Presentation: Preparing a Product Information document for a generic medicine - quality and regulatory expectations

Background

The Product Information (PI) document is an invaluable resource for consumers and health practitioners, providing an overview of critical information relating to the therapeutic good. For generic prescription medicines, it is expected that the PI will be aligned with that of the corresponding brand medicine. 

However, due to changes in regulatory practices, historic documents, and differences between goods and sponsors, this is not always achieved. This webinar aims to give an outline of the regulatory expectations for the Product Information document for generic medicines, clarify most common deficiencies and answer frequently asked questions. 

Speakers

• Leanne Cornell, Principal Evaluator (A/g), Pharmaceutical Chemistry Registration Section, TGA 
• Igor Huskic, Evaluator, Pharmaceutical Chemistry Registration Section, TGA 
• Amy Minett, Senior Pharmacist, Pharmacist Evaluation Section, TGA 
• Justin Spence, Evaluator, Pharmaceutical Chemistry Registration Section, TGA

Slides