This consultation closed on 21 January 2019.
On this page: Scheduling amendments referred to expert advisory committee | 1. Proposed amendments referred for scheduling advice to ACMS #26 | 2. Proposed amendments referred for scheduling advice to ACCS #24 | 3. Proposed amendments referred for scheduling advice to the Joint ACMS-ACCS #21 | How to respond | What will happen next | Privacy and your personal information | Enquiries
Scheduling amendments referred to expert advisory committee
Subdivision 3D.2 of the Therapeutic Goods Regulations 1990 (the Regulations) sets out the procedure to be followed where the Secretary receives an application under section 52EAA of the Therapeutic Goods Act 1989 (the Act) to amend the current Poisons Standard and decides to refer the proposed amendment to an expert advisory committee. These include, under regulation 42ZCZK, that the Secretary publish (in a manner the Secretary considers appropriate) the proposed amendment to be referred to an expert advisory committee, the committee to which the proposed amendment will be referred, and the date of the committee meeting. The Secretary must also invite public submissions to be made to the expert advisory committee by a date mentioned in the notice as the closing date, allowing at least 20 business days after publication of the notice.
In accordance with regulation 42ZCZK of the Regulations, the Secretary invites public submissions on scheduling proposals referred to the March 2019 meetings of the Advisory Committee on Medicines Scheduling (ACMS #26), the Advisory Committee on Chemicals Scheduling (ACCS #24), and the Joint Advisory Committee on Medicines and Chemicals Scheduling (Joint ACMS-ACCS #21).
Submissions must be received by close of business 21 January 2019. See How to respond.
1. Proposed amendments referred for scheduling advice to ACMS #26
In this section: 1.1 Paracetamol (modified release) | 1.2 Glyceryl trinitrate | 1.3 Isosorbide dinitrate | 1.4 Cetirizine hydrochloride | 1.5 Mometasone furoate
1.1 Paracetamol (modified release)
An invitation to comment on a delegate-initiated proposal to amend the scheduling of modified release paracetamol was published on the TGA website on 30 August 2018. This consultation closed on 31 October 2018.
1.2 Glyceryl trinitrate
1.2 Glyceryl trinitrate
CAS Number:
55-63-0
Alternative names
1,3-dinitrooxypropan-2-yl nitrate (IUPAC), nitroglycerin
Applicant
Delegate-initiated
Current scheduling
Glyceryl trinitrate is currently in Schedules 3 and 4 and Appendix G of the Poisons Standard as follows:
Schedule 3
GLYCERYL TRINITRATE:
- in preparations for oral use; or
- in preparations for rectal use.
Schedule 4
GLYCERYL TRINITRATE except when included in Schedule 3.
Appendix G
GLYCERYL TRINITRATE: 100 micrograms (Concentration (quantity per litre or kilogram))
Index
GLYCERYL TRINITRATE
Schedule 4
Schedule 3
Appendix G
Proposed scheduling
It is proposed to include glyceryl trinitrate in Appendix H of the Poisons Standard as follows:
Appendix H - New Entry
GLYCERYL TRINITRATE
Index - Amend Entry
GLYCERYL TRINITRATE
Schedule 4
Schedule 3
Appendix G
Appendix H
Key uses / expected use
Medicines
Reasons for proposal
As part of the review of the Scheduling Policy Framework (SPF) it was agreed that advertising of medicines containing Schedule 3 substances should be permitted unless there was reason not to. In order for these medicines to be lawfully advertised, they need to be included in Appendix H of the Poisons Standard.
A number of proposed inclusions to Appendix H were developed following consideration of submissions in response to the public consultation conducted from 4 June 2018 to 9 July 2018 and feedback from stakeholder workshops. The TGA sought comments from interested parties on the proposed Schedule 3 substances to be added to Appendix H of the Poisons Standard to allow them to be advertised direct to consumers. A group of stakeholders representing consumers, industry and healthcare professionals (the working group) were invited to comment on the Schedule 3 substances proposed for inclusion in Appendix H.
Based on consultation responses, the delegate of the Secretary of the Department of Health has decided to refer glyceryl trinitrate to the ACMS for further advice before making a decision.
1.3 Isosorbide dinitrate
1.3 Isosorbide dinitrate
CAS Number:
87-33-2
Alternative names
[(3S,3aS,6R,6aS)-3-nitrooxy-2,3,3a,5,6,6a-hexahydrofuro[3,2-b]furan-6-yl] nitrate (IUPAC)
Applicant
Delegate-initiated
Current scheduling
Isosorbide dinitrate is currently listed in Schedules 3 and 4 of the Poisons Standard as follows:
Schedule 3
ISOSORBIDE DINITRATE in oral preparations containing 10 mg or less of isosorbide dinitrate per dosage unit.
Schedule 4
ISOSORBIDE DINITRATE except when included in Schedule 3.
Index
Schedule 4
Schedule 3
Proposed scheduling
It is proposed to include isosorbide dinitrate in Appendix H of the Poisons Standard as follows:
Appendix H - New Entry
ISOSORBIDE DINITRATE
Index - Amend Entry
Schedule 4
Schedule 3
Appendix H
Key uses / expected use
Medicines
Reasons for proposal
As part of the review of the Scheduling Policy Framework (SPF), it was agreed that advertising of medicines containing Schedule 3 substances should be permitted unless there was reason not to. In order for these medicines to be lawfully advertised, they need to be included in Appendix H of the Poisons Standard.
A number of proposed inclusions to Appendix H were developed following consideration of submissions in response to the public consultation conducted from 4 June 2018 to 9 July 2018 and feedback from stakeholder workshops. The TGA sought comments from interested parties on the proposed Schedule 3 substances to be added to Appendix H of the Poisons Standard to allow them to be advertised direct to consumers. A group of stakeholders representing consumers, industry and healthcare professionals (the working group) were invited to comment on the Schedule 3 substances proposed for inclusion in Appendix H.
Based on consultation responses, the delegate of the Secretary of the Department of Health has decided to refer isosorbide dinitrate to the ACMS for further advice before making a decision.
1.4 Cetirizine hydrochloride
1.4 Cetirizine hydrochloride
CAS Number:
83881-52-1
Alternative names
IUPAC: 2-[2-[4-[(4-chlorophenyl)-phenylmethyl]piperazin-1-yl]ethoxy]acetic acid;hydrochloride
Applicant
Private Applicant
Current scheduling
Cetirizine is currently in Schedules 2 and 4 and Appendix K of the Poisons Standard as follows:
Schedule 2
CETIRIZINE in preparations for oral use except in divided preparations for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:
- in a primary pack containing not more than 10 days' supply; and
- labelled with a recommended daily dose not exceeding 10 mg of cetirizine.
Schedule 4
CETIRIZINE except
- when included in Schedule 2; or
- in divided preparations for oral use for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:
- in a primary pack containing not more than 10 days' supply; and
- labelled with a recommended daily dose not exceeding 10 mg of cetirizine.
Appendix K
CETIRIZINE
Index
CETIRIZINE
Schedule 4
Schedule 2
Appendix K
Proposed scheduling
It was proposed to amend the Poisons Standard as follows:
Schedule 2 - Amend Entry
CETIRIZINE in preparations for oral use except in divided preparations for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:
- in a primary pack containing not more than
120 days' supply; and - labelled with a recommended daily dose not exceeding 10 mg of cetirizine.
Schedule 4 - Amend Entry
CETIRIZINE except
- when included in Schedule 2; or
- in divided preparations for oral use for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:
- in a primary pack containing not more than
120 days' supply; and - labelled with a recommended daily dose not exceeding 10 mg of cetirizine.
- in a primary pack containing not more than
Key uses / expected use
Medicine for the treatment of hay fever and allergy symptoms.
Reasons for proposal
The risks associated with the proposed unscheduled 20 days' supply pack of cetirizine are no different to that of the smaller pack sizes and multiple buys of smaller sizes.
The benefits are consumer focused and concern convenience, utility and affordability especially for those Australians that have reduced access to pharmacy for work or geographical reasons.
Closing the alignment gap between Australia and other like major markets is a logical step given the proven safety profile of cetirizine in general sale, similarity of these markets to Australia and increasing globalisation.
International restrictions
The US, Canada, Norway, Sweden and Denmark permit the general sale of cetirizine in pack sizes that are at least 3 times larger than that currently permitted in Australia.
US and Canada have no pack size limit on cetirizine in general sale.
The UK and some Scandinavian countries allow general sale access to pack sizes of 30 and in the case of Denmark up to 100-day supply packs. The indications in these countries are also broader than those allowed in general sale in Australia.
1.5 Mometasone furoate
1.5 Mometasone furoate
CAS Number:
83919-23-7
Alternative names
IUPAC: ([(8S,9R,10S,11S,13S,14S,16R,17R)-9-chloro-17-(2-chloroacetyl)-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] furan-2-carboxylate)
Applicant
Private Applicant
Current scheduling
Mometasone is currently in Schedules 2 and 4 of the Poisons Standard as follows:
Schedule 2
MOMETASONE in aqueous nasal sprays delivering 50 micrograms or less of mometasone per actuation when the maximum recommended daily dose is no greater than 200 micrograms for the prophylaxis or treatment of allergic rhinitis for up to six months in adults and children 12 years of age and over.
Schedule 4
MOMETASONE except when included in Schedule 2.
Index
MOMETASONE
Schedule 2
Schedule 4
Proposed scheduling
It has been proposed to amend the Poisons Standard as follows:
Schedule 2 - Amended entry
MOMETASONE in aqueous nasal sprays delivering 50 micrograms or less of mometasone per actuation when the maximum recommended daily dose is no greater than 200 micrograms for the and when packed in a primary pack containing 200 actuations or less, for the short term prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years and over.
Schedule 3 - Proposed New Entry
MOMETASONE as the only therapeutically active substance in preparations for dermal use containing 0.1 percent or less of MOMETASONE in packs containing 15g or less.
Schedule 4 - Amended Entry
MOMETASONE except when included in Schedule 2 or 3.
APPENDIX H - New Entry
MOMETASONE
APPENDIX M - New Entry
MOMETASONE
Index - Amend Entry
MOMETASONE
Schedule 2
Schedule 3
Schedule 4
Appendix H
Appendix M
Key uses / expected use
- Anti-allergic and anti-inflammatory medicine
Reasons for proposal
- The applicant believes that mometasone furoate fits the profile of a Schedule 3 over the counter (OTC) product that will not cause complications or untoward clinical problems when used according to the labelling and with pharmacist advice.
- The superior efficacy and comparable side effect profile of mometasone furoate to other OTC topical corticosteroids, such as hydrocortisone and clobetasone, supports the suitability of mometasone as a Schedule 3 medicine.
- The switching of mometasone 0.1% to Schedule 3 is expected to result in considerable cost savings to the government and the consumer through awareness and access to an effective topical corticosteroid with an acceptable risk-benefit profile. It also provides the consumer with an alternative choice of topical corticosteroid for the relief of inflamed and itchy skin due to psoriasis, dermatitis and eczema, particularly in the flare-up situation.
International restrictions
- Internationally, mometasone has been marketed in the USA, Canada, UK and Europe since 1987 and in New Zealand since the mid-1980s.
- The applicant is not aware of any regulatory action taken by any regulatory body to amend or restrict the use of topical mometasone furoate.
2. Proposed amendments referred for scheduling advice to ACCS #24
2.1 N-methyl-2-pyrrolidone
2.1 N-methyl-2-pyrrolidone
CAS Number:
872-50-4
Alternative names
Methyl Pyrrolidone (INCI); 1-methyl-2-pyrrolidone (IUPAC)
Applicant
The National Industrial Chemicals Notification and Assessment Scheme (NICNAS)
Current scheduling
N-methyl-2-pyrrolidone is currently in Part 1, Schedules 5 and 6 and Appendix E, Part 3 of the Poisons Standard as follows:
Part 1 - Interpretation
"Designated solvent" means the following:
N-methyl-2-pyrrolidone.
Schedule 5
N-(N-DODECYL)-2-PYRROLIDONE in preparations containing 50 per cent or less of N-(N-dodecyl)-2-pyrrolidone or preparations containing 50 per cent or less of a mixture of any two or more of N-(N-dodecyl)-2-pyrrolidone, N-methyl-2-pyrrolidone or N-(N-octyl)-2-pyrrolidone except in preparations containing 25 per cent or less of designated solvents.
N-METHYL-2-PYRROLIDONE:
- when packed in single use containers having a capacity of 2 mL or less; or
- in preparations containing 50 per cent or less of N-methyl-2-pyrrolidone or preparations containing 50 per cent or less of a mixture of any two or more of N-methyl-2-pyrrolidone, N-(N-octyl)-2-pyrrolidone or N-(N-dodecyl)-2-pyrrolidone except in preparations containing 25 per cent or less of designated solvents.
N-(N-OCTYL)-2-PYRROLIDONE in preparations containing 50 per cent or less of:
- N-(N-octyl)-2-pyrrolidone or preparations containing 50 per cent or less of a mixture of any two or more of N-(N-octyl)-2-pyrrolidone, N-methyl-2-pyrrolidone or
- N-(N-dodecyl)-2-pyrrolidone except in preparations containing 25 per cent or less of designated solvents.
Schedule 6
N-METHYL-2-PYRROLIDONE except:
- when in Schedule 5; or
- in preparations containing 25 per cent or less of designated solvents.
Appendix E, Part 2
Standard statements:
When in Schedule 5:
- For advice, contact a Poisons Information Centre (e.g. phone Australia 13 11 26; New Zealand 0800 764 766) or a doctor (at once).
G3- If swallowed, do NOT induce vomiting.
E1- If in eyes wash out immediately with water.
When in Schedule 6:
- A - For advice, contact a Poisons Information Centre (e.g. phone Australia 13 11 26; New Zealand 0800 764 766) or a doctor (at once).
G3- If swallowed, do NOT induce vomiting.
E2- If in eyes, hold eyelids apart and flush the eye continuously with running water. Continue flushing until advised to stop by a Poisons Information Centre (e.g. phone Australia 13 11 26; New Zealand 0800 764 766) or a doctor, for at least 15 minutes.
Index
N-(N-DODECYL)-2-PYRROLIDONE
cross reference: DESIGNATED SOLVENT, N-(N-OCTYL)-2-PYRROLIDONE, N-METHYL-2-PYRROLIDONE
N-METHYL-2-PYRROLIDONE
Schedule 5
Schedule 6
Appendix E, Part 2
Proposed scheduling
It was proposed to amend the Schedule 6 Poisons Standard entry for N-methyl-2-pyrrolidone as follows:
Schedule 6 - Amended Entry
N-METHYL-2-PYRROLIDONE except:
- when included in Schedule 5; or
- in cosmetic preparations containing less than 2 per cent of the chemical; or
- in preparations not for cosmetic use containing 25 per cent or less of designated solvents.
Key uses / expected use
Cosmetic and domestic
Reasons for proposal
- The chemical has reported uses in cosmetic products available in Australia including mascara, skin moisturiser, hair colour stain removal solution and nail products.
- The chemical has been identified as a developmental toxin and is classified for reproductive toxicity - category 1B with hazard statement H360D (May damage the unborn child).
- The chemical is expected to be readily absorbed through the skin.
- Data from a quantitative risk assessment indicate that cosmetic uses at concentrations above 2 % may pose an unreasonable risk to the public.
- The chemical is prohibited in cosmetic products in the European Union under Article 15(2) of the Cosmetics Regulation 1223/2009.
- The chemical is listed REACH Annex XVII which restricts the use restrict the use of NMP in consumer applications to <0.3 % in the European Union.
- The Scientific Committee on Consumer Products (SCCP) is of the opinion that the presence of NMP with a maximum use concentration of 5% in cosmetic products is not safe for the consumer.
2.2 Polymer in Durazane 1500
2.2 Polymer in Durazane 1500
CAS Number:
475645-84-2
CAS name
Cyclosilazanes, di-Me, Me hydrogen, polymers with di-Me, Me hydrogen silazanes, reaction products with 3-(triethoxysilyl)-1-propanamine
Applicant
The National Industrial Chemicals Notification and Assessment Scheme (NICNAS)
Current scheduling
Polymer in Durazane 15000 is not currently scheduled
Proposed scheduling
It was proposed to amend the Poisons Standard as follows:
Schedule 6 - New Entry
POLYMER IN DURAZANE 1500 for use in coating wipes.
Appendix E, Part 2 - New Entry
POLYMER IN DURAZANE 1500
Standard statements: A (For advice, contact a Poisons Information Centre (e.g. phone Australia 13 11 26; New Zealand 0800 764 766) or a doctor (at once); E1 (If in eyes wash out immediately with water).
Appendix F, Part 3 - New Entry
POLYMER IN DURAZANE 1500
Warning Statements: 2 (Corrosive); 10 (May produce severe burns).
Safety directions: 1 (Avoid contact with eyes); 4 (Avoid contact with skin).
Index - New Entry
POLYMER IN DURAZANE 1500
Schedule 6
Appendix E, Part 2
Appendix F, Part 3
Key uses / expected use
Domestic - coating wipes containing the polymer up to 50% will be available to the general public to use on various substrates such as plastic, metal, stone, rubber, automotive trim, leather, vinyl and tyres. Wipes will be supplied in sealed pouches with up to 8 pouches in each packet with a pair of nitrile gloves. Each pouch contains 3 - 6 g of the polymer (10 mL).
Reasons for proposal
- Available for domestic use, therefore appropriate labelling is required to avoid corrosion / irritation risks to the public (including children).
- Durazane 1500 containing the polymer > 60% is corrosive to skin (GHS Cat 1B) and has moderate to high acute oral toxicity (LD50 between 200 - 2000 mg/kg bw in rats).
- Polymer in Durazane 1500 (> 60% polymer) has an LD50 value of between 200 - 2000 mg/kg bw in rats and warrants GHS classification 'Toxic if swallowed' (acute oral toxicity Category 3).
3. Proposed amendments referred for scheduling advice to the Joint ACMS-ACCS #21
3.1 Paracetamol
3.1 Paracetamol
CAS Number:
103-90-2
Alternative names
IUPAC: N-(4-hydroxyphenyl)acetamide; CAS: Acetaminophen; Other names: 4-Acetamidophenol, 4-acetaminophenol, 4-(acetylamino)-phenol, 4-(N-acetylamino)phenol, 4-hydroxyacetanilide, 4′-hydroxyacetanilide
Applicant
Australian Pesticides and Veterinary Medicines Authority (APVMA)
Current scheduling
Paracetamol is currently in Schedules 2, 3 and 4 and Appendix F, Part 3 of the Poisons Standard as follows:
Schedule 2
PARACETAMOL for therapeutic use:
- when combined with ibuprofen in preparations for oral use when labelled with a recommended daily dose of 1200 mg or less of ibuprofen in divided doses in a primary pack containing no more than 12 dosage units per pack; or
- in tablets or capsules enclosed in a primary pack containing not more than 100 tablets or capsules; or
- in tablets or capsules enclosed in a primary pack containing more than 100 tablets or capsules intended only as a bulk medicine pack and labelled 'For dispensing only' and 'This pack is not to be supplied to a patient'; or
- in individually wrapped powders or sachets of granules enclosed in a primary pack containing not more than 50 wrapped powders or sachets of granules; or
- in individually wrapped powders or sachets of granules enclosed in a primary pack containing more than 50 wrapped powders or sachets of granules intended only as a bulk medicine pack and labelled 'For dispensing only' and 'This pack is not to be supplied to a patient'; or
- in other preparations except:
- when included in Schedule 3 or 4; or
- in individually wrapped powders or sachets of granules each containing 1000 mg or less of paracetamol as the only therapeutically active constituent (other than caffeine, phenylephrine and/or guaifenesin or when combined with effervescent agents) when:
- enclosed in a primary pack that contains not more than 10 such powders or sachets of granules,
- compliant with the requirements of the Required Advisory Statements for Medicine Labels,
- not labelled for the treatment of children 6 years of age or less, and
- not labelled for the treatment of children under 12 years of age when combined with caffeine, phenylephrine and/or guaifenesin; or
- in tablets or capsules each containing 500 mg or less of paracetamol as the only therapeutically active constituent (other than caffeine, phenylephrine and/or guaifenesin or when combined with effervescent agents) when:
- packed in blister or strip packaging or in a container with a child-resistant closure,
- in a primary pack containing not more than 20 tablets or capsules,
- compliant with the requirements of the Required Advisory Statements for Medicine Labels,
- not labelled for the treatment of children 6 years of age or less, and
not labelled for the treatment of children under 12 years of age when combined with caffeine, phenylephrine and/or guaifenesin.
Schedule 3
PARACETAMOL when combined with ibuprofen in a primary pack containing 30 dosage units or less except when included in Schedule 2.
Schedule 4
PARACETAMOL:
- when combined with aspirin or salicylamide or any derivative of these substances except when separately specified in these Schedules;
- when combined with ibuprofen in a primary pack containing more than 30 dosage units;
- in slow release tablets or capsules containing more than 665 mg paracetamol;
- in non-slow release tablets or capsules containing more than 500 mg paracetamol;
- in individually wrapped powders or sachets of granules each containing more than 1000 mg paracetamol;
- in tablets or capsules enclosed in a primary pack containing more than 100 tablets or capsules except in schedule 2;
- in individually wrapped powders or sachets of granules enclosed in a primary pack containing more than 50 wrapped powders or sachets of granules except when included in Schedule 2;
- for injection.
It is also included under the entry PARACETAMOL in Appendix F, Part 3 as follows:
Appendix F, Part 3
Warning statements: 97 (Adults: Keep to the recommended dose. Don't take this medicine for longer than a few days at a time unless advised to by a doctor) and/or 98 (Children and adolescents: Keep to the recommended dose. Do not give this medicine for longer than 48 hours at a time unless advised to by a doctor.); 99 (If an overdose is taken or suspected, ring the Poisons Information Centre (Australia 13 11 26; New Zealand 0800 764 766) or go to a hospital straight away even if you feel well because of the risk of delayed, serious liver damage.); 100 (Do not take with other products containing paracetamol, unless advised to do so by a doctor or pharmacist.)
Index
PARACETAMOL
cross reference: ASPIRIN, IBUPROFEN, METOCLOPRAMIDE, SALICYLAMIDE, CAFFEINE
Schedule 4
Schedule 3
Schedule 2
Appendix F, Part 3
Proposed scheduling
A request has been made to create a new Schedule 6 entry for paracetamol for animal treatment as follows:
Schedule 6 - New Entry
PARACETAMOL for the treatment of animals.
Index - Amend Entry
PARACETAMOL cross reference: ASPIRIN, IBUPROFEN, METOCLOPRAMIDE, SALICYLAMIDE, CAFFEINE
Schedule 6
Schedule 4
Schedule 3
Schedule 2
Appendix F, Part 3
Key uses / expected use
Extension of current human therapeutic use to veterinary use (analgesic and antipyretic).
Reasons for proposal
- New active for veterinary use.
International restrictions
- According to the Applicant, the product XXXXXXXX has been registered for a number of years in Europe, although mostly in different forms - an oral 20% solution, and oral 10 and 20% premixes (for addition to feed), in addition to a 40% solution- and there have been no adverse reports from human exposure.
- Paracetamol as an oral treatment for pigs was assessed by the European Agency for the evaluation of Medicinal Products (EMEA) in 1999. It was determined that there was no need to establish an MRL[1] for paracetamol.
Footnotes
| [1] Maximum Residue Level |
|---|
How to respond
Submissions must:
- be relevant to the proposed amendment;
- address matters mentioned in section 52E of the Therapeutic Goods Act 1989;
- submitted by the closing date of 21 January 2019 to medicines.scheduling@health.gov.au for substances referred to the ACMS or Joint ACMS-ACCS, or chemicals.scheduling@health.gov.au for substances referred to the ACCS. (Please include 'Proposed Amendments to the Poisons Standard (Medicines/Chemicals)' in the subject line of the email);
- include whether or not you support the amendment/s; and
- be accompanied by a completed TGA Consultation submission coversheet
Submissions might also include:
- Suggested improvements; and/or
- An assessment of how the proposed change will impact on you. That is, what do you see as the likely benefits or costs to you (these may be financial or non-financial). If possible, please attempt to quantify these costs and benefits.
What will happen
All public submissions will be published on the TGA website at Public submissions on scheduling matters, unless marked confidential or indicated otherwise in the submission coversheet (see Privacy information).
Following consideration of public submissions received before the closing date and advice from the expert advisory committee/s, decisions on the proposed amendments will be published as interim decisions on the TGA website: Scheduling delegate's interim decisions & invitations for further comment on 6 June 2019.
Privacy and your personal information
- The TGA collects your personal information in this submission in order to:
- Contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.
- Help provide context about your submission (e.g. to determine whether you are an individual or a director of a company or representing an interest group).
- The TGA will disclose your name and (if applicable) your designation/work title on the TGA Internet site (i.e. make this information publicly available) if you consent to the publication of your name on the TGA Internet site (please complete the coversheet, see How to respond).
- Any text within the body of your submission that you want to remain confidential should be clearly marked 'IN CONFIDENCE' and highlighted in grey.
- Please note that the TGA will not publish personal information about you/others without your/their consent unless authorised or required by law.
- Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.
Enquiries
Any questions relating to submissions should be directed by email to medicines.scheduling@health.gov.au (for substances referred to the ACMS or Joint ACCS-ACMS) or chemicals.scheduling@health.gov.au (for substances referred to the ACCS).
Outcomes
-
Scheduling submissionsPublic submissions in response to the March 2019 ACMS/ACCS/Joint interim decision