Australia CTD Module 1 Update
The TGA has released a new version of Module 1: Administrative Information and Prescribing Information For Australia, dated November 2008. Fortunately this agency includes a nice Document Change Record at the beginning of the document. Changes include:
- References to TGA organisation and titles updated
- Text amended to reflect changes in GMP clearance for prescription medicines as a result of the introduction of TGA eBusiness Services (Part B Module 1.7)
- Addition of Module 1.13 Information relating to Pharmacovigilance (Part B Module 1.13)
Module 1.13 is entirely new. It consists of a Risk Management Plan for Australia, as outlined in Chapter 1.3 of EudraLex Volume 9A – Pharmacovigilance for Medicinal Products for Human Use (version September 2008).