Technical Alerts

The TGA has published an updated web page on revised guidance for listed medicines to include two new learning modules developed by the TGA to assist sponsors of listed medicines to understand how to use the Evidence Guidelines. These modules aim to supplement the information in the Evidence Guidelines. Click here to read more.

Yesterday we sent an alert about registering for the GMP Forum on Tuesday 21 March 2023, at the ICC Darling Harbour.

Important note - workshop places are limited to the first 60 people who apply to attend.

Particularly for sessions 3 and 4, the workshops may be more relevant for CM sponsors, so if these workshops are your preference, please register early to ensure you secure a workshop place.

For some sessions, you have the option of attending one workshop (limited to 60), or two consecutive talks – to select the correct session choices please check the program here before registering.

When finalising payment, it asks for the Client ID numbers – members are reminded to enter the code ‘CO-9001’ instead of their TGA client ID number (which do not work for this process), and to select the 19 option (GMP Forum 2023 Registration), per the TGA example on the website.

For all other registration, payment and event enquiries, please contact the TGA directly:

GMP Forum Team

1800 020 653

gmpforum@health.gov.au

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.