Healthy Skepticism Library item: 16182

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

PI and CMI online from Oct
Pharmacy Daily (Australia) 2009 Aug 6
http://www.pharmacydaily.com.au

Full text:

THE Therapeutic Goods Administration is proceeding with plans to make Product Information and Consumer Medicine Information publicly available, with details to be on its website by the end of October.

The move has been opposed by the Pharmacy Guild, which circulated a petition (PD 03 Apr) at the APP conference earlier this year urging the government to stop the web move, saying it would “unnecessarily complicate and duplicate the existing streamlined provision of such information via the dispensing process.”

Yesterday the TGA published an update to its Business Reform consultation held last month.

Improving access to PI and CMI details is a key initiative of the project, and will allow consumers to simply search and retrieve the information by looking for product names, active ingredients or
sponsor names.

The system will see sponsors upload PDF versions of the PI and CMI documents, which will be automatically linked to entries in the Australian Register of Therapeutic Goods.

Detailed instructions on the process will be available shortly, with details on currently marketed products to be captured between 9th September and 21st October.

CMI and PI for marketed products will be published from 29th Oct, while other products will be placed online from 29th October to 24th December.

The Business Reform Project also includes proposals for accelerated applications for new drugs, reducing timeframes to market by replacing the current 40 working day process with pre-submission
and improved submission validation Project for the Office of Prescription Medicines, which follows industry processes.