Technical Alerts

The TGA have published new Advertising guidance in relation to differentiating between consumer level advertising and advertising directed exclusively to health professionals, including where advertising may or may not need to be restricted. This can be particularly relevant to practitioner only companies, and those who conduct any kind of advertising or non-advertising (factual information) activities in relation to complementary medicine substances and products. More information available here.

This important technical alert for members includes information relating to substances eligible to be included in listed medicines and the regulatory framework.

Today's technical alert contains important information, context and considerations fro industry members in relation to:

- The TGA targeted compliance reviews of traditional indications

- All post market compliance reviews of listed medicines

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.