This section provides answers to frequently asked questions about licensing fees for medicines.
1. Definitions of different types of marketing authorisation applications
One of the most common questions we are asked is about the definitions of the different types of marketing authorisation applications. We are therefore publishing an extract from the MHRA fees legislation the The Medicines (Products for Human Use)(Fees) Regulations 2010 S.I No 551 which defines each of the different types of application:
MHRA fees definitions
(23Kb)
2. Clarification of terminology relating to periodic fees
You might find it useful to refer to the extracts in the document below from the The Medicines (Products for Human Use)(Fees) Regulations 2010 S.I No 551. They will help you determine how to calculate turnover and whether you can claim reduced or maintenance rates for any of your products.
Clarification of terminology relating to periodic fees (17Kb)
3. Payment easements for small companies - Definition of a small company
The Agency’s fees legislation currently has provision for some payment easements for small companies in relation to a number of capital fees.
Payment easements for small companies (26Kb)
Extract from MHRA fees legislation for further information (11Kb)
