Table of contents

Page last updated: September 2016

Part A – Guidelines for preparing the main body of a submission

Section 1 Context

Section 2 Clinical evaluation

Section 3 Economic evaluation

Section 3A Cost-effectiveness analysis

Section 3B Cost minimisation

Section 4 Use of the medicine in practice

Section 5 Options to present additional relevant information

Part B – Information requests for specific product types

Product type 1 – Fixed-dose combination products

Product type 2 – Nutritional products

Product type 3 – Vaccine products

Product type 4 – Codependent technologies