Technical Alerts

Please find below a list of legislative updates for 2023. In particular, complementary medicine sponsors should note that for medicines listed form 24 December 2022, standard conditions of listing are no longer applied through ELF at the time of Listing or by a Notice from the TGA, but applied through a NEW Determination.

- New Conditions of Listing Determination will apply to listed medicines included on the ARTG from 24 December 2022, replacing the previous application of conditions by a Notice (Letter) from the TGA. However, the content of the conditions remain unchanged. 

-New TGO Standard for Medicines using Serialisation or GTIN data matrix codes

- Updated Advertsising Code Compilation to include the most recent Covid-19 vaccine advertising permission.

- Updated Poisons Standard from 2023– changed format, definitions, substantive provisions. The TGA state there are no change to Scheduling of substances. CMA will be monitoring if there are impacts on herbs and asks members to note the below information (page 5 of this alert) regarding complex preparations that have more than one substance restricted by scheduling.

- Updated Therapeutic goods Regulations – to reflect changes to devices including nanomaterials and IVDs.

More information and details are available via this tech alert.

Registrations are open for the Good Manufacturing Practice (GMP) Forum, to be held in Sydney on 21 March 2023 at the International Convention Centre in Darling Harbour from 8.30am to 6.30pm.

The forum is an in-person only event and include a variety of plenary sessions, break-out sessions, workshops, exhibition stations and a networking event. The workshop program will be limited to 60 people per session so be sure to register early to secure your place.

A ticket fee of $350 per person applies for early-bird registration - until Sunday, 19 February.

A fee of $450 per person will apply from Monday 20 February (unless sold out earlier).

Click here to Register and to access the Forum program.

This technical alert  provides additional contextual information for members on recent TGA emails to sponsors in relation to pregnancy products and indications. 

The TGA has published a 'reminder about weight loss products' and new guidance aimed at consumers relating weight loss products. 

The focus of the guidance is to heighten consumer awareness around the regulation of therapeutic goods approved for supply in australia and especially, to deter the use of unapproved (illegal) goods not on the ARTG, but which are  available to Australian consumers via e-commerce platforms. The guidance also draws consumer attention to how to recognise AUST L and AUST R products, and advertising rules for weight loss products. 

Please read today's technical alert for more information and details including CMA's feedback on the development of the guidelines. 

A new format Poisons Standard will commence on 1 February 2023. The Therapeutic Goods (Poisons Standard—February 2023) Instrument 2022 repeals and replaces the Poisons Standard October 2022. The instrument is published in advance to allow time for states and territories to make necessary changes to their respective legislation that may refer to specific parts of the Poisons Standard.

The stated purpose of the changes in the Explanatory Statement is to ensure that the new Poisons Standard aligns with modern drafting conventions to the extent possible, and is clearer and easier to understand. The changes made fall into three categories: structure, readability and clarity, and formatting.

The TGA are holding a webinar: Introduction to the new formatting and structure of the Poisons Standard to highlight and answer questions about the key changes that have been made to the Poisons Standard. 

Webinar details

When: Wednesday 7 December 2022

Where: Online 

Time: 12:30 - 1:15pm AEDT  

CMA has the opportunity to provide feedback to the TGA via Industry Working Groups on areas of the website where members are experiencing difficulty, including:

- struggling to find information

- encountering broken links; or

 - where issues have been reported and members are not getting any response.

Members are invited to provide initial feedback via technical@cmaustralia.org.au by C.O.B. Friday 9 December for the next round of responses.

Sponsors of products that have particular names and/or indications relating to pregnancy are receiving educative warning emails.

This technical alert is intended to help give members supportive information on the background, context and content of the communication, and various options available for sponsors to consider for the products listed in the emails. 

The TGA has published outcomes of the consultation on proposed low0negligible risk changes to the Permissible Ingredients Determination, which occurred in August - September 2022.

The outcome of the consultation is largely aligned with CMA’s submission to the consultation, which advocated for a number of changes to reduce the level of impact of the proposal. These changes relate to warning statements for:

 - Valerian

 - Chelidonium

 - Chaparral

The final changes will commence on 1 March 2023, after which new (or newly ‘grouped’) medicines that are released for supply are generally expected to be compliant with new requirements.

For existing medicines, a one-year transition period will be instated to allow sponsors to ensure product compliance, ending on 1 March 2024. 

Please read today’s Tech Alert for more information and details.

A new Therapeutic Goods (Permissible Ingredients) Determination (No. 5) 2022 commenced on Tuesday 29 November 2022.

This Technical Alert contains all details of new, deleted and changed ingredients, and a comparison of all changes to the Determination for members. Please note that the information in this alert is included in a comparison table and is more detailed than the description published on the TGA website.

This alert details:

• NEW ingredients and specific requirements that apply to that ingredient, including;
• • shea butter ethyl esters;
  • 3-fucosyllactose;
  • hemp seed oil; and
  • the addition of an ingredient for flavour PIs: ‘monomenthyl glutarate’.

• CHANGED ingredients with the original requirements and the new or changed requirements, including:
• • aminocaproic acid;
  • atropine sulfate monohydrate;
  • sodium carbonate;
  • sodium carbonate monohydrate;
  • Curcuma zanthorrhiza;
  • Laurus nobilis;
  • Bay Oil; and
  • Laurel Leaf Oil

• DELETED ingredients, including:
• • ‘aminobenzoic acid’; and
  • Amyl cinnamic alcohol.

Transition Reminder

Members are reminded that the end of the transition period for certain ingredient changes is approaching on 28 February 2023.

Some changes relate to pregnancy warnings, or allergen warnings, which are often subject to retail or consumer level recalls if the required statements are not included.

Vitamin B6

- maximum daily dose change from 200mg to 100 mg (adults);

- maximum daily dose change for children (depending on age group)

- warning statements on labels for products containing > 10 mg pyridoxine per MRDD.

Artemisinin containing herbs

- End of transition period to include a pregnancy warning for certain existing artemisinin containing ingredients.

Mollusc derived ingredients

- Updated allergen warning

These ingredients were subject to changes following the outcomes of the 2021-22 Permissible Ingredients Consultation. Please see CMA's 27 September 2022 tech alert, the TGA Final Decisions Document and the TGA Oct 2022 publication on Vitamin B6 for more information. 

Please note: Due to recent changes in the Advertising Code ‘health warnings’, members should also ensure, as a priority, that relevant advertisements (e.g. where an advertisement facilitates directly the purchase or other supply of a medicine; and the medicine is not able to be physically inspected by a consumer before the purchase or other supply) have the required warnings.

TGA Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey closes 18 December 2022 

Pease note: Any sponsor who has at least one medicine included on the ARTG should complete this survey. Medicine sponsors that do not complete the survey will be assigned the highest survey risk score, meaning you have a very high chance of receiving a PV Inspection under the TGA's PVIP. 

The TGA's Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey is designed to inform the TGA about a sponsor's medicine portfolio, pharmacovigilance system, inspection history and compliance with Australian pharmacovigilance legislation and guidelines, and will serve as a tool to help prioritise and schedule pharmacovigilance inspections.

Sponsors are directed to complete and submit their survey responses online; the survey consists of 24 questions and must be completed in one attempt only. Partially completed surveys will not be recorded and cannot be retrieved for later use. After completing the survey, a message will be displayed on your screen saying that your response has been recorded. You may also download a copy of your responses for your own records (please note that a copy of your responses will not be sent to your e-mail).

The TGA request that stakeholders answer the questions carefully and truthfully as they may ask for evidence of responses during a pharmacovigilance inspection.

A copy of the survey questions is provided to assist stakeholders prepare their responses prior to submission.

Please visit the TGA website for more information, to access the survey questions and respond to the survey.