Technical Alerts

A number of end of year updates from the TGA include:

• TGA response to online publication of excipient ingredients
• Update to the Uniform Recall Procedure for Therapeutic Goods
• New TGA E-learning Modules for Listed Medicines
• Update to Advertising Guidance
• Published GMP Webinar on common GMP Clearance pitfalls 

The protection for the Australian Complementary Medicines industry to make country of origin claims and apply for the Australian Made logo has now been enshrined in legislation.

This important measures allows our industry to continue to expand our $1 billion plus export market for complementary medicines and secure local jobs into the future.

All the details on the Government announcement, the new Regulations, including which manufacturing steps are included, which are excluded, and a legislative outline, are included in this Member Alert.

The TGA are proceeding with a data protection scheme for Listed Assessed Medicines - those medicines which contain listable ingredients but are evaluated by the TGA for efficacy, prior to market entry.

Important changes have announced for CAFFEINE in foods. 

See the technical alert for more information.

BREAKING DEVELOPMENTS - Country of Origin Labelling New Regulations for Complementary Medicines.

Click here to read more.

The TGA has announced

- announced a new process for recognising comparable overseas bodies and their reports

-  announced a new consultation on medicine export processes

- released the Technical guidance on the interpretation of the PIC/S Guide to GMP for Medicinal Cannabis products.

The technical alert contains more details.

The Permissible Ingredient Determination (No. 4 of 2019) has been registered on the Federal Register of Legislation.

It contains changes to requirements for Andrographis paniculata, Vitex agnus-castus, Withania somnifora, Boron, Psyllium, Plantago spp, Isphagula spp,  Malus pumila and menthol and methyl salicylate containing ingredients.

See the technical alert for details.

A new Permitted Indications Determination is in effect, with a transition period end ate of 6 march 2021.

It includes 8  new indications, as well as more and less restrictive changes. For full details, go to the CMA technical alert.

An overview of the CMA submission and keys points are contained in the CMA member alert.

The full submission is located  here.

The application process for advertising pre-approvals is undergoing significant changes.  For full details see the CMA Technical Alert

Folate-containing foods for special medical purposes have now been declared therapeutic goods in a recent amendment to the Therapeutic Goods (Declared Goods) Order 2019.