Technical Alerts

An important reminder that the transition period for permissible indications ends on 5 March 2021. There are more than 2,000 products, or >20% of listings remaining to be transitioned. 

Please read this technical alert for more information about the end of the transition period and implications for sponsors and products.

Critical key points to understand in relation to the transition are that:

- The last day that sponsors will have to submit their application to re-list their medicine with permitted indications is 5 March 2021.

- Changes to indications only, remain free until 5 March 2021 due to the 18 month extension to the ‘fee free’ period previously supplied.

- Any products that do not have updated records by this date will be cancelled from the ARTG and sponsors will no longer be able to supply these medicines.

- An extension to the date cannot occur in the way that occurred for TGO 92, as the date is included in the Therapeutic Goods Act and there are not the same approval mechanisms in place to be able to extend the applicable date on an individual basis.

- There will not be any letters proposing to cancel the listing issued prior to the cancellation.

- Any cancellations that occur are not associated with Section 60 appeal rights.

- If sponsors do not have evidence of submitting their application to transition to permitted indications on or before 5 March 2021, then the medicine is likely to be captured in the automatic cancellation process

- Products that are automatically cancelled on 6 march 2021 that sponsors desire to retain would therefore need to be re-listed as new products.

The TGA have published a reminder for advertisers of their responsibility to ensure advertising complies with the legislative requirements specified in the Therapeutic Goods act (the Act). 

The reminder refers to the TGA advertising guidance, in addition to providing a new Advertising compliance checklist for consumer advertising, which is intended to be used in conjunction with the Act, the Therapeutic advertising Code (the Code) and published guidance.

Please click here for more important information in relation to advertising considerations, and to access a summary list of advertising resources.

Following the publication of an interim decision on 10 June 2020, and invitation for further comment on substances referred to the March ACMS/ACCS meetings, the Delegate of the Secretary has made a final decision to vary the interim decision and amend the current Poisons Standard in relation to melatonin. A Notice of final decision to amend the current Poisons Standard has been published on the TGA website. The decision will take effect on 1 June 2021.

Today's technical alert includes the scheduling decision and further information on the amendments.

The TGA have recently issued a safety advisory for Manasmithra Vatika (Manasanitram Pills), following a report of the presence of lead in the Ayurvedic product.

For more information about the safety advisory, please see today's technical alert.

Today's technical alert contains important information and considerations for industry members in relation to the TGA targeted compliance reviews of Listed medicines considered at risk of containing safrole, including Camphor oil, Cinnamomum camphora, Mace, Myristica fragrans, Nutmeg, Ocotea odorifera, Rosemary oil and Sassafras albidum.

The Sports Supplement decision has been released. Below is an overview summary breakdown of the effects of the decision. Please read today's full member alert for more information about the decision and RIS for Sponsors and Manufacturers. 

Essential Summary breakdown of effected products:

*(includes: gaining muscle; increasing mental focus; increasing metabolism; increasing stamina; increasing testosterone levels; reducing oestrogen levels or otherwise modifying hormone levels; losing weight or fat; preparing for workout; recovering from workout).

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.