Revised: 3 May 2013
Overview of Therapeutic Product Regulation.
How to seek approval for over the counter medicines.
How to seek approval for prescription medicines.
Information on the requirements for package labelling.
Permitted colourings for use in medicines and related products.
Medsafe's policy related to particular types of medicine and application
Indicative Processing Times for New Medicine Applications (NMAs) and Changed Medicine Notifications (CMNs)
The Medicines Assessment Advisory Committee (MAAC) advises the Minister of Health on the balance of benefits and risks of new medicines.
The current recommended composition for influenza vaccine.