Consultation Hub

We asked for feedback on a proposed standard for nicotine vaping products that have not been assessed by the TGA (unregistered nicotine vaping products). While it is possible that in the future there may be nicotine vaping products that have been assessed and approved by the TGA as medicines, we expect that in the meantime there will be a significant number of prescriptions written for unapproved goods for smoking cessation. We proposed a set of minimum safety and quality requirements for unregistered nicotine vaping products to support health professionals and consumers in knowing what is in the product being prescribed and used and to reduce the risks of accidental poisonings.

In this consultation we also asked for feedback on a proposal to exempt those unregistered nicotine vaping products that meet the requirements in the proposed standard from having to meet certain other default standards in the European Pharmacopoeia and the United States Pharmacopeia. 

We received 103 submissions in response to the consultation, including from research, government, health professional, consumer and industry organisations, as well as from individual consumers. There was broad support for the creation of a standard for unregistered nicotine vaping products. Respondents provided a range of views and suggestions to improve the standard, including:

• more strict labelling requirements, such as the need for a consistent measure of the concentration of nicotine in the product and clear rules about which label warning statements (e.g. ‘KEEP OUT OF REACH OF CHILDREN’, ‘Avoid contact with eyes’, ‘Avoid contact with skin’)
• the need for accurate labelling of nicotine concentration or content in the product
• information about additional ingredients associated with known inhalation harms
• diverse views on whether the standard should specify limits on nicotine concentration, container volume and flavours
• a preference that the standard also apply to products that may be listed on the Australian Register of Therapeutic Goods (ARTG) in the future as ‘Export Only’ medicines
• suggestions about different types of information manufacturers and others should be expected to hold about the products
• requests for the regulation of vaping devices.

Thank you to everyone who provided feedback and helped in the development of the standard.

In response to this feedback, the standard includes updated labelling requirements for nicotine concentration (including requiring nicotine concentration to be specified in mg/mL and warning statements to be provided), the prohibition of three additional ingredients with established inhalation risks, record keeping requirements for sponsors, a limit of nicotine concentration of 100 mg/mL in products and a requirement for actual nicotine concentration/content of a product to be within +/- 10% of what it says on the label. The standard has also been expanded to cover ARTG-listed ‘Export Only’ products.

Although the standard does not restrict the flavours of nicotine vaping products (other than those containing prohibited ingredients) or container sizes, it is important to remember that these factors, and others, are restricted by the person’s prescription. This allows the prescribing health professional and patient to work together to make sure that the right product is supplied to support nicotine and smoking cessation.

The new Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Order 2021 was published in May 2021 and comes into effect on 1 October 2021. This standard will apply to all unregistered nicotine vaping products in Australia (including compounded and clinical trial products and ARTG-listed as ‘Export Only’ products).

The Therapeutic Goods (Exempt Monographs) Determination 2021 (“the Determination”) was made at the same time as the standard. The purpose of the Determination is to exempt unregistered nicotine vaping products from certain pharmacopoeial standards that automatically apply to therapeutic goods.

To help explain the new requirements, TGA has published final guidance on the requirements of TGO 110 and other matters related to nicotine vaping products and vaping devices. The final guidance incorporates stakeholder feedback on the draft guidance published in May 2021.

Public consultation on the Delegate’s interim decision, in relation to scheduling proposals referred to the November 2020 meetings of the Advisory Committee on Medicines and Chemicals Scheduling, was held between 3 February 2021 and 4 March 2021.

We received 807 submissions in response to the public consultation, including one submission that was received offline. Respondents provided feedback on the proposed changes to the Poisons Standard. We appreciate all of the feedback that we received.

The Delegate’s final decisions on psilocybin and MDMA were deferred on 7 April 2021, pending an independent expert review and additional committee advice. The Delegate will consider all evidence provided, including the public submissions received, ahead of making the final decisions on these substances.

The final decisions for all other substances considered at the November 2020 meetings were published on 22 April 2021 on the TGA website.

We asked for feedback on a proposal to streamline how we enter information about the formulations of therapeutic goods into TGA electronic systems when an applicant is seeking market approval. To help make the application process more efficient, we proposed to stop entering three categories of formulations into a subordinate database of ingredient mixtures (known as the Proprietary Ingredients, or PI Table) before they are selected into an application onto the Australian Register of Therapeutic Goods (ARTG).

This proposal was limited to ingredient mixtures that contain an active ingredient (known as ‘Active Premixes’ and ‘Active Herbal Extracts’), and non-specific ‘Excipient Mixes’, which do not provide sufficient information on the purpose of the mixture.

Under the proposal there would be no change to how medicine and other therapeutic goods applications are evaluated or the amount of information publicly available about these therapeutic goods.

We received 14 submissions in response to the consultation. The majority of respondents supported the proposal to cease processing new Active Premixes, Active Herbal Extracts and non-specific Excipient Mixes into the PI Table, some stating that it was a sensible removal of redundant administrative processes, provided greater transparency and streamlining of administrative processes, was consistent with red tape reduction, and would reduce regulatory burden. However, there was concern about what expectations there would be for sponsors of existing ARTG entries that already use PI numbers within their formulation, i.e. whether existing ARTG entries would need to be updated and any cost implications. Many respondents also noted that sponsors can experience difficulties in obtaining formulation information from ingredient suppliers.

Some respondents requested a broader review of the administrative PI notification process, noting that there are broader issues associated with the use of PI numbers in formulations of medicines on the ARTG.

We appreciate all the feedback received and considered all responses before making a decision about this activity.

Based on our consideration of the issues raised in this feedback, we have agreed to stop processing notifications for new ingredient mixtures with an active ingredient or a non-specific purpose into the Proprietary Ingredients Table as of 20 July 2021. This means that no new PI numbers will be allocated to these types of formulations. Ingredient suppliers can still sell these mixtures to sponsors intended for use in medicines, but sponsors will need to select the individual ingredients into their application at the same time as they enter the rest of their medicines’ formulation details.

To help maintain the currency of information in our Proprietary Ingredients Table, we will also be inactivating (i.e. ‘hiding’) historic PI numbers for these types of mixtures where the ingredient mixture:

• is not linked to current ARTG entries, and
• was entered into the Proprietary Ingredient Table prior to 1 July 2020.

We will write to ingredient suppliers to advise them where we propose to inactivate their PI numbers, as part of our standard process for inactivating historic PI numbers that are not linked to current ARTG entries.

To address concerns raised about what impact this proposal may have on existing ARTG entries that use the affected PI numbers within their formulation we are:

• Keeping existing PI numbers active in the Proprietary Ingredient table if the ingredient mixture is included in current ARTG entries.
• Not requiring sponsors to make changes to existing ARTG entries, unless they choose to do so. In this case the sponsor can choose to correct the formulation of their ARTG entry, using existing variation processes.
• Updating relevant information on TGA website to support sponsors and suppliers in managing the change.

For more information see Streamlining proprietary ingredient categories.

In response to the call for a broader review of the administrative proprietary ingredients system, this activity is not expected to address the wider-scale challenges associated with use of PI numbers in ARTG entries. There are various categories of mixtures within the Proprietary Ingredients Table. The benefits and challenges associated with entering mixtures into the Proprietary Ingredients Table are different depending on the mixture’s purpose and formulation. Consequently, we propose to approach these challenges in a targeted and step-wise manner.