Technical Alerts

We are very pleased to announce that - as foreshadowed in our technical updates and primarily in response to CMA advocacy on this issue - the fee free period for transitioning ARTG listings to permitted indications has formally been extended for 18 months to 6 March 2021 - the final date that medicines can transition before auto-cancellation - and this fee-free information update has now been published on the TGA website.

As noted previously, there was a very short period after 6 September 2019 where the legislation was not yet in effect and if you received an invoice, this will need to be paid and then refunded.

We would like to thank all our members for your ongoing support and involvement.

Team CMA.

CMA is extremely pleased to provide that the TGA's Scheduling Committee and Delegate have accepted our application to downschedule herbs containing arbutin for oral use, and made the "interim decision" to make them available to practitioners, industry and the public again at the proposed limit. This includes herbs such as Bearberry and Damiana.

We particularly would like to thank our CMA members and our collaboration with the NHAA who made significant contributions to this effort.

An updated Advertising Approval Application form has been released, which includes some minor changes, including reflecting the updated complaints handling process.

The TGA have requested that applicants use the updated form, available here:

The purpose of this technical alert is to provide some additional clarification and information received in respect of the use of herbal and biological components. This is particularly in relation to the use of documentation where there are necessary differences between the manufacturing documents and the ARTG due to the system limitations of the ARTG.

On Friday 6 September 2019, the original "fee-free" period to update existing ARTG listings to permitted indications expired. However, CMA advocacy has resulted in an application for an extension to this period.

We are expecting a full 18-month extension period to 6 March 2021 for fee-free ARTG listing updates.

We are aware that the fee has now been turned on, contrary to original advice that the fee would not be turned on, and have spoken to the TGA who have provided the following updated information.

The legislation has been drafted, however, the Australian Government committee that approves regulations need to approve the final draft. The extended fee-free period will not be in effect until the final approval and legislative change occurs which is expected to be either in mid-September or mid-October (2-6 weeks). They have drafted the fee-free legislation to be backdated to 6 September so there will be no period where a fee is payable.

While the TGA prefers not to turn on the grouping fee for applications to change to permitted indications in the short-term, they have been advised that they should until the new legislation is in effect.

This means that in the next 2-6 weeks until the change is made and the fee turned off, sponsors can choose to:

1. Pay the fee when changing to permitted indications, and receive a refund* when the legislation is changed and backdated to 6 September.

*It's expected that the TGA will only refund applications that currently pass fee-free arrangements, that don't include other changes that trigger a 'new' or 'grouping' application such as changing a medicine name.

OR

CMA has been in ongoing discussions with the TGA on how the TGO 92 labelling order - which is due for final implementation in September 2020 - may be unintentionally causing negative and costly impacts upon brand logos, including locally or internationally registered trademarks, for complementary medicine sponsors.

We are very pleased to announce that through CMA advocacy, including direct CMA member involvement, the TGA have agreed to offer industry a specialised application process that is intended to provide relief to sponsors whose pre-existing brand logos or trademarks continue to be adversely affected. This specialised application process is being designed to be practical to achieve, and low in cost. It will help sponsors during the next few years, which allows the TGA additional time to examine more permanent options for additional branding flexibility for sponsors. Both the short term and long term processes will continue to have some conditions to ensure that the guiding principles of the TGO 92 – to have improved clarity of labels and medicine names for consumers – continue to be met.

Members should read the CMA technical alert here, if:-

• You have a brand name on your ARTG Certificate(s) of Listing and you think your brand logo might be affected by the TGO 92 requirements to have a continuous, uninterrupted, unbroken medicine name as part of Section 9(2) of the Order - this may include small graphics or taglines as part of your brand logo; and you would like to know more about the upcoming process; or

• Your brand name(s) are not included on the ARTG Certificates of Listings.

Please note this application process is not yet a public announcement by the TGA. They are working quickly to make these arrangements to help the complementary medicines industry on this branding issue. If you have any questions or comments, please contact us directly (Lucy.Lang@cmaustralia.org.au) rather than the TGA, until more information is published on their website.

Thanks for your ongoing support.

A correction has been made to the listing facility to allow for the correct expression of propolis and royal jelly ingredients, and their extracts, in their ARTG listings.

These changes will be made by the TGA for free in response to requests from sponsors to update their records before 31 March 2020. After this date, the changes will incur the standard fees.

A new consultation has been released regarding the next round of proposed changes to the Permissible Ingredients Determination. The changes are considered by the TGA to be low to negligible risk in nature, with proposed changes including label warning statements and mandatory ingredients.  Affected ingredients include boron, Withania somnifora, Vitex agnus-castus, Plantago spp, psyllium husk and some other minor amendments.

The legislative amendment capturing the most recent changes to the Determination was registered on 29 August 2019.

The TGA have announced a raft of changes to listed medicines containing caffeine, including caffeine as a component of a herbal ingredient. NOTE that some of these changes are IMMEDIATE, and some have an 18-month transition period.

All details are included in today's Technical Alert including CMA contact details if you are affected. We are currently communicating with the TGA on number of products expected to be affected by the immediate changes and next steps.

We are pleased to share with you an update on allowable Made in Australia claims and the Australian Made logo with regard to Australian complementary medicines.

To read the full alert, please click here.