This section details the fees payable for the regulation of medicines, including herbal and homeopathic medicines, and blood establishments and blood banks.
Please note there is no increase in fees for 2011-12.
All fees will be charged at 2010-11 rates and are in accordance with the current legislation - 'The Medicines (Products for Human Use)(Fees) Regulations 2010'.
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.
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
Final reminder to cancel medicines licences by the end of December 2011
Periodic fees and cancellation of licences - holders of authorisations, registrations and licences are required to notify the MHRA by 31 December 2011 to cancel authorisations, registrations and licences from 31 March 2012. If you have not cancelled them yet please do so as soon as possible.
This will ensure that you are not liable for a periodic fee in connection with a specific licence for the fee period 1 April 2012 to 31 March 2013.
Regulation 33 (5) (a) of the Medicines (Products for Human Use) (Fees) Regulations 2010 SI 2010 No.551 requires authorisation, registration or licence holders to give three-months notice to the licensing authority before the beginning of a fee period (i.e. 1 April) if they wish to cancel a licence. They will then not be liable for the periodic fee.
Fees for licence applications from April
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 (including extension applications) |
Fee £ | Fully compliant eCTD | |
|---|---|---|---|
| Major | |||
| National fee (including hybrid applications) | 105,146 | 100,252 | |
| Decentralised procedure where UK is CMS | 101,541 | 96,797 | |
| Major (reduced in exceptional circumstances1 or orders under Section 104/105) | 33,709 | 32,135 | |
| Outgoing Mutual Recognition (UK RMS) | |||
| - 1st wave | 44,934 | - | |
| - 2nd wave | 29,516 | - | |
| Incoming Mutual Recognition (UK CMS) and European reference products |
70,774 | 67,468 | |
| Abridged complex | |||
| National fee (including hybrid applications) | 29,068 | 27,716 | |
| Decentralised procedure where UK is CMS | 28,073 | 26,762 | |
| Outgoing Mutual Recognition (UK RMS) | |||
| - 1st wave | 11,623 | - | |
| - 2nd wave | 7,709 | - | |
| Incoming Mutual Recognition (UK CMS) and European reference products |
19,650 | 18,732 | |
| Abridged standard | |||
| National fee | 10,659 | 10,162 | |
| Decentralised procedure where UK is CMS | 10,294 | 9,812 | |
| Outgoing Mutual Recognition (UK RMS) | |||
| - 1st wave | 4,628 | - | |
| - 2nd wave | 3,855 | - | |
| Incoming Mutual Recognition (UK CMS) and European reference products |
7,200 | 6,864 | |
| Abridged simple | |||
| National fee | 2,906 | 2,771 | |
| Outgoing Mutual Recognition (UK RMS) | 2,769 | - | |
| Outgoing Mutual Recognition (informed consent) |
2,769 | - | |
| - 1st wave | 2,769 | - | |
| - 2nd wave | 2,769 | - | |
| Duplicates for all of the above outgoing Mutual Recognition applications when undertaken at the same time as the lead application | 2,769 | - | |
| Decentralised procedure where UK is RMS | |||
| Major | 154,706 | 147,479 | |
| Abridged complex | 45,312 | 43,195 | |
| Abridged standard | 19,910 | 18,980 | |
| Abridged simple | 10,303 | 9,788 | |
| Extension application | |||
| Extension application group (national fee) | 29,068 | 27,716 | |
| Extension application group bulk (national fee) 2 | 10,162 | 9,654 | |
| Extension application group | |||
| Decentralised procedure where the UK is RMS | 45,312 | 43,195 | |
| Decentralised procedure where UK is CMS | 28,073 | 26,762 | |
| Outgoing Mutual Recognition (UK RMS) | |||
| - 1st wave | 11,623 | - | |
| - 2nd wave | 7,709 | - | |
| Incoming Mutual Recognition (UK CMS) | 19,650 | 18,732 | |
| Extension application group bulk | |||
| Decentralised procedure where the UK is RMS | 19,910 | 18,980 | |
| Decentralised procedure where UK is CMS | 10,294 | 9,767 | |
| Outgoing Mutual Recognition (UK RMS) | |||
| - 1st wave | 4,628 | - | |
| - 2nd wave | 3,855 | - | |
| Incoming Mutual Recognition (UK CMS) | 7,200 | 6,864 | |
| Parallel import | Complex application 3 | 19,650 | - |
| Standard application 3 | 7,200 | - | |
| Simple application | 1,937 | - | |
| Change of ownership (including THMPD registrations) | 478 | - | |
| Manufacturers' licences (including THMPD and homeopathic medicinal products) | |||
| - Standard | 3,057 | - | |
| - Non-orthodox practitioner (NOP) | 178 | - | |
| - Change of ownership | 335 | - | |
| Wholesale dealers' licences (including THMPD and homeopathic medicinal products) 4 | |||
| - Standard 5 | 1,754 | - | |
| - Change of ownership | 388 | - | |
| Export certificates | |||
| - Per set (1 original + 2 copies) | 67 | - | |
| - Per set (urgent) | 148 | - | |
| - Extra copies (3rd copy +) | 33 | - | |
| GMP certificates | |||
| 1 additional copy | 67 | ||
| Clinical trials | |||
| Accreditation of Phase 1 units | 126 | - | |
| Certificate of accreditation | 67 | - | |
| Applications | Phase 1 trial | 2,255 | - |
| Phase II or Phase III trial where product being tested is unknown | 4,244 | - | |
| Phase II or Phase III trial where product being tested is known | 3,448 | - | |
| Phase IV trial | 265 | - | |
| Additional protocols | 265 | - | |
| Cross-referrals | 265 | - | |
|
Notes: 1. To which Section G of Part IV of the Annex to Council Directive 75/318/EEC refers. 2. For additional extension application groups involving authorisation of different strengths and pharmaceutical forms of the same active substance (and other changes) the usual complex to standard fee reduction will apply. 3. 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. 4. 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. 5. This rate includes an additional element equivalent to an inspection fee of one day for standard applications and 3.5 hours for reduced rate applications. If the application for a WDL is withdrawn before the inspection takes place, the equivalent inspection fee will be refunded. If the inspection takes longer than one day for a standard application, or 3.5 hours for a reduced rate application, an invoice will be raised for the balance due. |
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Contact for further information
For further information on licensing fees for medicines, please contact either Tracy Murray or Karen Salawu MHRA, 5 Magenta, 151 Buckingham Palace Road, Victoria, London, SW1W 9SZ, telephone 020 3080 6329.
