Navigating regulatory requirements is crucial for pharmaceutical and medical device companies to ensure compliance and facilitate smooth operations. This week the Therapeutic Goods Administration (TGA) of Australia provides essential guidance on various aspects that impact the industry.
For Authorised Prescriber (AP) applications, the Special Access Scheme (SAS) & Authorised Prescriber (AP) Online System (SAS & AP Online System) is the preferred method of submission. To assist medical practitioners in managing their AP applications, the SAS & AP Online System reduces administrative burden and provides additional reporting and management functions.
To reduce processing times, prescribers are strongly encouraged to submit applications through the SAS & AP Online System (the system). To register an account and submit AP applications, patients must submit six monthly patient data reports.
Introduction to Authorized Prescribers: Understanding the role and responsibilities of Authorized Prescribers under Australian law.
Online System Overview: Navigating the TGA’s online platform for submitting and managing Authorized Prescriber applications.
Application Process: Step-by-step instructions on how healthcare professionals can apply to become Authorized Prescribers.
Compliance and Reporting: Requirements for ongoing compliance, reporting obligations, and maintaining authorization status.
For detailed information, consult the TGA's Authorized Prescriber Online System Guidance here.
Amid global healthcare demands, the TGA guides exporting ventilators from Australia. This guidance outlines three pathways for exporting ventilators from Australia:
Gaining TGA Approval:
Ventilators must meet Australian regulatory requirements and be listed in the ARTG.
Likely classified as Class IIa or IIb devices.
Requires a Conformity Assessment Certificate demonstrating compliance with safety and performance Essential Principles.
Export Only:
Ventilators not intended for sale in Australia can be listed as Class I (Export Only) on the ARTG.
No TGA pre-processing review; self-certification is required by the manufacturer.
Importing countries may have restrictions due to lack of independent assessment.
Charitable Donation:
Exemption from ARTG inclusion if ventilators are not for commercial use or contain prohibited substances.
Conditions apply, including compliance with importing country's regulations.
Explore the full TGA guidance on Exporting Ventilators here for comprehensive details.
TGA’s guidance on Excluded Software outlines regulatory exemptions for software intended for medical purposes that do not qualify as medical devices. This guidance aims to assist sponsors, manufacturers, and software developers to understand the boundaries between software that is and is not regulated.Â
For more insights, refer to TGA’s guidance on Excluded Software here.
Comments