Posted by Michael Wonder on 12 Oct 2017
Product Information
12 October 2017 - Changes make critical clinical information easier to find.
From 2018 you’ll start to see changes to the format of Product Information (PI) documents. You’ll first notice the updated format with new medicines and any medicines where changes to the PI are made.
The changes will bring this important information together at the front of the PI document, helping health professionals quickly and easily locate this information and also aligning with other international regulators.
Under the old format the critical information for health professionals (indications, dosage and administration instructions, contraindications, precautions and adverse events information) has been located after information on the pharmacology and clinical trials of the medicine.
All PIs will be changed to the new format by the end of 2020.
