Technical Alerts

Cannabiniod update

In ongoing global recognition of the low risk safety profile of cannabidiol (commonly called 'CBD') and broad spectrum hemp extracts, the Republic of South Africa have gazetted a change to the Schedules of the MEDICINES AND RELATED SUBSTANCES ACT, 1965, to make two cannabis preparations for internal therapeutic use available as 'Category D' complementary medicines that can only make lower level therapeutic claims - the south African equivalent of listed complementary medicines in Australia.

The change means that two different preparations are now permitted:

- A low dose cannabidiol (currently in Australia this is the equivalent of a Schedule 4 registered medicine preparation; and proposed by the TGA to be a Schedule 3 Pharmacist Only registered medicines preparation);

- A cannabis extract with naturally occurring quantities of cannabiniods (other than cannabidiol) in the finished product (currently in Australia this preparation is the equivalent of a Schedule 9 prohibited substance - Substances which may be abused or misused, the manufacture, possession, sale or use of which should be prohibited by law except when required for medical or scientific research, or for analytical, teaching or training purposes with the approval of Commonwealth and/or State or Territory Health Authorities). 

Members can view the development and a comparison to current Australian down-scheduling proposals in today's technical alert.

Advertising Roundup

The TGA have issued a warning to Sponsors of cold and flu medicines that advertising cannot conflict with current public health campaigns, in particular, the messaging should not promote out-of-home activities such as work/school/other activities with (suppressed) symptoms, which would conflict with Government COVID-19 guidance.

The Federal Court have fined GSK and Novartis $4.5m for the misleading advertising of two OTC gels for joint pain that had the same active ingredient.

Members are reminded that the requirement to have pre-approval for advertisements appearing in specified media ends on June 30 2020.

The TGA have guidance available for advertisers on social media platforms.

The TGA have recently issued a safety advisory for Andrographis paniculata (Andrographis) following adverse event reports which have associated the use of Andrographis with potential taste disturbances, such as changes to the sense of taste, including the potential for complete loss of taste. For more information about the safety advisory, please see today's technical alert.

Today's technical alert contains some detail for members on the Data Protection Scheme for Listed (Assessed) complementary medicines, which is before the House of Representatives as part of an amendment Bill to the Therapeutic Goods Act 1989.

The Scheme provides a critical element of incentivising innovation into new therapeutic indications for ingredients used in listed complementary medicines.

This technical alert includes:

-A summary overview of the intended Scheme's purpose, benefits, operation and key functional elements; and

-Background to the Scheme and a copy of the relevant amendments coupled with legislative explanatory notes.

Further detailed parameters and context will become available as implementation of the scheme progresses.

For more information on flexibility on time frames for both the TGO 92 and TGO 10, please see today's technical alert. 

The TGA have published a revision to the Australian Regulatory Guidelines for Complementary Medicines (ARGCM), which replaces the previous version (ARGCM V8.0).

The ARGCM provides guidance for manufacturers, sponsors, healthcare professionals and the general public on the regulation of complementary medicines in Australia.

Click here for more information regarding the revised ARGCM.

Today's Member Alert contains new industry updates in relation to:

- The publication of CMA's position statement on the down-scheduling of Cannabidiol (CBD)

- AUST L(A) Data protection: the Therapeutic Goods Amendment (2020 Measures No.1)Bill 2020.

- The upcoming end to the Advertising Pre-approval process.

Please click here for more details.

Following the publication of an interim decision on 6 February 2020, and invitation for further comment on substances referred to the November 2019 ACMS/ACCS meetings, a second review of restrictions for caffeine occurred via the Scheduling mechanisms. The Delegate of the Secretary has made a final decision to affirm the interim decision and amend the current Poisons Standard in relation to caffeine. A Notice of final decisions to amend (or not amend) the current Poisons Standard, May 2020, has been published on the TGA website. The decision will take effect on 1 June 2020.

Today's technical alert includes:

-The scheduling decision

-An outline of the relationship of this decision to Listed Medicines and the Permissible Ingredients Determination

The TGA have issued a safety advisory statement for the potential of dose-related adverse events relating to vitamin B6, in particular noting that there may be side effects due to the ingestion of multiple complementary medicines, or side effects at doses below 50 mg.

The TGA are reviewing the issue, stating that the outcome of the review may result in changes to the requirements for medicines that contain vitamin B6.

In addition to background information, today's technical alert (available here) includes:

-Potential upcoming consultation in relation to vitamin B6

-CMA's response to the publication

This technical alert, available here, contains important detail and analysis regarding the upcoming PIC/S GMP Code Version 14, and helps members understand the upcoming PIC/S GMP Code by summarising key areas where expectations are, and are not, changing for listed medicine manufacturers.

The alert includes:

-The implementation date of Version 14 and transition periods;

-Information on Gap Analysis relating to clarification of interpretation and effect on Listed Medicine Manufacturers;

-Expectations regarding audits of raw material manufacturers/suppliers;

-Oversight of outsources testing and contract laboratories; and

-increased clarity of processes which permit reduced end testing.

Also included is information on increased publication of ARTG information.

It is expected that from 2021 certain Cannabidiol (CBD) products will have increased consumer access and be able to be purchased without a prescription. There are two "down-scheduling" consultations currently open, seeking public submissions on what form this consumer access may take. The Australian Government is proposing low-dose access via Pharmacists only. A private applicant is proposing wider consumer access to CBD of a similar preparation type. These two related consultations will result in only one final decision on CBD access and will take into account public submissions and expert Committee advice.

Please see the member alert for more information.