Technical Alerts

Today's technical alert discusses concerns for sponsors and manufacturers in relation to standardised herbal extracts and the requirements of the TGO 92 to declare the minimum quantity.

Historically, an average quantity was required to be declared on the ARTG however, newer entries do not include any quantity due to the discontinuation of Herbal Component Names on the ARTG. This raises issues when sponsors are releasing for supply, as the ARTG is mismatched to the label statement of quantity.

Please click here for further information outlining current advice on these unusual circumstances which affect ARTG entries, labels, and release for supply requirements.

IMPORTANT REMINDER FOR ALL SPONSORS AND ADVERTISERS.

CLICK HERE FOR MORE INFORMATION.

Today's technical alert covers contextual information for industry relating to infringement notice processes across regulatory agencies, including the Department of Agriculture, the TGA and the ACCC. 

It includes common information about infringement notices, their recent history, purpose, how they operate in the regulatory context, and key information for noting.

This includes the roles and responsibilities of the regulatory agency and the recipient, for which we encourage businesses to familiarise themselves with.

Today's alert is available on this link.

The Australian Government is developing an Information Standard for complementary medicine manufacturers and sponsors seeking to make 'Made in Australia' claims.

The discussion paper on the proposed Information Standard for Country of Origin Labelling (CoOL) is open for consultation, closing on 24 September 2020.

If adopted, products making a claim in line with the 2020 reforms will be required to disclose the proportion of Australian ingredients on labels when the product is claimed to be ‘Made in Australia'. Currently it is voluntary for the complementary medicines sector to make Australian origin claims, however  claims are subject to the same CoOL laws.

Please see today’s member alert for more details, background and further information on how to make a submission.

Please see today's technical alert in Word or PDF about the consultation on proposed changes to ingredients in the Permissible Ingredients Determination, including a member feedback form for your comments.

The TGA have advised that enhancements have been made to the TGA Business Services Portal on the TGA website to enable publication of approved Product Information (PI) and consumer Medicine Information (CMI) documents for some non-prescription medicines (and some biologicals).

PI and CMI documents for non-prescription medicines, including some registered complementary medicines, which meet the requirements, will have the (non-mandatory) option of online lodgement in TBS from today, 24 August 2020. Documents lodges online, when approved, will also become available for the public to access online via the TGA website. 

Please see today's technical alert for more information on the requirements fro lodging online PI and CMI documents. 

We are very pleased to announce the success of CMA's down-scheduling application to make herbs containing (beta) arbutin, such a s Bearberry, Damiana and others, again more available for use through significantly lower restrictions.

For more information including the effect of this decision on herbal medicines, dates, a brief background and other relevant details and information, please read today's member alert on arbutin changes. 

A new Permissible Ingredients Determination (No. 3) 2020 has commenced with one new ingredient and changes to existing ingredients, including reduced regulatory requirements in some instances.

This Technical Alert (available in Word or PDF) contains a detailed list of changes with a Notes field for sponsors to use to assist in identifying the changes relevant to products, as part of a table which includes:

- Each new or changed ingredient

- The original (previous) requirements that applied

- New (amended) specific requirements.

In particular, the amendments contain notable clarifications for products with herbs containing levodopa as a mandatory component.

Members interested in Fallopia multiflora (He Shou Wu or Fo-Ti) should also refer to today's alert.

There have been changes and updates and clarifications to the Therapeutic Goods legislation, the Australian Regulatory Guidelines for listed medicines, and the User Guide, in relation to new substance applications for listed medicines.

Notable changes include:

- Mandatory data requirements for preliminary assessments (under development)

- How the TGA will manage duplicate applications for the same new ingredient

- Clarification regarding types of substances that may be applied for, and naming applications prior to new substance applications

- More information on the evaluation phase of the application and the recommendation or refusal of an application

- Additional clarification for market exclusivity arrangements

For details and context please see the attached technical alert. We welcome your ongoing feedback in relation to these application processes and guidance documents.

The Australian Government has released and responded to the Independent Review of the TGA'S Advertising Framework, conducted by Rosemary Sinclair AM.

The background and twenty-two outcomes are summarised into the key takeaway messages for our members here, which is relevant to sponsors, retailers, consumers, and all who engage with therapeutic goods advertising.