Technical Alerts

From 1 July 2020, the Government have committed to the ceasing of all pre-approved advertisements in specified media for complementary medicines. From 14 November 2019, Complementary Health Care Council of Australia (CHCA) will no longer be accepting applicaton to pre-approve advertisments. Sponsors may prefer to apply before this date. From December 2020, an interim provider will be announced by the TGA to approve applications until pre-approvals cease in July 2020.

Details, including calendar links of important dates for you to place in your calendar (eg Outlook or Google), are included in this linked Member Alert.

We are also pleased to advise in this alert, that the TGA have finalised and published the arrangements that will allow listed medicine sponsors to apply for consent to supply medicines with names that do not conform to certain aspects of TGA's labelling order, until such time as a new consultation can be undertaken during 2021. This will help to protect the existing distinguishing marks within medicine name's of complementary medicine businesses, including logos, taglines, or registered trademarks.

Please see the linked technical alert below for important details, developments, and targeted discussions on important raw material and listed medicine ingredients updates:

1) CMA Version 4 Release of Allergens/Substances questionnaire: We are pleased to release a new Version 4 of the "Allergens and other Substances of Concern" raw material questionnaire for industry, with a number of improvements.

2) New Substance CMA working group: CMA are convening a new specific working group for members who are closely involved in NEW SUBSTANCE applications, including raw material supplies, sponsors, and consultants to discuss current policy issues, developments and options.

3) Comparable Overseas (Assessment) Bodies: A preview of the Comparable Overseas (Assessment) Bodies or "COBs" is now available through CMA, including the updated draft guidelines. The drafted list includes bodies such as FSANZ, EFSA, FDA, Health Canada, and more.

4) Proprietary Ingredients: Feedback from TGA/industry and a reminder for all suppliers and sponsors using PIs listed with the TGA.

5) Other updates, including a TGA flagged issue regarding the way the Permissible Ingredients Determination is made and used.

We would also like to advise the TGA have announced that Kaylene Raynes will be replacing Michael Shum as the Director of Business Improvement and Support Section of the Complementary & OTC Medicines Branch, a role that encompasses the remaining complementary medicine regulatory reforms. Michael will be entering the Prescription Medicines Branch.

Technical Alert link: RAW MATERIAL & LISTED MEDICINE INGREDIENT UPDATES

The TGA have launched a public consultation which proposes to make a large proportion of sports supplements into products regulated as therapeutic goods.

Steps underway by CMA, and other details regarding this consultation and next steps for members and affected industry stakeholders, are included in the attached Member's alert.

Team CMA.

CMA have published a new webpage for members, which collects a wide variety of compliance deadline dates for new or amended TGA requirements. This is to assist members as a general summary and reminder of upcoming dates.

The TGA Asssessed claimer logo and positive claimer of efficacy statement on AUST LA and AUST R complementary medicines has now been authorised. The TGA have released a legislative instrument enabling the use of the claimer, and associated guidelines outlining the way that the claimer can be used on labels and in advertising. There are two AUST R complementary medicines now implementing the claimer.

For details on the both the above, please see our technical alert today here.

As foreshadowed in our August member alerts, the Department of Industry, Innovation and Science has opened public consultation for the purpose of canvassing options for the continued eligibility of origin claims in the complementary medicines sector.

For full details, read the Alert here.

CMA have been monitoring and discussing regulatory expectations for probiotic products with the TGA and our membership. Today's technical alert covers several recent issues surrounding probiotic products, including several each relating to:

• Probiotic labelling under TGO 92; and
  
• Product enumeration and stability considerations

For full details, please find today's alert here.

The legislative amendment to the Therapeutic Goods Regulations to extend the fee free period for listed complementary medicine sponsors has been signed into effect by the Governer-General. The fee for changing existing listings to permitted indications has been turned off in the TGA listing system. No fee is payable if the listing is amended by the end of 5 March 2021.

If you have a paid for an application to change an existing listing to permitted indications between 6 September and today, you are eligible for a refund. It will assist the TGA to find and process your refund if you email complementary.medicines@health.gov.au with the application ID and invoice number.

In 2014, the TGA examined cases of allergy and anaphylaxis regarding Andrographis paniculata ('Andrographis'), and published a safety alert in 2015. At that time, industry supported the introduction of a warning statement for this herb with adequate transition time, however, a warning statement was not implemented by the TGA.

Additional cases of allergy and anaphylaxis have been reported since 2015, and the TGA have signalled that they are intending to require a new allergy and anaphylaxis label warning statement for immediate implementation in mid-October (2019), for any Andrographis medicine that is 'released for supply' from the date of the upcoming October Permissible Ingredients Determination. 

If you are a sponsor with an Andrographis product, please be aware of an upcoming announcement. CMA are examining whether there are possibilities to minimise impacts.

In response to issues surrounding the use of 'black salve' in the community, a delegate of the TGA previously made an application to the Advisory Committee of Medicine Scheduling to make Sanguinaria canadensis, or blood root, a Schedule 10 substance when containing 0.01% or more of sanguinarine. S10 are substances of such danger to health as to warrant prohibition of sale, supply and use.

Following the initial round of consultation, the TGA have made an interim decision (subject to final round of consultation) to confirm this scheduling approach.

This decision is expected to:

• Not affect medicines currently listed on the ARTG, including other herbs with sanguinarine as a component such as Greater Celandine (Chelidonium majus), or suitably dilute homoeopathic listings of S. canadensis.
• Make ineligible any and all supply of black salve or similar topical preparations or any preparations of blood root with more than 0.01% sanguinarine in Australia.
• It may affect some practitioners who use blood root as a tincture for oral use.

The TGA have launched an online TBS application form for applying for the evaluation of a new substance, including the ability to upload supporting documentation online, and making the required declarations to submit the application. It also includes the ability to request the two year exclusivity period.

The online form is accompanied by a new application user guide describing all steps of submitting the online application for a new substance.

We recommend saving as you go where possible, as the portal is known to occasionally "time out", which can cause loss of any unsaved information on the application page you are in.

Please advise us if there are any process issues arising with the use of the new form or user guide.