Fees for licence applications

 

Under this section you will find relevant fees for medicines, including herbal and homeopathic medicines, and blood banks and blood establishments applicable from 1 April 2014.

Fees for licence applications from 1 April 2014

The table on this page provides the details of the fees payable for licence applications. The details for other fees are available in the subsections of this section listed within the left-hand navigational structure.

Details of the MHRA's bank accounts to be used when remitting payment of your invoice/s or in advance of your application/s.
Bank account details

Please note: Where a half fee is applicable, the sum will always need to be rounded up, eg if the fee is £599, then the half fee is £300.

Licence applications

Marketing authorisations (including extension applications)

Fee £
  Major  
  National fee (including hybrid applications) 103,059
  Decentralised procedure where UK is CMS 99,507
  Major (reduced in exceptional circumstances1 or orders under Section 104/105) 33,035
  Outgoing Mutual Recognition (UK RMS)  
   - 1st wave 46,192
   - 2nd wave 30,342
  Incoming Mutual Recognition (UK CMS)
and European reference products
69,357
  Abridged complex  
  National fee (including hybrid applications) 28,492
  Decentralised procedure where UK is CMS 27,511
  Outgoing Mutual Recognition (UK RMS)  
   - 1st wave 11,948
   - 2nd wave 7,925
  Incoming Mutual Recognition (UK CMS)
and European reference products
19,256
  Abridged standard  
  National fee 10,447*
  Decentralised procedure where UK is CMS 10,087
  Outgoing Mutual Recognition (UK RMS)  
  - 1st wave 4,758
  - 2nd wave 3,963
  Incoming Mutual Recognition (UK CMS)
and European reference products
7,056
   Abridged simple  
  National fee 2,849
  Decentralised Procedure where UK is CMS 2,849
  Outgoing Mutual Recognition (UK RMS) 2,849
  Outgoing Mutual Recognition
(informed consent)
2,849
   - 1st wave 2,849
   - 2nd wave 2,849
  Duplicates for all of the above outgoing Mutual Recognition applications when undertaken at the same time as the lead application 2,849
Decentralised procedure where UK is RMS  
  Major 143,134
  Abridged complex 41,922
  Abridged standard 18,422*
  Abridged simple 9,535
Extension application  
  Extension application group (national fee) 28,492
  Extension application group bulk (national fee) 10,447
  Extension application group  
  Decentralised procedure where the UK is RMS 41,922
  Decentralised procedure where UK is CMS 27,511
  Outgoing Mutual Recognition (UK RMS)  
   - 1st wave 11,948
   - 2nd wave 7,925
  Incoming Mutual Recognition (UK CMS) 19,256
  Extension application group bulk  
  Decentralised procedure where the UK is RMS 18,422
  Decentralised procedure where UK is CMS 10,087*
  Outgoing Mutual Recognition (UK RMS)  
   - 1st wave 4,758
   - 2nd wave 3,963
  Incoming Mutual Recognition (UK CMS) 7,056*
Parallel import Complex application 2 20,200
  Standard application 2 7,403
  Simple application 1,991
     
Change of ownership (including THMPD registrations) 491
Manufacturers' licences (including THMPD and homeopathic medicinal products Standard 3,143
  Non-orthodox practitioner (NOP) 183
  Change of ownership 344

Notes:

1. To which Section G of Part IV of the Annex to Council Directive 75/318/EEC refers.
2. An application for a Parallel Import licence for a product where there is no common origin between the imported and UK reference product – similar definitions for incoming Mutual Complex and Standard applications apply.

 

* Where relevant, these standard, rather than complex, fees will be charged where the application is only concerned with the introduction of new suppliers of defined simple Active Pharmaceutical Ingredients (APIs). More information can be found on Fees for New Suppliers of Defined Simple Active Pharmaceutical Ingredients (Updated March 2013)PDF file (opens in new window) (20Kb)

Contact for further information

The Regulatory Information Service (RIS) acts as the single main point of contact for the marketing authorisation holders of medicines and their representatives. All enquiries relating to product licenses and any associated regulatory activity should initially be referred to RIS, where the staff will endeavour to provide an answer to the enquiry and, if unable to do so, will refer to other defined areas of the Agency for an appropriate response. Contact details are available on the Regulatory Information Service (RIS) for medicines page.

Page last modified: 01 April 2014