We asked, You said, We did

Below are some of the issues we have recently consulted on and their outcomes.

We asked

We asked for feedback on potential refinements to the existing regulatory requirements for patient information materials, including the content and form of the materials and exempt devices.

You said

A total of 34 submissions were received with more than half of the submissions from health care professionals and hospitals who are responsible for providing information to patients. Submissions were also received from consumers, professional health related societies and the medical device sector.

Almost all respondents, including the consumers, agreed with the proposals for providing information in a range of formats. This would allow information to be recorded in electronic formats such as electronic patient records and MyHealth records. Although, several respondents considered that regardless of how the information is kept, patients should also have the option to receive a hard copy.  Most were in favour of flexibility in the way information is provided. There were also suggestions for providing patient information materials in different languages and in audio form. The medical device industry respondents noted that electronic formats would reduce cost and some health care providers considered that costs are offset by benefits. However, there were several concerns raised about the burden on hospital staff and administration times if the system is too demanding or complex.

The majority of respondents agreed that it is unnecessary to provide patient implant cards if the device is going to be absorbed by the body within a certain timeframe. Those that stated they did not agree had concerns over delayed reactions to such implants. The suggested timeframes varied from days to 2 years, but the majority of those who responded opted for periods of 3 to 6 months.

The strong majority of respondents agreed that it is unnecessary to provide patient implant cards for pedicle screws, given that many types of screws could be used in one surgery.  There were suggestions that a system implant card is sufficient (that covers all implanted devices from one system), or that a generic patient information leaflet could be provided. In general, the responses indicate that it is unnecessary to provide patient implant cards for each screw or component, but the requirement for a patient information leaflet should be retained.

Although only a few respondents had comments on other devices which could be exempt from the requirements, there was strong representation for exempting reloads with staple line reinforcement, sutures with pledgets, and pledgets alone from requiring patient implant cards. There was also a recommendation to ensure alignment with the European requirements by exempting spinal rods, suture anchors, wedges (augments), laminar hooks, non-expandable cages, interspinous spacers, and bone screws.

There were also some questions about certain devices such as coronary stents and dental crowns, which indicated that there was still some confusion about the regulatory requirements for these devices.

It was noted that there was a need for increased communication about the implementation including education for hospitals, procurement officers and clinicians in relation to the provision of these materials.

We did

Based on the outcomes from the consultation, agreement will be sought from the Government to consider refinements to the Regulations. These refinements would:

  • allow more flexibility in how patient information materials can be provided including in a range of formats such as electronic format and at either pre or post surgery (i.e. not necessarily supplied with the device in the packaging);
  • exempt devices absorbed by the body within a defined time period from the requirement for a patient implant card but maintain the requirement for a patient information leaflet;
  • exempt pedicle screws from the requirement to have a patient implant card. The requirement for a patient information leaflet will be retained, but could be incorporated into a system patient information leaflet where appropriate; and
  • create the power for a TGA delegate to consider exempting other devices where clinically appropriate to ensure alignment with Europe, where possible.

Guidance documents will be updated to address other concerns raised in the consultation. Continued education will also be provided, including clear messages to relevant groups such as hospitals, surgeons, clinicians and procurement officers in relation to the implementation of patient information materials.          

Guidance will be further updated following a decision from the Government on the proposed refinements.

We asked

Public consultation was held between 30 July 2021 and 27 August 2021 on the Delegate’s interim decision in relation to a scheduling proposal about nitrous oxide that was referred to the March 2021 joint meeting of the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling.

You said

We received seven submissions in response to the public consultation. Respondents provided feedback on the proposed changes to the Poisons Standard.

We did

The Delegate considered all submissions prior to making a final decision on this proposal. The final decision was published on 8 October 2021 on the TGA website.

We asked

Public consultation was held between 20 July 2021 and 17 August 2021 on the Delegates’ interim decisions in relation to scheduling proposals referred to the March 2021 meetings of the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling.

You said

We received 34 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 did

The Delegates considered all submissions prior to making their final decisions on these proposals. The final decisions were published on 9 September 2021 on the TGA website.

We asked

We asked for feedback on potential refinements to the Regulations in relation to classification rules for medical devices that are substances introduced into the human body via a body orifice or applied to the skin.

You said

A total of 45 submissions were received. They comprised of 17 from the medical device or medicine industry (manufacturers, sponsors or peak body associations) and 28 from consumers.

The 28 responses from consumers have been noted but have not been taken into account in this consultation. It appears these respondents misunderstood the intent of the consultation due to social media incorrectly suggesting the consultation was in relation to microchipping individuals.

Of the remaining 17 respondents, the majority (11) did not support the proposal to refine the Regulations. While, the other six respondents supported the proposed refinements.

There seemed to be a general misunderstanding of the consultation and types of devices covered by the relevant classification rule. Some respondents were unsure how their product would be regulated under the proposed refinement, and some did not support the proposal if it meant their products would become a medicine. Some respondents raised issues that were not directly related to the questions in this consultation, including concerns about the interface between medical devices and foods. The intent of the proposed refinement to the classification rule was not for products to change regulatory pathways, but rather to provide clarity about which pathway the product should take (i.e. medicine or medical device).

Some respondents believed there would be an increased regulatory burden should the classification rule be amended. They believed that Australia would not align with Europe. Where sponsors may not have the resources to support a product to be regulated as a medicine in Australia, whilst the same product would be regulated as a medical device in Europe. Some respondents also noted that Australian patients may miss out on a number of products if there was a change in the regulatory pathway. Not all sponsors would continue to supply the product if it deviated from other major markets in its classification and regulatory pathway.

Importantly, some respondents did not appreciate that:

  • any product that is a substance-based medical device will be a Class IIb device instead of a Class III device (so it represents lower regulatory burden than in Europe); and
  • the mode of action will be reviewed should the product appear to not meet the definition of a medical device as defined in the Therapeutic Goods Act; and
  • without the proposed refinement, from 25 November 2021, some products would be reclassified to Class III devices and the regulatory burden increased.

This consultation strongly highlighted that clarification was urgently needed on this topic, including on a number of other matters in relation to this classification rule and definitions. There is an urgent need to clarify and provide a definition for absorption, chemical action and physical barriers, both of which help determine whether a product should be regulated as a medicine or medical device.

We did

Whilst industry concern over misalignment with Europe and their Medical Device Regulations were noted, the Australian regulatory framework and definitions are different to those in Europe. The proposed refinements to the Medical Device Regulations (as set out in the consultation paper) would not have the effect of pushing any of these products to be considered as medicines – the proposed refinements would principally reduce some of the confusion in the language of the device classification rules and avoid any such products being up-classified to the Class III level.

Based on the outcomes from the consultation, agreement will be sought from the Government to consider refinements to the Regulations. These refinements would remove reference to products that are systemically absorbed and provide clarity around the regulation of these products.

Guidance will be further updated post a decision from Government on the proposed refinements and to address other concerns raised in this consultation as well as continued education in relation to the regulation of products containing substances.

We asked

We asked for feedback on proposals to remake some of the legislative instruments relating to human cell and tissue (HCT) products (including blood and blood components), which sunset in October 2021.

You said

We received 33 submissions in response to the consultation, including from government, sponsors, industry organisations, as well as from individual consumers. There was broad support for the remaking the legislative instruments relating to human cell and tissue (HCT) products (including blood and blood components), with proposed amendments. Responses from the eye banking sector did not initially support some proposed changes.  

In addition, stakeholders provided a range of views and suggestions to improve the standard, including:

  • Label requirements too onerous for biologicals not for supply in Australia.
  • Introduce risk-based assessments as an alternative for HTLV serological testing for donor screening requirements.
  • Donor history requirements specified in TGO 108 as burdensome for ‘export only’ plasma for fractionation (PFF).

The changes proposed in the public consultation and above referenced feedback have been incorporated in the final standards.

Some feedback was not accepted as matters either affected or were beyond scope of the quality, safety, efficacy of therapeutic goods.

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

We did

Most changes proposed in the standards are deregulatory or the current sponsors already comply with the new requirements.

To allow sponsors to meet the quality system requirements a 12-month transition period will be allowed for all standards from 1 October 2021 to 30 September 2022.  During this time the former Orders may be conformed with, despite being repealed, as an alternative to the new standards.

The exception to this are donors whose ocular tissue will be released for supply solely for the purpose of corneal transplantation (‘cornea only donors’). TGO 108 will now mandate additional serological testing for human T cell leukaemia virus types 1 and 2 (HTLV-1/2) and syphilis, with nucleic acid amplification testing (NAT) for human immunodeficiency virus types 1 and 2 (HIV), Hepatitis C virus (HCV) and Hepatitis B virus (HBV) for these donors. An extended transition timeframe of 3 years for ‘cornea only donors’ from additional donor testing requirements in TGO108 to allow adequate time for availability of appropriate testing facilities in some states and territories.  

The new orders TGO107, TGO 108 and TGO109 come into effect on 30 September 2021.The Therapeutic Goods (Biologicals - Specified Things) Instrument 2021 also comes into effect on 30 September 2021.

 

 

 

We asked

We asked for feedback on proposals for improving the Therapeutic Goods Advertising Code (No.2) 2018 (the Code). The proposals included changes to provisions of the Code that had been identified as being unclear, inconsistent, or otherwise difficult to work with. The proposals were designed to improve advertising compliance, minimise advertising compliance costs, and ensure Code provisions work as intended.

We canvassed stakeholder preferences for different options for some provisions. We also invited stakeholders to identify other areas where the Code could be improved.

You said

We received 67 submissions in response to the consultation, including from sponsors, manufacturers, advertisers, marketers and sellers of therapeutic goods, peak industry bodies and associations, regulatory affairs firms, policy advocates, and health professional and consumer organisations. There was broad support for amending the Code to reduce complexity and increase clarity for users. Stakeholders also advocated for a review of current guidance on the Code to ensure it remains contemporary and easily accessible.

On some proposals, there were widely divergent views:

  • There was broad support for clarifying the requirements around claims in advertising, including ‘therapeutic’ and ‘non-therapeutic’ claims, and the evidence requirements for each. But there was a divergence of views as to whether this should be done in the Code, or in guidance.
  • The proposal to strengthen the rules around the use of language and images in advertising that may invoke a sense of fear or distress in consumers also produced a range of views.
  • Stakeholder views about who should and who should not be allowed to make product endorsements and testimonials for use in advertising were widely divergent.
  • There was also a range of views around the rules relating to advertising involving the offer or provision of free samples of goods, and the criteria that should apply when determining what types of goods should be exempted from any general restrictions on this practice.

However, stakeholders broadly supported the introduction of alternative mandatory statements in advertisements for typically ‘non-consumer’ therapeutic goods. Many stakeholders also indicated they wanted simpler rules around the use of existing mandatory statements and health warnings in advertisements.

Thank you to everyone who provided feedback.

We did

In response to this feedback, we have decided to re-write the Code using a simplified structure and plainer language. We will also ensure the guidance on the Code is more accessible and user-friendly.

On specific Code issues, we are reflecting on feedback and undertaking further targeted consultations with members of the Therapeutic Goods Advertising Consultative Committee.

We aim to prepare and publish the new Code by the end of 2021. Please subscribe to the TGA Advertising email list to be notified of progress.

We asked

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. 

You said

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.

We did

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.

We asked

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.

You said

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.

We did

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

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.

You said

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 did

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.

We asked

We asked for feedback on whether to amend the definition of the CCS within the Australian medical device framework which is reflected in the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations). The Australian definition currently includes devices that come into contact with the common iliac arteries, which is consistent with the definition outlined in guidance published by the International Medical Device Regulators Forum (IMDRF) and as adopted by other countries such as Singapore, but is not aligned with the definition adopted in the European Union (EU).

You said

Four submissions were received, all of which were from medical device sponsors (suppliers). They all supported removing iliac arteries from the definition of CCS to align with the definition adopted in the EU. The reason cited for this was a decreased regulatory burden for devices with EU certification, where sponsors may not have to provide additional and/or different evidence to the TGA. This in turn, would encourage and allow these devices to be supplied more easily to the Australian market. Respondents pointed out that if the inconsistency continued, there would be an extra cost and regulatory burden for approval to include their devices in the Australian Register of Therapeutic Goods (ARTG). Respondents also noted that Australia is already missing out on a number of these devices due to the cost, processes, documentation and time to meet the differences between these regulatory requirements.

Respondents noted that Australian patients would benefit from amending the definition to exclude iliac arteries from the definition of the CCS, through greater access to more medical devices for the treatment of iliac arteries pathologies without increased risks.

We did

A small number of responses, all from medical device sponsors, were received. Noting there were no responses from clinicians or health care workers, we undertook further targeted consultation to understand the clinical implications and risks associated with amending the definition of the CCS by removing iliac arteries from the definition. By removing iliac arteries from the definition of CCS, devices used in those arteries would be in a lower risk classification.

Several clinical colleges and surgical groups were invited to comment on the risks and implications of removing the common iliac arteries from the definition of the CCS. We received three responses from the Australian and New Zealand Society for Vascular Surgery (ANZSVS), the Royal Australasian College of Surgeons (RACS) and the Cardiac Society of Australia and New Zealand (CSANZ). These organisations expressed strong support to retain the current definition of the CCS and to remain aligned with the IMDRF guidance. They were concerned that a change may have potential safety implications for devices used in these vessels. It was also noted, as an aside, that the use of Latin is uncommon in modern clinical practice.

We also received advice from the Prostheses List Advisory Committee’s Clinical Advisory Groups (CAGs) for cardiac prostheses and cardiothoracic prostheses. Both CAGs indicated that the common iliac arteries are definitely considered part of the central circulatory system by clinicians and should not be removed from the definition in the Regulations.

We have reviewed all responses and considered the risks associated with removing iliac arteries from the definition of CCS. Clinical groups and associations expressed support to retain the current definition of the CCS. Therefore, on balance, the TGA intends to not amend the definition of the CCS within the Australian Regulations.

We asked

Public consultation on scheduling proposals referred to the March 2021 meetings of the Advisory Committee on Medicines and Chemicals Scheduling was held between 24 December 2020 and 27 January 2021.

You said

We received 409 submissions in response to the public consultation, including 7 submissions that were received offline. Respondents provided feedback on the proposed changes to the Poisons Standard. We appreciate all of the feedback that we received.

We did

The Delegate considered all submissions prior to making an interim decision on these proposals. The interim decision for nitrous oxide was published on 30 July 2021, and the interim decisions for the remaining substances were published on 20 July 2021.

We asked

Between September and December 2020, the TGA sought feedback to help inform the planning and design of the implementation of identifiers for Australian medical devices and the establishment of the Australian Unique Device Identification database. This is the second consultation and builds on the findings from the first. Specifically the TGA sought feedback on:

  1. What are the benefits of an Australian UDI System across the broader health system?
  2. Should the first phase of an Australian implementation be limited to a small number of high-risk devices?
  3. If the Australian implementation fully aligns with the IMDRF guidance, what will the impact be?
  4. What mechanisms should be considered for submitting the UDI data to the TGA?
  5. What might the benefits be for implementing the EU Basic UDI-DI in Australia?
  6. What are the benefits of the Global Medical Device Nomenclature (GMDN) and how is it being used?

You said

Ninety responses were received with sixty percent of responses from medical device manufacturers and/or sponsors. The remaining respondents represent most other segments of Australia’s healthcare system, however it was noted that no submissions were received from Registries or General Practitioners.

Respondents provided wide-ranging comments and suggestions across all questions. Overall, the responses demonstrate continued strong support for the Australian implementation as well as many valuable comments and suggestions on the implementation approach and phasing.

The TGA appreciates all the feedback and thanks all respondents.

We did

We have analysed all responses and the results will inform Australian Government policy decisions going forward. In line with your strong feedback on ongoing engagement, the TGA will continue to work closely with stakeholders as we progress the implementation.

We asked

Public consultation on the Delegate’s interim decision on nicotine scheduling was held between 23 September and 12 November. The interim decision and public consultation relate to a delegate-initiated proposal referred to the June 2020 meeting of the Advisory Committee on Medicines and Chemicals Scheduling in joint session (Joint ACMS-ACCS #25).

You said

We received 2385 submissions in response to the public consultation, including seven submissions that were received offline. Respondents provided feedback on the proposed changes to the Poisons Standard. We appreciate all of the feedback that we received.

We did

The Delegate considered all submissions prior to making the final decision on nicotine scheduling. The final decision was published on 21 December 2020 on the TGA website.

We asked

Public consultation on the Delegate’s interim decisions, in relation to scheduling proposals referred to the June 2020 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS), was held between 9 September 2020 and 13 October 2020.

You said

We received 41 submissions in response to the consultation. Respondents provided feedback on the proposed changes to the Poisons Standard. We appreciate all of the feedback we received.

We did

The Delegate considered all submissions in making the final decision on these proposals.

Final decisions regarding oxymetazoline, eletriptan, clotrimazole, sildenafil, ibuprofen and cumyl-pegaclone were published on 25 November 2020.

The final decision for cannabidiol (private application and delegate initiated) was published on 15 December 2020.

We asked

We asked for feedback on our draft Therapeutic Goods Order 106 – Standard for Serialisation and Data Matrix Codes (TGO 106) because we want to make sure the standard is fit for purpose and provides clarity for early adopters of medicine serialisation and data matrix codes on medicines supplied in Australia.

You said

We received 43 submissions in response to the consultation. Respondents provided a range of suggestions to improve the new Order and associated guidance, with many supporting the implementation of a standard to provide consistent regulatory requirements which align with international standards. We appreciate all the feedback we received.

We did

We did

We considered all feedback received and made changes to the standard and guidance. We implemented the updated standard in March 2021. For more information, see new standard for serialisation and data matrix codes on medicines.

Changes we made in consideration of feedback included:

  • Extending the delayed commencement period to allow sufficient time for medicine manufacturers and sponsors already serialising medicines or using data matrix codes to comply with the standard. The standard now commences on 1 January 2023.
  • Reducing requirements to allow sponsors to use data matrix codes to identify medicines without a serial number where serialisation is not required. Medicines that are not serialised will not need to include additional data elements in a data matrix. These changes help to maintain benefits for scanning in health care settings where appropriate technology exists and assist those gradually implementing data matrix codes.
  • Restructuring the standard to streamline and clarify requirements for medicines that are serialised versus medicines that are not serialised but have a data matrix code that contains a GS1 Global Trade Item Number (GTIN).
  • Updating the guidance to clarify requirements for the primary pack and the information that needs to be included in a data matrix code. Primary pack is different to primary packaging, as explained in the guidance and new medicine packaging definitions for sponsors webpage.