Technical Alerts

The TGA have announced new arrangements to allow continued and flexible oversight of licenced domestic manufacturers by performing remote GMP inspections for some overseas manufacturers from July 2020, following the suspension of overseas GMP inspections and QMS audits due to COVID-19 travel restrictions. Click here for more information.

Today's technical alert includes information on:

- The successfully updated System for Australian Recall Actions (SARA) database’s search facility, undertaken in response to requests from industry and other stakeholders to provide better access to TGA recall data;

- The TGA Data matrix (Serialisation) “TGO 106” consultation, which proposes requirements for serialisation and the use of data matrix codes on the labels of certain medicines in the Australian supply chain; and

- The announcement of the TGA Pharmacovigilance Risk Survey, open to Sponsors until 30 September 2020.

Access the full alert here.

Pre-approvals are no longer required for advertisements appearing in specified media. Please note, all advertisements for therapeutic goods are still required to comply with the therapeutic goods regulatory requirements.

CMA always recommend the use of our highly experienced regulatory affairs consultants, included on the CMA Regulatory Affairs consultants web page to help assess advertisements.

Click here for a summary list of links to information and guidance to assist members in shortcuts to navigating useful areas for listed medicines, but please refer to the Advertising Hub

Today's technical alert contains important information for members on pregnancy indications, pregnancy products and other relevant information including current consultation. Please click here to view the alert.

Today's technical alert includes an update regarding TGA fees and charges from July 1 2020 for Section 14/14A consents and information about the PIC/S Guide to GMP PE009-14: transition to new requirements for medicinal products.

Please see the full technical alert for details.

The Department of Water, Agriculture and the Environment (DAWE) have published a notice alerting to recurring issues with importers not holding valid import permits for a variety of products, including medicines and foods.

Most biological products require a valid bio security import permit. You must have a valid import permit issued by DAWE before your goods arrive in Australia, or there is risk of incurring significant costs, commercial burdens and delays. 

For more information, please see today's technical alert.

Following public consultation, the TGA have published an interim decision on the proposed amendments entries for Arbutin and Melatonin to the Poisons Schedule, referred to the joint meetings of both chemicals and medicines scheduling committees in March 2020.

In Accordance with regulation 42ZCZP, interested persons (including the applicant requesting the amendment)are invited to make submissions to the Secretary in relation to these interim decisions on or before 9 July 2020.

The date of implementation for changes to both Arbutin and Melatonin is 1 October 2020.

Please view the full technical alert here for more information.

A new Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2020 (the Determination) has commenced. This instrument is made under section 26BB of the Therapeutic Goods Act 1989 (the Act)and repeals the Therapeutic Goods (Permissible Ingredients) Determination no. 1 of 2020.

This technical alert includes a summary of all changes to the determination, in addition to a list of changes with a Checklist/Notes field for sponsors to use, as part of a table detailing every change to check against products, including:

- Each new or changed ingredient

- The original requirements

- The new (amended) specific requirements & any applicable concentration percentages

Please view the full technical alert here for more information.

Today's technical alert includes some important information for members applying for Section 14/14A consents, including those seeking extra time to comply with the requirements of the TGO 92 due to recent business disruptions. 

Please find today's alert here.

From 1 September the transition period to the TGO 92 ends, meaning from that date, products 'released for supply' by the manufacturer are required to comply with the TGO 92 as the standard for labels od non-prescription medicines.

In response to requests from CMA and other industry, the TGA are providing a streamlined mechanism whereby sponsors who have been experiencing administrative delays and challenges due to the Covid-19 disruptions, are able to request consent via a form to supply listed medicines with labels that continue to comply with the older TGO 69 labelling order until 6 March 2021. Registered medicines will be given until this time and potentially longer depending upon request and circumstances. The cost of this Section 14/14A application is $480 which will accommodate up to 20 products.

Please read this technical alert for more information and details on how to apply.