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Consultation: Non-steroidal anti-inflammatory drugs: proposed additional advisory statement

NSAIDs for oral use: diclofenac, flurbiprofen, ibuprofen, ketoprofen, mefenamic acid and naproxen

11 October 2016

This consultation closed on 22 November 2016.

Invitation to comment

The TGA sought comments from interested parties on the wording of an additional advisory statement for the non-steroidal anti-inflammatory drugs (NSAIDs) diclofenac, flurbiprofen, ibuprofen, ketoprofen, mefenamic acid and naproxen, for inclusion in the Required Advisory Statements for Medicine Labels (RASML) document.

The additional RASML advisory statement for these non-aspirin NSAIDs is proposed in order to appropriately caution against use by women who may become pregnant.

It is proposed that this new statement be incorporated into the RASML as an extension to the current RASML advisory statement for non-aspirin NSAIDs in regards to use in pregnancy, as follows (the proposed additional text is indicated by underlining [the underlining is not proposed to be required on affected medicine labels]):

Do not use if likely to become pregnant, or during the first 6 months of pregnancy except on doctor's advice. Do not use at all during the last 3 months of pregnancy.

It is proposed that this extended statement should be required for the labels of all oral non-aspirin NSAIDs; including medicines indicated exclusively for dysmenorrhoea (period pain).

The TGA also proposes to take this opportunity to make some editorial changes in order to harmonise the entries for each of these medicines as far as possible. The proposed individual RASML entries are set out below.

Proposed amended RASML entries for medicines containing diclofenac for oral administration
Column 1
Substance(s)
Column 2
Conditions
Column 3
Required statement(s)
Diclofenac In preparations for oral use in adults and children aged 12 years and over
  • Do not use if you have a stomach ulcer.
  • Do not use if you have impaired kidney function.
  • Do not use if you have heart failure.
  • Do not use if you are allergic to diclofenac or other anti-inflammatory medicines.
  • If you get an allergic reaction, stop taking and see your doctor immediately.
  • Unless a doctor has told you to, do not use if you have asthma.
  • Unless advised by your doctor or pharmacist, do not use with other products containing diclofenac, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly.
  • Do not use for more than a few days at a time unless a doctor has told you to. Do not exceed the recommended dose. Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage.
  • Do not use if likely to become pregnant, or during the first 6 months of pregnancy except on doctor's advice. Do not use at all during the last 3 months of pregnancy.
Diclofenac In preparations for oral use in children under 12 years of age
  • Do not use if you have a stomach ulcer.
  • Do not use if you have impaired kidney function.
  • Do not use if you have heart failure.
  • Do not use if you are allergic to diclofenac or other anti-inflammatory medicines.
  • If you get an allergic reaction, stop taking and see your doctor immediately.
  • Unless a doctor has told you to, do not use if you have asthma.
  • Unless advised by your doctor or pharmacist, do not use with other products containing diclofenac, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly.
  • Do not use for more than a few days at a time unless a doctor has told you to. Do not exceed the recommended dose. Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage.
  • Do not use if likely to become pregnant, or during the first 6 months of pregnancy except on doctor's advice. Do not use at all during the last 3 months of pregnancy.
  • Ask your doctor or pharmacist before use of the medicine in children suffering from dehydration through diarrhoea and/or vomiting.

The requirements for all oral OTC diclofenac medicines for use in adults are now the same. Therefore, there will no longer be a separate RASML entry for diclofenac with the Condition 'In preparations for oral use when indicated exclusively for the treatment of dysmenorrhoea'.

Proposed amended RASML entries for medicines containing flurbiprofen for oral administration
Column 1
Substance(s)
Column 2
Conditions
Column 3
Required statement(s)
Flurbiprofen In preparations for oral use in adults and children aged 12 years and over
  • Do not use if you have a stomach ulcer.
  • Do not use if you have impaired kidney function.
  • Do not use if you have heart failure.
  • Do not use if you are allergic to flurbiprofen or other anti-inflammatory medicines.
  • If you get an allergic reaction, stop taking and see your doctor immediately.
  • Unless a doctor has told you to, do not use if you have asthma.
  • Unless advised by your doctor or pharmacist, do not use with other products containing flurbiprofen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly.
  • Do not use for more than a few days at a time unless a doctor has told you to. Do not exceed the recommended dose. Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage.
  • Do not use if likely to become pregnant, or during the first 6 months of pregnancy except on doctor's advice. Do not use at all during the last 3 months of pregnancy.
Flurbiprofen In preparations for oral use in children under 12 years of age
  • Do not use if you have a stomach ulcer.
  • Do not use if you have impaired kidney function.
  • Do not use if you have heart failure.
  • Do not use if you are allergic to flurbiprofen or other anti-inflammatory medicines.
  • If you get an allergic reaction, stop taking and see your doctor immediately.
  • Unless a doctor has told you to, do not use if you have asthma.
  • Unless advised by your doctor or pharmacist, do not use with other products containing flurbiprofen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly.
  • Do not use for more than a few days at a time unless a doctor has told you to. Do not exceed the recommended dose. Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage.
  • Do not use if likely to become pregnant, or during the first 6 months of pregnancy except on doctor's advice. Do not use at all during the last 3 months of pregnancy.
  • Ask your doctor or pharmacist before use of the medicine in children suffering from dehydration through diarrhoea and/or vomiting.
Proposed amended RASML entries for medicines containing ibuprofen for oral administration
Column 1
Substance(s)
Column 2
Conditions
Column 3
Required statement(s)
Ibuprofen For the purpose of exclusion from the schedules to the SUSMP, when in preparations for oral use in adults and children aged 12 years and over
  • Do not use if you have a stomach ulcer.
  • Do not use if you have impaired kidney function.
  • Do not use if you have heart failure.
  • Do not use if you are allergic to ibuprofen or other anti-inflammatory medicines.
  • If you get an allergic reaction, stop taking and see your doctor immediately.
  • Unless a doctor has told you to, do not use if you have asthma.
  • Unless advised by your doctor or pharmacist, do not use with products containing ibuprofen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly.
  • Do not use for more than a few days at a time unless a doctor has told you to. Do not exceed the recommended dose. Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage.
  • Do not use if likely to become pregnant, or during the first 6 months of pregnancy, except on doctor's advice. Do not use at all during the last 3 months of pregnancy.
  • Unless a doctor has told you to, do not use if you are aged 65 years or over.
Ibuprofen When included in a schedule to the SUSMP for oral use, in preparations for oral use in adults and children aged 12 years and over
  • Do not use if you have a stomach ulcer.
  • Do not use if you have impaired kidney function.
  • Do not use if you have heart failure.
  • Do not use if you are allergic to ibuprofen or other anti-inflammatory medicines.
  • If you get an allergic reaction, stop taking and see your doctor immediately.
  • Unless a doctor has told you to, do not use if you have asthma.
  • Unless advised by your doctor or pharmacist, do not use with products containing ibuprofen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly.
  • Do not use for more than a few days at a time unless a doctor has told you to. Do not exceed the recommended dose. Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage.
  • Do not use if likely to become pregnant, or during the first 6 months of pregnancy except on doctor's advice. Do not use at all during the last 3 months of pregnancy.
Ibuprofen For the purpose of exclusion from the schedules to the SUSMP, when in preparations for oral use in children under 12 years of age
  • Do not use if you have a stomach ulcer.
  • Do not use if you have impaired kidney function.
  • Do not use if you have heart failure.
  • Do not use if you are allergic to ibuprofen or other anti-inflammatory medicines.
  • If you get an allergic reaction, stop taking and see your doctor immediately.
  • Unless a doctor has told you to, do not use if you have asthma.
  • Unless advised by your doctor or pharmacist, do not use with products containing ibuprofen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly.
  • Do not use for more than a few days at a time unless a doctor has told you to. Do not exceed the recommended dose. Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage.
  • Do not use if likely to become pregnant, or during the first 6 months of pregnancy except on doctor's advice. Do not use at all during the last 3 months of pregnancy.
  • Ask your doctor or pharmacist before use of the medicine in children suffering from dehydration through diarrhoea and/or vomiting.
  • Unless a doctor has told you to, do not use if you are aged 65 years or over.
  • Unless a doctor has told you to, do not use in children 6 years of age or less.
Ibuprofen When included in a schedule to the SUSMP, in preparations for oral use in children under 12 years of age
  • Do not use if you have a stomach ulcer.
  • Do not use if you have impaired kidney function.
  • Do not use if you have heart failure.
  • Do not use if you are allergic to ibuprofen or other anti-inflammatory medicines.
  • If you get an allergic reaction, stop taking and see your doctor immediately.
  • Unless a doctor has told you to, do not use if you have asthma.
  • Unless advised by your doctor or pharmacist, do not use with products containing ibuprofen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly.
  • Do not use for more than a few days at a time unless a doctor has told you to. Do not exceed the recommended dose. Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage.
  • Do not use if likely to become pregnant, or during the first 6 months of pregnancy except on doctor's advice. Do not use at all during the last 3 months of pregnancy.
  • Ask your doctor or pharmacist before use of the medicine in children suffering from dehydration through diarrhoea and/or vomiting.

The requirements for all SUSMP-scheduled oral ibuprofen medicines for use in adults are now the same. Therefore, there will no longer be a separate RASML entry for ibuprofen with the Condition 'In preparations for oral use when indicated exclusively for the treatment of dysmenorrhoea'.

Proposed amended RASML entries for medicines containing ketoprofen for oral administration
Column 1
Substance(s)
Column 2
Conditions
Column 3
Required statement(s)
Ketoprofen In preparations for oral use in adults and children aged 12 years and over
  • Do not use if you have a stomach ulcer.
  • Do not use if you have impaired kidney function.
  • Do not use if you have heart failure.
  • Do not use if you are allergic to ketoprofen or other anti-inflammatory medicines.
  • If you get an allergic reaction, stop taking and see your doctor immediately.
  • Unless a doctor has told you to, do not use if you have asthma.
  • Unless advised by your doctor or pharmacist, do not use with products containing ketoprofen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly.
  • Do not use for more than a few days at a time unless a doctor has told you to. Do not exceed the recommended dose. Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage.
  • Do not use if likely to become pregnant, or during the first 6 months of pregnancy except on doctor's advice. Do not use at all during the last 3 months of pregnancy.
Ketoprofen In preparations for oral use in children under 12 years of age
  • Do not use if you have a stomach ulcer.
  • Do not use if you have impaired kidney function.
  • Do not use if you have heart failure.
  • Do not use if you are allergic to ketoprofen or other anti-inflammatory medicines.
  • If you get an allergic reaction, stop taking and see your doctor immediately.
  • Unless a doctor has told you to, do not use if you have asthma.
  • Unless advised by your doctor or pharmacist, do not use with products containing ketoprofen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly.
  • Do not use for more than a few days at a time unless a doctor has told you to. Do not exceed the recommended dose. Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage.
  • Do not use if likely to become pregnant, or during the first 6 months of pregnancy except on doctor's advice. Do not use at all during the last 3 months of pregnancy.
  • Ask your doctor or pharmacist before use of the medicine in children suffering from dehydration through diarrhoea and/or vomiting.

The requirements for all oral OTC ketoprofen medicines for use in adults are now the same. Therefore, there will no longer be a separate RASML entry for ketoprofen with the Condition 'In preparations for oral use when indicated exclusively for the treatment of dysmenorrhoea'.

Proposed amended RASML entries for medicines containing mefenamic acid for oral administration
Column 1
Substance(s)
Column 2
Conditions
Column 3
Required statement(s)
Mefenamic acid In preparations for oral use
  • Do not use if you have a stomach ulcer.
  • Do not use if you have impaired kidney function.
  • Do not use if you have heart failure.
  • Do not use if you are allergic to mefenamic acid or other anti-inflammatory medicines.
  • If you get an allergic reaction, stop taking and see your doctor immediately.
  • Unless a doctor has told you to, do not use if you have asthma.
  • Unless advised by your doctor or pharmacist, do not use with products containing mefenamic acid, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly.
  • Do not use for more than a few days at a time unless a doctor has told you to. Do not exceed the recommended dose. Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage.
  • Do not use if likely to become pregnant, or during the first 6 months of pregnancy except on doctor's advice. Do not use at all during the last 3 months of pregnancy.

Medicines containing mefenamic acid are currently only registered for oral use for treatment of dysmenorrhoea. However, as the requirements for all SUSMP-scheduled oral NSAIDs for use in adults are now the same, the Condition 'In preparations for oral use when indicated exclusively for the treatment of dysmenorrhoea' is proposed to be changed to 'In preparations for oral use', for consistency with the entries for the other NSAID substances.

Proposed amended RASML entries for medicines containing naproxen for oral administration
Column 1
Substance(s)
Column 2
Conditions
Column 3
Required statement(s)
Naproxen In preparations for oral use in adults and children aged 12 years and over
  • Do not use if you have a stomach ulcer.
  • Do not use if you have impaired kidney function.
  • Do not use if you have heart failure.
  • Do not use if you are allergic to naproxen or other anti-inflammatory medicines.
  • If you get an allergic reaction, stop taking and see your doctor immediately.
  • Unless a doctor has told you to, do not use if you have asthma.
  • Unless advised by your doctor or pharmacist, do not use with products containing naproxen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly.
  • Do not use for more than a few days at a time unless a doctor has told you to. Do not exceed the recommended dose. Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage.
  • Do not use if likely to become pregnant, or during the first 6 months of pregnancy except on doctor's advice. Do not use at all during the last 3 months of pregnancy.
Naproxen In preparations for oral use in children under 12 years of age
  • Do not use if you have a stomach ulcer.
  • Do not use if you have impaired kidney function.
  • Do not use if you have heart failure.
  • Do not use if you are allergic to naproxen or other anti-inflammatory medicines.
  • If you get an allergic reaction, stop taking and see your doctor immediately.
  • Unless a doctor has told you to, do not use if you have asthma.
  • Unless advised by your doctor or pharmacist, do not use with products containing naproxen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly.
  • Do not use for more than a few days at a time unless a doctor has told you to. Do not exceed the recommended dose. Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage.
  • Do not use if likely to become pregnant, or during the first 6 months of pregnancy except on doctor's advice. Do not use at all during the last 3 months of pregnancy.
  • Ask your doctor or pharmacist before use of the medicine in children suffering from dehydration through diarrhoea and/or vomiting.

The requirements for all oral OTC naproxen medicines for use in adults are now the same. Therefore, there will no longer be a separate RASML entry for naproxen with the Condition 'In preparations for oral use when indicated exclusively for the treatment of dysmenorrhoea'.

Timetable

Document released for consultation on Tuesday 11 October 2016.

Interested parties should respond by close of business on Tuesday 22 November 2016.

Feedback will be released following consideration of submissions. (see 'What will happen').

About the consultation

A recent TGA review (Safety review of the risk of miscarriage associated with the use of oral NSAIDs [link to be added] - considered by the ACSOM Meeting 30, 20 November 2015 has identified a need for amendment to the current RASML advisory statement against use of non-aspirin NSAIDs in pregnancy to appropriately caution women who may become pregnant.

With this consultation, the TGA is seeking comments on the proposed wording of this amended RASML advisory statement.

Through the consultation process, the TGA is requesting comments that will help ensure that the wording of the proposed advisory statement is appropriate and supports the quality use of the medicines; and that the label changes that would be required for these medicines are made in the most convenient, efficient and cost-effective way.

Background

Scheduling of medicines

The Standard for Uniform Scheduling of Medicines and Poisons (SUSMP) sets out the level of control on the availability of medicines in Australia. The majority of OTC medicines that are included in the SUSMP fall under one of the following classifications: Schedule 2 - Pharmacy Medicine (available from a pharmacy without a prescription); or Schedule 3 - Pharmacist Only Medicine (available from a pharmacist without a prescription. Medicines that are not included in the SUSMP are referred to as 'unscheduled' medicines. These are freely available from general retail outlets such as supermarkets.

Advisory statements

Consumers rely on information from their health practitioner, pharmacist and medicine label in order to use medicines safely and effectively. The enhanced access and availability of non-prescription medicines means that consumers may not always receive comprehensive advice from a doctor or pharmacist. Therefore, the label needs to contain the directions and advisory statements that are needed for safe and effective use of the medicines.

The TGA Labelling Orders require medicine labels to include 'warning statements' where these apply to the medicines. Medicines that are compliant with new Labelling Order, Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines (TGO 92) are also subject to requirements for how and where the warning statements are displayed on the medicine label (for further information see Medicine Labels: Guidance on TGO 91 and TGO 92).

The warning statements required by the Labelling Orders include 'any advisory statements specified in the instrument made under subsection 3(5A) of the Act, as in force from time to time'.

The RASML

The RASML sets out the advisory statements that are required to be included on the labels of specified medicines. The RASML is registered on the Federal Register of Legislative Instruments as the Medicines Advisory Statements Specification ('the Specification') under subsection 3(5A) of the Therapeutic Goods Act 1989.

The current version of the Specification is the Medicines Advisory Statements Specification 2016 (MASS 2016). The MASS 2016 incorporates two versions of the RASML (currently RASML No. 2 and RASML No. 3) as schedules 1 and 2, respectively, to allow for a transition period for adoption of new advisory statements onto medicine labels. RASML No. 2 is the current version. RASML No. 3 will come into effect on 1 July 2017.

The advisory statements required by the RASML are designed to inform consumers about specific risks related to the use of medicines that have been identified during development and evaluation of new medicines, or subsequent pharmacovigilance activities, testing, adverse event reports or from other scientific or clinical information.

The RASML permits the wording of the actual statements that are included on medicine labels to differ from the wording set out in the RASML, as long as the intent is the same. For example, in some cases the statements in the RASML include information in square brackets such as '… [this product/insert name of product]…', which indicate text that can be either be varied as indicated, or left out altogether.

Current RASML statements for NSAIDs for oral use

NSAIDs are available in a variety of doses and formulations, and are widely used to treat pain, inflammation and fever. They can be used to treat the symptoms of arthritis, rheumatism, muscle strains, sprains, tendonitis and period pain.

The current edition of RASML (RASML No. 2) already requires all oral OTC medicines containing any of the NSAIDs diclofenac, flurbiprofen, ibuprofen, ketoprofen, mefenamic acid or naproxen to carry on their labels the following advisory statements:

  • Do not use [this product/ insert name of product] if you have a stomach ulcer.
  • Do not use if you have impaired kidney function.
  • Do not use if you have heart failure.
  • Do not use [this product/ insert name of product] if you are allergic to [substance name] or other anti-inflammatory medicines.
  • If you get an allergic reaction, stop taking and see your doctor immediately.
  • Unless a doctor has told you to, do not use [this product/ insert name of product] if you have asthma.
  • Unless advised by your doctor or pharmacist, do not use [this product/ insert name of product] with products containing [substance name], aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly.
  • Do not use for more than a few days at a time unless a doctor has told you to. Do not exceed the recommended dose. Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage.

In addition:

  • Use in pregnancy: All oral NSAID medicines that are NOT indicated exclusively for period pain (dysmenorrhoea) are currently required to carry the statement 'Do not use [this product/ insert name of product] during the first 6 months of pregnancy except on doctor's advice. Do not use at all during the last 3 months of pregnancy'.
  • Statements relating to use in specific age groups: All oral NSAID medicines for use in children under 12 years of age are required to also carry the statement 'Ask your doctor or pharmacist before use of the medicine in children suffering from dehydration through diarrhoea and/or vomiting'. Unscheduled oral ibuprofen preparations are also required to carry the statement 'Unless a doctor has told you to, do not use if you are aged 65 years or over', and, if indicated for children under 12 years of age, they must also carry the statement 'Unless a doctor has told you to, do not use in children 6 years of age or less'.

Proposed additional RASML statement for NSAIDs for oral use

The TGA has completed a safety review of the risk of miscarriage associated with the use of oral NSAIDs. The review involved:

  • comparison of Product Information (PI) documents and international product information/reference documents for all NSAIDs
  • review of mandated warnings, published literature and therapeutic guidelines
  • analysis of adverse event reports
  • obtaining expert advice from the Advisory Committee on the Safety of Medicines (ACSOM).
  • In summary, the TGA review found that there was a known association between use of non-aspirin NSAIDs and increased risk of miscarriage, particularly when the medicine was taken close to the time of conception. However, warnings about this risk on medicine labelling are currently not consistent across these products.
  • The current RASML advisory statement that warns against use in pregnancy is not required for all oral OTC non-aspirin NSAIDs, and does not address the use in women who have just conceived and are therefore unlikely to be aware that they are pregnant. This is relevant, as the data suggests that the risk is greatest when the medicine is taken close to the time of conception.
  • The review recommended that non-aspirin NSAID products that are indicated exclusively for period pain should have the risk of use in pregnancy warning included on their labels. Given that these NSAIDs have the same active ingredient as other NSAID products that are not indicated exclusively for period pain, there is potential for these products to be used for other indications, without being advised of the risk of use in pregnancy.

The TGA proposes that the RASML should be updated to require the following amended advisory statement on all oral non-aspirin NSAID OTC medicines.

  • Do not use if likely to become pregnant, or during the first 6 months of pregnancy except on doctor's advice. Do not use at all during the last 3 months of pregnancy.

Proposed editorial changes

The order in which the individual statements are listed has been harmonised for all of the entries (this means that the order has been changed in some cases). Statements are not required to be set out on medicine labels in the order in which they appear in the RASML, so this editorial change will not have any impact on any medicine label.

For increased clarity and conciseness, the wording '… [this product/insert name of product]…', has been removed wherever it occurs in these entries. The RASML permits the wording of the actual statements that are included on medicine labels to differ from the wording set out in the RASML, as long as the intent is the same; and the intent of the square brackets has always been to indicate text that can be either be varied as indicated, or left out altogether. So this editorial change will not have any impact on any medicine label.

Content of submissions

  • Submissions may address the proposed advisory statements and other identified issues. In addition, submissions might include:
  • Whether or not you support the wording of the advisory statement. If you do not support the wording of the statement you may make suggestions for an alternative acceptable to you.
  • 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.

Enquiries

Enquiries should be directed via email to rasml@tga.gov.au.

What will happen

All submissions will be placed on this website unless marked confidential or indicated otherwise in the submission form (see Privacy information).

Submissions will be reviewed by the TGA and feedback on submissions will be provided through this website.

It is proposed that the advisory statements will be included in the next update to the RASML ('RASML 4'), with an anticipated date of publication on the FRLI in June 2017, and an anticipated date of effect 18 months later (i.e. December 2018) to allow affected sponsors time to update their labels. However, the TGA will expect that all new medicines registered by the TGA from the date of publication of the outcomes of this current consultation will include all the requirements.

Privacy 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).
    • seek feedback about how the consultation was undertaken.
  • 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.
  • More information on consultations and privacy is included in the submission form and on our website.