Technical Alerts

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. 

Following prior advice that major international changes in taxonomic naming protocol was to occur for Lactobacillus spp., those changes have now been announced in the scientific community and published in the International Journal of Systematic and Evolutionary Microbiology. The full article confirming and describing the taxonomy change is available free of charge here.

This technical alert includes a table comparing all existing names for all TGA Lactobacillus active ingredients with the updated scientific names. Please see the full technical alert for more information.

Today's Technical Alert contains reminders for:

-ingredient name harmonisation (30 April 2020); and

-Final transition date fro label warning statements for Andrographis paniculata (2 May 2020).

Please click here for more information.

Please see the latest CMA Techincal Alert for more information and updates to the COLD warning statement.

This technical alert is an update for industry on the following matters in relation to COVID19 developments:

• Current TGA approach to domestic GMP inspections
• Advice in relation to extending GMP clearances
• Changes to hand sanitiser regulation - a new "excluded goods" category which declares that specified products are not therapeutic goods. This is to facilitate the manufacture and supply of large quanitties of hand sanitisers during the current pandemic's high demand. These new "excluded goods" hand sanitisers must comply with specified formulation, manufacturing, labelling, and advertising requirements. These requirements (including amended requirements). More here.

CMA has written to the Australian Health Protection Principal Committee (AHPPC), chaired by the Chief Medical Officer requesting that complementary medicine manufacturers, suppliers and laboratories are classed as Essential Services. Read more here.

Please read the latest guidelines on essential and non-essential services.

COVID-19 has placed all in busy and challenging times. Please CMA's tech alert for a summary of activities relevant to our sector in relation to this developing situation.