Therapeutic Goods Order No. 65 Child-resistant packaging for therapeutic goods - Schedules and supplementary notes
These are the Schedules and Supplementary Notes for TGO 65 Child-resistant packaging for therapeutic goods <http://www.tga.gov.au/docs/html/tgo/tgo65.htm>.
Note: If you intend to rely on any legislation referred to on this website, you should access copies of the official versions on the Attorney General's Department's ComLaw website <http://www.comlaw.gov.au> (incorporating the Federal Register of Legislative Instruments (FRLI)). Instruments are amended from time to time and may, on occasions, be replaced or new instruments made.
First Schedule
ANTI-ARRHYTHMICS - All preparations containing one or more ANTI-ARRHYTHMIC ingredients including but not limited to the following:
| Amiodarone | Disopyramide | Flecainide |
| Mexiletine | Procainamide | Quinidine |
| Sotalol | Verapamil |
ANTICONVULSANTS - All preparations containing one or more ANTICONVULSANT ingredients including but not limited to the following:
| Carbamazepine | Clonazepam | Ethosuximide |
| Gabapentin | Lamotrigine | Levetiracetam |
| Methylpheno-barbitone | Oxcarbazepine | Phenytoin |
| Primidone | Sodium valproate | Sulthiame |
| Tiagabine | Topiramate | Vigabatrin |
ANTIHISTAMINES - All preparations containing one or more ANTIHISTAMINE ingredients including but not limited to the following:
| Antazoline | Astemizole | Azatadine |
| Brompheniramine | Cetirizine | Chlorpheniramine |
| Clemizole* | Cyproheptadine | Dexchlorpheniramine |
| Dimenhydrinate | Diphenhydramine | Doxylamine |
| Fexofenadine | Hydroxyzine | Loratadine |
| Mepyramine | Methdilazine | Pheniramine |
| Promethazine | Terfenadine | Trimeprazine |
* in dosage forms other than ointment or suppository
ASPIRIN
BETA BLOCKERS - All preparations containing one or more BETA BLOCKER ingredients including but not limited to the following:
| Atenolol | Carvedilol | Esmolol |
| Metoprolol | Oxprenolol | Pindolol |
| Propranolol | Sotalol | Timolol |
CALCIUM ANTAGONISTS - All preparations containing one or more CALCIUM ANTAGONIST ingredients including but not limited to the following:
| Amlodipine | Diltiazem | Felodipine |
| Lercanidipine | Nifedipine | Nimodipine |
| Perhexiline | Verapamil |
CAMPHOR (including CAMPHORATED OIL) in liquid preparations when included in Schedule 4, 5 or 6 of the Poisons Standard.
CHLOROQUINE
CINEOLE in a volume of 2 litres or less, when included in Schedule 6 of the Poisons Standard.
CLONIDINE
CLOZAPINE
COLCHICINE
DEXAMPHETAMINE
DEXTROPROPOXYPHENE
DIGITALIS GLYCOSIDES
DIPHENOXYLATE HYDROCHLORIDE WITH ATROPINE SULPHATE
ESSENTIAL OILS in a volume of 200 millilitres or less, when included in Schedule 5 or 6 of the Poisons Standard, including but not limited to the following:
| Anise oil | Basil oil | Bay oil |
| Cajuput oil | Cassia oil | Cinnamon bark oil |
| Cinnamon leaf oil | Clove oil | Marjoram oil |
| Nutmeg oil | Pennyroyal oil | Sage (Dalmatian) oil |
| Thyme oil |
EUCALYPTUS OIL in a volume of 2 litres or less, when included in Schedule 6 of the Poisons Standard.
FLUORIDE SALTS in packs containing the equivalent of more than 100 milligrams of elemental fluorine.
HYDROXYCHLOROQUINE
IRON COMPOUNDS - All solid dosage forms except preparations containing the equivalent of 5 milligrams or less of elemental iron in each dosage unit; and in liquid preparations containing the equivalent of more than 250 mg of elemental iron in the total contents of the container.
LITHIUM CARBONATE
MELALEUCA OIL (Tea-tree Oil) in a volume of 200 millilitres or less, when included in Schedule 6 of the Poisons Standard.
METHADONE
METHYLPHENIDATE
METHYL SALICYLATE in liquid preparations containing more than 50 per cent volume in volume of methyl salicylate, in a volume of 200 mL or less.
MINOXIDIL in liquid preparations or preparations for oral administration.
MONOAMINE OXIDASE INHIBITORS - All preparations containing one or more MONOAMINE OXIDASE INHIBITOR ingredients including but not limited to the following:
| Phenelzine | Tranylcypromine |
NARCOTIC ANALGESICS - All preparations containing one or more NARCOTIC ANALGESIC ingredients including but not limited to the following:
| Buprenorphine | Codeine | Dextromoramide |
| Dihydrocodeine | Diphenoxylate | Fentanyl |
| Hydromorphone | Morphine | Oxycodone |
| Pentazocine | Pethidine |
NATEGLINIDE
ORPHENADRINE
PARACETAMOL - All solid dosage forms and liquid preparations.
PHENOTHIAZINES - All preparations containing one or more PHENOTHIAZINE ingredients including but not limited to the following:
| Chlorpromazine | Fluphenazine | Pericyazine |
| Perphenazine | Prochlorperazine | Promazine* |
| Promethazine | Thioridazine | Trifluoperazine |
| Trimeprazine |
* other than liquid for injection
PIOGLITAZONE
QUININE
SULPHONYLUREAS - All preparations containing one or more SULPHONYLUREA ingredients including but not limited to the following:
| Glibenclamide | Gliclazide | Glipizide |
| Tolazamide | Tolbutamide |
THEOPHYLLINE
TRICYCLIC, TETRACYCLIC AND OTHER ANTIDEPRESSANTS - All preparations containing one or more TRICYCLIC, TETRACYCLIC AND/OR OTHER ANTIDEPRESSANT ingredients including but not limited to the following:
| Amitriptyline | Clomipramine | Desipramine |
| Dothiepin | Doxepin | Fluoxetine |
| Fluvoxamine | Imipramine | Mianserin |
| Moclobemide | Nefazodone | Nortriptyline |
| Paroxetine | Reboxetine | Sertraline |
| Trimipramine | Venlafaxine |
ZIPRASIDONE
Second Schedule
| Name of Closure | Approved Sizes | For Use With | Known Australian Distributor | Manufacturer | Date of Acceptance in Australia | Standard Complied With |
|---|---|---|---|---|---|---|
| ANCHOR CR | 28 mm | Glass or plastic standard thread containers | Anchor Plastics Pty Ltd 5 Marshall Road KIRRAWEE NSW 2232 (02) 9521 3688 |
Anchor Plastics Pty Ltd | February 1992 | AS 1928-1982 (certified Dec 91) |
| ARGUS-LOC I |
28, 33, & 38 mm 24 mm |
Glass, polyethylene terephthalate (PET) or high density polyethylene (HDPE) containers with Glass Packaging Institute (GPI) or Society of the Plastics Industry (SPI) 400/405 neck finish | ACI Plastics Packaging 4 Kingsway MOORABBIN VIC 3189 (03) 9555 0444 |
Owens-Illinois (USA) |
Original approval pre-1985 July 2002 |
Unknown US16 CFR 1700 for Senior Adult Use Effectiveness |
| ARGUS-LOC TAMPERTEL | 24, 28, & 38 mm with Tampertel T/E1 break band | Glass, PET or HDPE containers with Tampertel neck finish | ACI Plastics Packaging 4 Kingsway MOORABBIN VIC 3189 (03) 9555 0444 |
ACI Plastics Packaging | July 2002 | Approval based on equivalence of CR mechanism to previously approved Argus-Loc |
| BORMIOLI |
28 mm with T/E feature 18, 24, 28 & 35 mm |
Glass PFP finish or plastic BMP finish bottles | Unspecified | Bormioli Rocco E Figlio (Italy) |
November 2000 June 2002 |
US 16CFR 1700 (certified Aug 98) Plus ISO 8317:1989 (certified Mar 2000) |
|
CLIC-LOC II (previously known as Clic-Loc) |
28 & 38 mm 24 mm |
Standard thread glass or plastic containers | ACI Plastics Packaging 4 Kingsway MOORABBIN VIC 3190 (03) 9555 0444 |
ACI Plastics Packaging under licence from Owens-Illinois (USA) |
February 1991 May 1991 |
Approval based on equivalence to US manufactured Clic-Loc II closures and certification of these against US 16CFR 1700 (certified Oct 73 / Dec 74) |
| CLIC-LOC III | 33 mm | Standard thread glass or plastic containers | ACI Plastics Packaging 4 Kingsway MOORABBIN VIC 3190 (03) 9555 0444 |
ACI Plastics Packaging under licence from Owens-Illinois (USA) | Unknown | US 16CFR 1700 (certified Jan 96) |
| CORMACK/ KERR CRIII | Closures within size ranges 16-30 mm & 31-50 mm | Glass or plastic containers with standard Standard Plastic 400 (SP-400) neck finish | Cormack Packaging Pty Ltd 20-26 Harley Crescent CONDELL PARK NSW 2200 (02) 9707 8000 |
Cormack Packaging Pty Ltd under licence from Kerr (USA) | December 1999 | AS 1928-1982 |
| DUMA Twist-Off | 35 35 mm with T/E feature | Duma Twist-Off or Duma Twist-Off Q HDPE containers with standard neck finish | Unspecified | Superfos Pharma Pack (Denmark) | May 2002 | ISO 8317:1989 US 16CFR 1700 for Senior Adult Use Effectiveness (certified Jul 97) |
| EASY LOK | 28 and 38 mm | Alto Plastics Ltd 19 Keeling Road PO Box 21308 Henderson, Auckland New Zealand +64(9)836 0225 |
Alto Plastics Ltd (New Zealand) | July 1983 | Unknown | |
| GAPLAST | 36 mm continuous thread closure | 60K or 30K polypropylene Gaplast round bottles | Unspecified | Gaplast GmbH (Germany) | February 1999 | ISO 8317:1989 (certified Nov 98) plus US 16CFR 1700 for Senior Adult Use Effectiveness (certified Nov 98) |
| KERR CR-1 | 20, 22, 24, 28, 30, 33 & 38 mm | Glass or plastic containers with standard SP-400 neck finish | Cormack Packaging 20-26 Harley Crescent CONDELL PARK NSW 2200 (02) 9707 8000 |
Cormack Packaging | Pre-1980 | Unspecified |
| KERR TE CR-1 | 20, 24, 28, 33 & 38 mm | with T/E feature Glass or plastic containers with standard SP-400 neck finish | Cormack Packaging 20-26 Harley Crescent CONDELL PARK NSW 2200 (02) 9707 8000 |
Kerr Group (USA) | October 1993 | Approval based on equivalence to Kerr CR-1 (non-TE range) |
| PP28 CLIC-LOC | 28 mm with T/E feature |
Glass containers with standard PP28 neck finish, or plastic containers with equivalent neck finish. | Unspecified | United Closures & Plastics Plc (UCP) (England) | September 2001 | ISO 8317:1989 (certified May 96) |
| REXAM Series FG |
33 mm 38 mm |
For use with HDPE bottles with 33-400 or 38-400 neck finishes | Unspecified | Rexam PLC (USA) |
July 2001 October 2000 |
US 16CFR 1700 full protocol (certified May 2001) US 16CFR 1700 for Senior Adult Use Effectiveness |
| SAF-CAP I Dropper Closure | 24 mm | For use with HDPE bottles | Cormack Packaging 20-26 Harley Crescent CONDELL PARK NSW 2200 (02) 9707 8000 |
Van Blarcom Cosures Inc. (USA) | July 1992 | US 16CFR 1700 (certified Aug 91) plus US 16CFR 1700 for Senior Adult Use Effectiveness (certified Sep 97) |
| SAF-CAP III | 24, 28, 33, 38 & 45 mm | For use with glass or plastic bottles with standard continuous thread | Unspecified | Van Blarcom Closures (USA) | July 1997 | US 16CFR 1700 (certified Jan 96) plus Senior Adult Use Effectiveness (certified Feb 96) |
| SAFE VISTOP | 28 mm with T/E feature and Clic-Loc Technology | Glass bottles with standard neck finish PP28S (28 mm o/d thread diameter with Pilfer Proof ring) | Vidchem Pty Ltd 1a/307 Wattletree Road MALVERN VIC 3144 (03) 9500 0005 |
Astra Plastique (France) | May 2000 | ISO 8317:1989 (certified Aug 99) |
| SECRO |
- Secro 92 (18 mm) dropper closure with T/E feature - Secro PP24 (24 mm) with T/E feature - Secro PP28 (28 mm) with T/E feature |
For use with glass or plastic [PET, polypropylene (PP), HDPE] containers with Secro 92, Secro PP24 or Secro PP28 neck finishes | Cormack Packaging Pty Ltd 20-26 Harley Crescent CONDELL PARK NSW 2200 (02) 9707 8000 |
Stella Kunststofftechnik GmbH (Germany) | December 2000 | ISO 8317:1989 (certified Mar 94 / Aug 95) |
| SUNBEAM FG | 28 mm | HDPE containers | Alto Plastics Ltd 19 Keeling Road PO Box 21308 Henderson, Auckland New Zealand +64(9)836 0225 |
Alto Plastics Ltd (New Zealand) | July 1984 | US 16CFR 1700 |
| TAMPERDISC | 24, 28, 33 & 38 mm with T/E feature | Glass or plastic (PET, PP, HDPE) bottles utilising British Standards Institute (BSI) standard thread | Williamson Plastics Pty Ltd 99 Rookwood Road YAGOONA NSW 2199 (02) 9790 4026 |
Williamson Manufacturing Pty Ltd | August 1996 | Approval based on equivalence to Willsafe closure. |
| WILLIAMSON 2000 SERIES |
20, 24 & 28 mm 20 and 24 mm dropper closure |
Glass or plastic (PET, PP, HDPE) bottles utilising BSI standard thread | Williamson Plastics Pty Ltd 99 Rookwood Road YAGOONA NSW 2199 (02) 9790 4026 |
Williamson Manufacturing Pty Ltd | February 2001 | AS 1928 - 1982 (certified Dec 2000) |
| WILLSAFE |
24, 33 & 38 mm 28 mm 20 mm |
Glass or plastic (PET, PP, HDPE) bottles utilising BSI standard thread | Williamson Plastics Pty Ltd 99 Rookwood Road YAGOONA NSW 2199 (02) 9790 4026 |
Williamson Manufacturing Pty Ltd |
February 1988 April 1989 November 1993 |
AS 1928 - 1982 (certified Mar 89) |
1Tamper-evident
Supplementary notes
Child-resistant packaging for therapeutic goods
The following Supplementary Notes are intended to explain various parts of the Order and do not form part of the Order. Unless otherwise indicated, these notes apply to both reclosable and non-reclosable forms of child-resistant packaging.
GENERAL
A Scope of the Order
The requirements of this Order apply to therapeutic goods that come within the operation of the Therapeutic Goods Act 1989 (the Act).
As a standard determined in accordance with section 10 of the Act, the scope of this Order is limited to medicines, and other therapeutic goods that are not classified as medical devices. Hospital, household and commercial disinfectants regulated as therapeutic goods fall within this latter category.
This Order broadens the scope of application of standards for child-resistant packaging from only medicines containing certain specified substances, as given in Therapeutic Goods Orders No. 20 Child Resistant Containers (TGO 20) and No. 33 Amendment of Schedules to Therapeutic Goods Order No. 20 Child Resistant Containers (TGO 33). The scope now covers medicines and other therapeutic goods containing any of the substances specified in the First Schedule to the Order, as well as other therapeutic goods which imply, through their presentation, that the packaging is child-resistant.
This means that whilst the use of child-resistant packaging is not mandatory unless the goods contains a substance specified in the First Schedule, if the goods are presented in a way that could reasonably cause consumers to believe the packaging is child-resistant, then the provisions of this Order relating to performance standards (paragraphs 3 and 4) apply. Presentations considered to imply packaging is child-resistant include closures with the push-down and turn graphics typically used on child-resistant caps and label statements referring to the closure as being child-safe or preventing access by children.
B Provision for exemption for specific goods
The Act requires therapeutic goods to comply with standards, including standards for labelling and packaging, which are determined in accordance with section 10 of the Act. However the Act provides a mechanism for seeking an exemption for individual goods from compliance with standards.
Where exemption from any aspect of this Order is sought, the Sponsor should apply in writing to the Therapeutic Goods Administration (TGA) for a formal exemption stating precisely the particular requirement against which the exemption is sought, and providing justification for the exemption.
As the requirements of this Order are intended to contribute to reducing the incidence of accidental poisoning in children, Sponsors should be aware that exemptions would only be considered where it can be established that the exemption sought will not compromise safety, or exceptional circumstances otherwise exist.
C General exemptions
Certain classes of therapeutic goods are exempt from compliance with the child-resistant packaging requirements specified in this Order and are referred to in paragraph 1 of this Order.
In general, these classes of goods are those for which the risk of accidental ingestion by children is reduced, for example by the particular presentation [see subparagraphs 1(1)(a)(ii), (iii), (iv) and (v)], or where availability to children is minimal, for example, goods not at their final stage of manufacture, or goods only for use in a public hospital, private hospital or nursing home. Subparagraph 1(1)(a)(x) also exempts goods that are solely for export.
Subparagraph1(1)(a)(vi) of this Order exempts goods that fall within the description of Item 9(a) of Schedule 5 to the Regulations from the requirements of this Order. These goods are medicines used as starting materials used in the manufacture of therapeutic goods except when pre-packaged for supply for other therapeutic purposes or formulated as a dosage form. This means that active ingredients and excipients intended for use in the manufacture of medicines or other therapeutic goods are exempt. However, if the same ingredients are prepackaged ready for sale they are not exempt. For example, an ingredient such as eucalyptus oil can be used in manufacture of medicines, in which case it is exempt from these requirements; alternatively it can be pre-packaged for sale to the public, in which case it is not exempt. Similarly bulk finished tablets which are still to be packaged for supply are exempt from the requirements in this Order as they have not reached their final stage of manufacture [see subparagraph 1(1)(a)(vii)]. However, large pack sizes are only exempt if these packs are not for retail supply [subparagraph 1(1)(a)(i)].
The general exemptions also recognise that certain patients may be disadvantaged through the supply of medications in child-resistant packaging, which the patient may experience difficulty in opening. To remedy this, healthcare professionals authorised under relevant State or Territory legislation to supply or prescribe may determine in individual cases that the supply of goods in child-resistant packaging complying with this Order is not appropriate.
D Interpretation
Throughout this Order, the term 'child-resistant packaging' has been used in preference to the term 'child-resistant containers' used in the superseded Therapeutic Goods Orders, TGOs 20 and 33. This changed terminology reflects that currently used in the Standards listed in paragraph 4(1)(a), and recognises that child-resistance is associated with a package as a whole rather than any individual component of the package such as a closure or a bottle. Testing protocols for child-resistance necessarily involve a complete package, and it is the complete package to which any certification relates.
The definition of 'child-resistant packaging' includes the term 'young children' and this should be taken to mean children within the age groups specified in the protocols given in the Standards referred to in paragraph 4(1)(a) for the testing of child-resistance. This age group is most commonly specified as 42 to 51 months of age.
While packaging that complies with the requirements of any of the Standards can be expected to be difficult for children of other ages to open, the ability of children outside the given age range to open the package is not tested and thus cannot be assumed.
It should be noted also that 'child-resistant' is not synonymous with 'child-proof' and that compliance of a package with any of the Standards does not mean that all children included in the test group were unable to open the package or gain access to its contents.
E General requirements
Clause 3 of this Order specifies a number of general requirements for child-resistant packaging. Where relevant, these requirements apply to both reclosable and non-reclosable forms and are consistent with the requirements specified in Section 1 (Scope and General Requirements) of the Australian Standard AS 1928-2001 Child-resistant packages. These requirements are specified in this Order to ensure their applicability to child-resistant packaging complying with any of the other Standards.
In this Order, fitness for purpose extends to include consideration of the child-resistant properties of the package rather than being limited to the more general concept of suitability of the package, including its material of construction, for use with therapeutic goods.
The Order makes a distinction between the shelf-life of the goods and their in-use life. Shelf-life relates to the expiry dating of the goods and, as for any packaging used for therapeutic goods, child-resistant packaging must retain its integrity and functionality for the duration of this period. In-use life refers to the number of times the container will be opened, or doses removed, in order to completely use the contents of the container. The particular child-resistant package chosen for use must be able to withstand this number of openings and closings (if a reclosable container) or removal of all individual doses (if a non-reclosable container) without any deterioration in the child-resistant characteristics or performance.
The requirement that performance of the child-resistant feature not be adversely affected by the contents of the package is most relevant to reclosable packages and is based on the established incompatibility of some plastics with particular hydrocarbon solvents, and evidence that this incompatibility can cause failure of a child-resistant closure.
RECLOSABLE PACKAGES
F Standards for reclosable packages
Clause 4 of this Order defines the required standards for reclosable child-resistant packaging. These requirements are based on the alternatives of:
- compliance with any of five national or international Standards for reclosable child-resistant packaging, and
- continued recognition of prior approvals of closures or container/closure systems.
Inclusion of a range of international Standards is intended to facilitate the use of packaging originating overseas, and to minimise the need for exposure of child panels to testing requirements. Notwithstanding slight differences among the five Standards, compliance with any of these Standards is considered to provide sufficient assurance that a package is of an acceptable standard. There is no order of precedence for the Standards, and if compliance is established against an overseas Standard, testing in accordance with the applicable Australian Standard is not required.
The responsibility for compliance with child-resistant packaging requirements rests with the Sponsors of therapeutic goods to which this Order applies. Nevertheless it is in the interests of suppliers and manufacturers of reclosable packaging claimed to be child-resistant to ensure that their packaging has been certified as complying with one of the Standards and that it therefore can be recognised by the TGA as complying with that Standard.
If reclosable packaging is used for a therapeutic good to which this Order applies, the alternative to use of packaging complying with one of the Standards is the use of a packaging system described in the Second Schedule to this Order. This is largely a 'grandfather' provision to allow the continued use of current packaging on existing goods, with the Second Schedule listing those closures and container/closure systems approved for use prior to the commencement of this Order. While no provisions for phasing out these forms of packaging have been included, it is expected that for new goods being introduced to the market, Sponsors will preferentially select packaging that is compliant with one or more of the current Standards specified under paragraph 4(1)(a).
G Evidence of compliance with Standards
Where a Sponsor chooses to use a reclosable child-resistant package that complies with any of the Standards, the Sponsor is required to hold, and be able to submit upon request, documentation establishing this. Depending on the level of assessment of the goods, these data may or may not routinely be requested by TGA during the evaluation processes.
In most cases the required documentation will consist of authorised copies of certifications or test certificates from a recognised overseas testing authority2 that is accredited to conduct testing and certification of child-resistant packaging, with sufficient information to establish that the package intended for use is the package tested. On occasions, particularly for packaging manufactured in Australia, Sponsors may hold actual test data establishing compliance. This is acceptable but, as with certifications, it should be clearly demonstrable that the data do apply to the package intended for use.
Many of the Standards permit extrapolation of test results over a range of similar packages, for example over a range of closure or container sizes provided all other characteristics of the package remain the same. As an example, Australian Standard AS 1928-2001 groups closures sizes into the ranges of less than 18 mm in diameter, 18-38 mm in diameter and greater than 38 mm in diameter and allows extrapolation of results to cover the range. Extrapolation of results from one package to another as permitted by the Standards is acceptable for the purposes of compliance with this Order.
In circumstances where a particular package has been certified against a superseded version of one of the Standards, the performance of supplementary testing rather than a full test protocol may be sufficient to establish that the package complies with current requirements.
2 Examples of recognised overseas testing authorities accredited to conduct testing and certification of child-resistant packaging include the British Standards Institute (BSI) Supervisory Committee for Child Resistant Containers, Burford Research Consultants (UK), Perritt Laboratories (USA), Great Lakes Marketing (Toledo, USA), and Laboratoire National D'Essais (France)
H Other evidence
For reclosable packages, subclause 4(3) requires that Sponsors hold evidence to demonstrate that the general requirements of fitness for purpose, retention of child-resistant properties, and lack of adverse effect of the contents on the child-resistant properties, are met.
This requirement applies to both new and existing packaging and may necessitate Sponsors of therapeutic goods being pro-active in obtaining or generating such evidence. While it is not the intention of this requirement to necessitate further child panel testing, an absence of reported failures of the child-resistant feature is not adequate. Considerable information on compatibility is likely to be available from packaging manufacturers, and Sponsors should be able to establish a simple test protocol specific to each combination of content/package. This may involve a combination of pack opening and closing at intervals over the expected shelf-life of the goods, plus confirmation of continuing compliance of component deliveries to quality control specifications in line with normal GMP requirements.
As changes in specification (including changes in materials or method of manufacture) for any component of the package may affect performance, subclause 4(4) requires Sponsors to hold evidence that any such changes do not compromise child-resistance.
Subclause 4(5) specifies the additional evidence Sponsors should obtain to ensure that the expected child-resistant performance of the selected package is achieved and maintained during the packaging processes. The application of this information should be reflected in routine quality control testing. It should be noted that the requirement of paragraph 4(5)(a) for Sponsors to hold information on the types and sizes of container to which a specified closure may be applied relates only to those containers of immediate relevance to the Sponsor's range of goods, and not all possible combinations of packaging components.
I Directions for opening and closing
As failures of reclosable child-resistant packaging can result from closures not being adequately tightened or re-fastened, subclause 4(6) requires that any reclosable child-resistant package include on it adequate directions for both opening and closing. These instructions may appear in the form of words or graphics on the package itself, or be conspicuously placed elsewhere on the label. Any written instructions must appear in the English language, but the inclusion of additional languages is not precluded.
J Dropper applicators
Subclause 4(8) relates to goods that are supplied with a separate dropper or applicator that may be left in place on the container, in place of the original closure, once the good are in-use. Goods commonly presented in this way include minoxidil lotions and paracetamol infant drops.
This requirement has been introduced to ensure that the convenience of leaving a dropper or applicator in the container of goods warranting child-resistant packaging does not compromise child-safety throughout the in-use life of the goods.
NON-RECLOSABLE PACKAGES
K Requirements for non-reclosable packages
Clause 5 relates to non-reclosable packaging, which is packaging that once opened, is not capable of being reclosed to its original form. Non-reclosable packaging meeting the criteria given in subclauses 5(1) and 5(2), including blister and strip packaging as defined under 'Interpretation', are acceptable forms of child-resistant packaging for the purposes of this Order. The requirements for non-reclosable packages are as previously given in TGO 20.
THE SCHEDULES
L THE FIRST SCHEDULE
Goods containing any of the substances listed in the First Schedule to this Order, or salts, esters or other derivatives of these substances, must have child-resistant packaging unless a general exemption exists under paragraph 1(1)(a).
Substances are included in the First Schedule primarily on the basis of their toxicity and likelihood of adverse consequences if accidentally ingested in overdose by a child. Other factors taken into account include actual reports of accidental poisoning involving those substances, and availability and use of the substance in the community.
The First Schedule categorises a number of substances by therapeutic group. In such cases, this Order applies to all substances in the named therapeutic group, irrespective of whether the particular substance is mentioned individually or not. As a consequence, if a new substance is marketed that falls into any of the therapeutic groups listed, then goods containing that substance will be required to have child-resistant packaging unless a general exemption exists under paragraph 1(1)(a) for the particular dosage form or a specific exemption is granted under section 14 of the Act for the goods.
It should be expected that the First Schedule will be subject to regular review and amendment from time to time as new information becomes available, or new substances receive marketing authorisation.
M THE SECOND SCHEDULE
As outlined under section F above, the Second Schedule provides for the ongoing use of reclosable closures and container/closure systems that were accepted under previous Therapeutic Goods Orders as being of an acceptable child-resistant standard at the time. The packaging listed in the Second Schedule would not necessarily comply with current Standards for child-resistance and/or senior friendliness.
To assist Sponsors in making packaging choices, the details of each closure or container/closure system included in the Second Schedule have been expanded to include, wherever possible, reference to the original date of approval and the Standard to which the packaging complied.
It is anticipated that the number of these closures and container/closure systems remaining in the marketplace will diminish with time through natural attrition, and supersession by newer versions compliant with current Standards.
The Second Schedule does not include details of all child-resistant packaging meeting the requirements of this Order, as it intentionally omits that packaging established as complying with one or more of the Standards specified under paragraph 4(1)(a). For the convenience of Sponsors however, a reference list of such packaging will be maintained by the TGA.