Technical Alerts

Today's important member alert contains important information for members, including sponsors, manufacturers, retailers and practitioners, in relation to the TGA's decision not to amend the Poisons Standard for amygdalin and hydrocyanic acid.

Whilst amygdalin for therapeutic use has been prohibited via Scheduling for many years, it can be a substance found in low or trace amounts in a range of foods and herbal medicines from the Prunus (such as almond, cherry) and Malus (apple) species

Members are strongly encouraged to read today’s full alert for further details, context and possible impacts. Today's alert also includes a timeline summarising the Scheduling history of amygdalin.

Members are reminded that the end of the transition period for existing products that contain inorganic magnesium salts and Andrographis is 28 Feb 2022. Sponsors have been provided a 12-month transition period from 1 March 2021 to bring existing listed medicine products into compliance:

 - Existing products that contain Andrographis must include a taste disturbance warning from March 1 2022.

 - Existing products that contain inorganic magnesium salts must include a laxative warning on labels from 1 March 2022 when the magnesium meets the requirements of the Permissible Ingredients Determination.

Please read today’s technical alert for more details.

Please read today's tech alert for further information on:

 - Titanium dioxide (TiO2) - Europe update;

 - Proposed amendments to the Poisons Standard: Cannabis and       tetrahydrocannabinols; 

 - Medicines Advisory Statements Specification (MASS) updates for   registered medicines - menthol, methyl salicylate, melatonin; and 

 - TGA stakeholder survey report 2021.

The TGA have published new Guidance on applying the new Advertising Code rules. The new Advertising Code (2021) took effect on 1 January 2022 and is subject to a 6-month transition period until 30 June 2022 where both the 2018 and 2021 Advertising Codes will apply.

Please read today’s Member Alert for more details, including information on mandatory statements, testimonials and endorsements, health warnings and how to register for the upcoming TGA Advertising Code webinar on Thursday, 20 January 2022. 

The TGA have published outcomes of the consultation on proposed low-negligible risk changes to the Permissible Ingredients Determination, which occurred in August-September 2021. These changes include amendments to:

 - Vitamin B6 containing products

 - Artemisinin containing products

 - Allergen statement for mollusc-derived ingredients

The final changes will commence on 1 March 2022, after which new (or newly ‘grouped’) medicines that are released for supply are generally expected to be compliant with new requirements.

For existing medicines, a one-year transition period will be instated to allow sponsors to ensure product compliance, ending on 1 March 2023. 

Please read today’s Tech Alert for more information and details.

The TGA have published a new Advertising Code (2021) from commencement on 1 January 2022 with a 6 month transition period ending on 30 June 2022.

The Therapeutic Goods (Therapeutic Goods advertising Code) Instrument 2021 has been made under section 42BAA of the Therapeutic Goods Act 1989 commencing 1 January 2022 and repeals the Therapeutic Goods Advertising Code (No. 2) 2018. 

NOTE: Despite the repeal of the former 2018 Advertising Code, it will continue to apply for the duration of the 6-month transition period, such that requirements specified in the former code may continue to be complied with during transition.

Please read today’s full member alert for further information and details on changes to the Code, including a table of comparative changes on warnings statements.

Today's Technical Alert provides information on the Required Advisory Statements for Medicine Labels (RASML) consultation outcomes for menthol; methyl salicylate; and melatonin. RASML statements become adopted by the Medicines Advisory Statements Specification (MASS).

These changes to RASML /MASS largely affect registered complementary medicines and are not yet updated to reflect the changes, but are expected to be updated in late 2021 or early 2022.

A transition period of 18 months from commencement will allow for any existing medicines to have their labelling updated. More information is included in this technical alert including context and a comparison between the requirements and those currently outlined for menthol and methyl salicylate in listed medicines in the Permissible Ingredients Determination.

Today's Technical Alert provides important information for sponsors in relation to discrepancies between the Permissible Ingredients Determination and the Poisons Standard; and the Permissible Ingredients Determination and the TGO 95 (Child-resistant packaging requirements for medicines).

Sponsors are encouraged to review the specific information provided in this technical alert to help ensure products are compliant with applicable mandatory requirements.

Please read today’s full alert for further details

Following collaboration with the TGA-Industry Working Group on GMP (TIWGG), the TGA have provided an update on certain temporary measures introduced last year for overseas manufacturers. 

Today's tech alert provides information on the latest update and includes details for sponsors and manufacturers on the following and requests any feedback to CMA through our ongoing participation on TIWGG:

- Ongoing use of Remote Inspections.

- Compliance verification pathway.

- Mutual Recognition Agreement (MRA) pathway.

- Remote GMP Inspections.

- GMP clearance

- Fees and charges associated with inspection and GMP clearance processes.

Today's member alert contains clarifying information for members who are involved in the sale, labelling, or advertising of listed medicines with substances derived from seafood (fish, crustacea or mollusc). These warning statements have been in a state of change to modernise warning statements and changes are still occurring. 

Today’s alert includes a summary overview of current regulatory status relating to seafood warnings (both current and likely forthcoming due to existing consultations) and recently revised eBS Code Table warnings and listed medicine validation rules for sponsors.

A selection of sponsors may notice ARTG changes on some listings, affected sponsors will be contacted by the TGA about changes and opportunities to update ARTG records without charge in the near future. Sponsors who are not contacted may also choose to update ARTG records with updated warnings described in this alert as per normal processes (Noting that the ARTG record does not affect legislative requirements, which continue to apply irrespective of the ARTG record).