Fees for medicines, blood establishments and blood banks

This section details the fees payable for the regulation of medicines, including herbal and homeopathic medicines, and blood establishments and blood banks. These fees were implemented following our consultation, MLX 344, issued on 17 October 2007.

Details of the MHRA's bank accounts to be used when remitting payment of your invoice/s or in advance of you application/s.
› Bank account details
 
Periodic (Service) fees for 2008/2009
 Companies are reminded that settlement of the 2008/09 invoices, which were issued on 30 May 2008, is now due.
 
If you have not already done so, please make payment of the full invoice value immediately and arrange for your corresponding fee schedule to be completed, signed and submitted to the Accounts Receivable (AR) team. If it is then apparent that a lower fee was payable, the AR department will raise a credit note or refund for the amount that is subsequently due.
 
Alternatively, if there are any reasons that are preventing you from settling these invoices, then please call the AR team on 020 7084 2533.
 
Fees for licence applications 
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.

LICENCE APPLICATIONS

MARKETING AUTHORISATIONS

Fee £ Fully compliant eCTD
  MAJOR    
  National Fee (including Hybrid applications 3 ) 98,491 93,907
   Decentralised procedure where UK is CMS 95,114  90,671
   MAJOR (reduced in exceptional circumstances1 OR Orders under Section 104/105) 31,576 30,101
  OUTGOING MUTUAL RECOGNITION    
   - 1st WAVE 42,090 -
   - 2nd WAVE 27,648 -
   INCOMING MUTUAL RECOGNITION  and European reference products 66,295 63,198
   ABRIDGED COMPLEX    
   National Fee (including Hybrid applications 3 ) 27,228 25,962
   Decentralised procedure where UK is CMS 26,296 25,068
   OUTGOING MUTUAL RECOGNITION    
   - 1st WAVE 10,883 -
   - 2nd WAVE 7,221 -
   INCOMING MUTUAL RECOGNITION  and European reference products 18,406 17,546
   ABRIDGED STANDARD    
   National Fee  (including Hybrid applications 3 ) 9,984 9,519
   Decentralised procedure where UK is CMS 9,642 9,191
   OUTGOING MUTUAL RECOGNITION    
  - 1st WAVE 4,333 -
  - 2nd WAVE 3,611 -
  INCOMING MUTUAL RECOGNITION and European reference products 6,745 6,430
   ABRIDGED SIMPLE    
   National Fee 2,722 2,596
   OUTGOING MUTUAL RECOGNITION 2,593 -
   OUTGOING MUTUAL RECOGNITION  (Informed consent) 2,593 -
   - 1st WAVE 2,593 -
   - 2nd WAVE 2,593 -
  Duplicates for all of the above Outgoing Mutual Recognition applications when undertaken at the same time as the lead application 2,593 -
DECENTRALISED PROCEDURE WHERE UK IS RMS     
  Major 144,914 138,145
  Abridged complex 42,444 40,461
  Abridged standard 18,650 17,779
PARALLEL IMPORT   1,815 -
CHANGE OF OWNERSHIP (incl. THMPD registrations)  448 -
MANUFACTURER'S LICENCES (incl. THMPD and Homoeopathic Medicinal Products)     
  - STANDARD 2,911 -
  - Non Orthodox Practitioner (NOP) 169 -
  - CHANGE OF OWNERSHIP 319 -
WHOLESALE DEALER'S LICENCES (incl. THMPD and Homoeopathic Medicinal Products)     
   - STANDARD 1,670 -
   - REDUCED RATE  2 715 -
 - CHANGE OF OWNERSHIP 369 -
 EXPORT CERTIFICATES     
  - Per set (1 original + 2 copies) 63 -
  - Per set (URGENT) 141 -
  - Extra copies (3rd copy + ) 31 -
 CLINICAL TRIALS    
 Applications Phase 1 Trial 2,146 -
  Phase II or Phase III trial where product being tested is unknown 4,040 -
  Phase II or Phase III trial where product being tested is known 3,283 -
  Phase IV trial 252 -
  Additional protocols 252 -
  Cross-referrals 252 -

Notes:

1. To which Section G of Part IV of the Annex to Council Directive 75/318/EEC refers.

2. Special reduced rate to apply for wholesale dealers handling GSL products only and for registered retail pharmacies and small wholesale dealers where wholesaling of licensed products does not exceed 15% or £35,000 of total turnover in licensed products.

3. Hybrid applications
Directive 2004/27/EC expands the scope of what was previously known as the “proviso” paragraph, (this was the final paragraph of Article 10(1)(a)(iii)) to include all applications which do not meet the strict definition of a generic product. This includes those applications presenting the results of new pre-clinical and/or clinical data. This could occur where either, simple bioequivalence cannot be demonstrated or, those applications are for changes to the therapeutic indications, strengths, pharmaceutical forms, routes of administration or active substance compared to an authorized reference product. It is proposed to amend the definition of a complex application to cover all applications made under the expanded “proviso”. The usual fee for a Complex application will then apply.

Contact for further information
For further information on licensing  fees for medicines, please contact either Sue Jones,  Karen Salawu or Tracy Murray 16-106, MHRA, Market Towers, 1 Nine Elms Lane, London SW8 5NQ, telephone 020 7084 2652.


Page last modified: 07 July 2008