non‑Steroids).\n\nIbutilide (Antiarrhythmics).\n\nIdarubicin (Antineoplastic Agents).\n\nIfosfamide (Antineoplastic Agents).\n\nImatinib (Antineoplastic Agents).\n\nImipramine (Antidepressants).\n\nIndapamide (Diuretics).\n\nIndomethacin (Antiinflammatory and Antirheumatic Products, Non-Steroids).\n\nIrbesartan (Angiotensin II Antagonists).\n\nIrinotecan (Antineoplastic Agents).\n\nIron compounds, in a pack containing a total of more than 250 milligrams of elemental iron, except for divided preparations in which:\n\n(a) the iron is compounded with one or more other active ingredients; and\n\n(b) the amount of elemental iron per dosage unit is 5 milligrams or less.\n\nHowever 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.\n\nIsradipine (Calcium Channel Blockers).\n\nIvabradine.\n\nKetoprofen (Antiinflammatory and Antirheumatic Products, Non‑Steroids).\n\nKetorolac (Antiinflammatory and Antirheumatic Products, Non‑Steroids).\n\nKetotifen (Antihistamines).\n\nLabetalol (Beta Blocking Agents).\n\nLacosamide (Antiepileptics).\n\nLamotrigine (Antiepileptics).\n\nLanthanum.\n\nLapatinib (Antineoplastic Agents).\n\nLenalidomide.\n\nLercanidipine (Calcium Channel Blockers).\n\nLevamisole (Antineoplastic Agents).\n\nLevetiracetam (Antiepileptics).\n\nLevobunolol (Beta Blocking Agents).\n\nLevobupivacaine (Anaesthetics, Local).\n\nLevocabastine (Antihistamines).\n\nLevocetirazine (Antihistamines).\n\nLevodopa (Anti‑Parkinson Drugs).\n\nLignocaine (Antiarrhythmics; also Anaesthetics, Local).\n\nLisinopril (ACE Inhibitors).\n\nLithium carbonate (Antipsychotics).\n\nLomustine (Antineoplastic Agents).\n\nLoperamide (Opioids).\n\nLoratadine (Antihistamines).\n\nLorazepam (Benzodiazepine Derivatives).\n\nLormetazepam (Benzodiazepine Derivatives).\n\nLosartan (Angiotensin II Antagonists).\n\nLumefantrine (Antimalarials).\n\nLumiracoxib (Antiinflammatory and Antirheumatic Products, Non‑Steroids).\n\nMarjoram oil, except:\n\n(a) when packed in a container having a nominal capacity of 50 millilitres or less and fitted with a restricted flow insert; or\n\n(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 Part 2.\n\nMeclozine (Antihistamines).\n\nMefenamic Acid (Antiinflammatory and Antirheumatic Products, Non‑Steroids).\n\nMefloquine (Antimalarials).\n\nMelaleuca oil, except:\n\n(a) when packed in a container having a nominal capacity of 15 millilitres or less and fitted with a restricted flow insert; or\n\n(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 Part 2.\n\nMeloxicam (Antiinflammatory and Antirheumatic Products, Non‑Steroids).\n\nMelphalan (Antineoplastic Agents).\n\nMemantine (Anti‑Dementia Drugs).\n\nMepivacaine (Anaesthetics, Local).\n\nMepyramine (Antihistamines).\n\nMequitazine (Antihistamines).\n\nMercaptopurine (Antineoplastic Agents).\n\nMetformin (Oral Blood Glucose Lowering Agents).\n\nMethadone (Opioids).\n\nMethdilazine (Antihistamines).\n\nMethotrexate (Antineoplastic Agents).\n\nMethyl aminolevulinate (Antineoplastic Agents).\n\nMethyl salicylate, in a liquid preparation containing 5 per cent or more of methyl salicylate.\n\nMethylphenidate (Centrally Acting Sympathomimetics).\n\nMethylphenobarbitone (Antiepileptics).\n\nMethyltrimeprazine (Antipsychotics).\n\nMethysergide (Ergot Alkaloids).\n\nMetoclopramide (Antiemetics and Antinauseants).\n\nMetoprolol (Beta Blocking Agents).\n\nMexiletine (Antiarrhythmics).\n\nMianserin (Antidepressants).\n\nMidazolam (Benzodiazepine Derivatives).\n\nMiglitol (Oral Blood Glucose Lowering Agents).\n\nMinoxidil, in a liquid preparation or a preparation for oral administration.\n\nMirtazapine (Antidepressants).\n\nMitomycin (Antineoplastic Agents).\n\nMitotane (Antineoplastic Agents).\n\nMitoxantrone (Antineoplastic Agents).\n\nMoclobemide (Antidepressants; also Monoamine Oxidase Inhibitors).\n\nModafinil (Centrally Acting Sympathomimetics).\n\nMONOAMINE OXIDASE INHIBITORS.\n\nMorphine (Opioids).\n\nMouthwash preparations — see Ethanol.\n\nNabumetone (Antiinflammatory and Antirheumatic Products, Non‑Steroids).\n\nNadolol (Beta Blocking Agents).\n\nNaproxen (Antiinflammatory and Antirheumatic Products, Non‑Steroids).\n\nNateglinide (Oral Blood Glucose Lowering Agents).\n\nNebivolol (Beta Blocking Agents).\n\nNefazodone (Antidepressants).\n\nNicotine.\n\nNifedipine (Calcium Channel Blockers).\n\nNilotinib (Antineoplastic Agents).\n\nNimodipine (Calcium Channel Blockers).\n\nNitrazepam (Benzodiazepine Derivatives).\n\nNortriptyline (Antidepressants).\n\nNutmeg oil, except:\n\n(a) when packed in a container having a nominal capacity of 25 millilitres or less and fitted with a restricted flow insert; or\n\n(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 Part 2.\n\nOlanzapine (Antipsychotics).\n\nOlmesartan (Angiotensin II Antagonists).\n\nOndansetron (Antiemetics and Antinauseants).\n\nOPIOIDS.\n\nOpium (Opioids).\n\nORAL BLOOD GLUCOSE LOWERING AGENTS.\n\nOrphenadrine (Anticholinergics; also Anti-Parkinson Drugs).\n\nOxazepam (Benzodiazepine Derivatives).\n\nOxcarbazepine (Antiepileptics).\n\nOxprenolol (Beta Blocking Agents).\n\nOxybuprocaine (Anaesthetics, Local).\n\nOxybutamine (Anticholinergics).\n\nOxycodone (Opioids).\n\nOxymetazoline.\n\nPaclitaxel (Antineoplastic Agents).\n\nPaliperidone (Antipsychotics).\n\nPapaver somniferum (Opioids).\n\nParacetamol ‑ all solid dosage forms and liquid preparations.\n\nParecoxib (Antiinflammatory and Antirheumatic Products, Non‑Steroids).\n\nParoxetine (Antidepressants).\n\nPemetrexed (Antineoplastic Agents).\n\nPennyroyal oil, except in a preparation containing 4 per cent or less of d‑pulegone.\n\nPentazocine (Opioids).\n\nPentoxyverine.\n\nPergolide (Anti‑Parkinson Drugs).\n\nPerhexiline (Calcium Channel Blockers).\n\nPericyazine (Antipsychotics).\n\nPerindopril (ACE Inhibitors).\n\nPerphenazine (Antipsychotics).\n\nPethidine (Opioids).\n\nPhenelzine (Monoamine Oxidase Inhibitors).\n\nPhenindione (Antithrombotic Agents).\n\nPheniramine (Antihistamines).\n\nPhenobarbitone (Antiepileptics).\n\nPhenylbutazone (Antiinflammatory and Antirheumatic Products, Non‑Steroids).\n\nPhenylephrine.\n\nPhenytoin (Antiepileptics).\n\nPholcodine.\n\nPilocarpine (Anticholinergics).\n\nPimozide (Antipsychotics).\n\nPindolol (Beta Blocking Agents).\n\nPioglitazone (Oral Blood Glucose Lowering Agents).\n\nPiroxicam (Antiinflammatory and Antirheumatic Products, Non‑Steroids).\n\nPolygala senega (Senega).\n\nPotassium clorazepate (Benzodiazepine Derivatives).\n\nPotassium salts, in a pack containing a total of more than 4000 milligrams of elemental potassium, except:\n\n(a) in a divided preparation in which the amount of elemental potassium per dosage unit is 40 milligrams to less; or\n\n(b) when the potassium is present in the form of glucosamine sulfate potassium chloride complex.\n\nPramipexole (Anti‑Parkinson Drugs).\n\nPrasugrel (Antithrombotic Agents).\n\nPregabalin (Antiepileptics).\n\nPrimaquine (Antimalarials).\n\nPrimidone (Antiepileptics).\n\nProcainamide (Antiarrhythmics).\n\nProcaine (Anaesthetics, Local).\n\nProcarbazine (Antineoplastic Agents).\n\nProchlorperazine (Antipsychotics).\n\nProcyclidine (Anticholinergics; also Anti-Parkinson Drugs).\n\nProguanil (Antimalarials).\n\nPromazine (Antipsychotics).\n\nPromethazine (Antihistamines; also Antipsychotics).\n\nPropranolol (Beta Blocking Agents).\n\nProtriptyline (Antidepressants).\n\nPseudoephedrine.\n\nPyrimethamine (Antimalarials).\n\nQuetiapine (Antipsychotics).\n\nQuinapril (ACE Inhibitors).\n\nQuinidine (Antiarrhythmics).\n\nQuinine (Antimalarials).\n\nRaltitrexed (Antineoplastic Agents).\n\nRamipril (ACE Inhibitors).\n\nReboxetine (Antidepressants).\n\nRemifentanyl (Opioids).\n\nRepaglinide (Oral Blood Glucose Lowering Agents).\n\nRiluzole.\n\nRisperidone (Antipsychotics).\n\nRituximab (Antineoplastic Agents).\n\nRivaroxaban (Antithrombotic Agents).\n\nRivastigmine (Anti‑Dementia Drugs).\n\nRopinirole (Anti‑Parkinson Drugs).\n\nRopivacaine (Anaesthetics, Local).\n\nRosiglitazone (Oral Blood Glucose Lowering Agents).\n\nRotigotine (Anti-Parkinson Drugs).\n\nSage oil Dalmatian, except in a preparation containing 4 per cent or less of thujone.\n\nSalbutamol.\n\nSassafras oil, except in a preparation containing 1 per cent or less of safrole.\n\nSelegiline (Anti‑Parkinson Drugs).\n\nSertraline (Antidepressants).\n\nSitagliptin (Oral Blood Glucose Lowering Agents).\n\nSodium valproate (Antiepileptics).\n\nSolifenacin (Anticholinergics).\n\nSorafenib (Antineoplastic Agents).\n\nSotalol (Antiarrhythmics; also Beta Blocking Agents).\n\nSpironolactone (Diuretics).\n\nStar anise oil, except:\n\n(a) when packed in a container having a nominal capacity of 50 millilitres or less and fitted with a restricted flow insert; or\n\n(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 Part 2.\n\nSulfadoxine (Antimalarials).\n\nSulindac (Antiinflammatory and Antirheumatic Products, Non‑Steroids).\n\nSulpiride (Antipsychotics).\n\nSulthiame (Antiepileptics).\n\nSunitinib (Antineoplastic Agents).\n\nTea tree oil - see Melaleuca oil.\n\nTegafur (Antineoplastic Agents).\n\nTelmisartan (Angiotensin II Antagonists).\n\nTemazepam (Benzodiazepine Derivatives).\n\nTemozolomide (Antineoplastic Agents).\n\nTeniposide (Antineoplastic Agents).\n\nTerfenadine (Antihistamines).\n\nTetrabenazine (Antipsychotics).\n\nTheophylline.\n\nThiethylperazine (Antihistamines).\n\nThioguanine (Antineoplastic Agents).\n\nThioridazine (Antipsychotics).\n\nThiotepa (Antineoplastic Agents).\n\nThyme oil, except:\n\n(a) when packed in a container having a nominal capacity of 25 millilitres or less and fitted with a restricted flow insert; or\n\n(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 Part 2.\n\nThyroxine.\n\nTiagabine (Antiepileptics).\n\nTiaprofenic acid (Antiinflammatory and Antirheumatic Products, Non‑Steroids).\n\nTiclopidine (Antithrombotic Agents).\n\nTimolol (Beta Blocking Agents).\n\nTolazamide (Oral Blood Glucose Lowering Agents).\n\nTolbutamide (Oral Blood Glucose Lowering Agents).\n\nTolterodine (Anticholinergics).\n\nTopiramate (Antiepileptics).\n\nTopotecan (Antineoplastic Agents).\n\nTramadol (Opioids).\n\nTrandolapril (ACE Inhibitors).\n\nTranylcypromine (Monoamine Oxidase Inhibitors).\n\nTrastuzumab (Antineoplastic Agents).\n\nTrazodone (Antidepressants).\n\nTretinoin (Antineoplastic Agents).\n\nTriamterene (Diuretics).\n\nTriazolam (Benzodiazepine Derivatives).\n\nTrifluoperazine (Antipsychotics).\n\nTrimeprazine (Antihistamines; also Antipsychotics).\n\nTrimipramine (Antidepressants).\n\nTriprolidine (Antihistamines).\n\nTropicamide (Anticholinergics).\n\nTropisetron (Antiemetics and Antinauseants).\n\nValdecoxib (Antiinflammatory and Antirheumatic Products, Non‑Steroids).\n\nValproic acid (Antiepileptics).\n\nValsartan (Angiotensin II Antagonists).\n\nVarenicline.\n\nVenlafaxine (Antidepressants).\n\nVerapamil (Antiarrhythmics; also Calcium Channel Blockers).\n\nVerteporfin (Antineoplastic Agents).\n\nVigabatrin (Antiepileptics).\n\nVinblastine (Antineoplastic Agents).\n\nVincristine (Antineoplastic Agents).\n\nVindesine (Antineoplastic Agents).\n\nVinorelbine (Antineoplastic Agents).\n\nWarfarin (Antithrombotic Agents).\n\nWintergreen oil — see Methyl salicylate.\n\nXylometazoline.\n\nZaleplon (Benzodiazepine Derivatives and Benzodiazepine Related Drugs).\n\nZiprasidone (Antipsychotics).\n\nZolpidem (Benzodiazepine Derivatives and Benzodiazepine Related Drugs).\n\nZonisamide (Antiepileptics).\n\nZopiclone (Benzodiazepine Derivatives and Benzodiazepine Related Drugs).\n\nZuclopenthixol (Antipsychotics).","sortOrder":13}],"analysis":{"flash_summary":{"complexity_score":7,"scope_assessment":{"changed":true,"description":"Yes. The Order formally supersedes Therapeutic Goods Order No.65 under its transition clause (s3) and sets a specific, enumerated scope by naming classes (Schedule 1 Part 1) and individual substances with strength/pack‑size limits (Schedule 1 Part 2). That replaces the prior regime after the transition date and clarifies which medicines fall within the packaging requirements (see ss3,6 and Schedule 1)."},"complexity_factors":["Extensive, detailed Schedule listing many substance classes and individual substances with strength/pack-size carve-outs (Schedule 1 Parts 1–3; see s6).","Multiple alternative national and international Standards accepted for reclosable packages (s9(1)), requiring cross‑reference to external test protocols.","Record‑keeping and evidence obligations for sponsors about certification, test protocols and quality control (s9(2)–(5)).","Numerous specific exemptions and conditional carve‑outs (s7; many conditional exceptions in Schedule 1 Part 2), increasing application complexity.","Different regimes for reclosable (performance‑based testing) and non‑reclosable packages (design/material rules without current performance testing) (s4(9)–(10), s10).","Transitional arrangements replacing an earlier Order (TGO No.65) up to 31 Aug 2010 then mandatory from 1 Sep 2010 (s3), requiring supply‑chain change management.","Delegated discretion and external dependence: Secretary may grant exemptions (s6(2) referencing ss14 and 14A of the Act) and advisory committee criteria guide risk decisions (s4(4)).","Technical definitions and age/test protocols embedded by reference (definitions in s5; testing age range in s5 note; s9 cross‑references Standards).","Compliance risks span product design, manufacturing, testing, labelling and pharmacist repackaging practices (ss8,9,10)."],"plain_english_summary":"This Order requires sponsors to supply certain human medicines in child‑resistant packaging. It identifies affected medicines by listing classes and individual substances, prescribes recognised standards for reclosable closures and material/design limits for non‑reclosable blister/strip packs, and sets out exemptions and a transition timetable.\n\nIt affects medicine sponsors, packagers and pharmacists (bulk packs are exempt). Sponsors must hold evidence of compliance and pay for testing/packaging; the Order’s stated aim is to reduce accidental child poisoning but it imposes testing, design and labelling burdens on industry (see ss6,7,9)."},"kimi_summary":{"_metrics":{"model":"kimi-k2.5","source":"moonshot-realtime","completionTokens":2108},"content_quality":"ok","complexity_score":6,"scope_assessment":{"changed":false,"description":"The Order maintains its original stated objective of setting child-resistant packaging requirements for high-risk medicines. While it replaced the earlier Therapeutic Goods Order No. 65 (as noted in the transition provisions), the scope remains focused on reducing accidental childhood poisoning through packaging standards and has not expanded beyond this public health safety remit."},"complexity_factors":["Extensive interpretation section with 20+ defined technical terms (e.g., 'restricted flow insert', 'blister', 'reclosable package')","Cross-references to 5 different international and national standards for reclosable package testing (ISO 8317, BS EN ISO 8317, CSA Z76.1-99, US 16 CFR 1700, AS 1928-2007)","Dual regulatory regimes: performance-based testing for reclosable packages versus design-based construction rules for non-reclosable packages","Schedule 1 contains three parts with extensive substance listings — Part 1 covers 24 broad drug classes, Part 2 lists specific substances with strength/pack size thresholds, and Part 3 provides an alphabetical cross-reference","12 exemption categories in section 7 with nested conditional logic (e.g., essential oils exempt only if in containers under specific sizes with restricted flow inserts)","Evidence retention requirements requiring sponsors to hold compliance certificates, test protocols, and quality control documentation"],"plain_english_summary":"This Order requires sponsors in Australia to supply potentially lethal medicines in child-resistant packaging so that most children under five can’t open them but older adults can—covering many antidepressants, blood‑pressure drugs, opioids, iron, epilepsy medicines and some essential oils. Reclosable containers must meet child‑performance tests; non‑reclosable formats must follow strict design/material rules. Exemptions include injections, hospital‑only products, very small containers, export‑only items, or cases with a Secretary’s exemption. The aim is to reduce accidental child poisonings."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-order-no-80-child-resistant-packaging-requirements-for-medicines-27-08-2008","history":"/api/acts/therapeutic-goods-order-no-80-child-resistant-packaging-requirements-for-medicines-27-08-2008/history","analysis":"/api/acts/therapeutic-goods-order-no-80-child-resistant-packaging-requirements-for-medicines-27-08-2008/analysis","conflicts":"/api/acts/therapeutic-goods-order-no-80-child-resistant-packaging-requirements-for-medicines-27-08-2008/conflicts","importantCases":"/api/acts/therapeutic-goods-order-no-80-child-resistant-packaging-requirements-for-medicines-27-08-2008/important-cases","documents":"/api/acts/therapeutic-goods-order-no-80-child-resistant-packaging-requirements-for-medicines-27-08-2008/documents"}}