Technical Alerts

The Federal Register of Legislation has been updated to allow low-THC hemp seeds and hemp seed products as foods under the Food Standards Australia New Zealand Food Standard. However, restrictions under the Poisons Standard may still apply under Australian State and Territory and NZ law.

For more information, please click here.

The attached technical alert contains details of the revisions to the permitted indication list, details around requesting an extension if desired, and the proposed implementation including future applications for indications.

CMA has made the following submission regarding intentional omissions or changes to the existing Listed medicine system. CMA did not repeat general indication requests made by individual members as the TGA has provided that each submission would be fully assessed and repetition would slow down the process.

Biomarker / biological substrates

Maternal health and infancy

Traditional qualifiers

Mild and Medically Diagnosed including BPH, etc.

As recently discussed at CMA Board and Regulatory Policy meetings, we believe the Amendment Bill for the reformed framework to complementary medicines is a beneficial move forward for the complementary medicines industry.CMA has identified a few items for amendment to improve the overall outcome. The proposed amendments are minor in nature, there is no intent or likelihood of preventing Bill passage. As agreed, CMA has produced a template letter to the Minister on behalf of member sponsors* to create a broad industry show of support for these small amendments with important positive impacts. To access the letter, you will need to be logged in as a member to the CMA website.
 
If in agreeance, please return a finalised letter signed by a company representative to Lucy.Lang@cmaustralia.org.au by COB Monday, 9 October, for presentation to the Minister by CMA.

Release of Consultation Document – New Assessment Pathways

The TGA has released its ‘Consultation: Business process improvements supporting complementary medicines assessment pathways’. It details new business processes associated with regulatory reforms for Complementary Medicines, which are under implementation in response to the Medicines and Medical Devices Regulation (MMDR) Review. The consultation contains a broad amount of information relating to the TGA’s new ‘risk-based approach to regulating complementary medicines: three assessment pathways’, and includes the following topics and questions.

Please click here to read the alert

The TGA has just released its Consultation: 'Business process improvements supporting complementary medicines assessment pathways’ with further details on the new pathway and new processes applicable under regulatory reform. Additionally, it has released the new GMP Clearance Application e-forms. For further information please click here.

This month the TGA published the document Fees and charges: summary from 1 July 2017 providing an update regarding fees and charges.

In addition, the TGA has provided at the latest TGA Industry Forum, a summary of fees and charges proposed as a result of regulatory reforms, which will be introduced in changes to the Therapeutic Goods (Charges) Regulations.  These fees are indicative and subject to Ministerial approval. All fee changes are subject to Regulation amendment and some correspond with Charges Act amendments.

The TGA has released the consultation paper: Therapeutic Goods Advertising Code - Proposed improvements, including proposed framework for Schedule 3 medicine advertising.

Today the TGA released the revised Pharmacovigilance Guidelines and further information about the Pharmacovigilance Inspection Program (PVIP) including the PVIP Inspection Guidelines. For more information please click here

Registration opens at 9am tomorrow for the TGA's Pharmacovigilance Inspection Program Information Sessions, being run out of Sydney, Melbourne and Brisbane. For more information please click here.

An amendment order to amend the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines (TGO 92) has now been registered on the Federal Register of Legislation. Please click here for more information.