Statutory guidance

MHRA fees 2014/15

Published 18 December 2014

Active pharmaceutical ingredients manufacturers and importers registration: fees

Fees for registration of active substance manufacturers Fees Notes
New applications    
New application for registration as a manufacturer of active substances £5006 £3143 application fee plus £1863 assessment fee
Fees for registration of active substance importer or distributor Fees Notes
New applications    
New application for registration as an importer or distributor of active substances £3157 £1803 application fee plus £1354 assessment fee
Additional fee if the risk assessment of the initial application triggers an inspection £582 £1936 Inspection fee less £1354 assessment fee
Inspection fee (per site if required) £1936 Charged for inspections conducted post registration
Variations    
Notification of changes (variation) £257  
Inspection fee (per site if required) £1936  
Annual compliance report    
Assessment of the annual compliance report £257 Subsequent to 2013, 30 April of each reporting year
Annual compliance report where a variation is required £514 When there have been changes during the year which need to be updated. £257 Notification of changes fee + £257 annual compliance report assessment fee.

Active substance importers or distributors: fees

Application for registration £1,803
Assessment of initial application: active substance importer / distributor £1,354
Additional fee for the first day of inspection if triggered following risk-assessment of the application £582
Assessment of the Annual Compliance Report: Active Substance Importer / Distributor £257
Notification of changes £257
Standard daily rate for Inspection £1,936
Persons appointed appeals procedure fee £10,000

Active substance manufacturers: fees

Application for registration £3,143
Assessment of Initial Application £1,863
Additional fee for the first day of an inspection if triggered following risk-assessment of the application £792
Assessment of the Annual Compliance Report £257
Notification of Changes £257
Inspection days £2,655

Blood banks: application fees for a Review Panel hearing

Fee £10,000

Notes: This fee will be payable on application for a Review Panel hearing and applies to all Review Panel proceedings related to an applicant who disagrees with a decision of the licensing authority and who has made an application to be heard pursuant to the relevant sections of the Human Medicines Regulations 2012 and subordinate legislation. A fee will be payable in respect of requests for hearings relating to marketing authorisations, manufacturer’s licences and authorisations, clinical trials applications, herbal and homeopathic registration and blood establishments and blood banks.

If the outcome of the hearing is positive for the company and the original advice is overturned, the fee will be refunded. If an application is made and subsequently withdrawn before a panel has been appointed to consider the case, a partial refund will be made (60%). If the application is withdrawn after the panel has been appointed, no refund will be applicable

Blood banks and other blood establishments: fees

Blood Establishments Fee Notes
New Applications    
Standard application plus full inspection fee £5,657 £3074 application fee plus £2583 inspection fee
Inspection fee (per additional site if required) £2,583  
Variations    
Standard variation £518  
Periodic Fee    
Annual fee £463  
Inspections    
Standard Inspection Fee: daily rate £2,583  
Haemovigilance    
Annual fee £492 Cost to the MHRA of operating the system for receiving and assessing reports of serious adverse events and reactions
Hospital Blood Banks and facilities Fee Notes
Inspections    
Inspection fee (per additional site if required) £2,583  
Haemovigilance    
Annual fee £492 In respect of cost to the MHRA of operating the system for receiving and assessing reports of serious adverse events and reactions(2)
Compliance    
Annual fee £683 In respect of receipt and assessment of annual compliance reports submitted by hospital blood banks to the MHRA(3)
1. ‘Facility’ is defined in SI 2006/2013 as: “a hospital, any other facility or service owned or managed by a health service body, a care home, an independent clinic, a manufacturer, or a biomedical research institute”    
2. SI 2006/2013 exempts from payment of the annual haemovigilance fee a facility that has entered into an arrangement with a hospital blood bank for that hospital blood bank to report serious adverse events or reactions on the facility’s behalf    
3. The annual compliance fee is only payable by hospital blood banks, not by facilities. It is charged in addition to any inspection fee that may be payable    

Blood facilities: contract laboratories fees

Inspections  
Inspection fee* (per additional site if required) £2,583
*For contract laboratories that test blood components on behalf of blood establishments or hospital blood banks  

Broker registration fees

Broker registration fees Fees Notes
New Applications    
New application for registration as a broker £3157 (£1803 application fee + £1354 assessment fee)
Additional fee if the risk assessment of the initial application triggers an inspection £582 (£1936 Inspection fee less £1354 assessment fee)
Inspection Fee (per site if required) £1936 Charged for inspections conducted post registration
Variations    
Notification of Changes (Variation) £257  
Annual Compliance Report    
Assessment of the Annual Compliance Report £257 Subsequent to 2013, 30 April of each reporting year
Annual Compliance where a variation is required £514 When there have been changes during the year which need to be updated. £257 Notification of Changes fee + £257 Annual Compliance Report assessment fee.

Clinical trials: application fees

Fee description Type of fee Fee
Applications with an IMP dossier Higher fee (Phase 1, Full and Simplified IMPD) £ 3400
Applications without an IMP dossier Lower fee (Phase IV, Cross referral, Additional protocol) £250
CT variations/amendments   £250

Notes:

There is no annual Clinical Trials fee and no fee for Phase IV notifications The requirement to provide payment of capital fees at the time of submission is a legal requirement specified in the MHRA Fees Regulations. Payment at a different time (e.g. on invoice) is not acceptable. For a cross-referral or additional protocol submission, no new IMPD or IB data should be provided; however, copies of the relevant manufacturer’s authorisation(s) and QP declaration (if applicable) should be provided since these are study specific. Proof of payment must be clearly stated in the covering letter and/or as a separate document (e.g. photocopy of cheque/confirmation of bank transfer). It is essential that the EudraCT number is quoted when making payments for clinical trials. Please also make reference to the product name, protocol code and clinical trial authorisation (CTA) number (where available).

Clinical trials for devices: fees

The fee depends on the class of your device. The figure in brackets is the fee for re-notification in the event of an objection  
Class I, IIa, or IIb other than implantable or long-term invasive  
£3,820 (£2,920)
Class IIb implantable or long-term invasive, Class III, and active implantable  
£5,040 (£3,570)

Drug-device combination products: fees

Device which incorporates a known medicinal substance from a source previously used in medicinal products or in medical devices where the MHRA has previously been consulted £4,595
Request by a notified body to the MHRA to supply an additional assessment report £909
Device which incorporates a known medicinal substance from a new source £10,711
Notified body request to the MHRA to supply an additional assessment report £2,542
Device incorporating a new active substance £46,996
Request by a notified body for the MHRA to supply an additional assessment report £11,668

Notes:

  • where a half fee is applicable, the sum will always need to be rounded up, e.g. if the fee is £599, then the half fee is £300
  • if a device incorporates two or more medicinal substances the fee will be for the higher priced substance
  • the same fee applies regardless of the strength or concentration of the medicinal substance.
  • one fee will apply to multiple applications made at the same time for a range of similar devices (e.g. a range of catheters made of the same material) incorporating the same medicinal substance at the same level

Homoeopathic National Rules Scheme: fees

Standard  
5 stocks or fewer £1,209
more than 5 stocks £1,458
Reduced  
Stock already assessed  
5 stocks or fewer £898
more than 5 stocks £1,127
Formulation already assessed  
5 stocks or fewer £898
more than 5 stocks £1,127
Both stock and formulation already assessed  
5 stocks or fewer £574
more than 5 stocks £813
Supplementary fees  
New method of sterilisation (non-pharmacopoeial) £2,393
New excipients £7,983
New sources TSE risk actives/excipients (non-CEP) £705

Homoeopathic National Rules Scheme: fees for inspections

Inspections are charged at a daily rate  
Type of inspection  
All GMP, GCP and pharmacovigilance inspections £2,655 (daily rate)

These include the following (this is not an exhaustive list)

  • intermediate biological sites
  • manufacturers of active pharmaceutical ingredients (API)
  • sterile, non-sterile and assembly sites
  • non-routine inspections
  • pharmacovigilance inspections, including those of service providers
  • clinical trials
  • contract laboratories
  • homoeopathic manufacturers
  • blood banks
  • blood establishments
Office-based risk assessments £1,863 (see notes below)
GDP (wholesale dealers* including homeopathic wholesalers)    
*A reduced rate fee for a wholesale dealer inspection will be payable by wholesale dealers who handle 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 ONLY where an inspector spends less than 3.5 hours on site. This fee will be £1,328    
Full day rate £1,936    
Reduced rate (see notes below) £941  
Office based risk assessments (see notes below) 1,354    

Notes: read before applying for an office-based risk assessment:

  1. Minimum fee of one day (with the exception of the GDP inspections)
  2. Inspection daily rate is calculated against a standard 7 hour working day (excluding lunch breaks). Number of days spent on site for fees purposes will be calculated by dividing the number of hours on site by 7. Additional part days of less than 3.5 hours will be charged at half the daily rate and part days in excess of 3.5 hours will be charged at the full daily rate.
  3. Daily rate fee includes pre-inspection preparation, travelling time, reporting of inspections and resolving issues. It also incorporates activities such as evaluation of compliance assessment report and other support functions and directly related overheads.
  4. A reduced rate fee for a wholesale dealer inspection will be payable by wholesale dealers who handle 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 ONLY where an inspector spends less than 3.5 hours on site. This fee will be £1,328.
  5. For inspections where two (or more) fully qualified inspectors undertake the inspection, the time on site for fees purposes will be the aggregated time for both inspectors.
  6. For inspections attended by two or more inspectors, one or more of who is in training, only the cost of one inspector will be charged. The status of the inspectors will be made clear to the company at the start of the inspection.
  7. The office based risk assessment fee will be charged where a risk assessment is conducted which does not lead to an inspection

Inspection: fees

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.

From 1 April 2014 fees for inspections will continue to be charged at a daily rate as follows:

Type of inspection Daily rate £ Pack Size Legal Status
All GMP, GCP and Pharmacovigilance inspections including:(This is not an exhaustive list):intermediate biological sitesmanufacturers of active pharmaceutical ingredients (API)sterile, non-sterile and assembly sitesnon-routine inspectionspharmacovigilance inspectionclinical trialscontract laboratorieshomeopathic manufacturers 2,655 18 P
Office based risk assessments (see notes below) 1,863 18 P
GDP (wholesale dealers including homeopathic wholesalers):      
Full day rate 1,936    
Reduced rate (see notes below) 941    
Office based risk assessments (see notes below)      

Notes:

  1. There is a minimum fee of 1 day (with the exception of the GDP inspections).
  2. The inspection daily rate is calculated against a standard 7 hour working day (excluding lunch breaks). Therefore the number of days spent on site for fees purposes will be calculated by dividing the number of hours on site by 7. Additional part days of less than 3.5 hours will be charged at half the daily rate and part days in excess of 3.5 hours will be charged at the full daily rate.
  3. The daily rate fee includes pre-inspection preparation, travelling time, reporting of inspections and resolving issues. It also incorporates activities such as evaluation of compliance assessment report and other support functions and directly related overheads.
  4. A reduced rate fee for a wholesale dealer inspection will be payable by wholesale dealers who handle 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 only where an inspector spends less than 3.5 hours on site.
  5. For inspections where two (or more) fully qualified inspectors undertake the inspection, the time on site for fees purposes will be the aggregated time for both inspectors.
  6. All accredited inspectors attending an inspection will be charged for, but inspectors in training will not. The status of the inspectors should be made clear to the company at the start of the inspection.
  7. The office based inspection risk assessment fee will be charged where a risk assessment is conducted which does not lead to an inspection.

Licence applications: marketing authorisations (including extension applications) fees

Major  
National fee (including hybrid applications) £103,059
Decentralised procedure where the UK is a concerned member state (CMS) £99,507
Major (reduced in exceptional circumstances or orders under Section 104/105) £33,035
Outgoing mutual recognition where the UK is the reference member state (RMS)  
1st wave £46,192
2nd wave £30,342
Incoming mutual recognition with the UK as a CMS and European reference products £69,357
Abridged complex  
National fee (including hybrid applications) £28,492
Decentralised procedure where the UK is a concerned member state (CMS) £27,511
Outgoing mutual recognition where the UK is the reference member state (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 (UK 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 the UK is a CMS £2,849
Outgoing mutual recognition where the UK is an 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 the 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 the 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
(To which Section G of Part IV of the Annex to Council Directive 75/318/EEC refers)  
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) (20Kb)

Licence applications: manufacturers licence (including THMPD and homeopathic medicinal products)* fees

*To which section G of part IV of the Annex to Council Directive 75/318/EEC refers

Standard £3,143
Non-orthodox practitioner (NOP) £183
Change of ownership £344

Licence applications: parallel imports fees

Complex application* £20,200
Standard application* £7,403
Simple application £1,991
Change of ownership (including THMPD registrations) £491
*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  

Licence applications: Phase 1 Accreditation Scheme fees

Phase I Accreditation Scheme Fee
Accreditation of Phase 1 units £130
Certificate of accreditation £69

Licence applications: wholesale dealer’s licence fees

Standard £1,803
Change of ownership £399

Medicines/medical devices export certificates: fees

| Urgent request: two working days per set | | Original and two copies | £152 | | Standard request: ten working days per set | | Original and two copies | £68 | | Each additional copy | £34 | ##Registration of brokers: fees

Periodic fees from 1 April 2014: per licence fee period

Type of licence Fee
New active substance (2) £24,821
Derivatives with a different route of administration (1) or complex abridged (2) £10,221
Other derivatives (1) £6,899
Legal status/sale category Fee type - see note 3
POM  
Standard fee* £2,556
Reduced rate fee £1,275
‘Maintenance’ fee £323
All others (P, GSL, PLPI and None) £323
Type of licence Fee
Herbal £80
Homeopathic and Anthroposophic PLRs (per PLR) £80
Simplified Homeopathic Registration No fee
National Rules Homeopathic Authorisation £80
Manufacturer’s licence £493
Wholesale dealer’s licence £303
Wholesale dealer’s licence (reduced rate or GSL) (4) £181
THMPD registration £80

Notes:

  1. Payable for first five complete fee periods following the year of grant. Includes Reduced Major Drugs with turnover greater than £200,000 - otherwise treat as POM.
  2. Payable for first three complete fee periods following the year of grant.
  3. Standard fee - This fee relates to Prescription Only Medicine (POM) products only and means the periodic fee payable where the value of the product sold or supplied does exceed £35,000 in the relevant fee period. Reduced fee - This fee related to POM products only and means the periodic fee payable where the value of the product sold or supplied does not exceed £35,000 in the relevant fee period. Lower fee - This fee means the periodic fee payable relating to a POM is not expected to be manufactured, or imported into the United Kingdom during the relevant fee period and: (a) that the medicinal product has not been manufactured or imported into the UK during the period of 12 months preceding the commencement of the relevant fee period; OR (b) where the medicinal product had been manufactured or imported into the UK during the period referred to in (a) above that the value of that product sold or supplied did not exceed £1,000 during that period

  4. Wholesale dealer’s licence (reduced rate or GSL) The reduced fee payable under regulation 37(3) is applicable where the wholesale dealer’s licence— (a) relates to anything done in a registered pharmacy by or under the supervision of a pharmacist and amounts to wholesale dealing, where such dealing constitutes no more than 15% of the total value of the sale of authorised medicinal products carried on at that pharmacy; (b) does not relate to anything done in a registered pharmacy, where the total value of the sale by way of wholesale dealing in authorised medicinal products does not exceed £35,000; or (c) relates to general sale list medicines only.

All other legal status medicinal products

Lower fee - This fee is payable relating to pharmacy medicines, general sale list medicines or ‘none’ status medicines regardless of turnover.

*Reminder to cancel licences by the end of December 2014

Holders of Manufacturers and Wholesale Dealer’s licences are required to notify the MHRA at pcl@mhra.gsi.gov.uk by 31 December, this will ensure that you are not liable for a periodic fee for the period 1 April 2014 to 31 March 2015.

Licence renewals, reclassifications and assessment of labels and leaflets: fees

Where a half fee is applicable, the sum will always need to be rounded up e.g. if the fee is £599 the half fee is £300

Licence Renewal Applications Fee  
Manufacturers’ licences Non-orthodox practitioner (NOP) £178  
Outgoing mutual recognition First renewal of a major application (1)   £10,758
All others (2) £830  

Fees are currently not applicable to national and mutual recognition decentralised procedure (MR-DC) authorisations where the UK is a concerned member state (CMS).

Reclassification Fee
POM to P - Additional for MA or PI application with reclassification element from POM to P (3), (4) £13,324
Reclassification variation application POM to P (3),(4) £13,324
P to GSL - Additional fee for MA or PI application with reclassification element from P to GSL (3), (4) £9,069
Reclassification variation application P to GSL £9,069
Reclassification variation application (MA) (analogous product) (4) £816
Reclassification Type IB variation application (MA) (analogous product) (4) £308
Reclassification variation application (PI) (analogous product) £397
Assessment of labels and leaflets  
Single or first application (5) £575
National (BROMI) - Article 61 (3) Notification (6) £207
Parallel imports £364

Notes:

  1. If a number of such renewal applications are made at the same time and in relation to products with the same active ingredient, dosage form, indications, Periodic Safety Update Report (PSUR) and renewal date, the full fee is charged for the first application, but a fee of £830 will be payable in respect of each of the other applications.
  2. If a number of such renewal applications are made at the same time and in relation to products with the same active ingredient, dosage form, indications, PSUR and renewal date, the full fee is charged for the first application, but a 50% “discount” applies to each other application.
  3. Where the Agency is of the view that a major reclassification application does not require consideration by a medicines advisory committee a 50% reduction of the fee applies.
  4. If multiple MA applications with reclassification elements are made at the same time and in relation to products with the same active ingredient, the full additional fee is charged for one application but only £816 for each other application. If multiple reclassification variation applications are made at the same time and in relation to products with the same active ingredient, the full fee is charged for the one application but in relation to each other application the fee is only £816, or £408 for PLPI variations in the case of other applications where there is an analogous product already with the same legal status.
  5. For all label and leaflet applications, a bulk “discount” applies where a number of simultaneous applications are made for identical changes covering a range of strengths of the same dosage form. The first application is charged at the full rate shown and second and subsequent applications are charged at 50%.
  6. See more on national leaflets and labels.

Safety and quality vetting of unlicenced imported medicines fees

Number of notifications estimated for coming year Additional sum to be paid*
1 – 20 £130
21 – 100 £519
21 – 1,000 £2,077
1,001 – 5,000 £10,383
5,001 – 20,000 £25,957
20,001 – 50,000 £51,914
50,001 – 100,000 £103,828
100,001 + £155,742

*Additional sum to be paid with annual periodic fee for Manufacturers Licence holders and wholesale dealer licence holders

Scientific advice meetings: fees

Quality development only £2,445
Safety development only £2,445
Quality and safety development £3,441
Clinical development only £3,070
Quality and clinical development £4,027
Safety and clinical development £4,027
Quality, safety and clinical development £4,985
Discussion on development of paediatric forms and uses meeting criteria for waiver set down in schedule 5 paragraph 10 of SI 2008 No.552 No fee
Pre-consultation application meetings on devices incorporating an ancillary medicinal substance*  
Quality development only £832
Safety development only £832
Quality and safety development £1,054
Clinical development only £1,054
Quality and clinical development £1,443
Safety and clinical development £1,443
Quality, safety and clinical development £1,831
Broader scope meetings £4,945
Pharmacovigilance advice meetings  
Standard meeting £3,402
Major meeting £4,027
Post-authorisation regulatory advice meetings £3,070
Advertising advice £2,445
Advice on labels and leaflets £2,445
Reclassification advice meetings  
P to GSL switch £3,070
POM to P switch £4,027

*Scientific advice on the medicinal substance aspects of the device product.

Simplified Homoeopathic Registration Scheme: fees

Standard      
5 stocks or fewer £878 more than 5 stocks £1,149
Reduced      
Stock already assessed      
5 stocks or fewer £531 more than 5 stocks £782
Formulation already assessed      
5 stocks or fewer £ 531 more than 5 stocks £782
Both stock and formulation already assessed      
5 stocks or fewer £177 more than 5 stocks £437

Simplified Homoeopathic Registration Scheme: Decentralised Procedure applications: fees

Where the UK is CMS 5 stocks or fewer £478 more than 5 stocks £625
Where the UK is RMS 5 stocks or fewer £956 more than 5 stocks £1,251

Simplified Homoeopathic Registration Scheme: Mutual Recognition Procedures: fees

Mutual recognition outgoing  
5 stocks or fewer £319
more than 5 stocks £416
Mutual recognition incoming  
5 stocks or fewer £557
more than 5 stocks £709

Traditional Herbal Registration Scheme: fees

Standard  
3 or fewer existing herbal active ingredient £2,692
more than 3 existing herbal active ingredients £4,038
Reduced  
Category I  
3 or fewer existing herbal active ingredients £599
more than 3 existing herbal active ingredients £897
Category II  
3 or fewer existing herbal active ingredients £897
more than 3 existing herbal active ingredients £1,347
Complex  
single new herbal active ingredient £5,384
2 or more new herbal active ingredients £8,077
Traditional Herbal Registration Scheme: supplementary fees  
Ancillary vitamins / minerals  
Existing Sources plus CEP £1,197
New sources (non-CEP) £2,393
New excipients £7,984
New sources TSE risk excipients (non-CEP) £709
Sterile products £2,393
Inspection of Manufacturers  
Full day £1,615
Half day £994
Inspection of Wholesale Dealers  
Full day £1,367
Half day £744
Inspection of non-orthodox practitioners £295

*Reduced registration application category I” means an application, other than a complex registration application, for a traditional herbal registration relating to a medicinal product which is presented in the form of a herbal tea; “reduced registration application category II” means an application, other than a complex registration application, for a traditional herbal registration where the application falls within one of the descriptions specified in sub-paragraphs (a) to (d) as follows— (a) the application relates to a medicinal product which is presented in the form of a herbal tincture (b) the application relates to a medicinal product which is presented in the form of an essential oil (c) the application relates to a medicinal product which is presented in the form of a fatty oil or (d) the application relates to a medicinal product which contains only “herbal substances in a capsule”

Variation: Homoeopathic National Rules Scheme fees

Standard variation application £270
Indication £416
Other applications (for up to 30 variations where no further medical, technical or scientific assessment is required) £137
Other applications (for any subsequent variations where no further medical, technical or scientific assessment is required) £69

Variations: Homoeopathic Simplified Scheme fees

New technical £270
Other applications (where further medical, technical or scientific assessment is required) £270
Other applications (for up to 30 variations where no further medical, technical or scientific assessment is required) £137
Other applications (for any subsequent variations where no further medical, technical or scientific assessment is required) £69

Variations: licence variations application fees

Type 1A National/CMS No fee
Type 1A RMS No fee
Type 1B National/CMS £308
Type 1B RMS or reference authority for worksharing £611
Type II National/CMS £816
Type II RMS or reference authority for worksharing £989
Type II complex National/CMS £9,232
Type II complex RMS or reference authority for worksharing £16,007
Extended type II complex National/CMS £28,492
Extended type II complex RMS or reference authority for worksharing £39,829

Re-submissions of type IB and II variations following invalidation: Within the re-submission, a copy proof of payment from the invalidated variation and an additional proof of payment to cover the 10% invalidation fee is required

Variations: licence variations applications groups fees

Where a half fee is applicable the sum will always be rounded up e.g. if the fee is £599 he half fee is £300

Minor variation (type 1B) group fee where the UK is:  
Concerned member state (CMS) £691
Reference member state (RMS) or Reference authority for worksharing £1,361
Major variation (Type II) group fee where the UK is:  
CMS £1,836
RMS or Reference authority for work sharing £2,218
Major variation (Type II) complex group fee where UK is:  
CMS £10,011
RMS or Reference authority for work sharing £16,926
Major variation (Type II) Extended complex group fee where UK is:  
CMS £29,196
RMS or Reference authority for work sharing £40,804
Minor variation (Type IB) group fee (national) £691
Major vatiation (Type II) group fee (national) £1,836
Major variation (Type II) complex group fee (national) £10,011
Major variation (Type II) extended complex group fee (national) £29,196

Variations: other licence variations applications fees

Parallel import (PI)  
Standard £397
Administrative No fee
Manufacturer’s licences (including traditional herbal medicines)  
Standard £514
Administrative £257
Wholesale dealers’ licences (includes THMPD)  
Standard £486
Administrative £257
Clinical trial authorisations  
Amendments to 1 part of dossier £250
Amendments to 2 parts of dossier £250
Amendments to 3 parts of dossier £250
Protocol £250

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

Variations: Traditional Herbal Registration Scheme fees

Standard £267
Complex £706
New excipient £7,984
Administrative £169

Notes: 1. Reductions for ‘bulks’ of single or group variations (ie same changes different authorisations belonging to the same company) are available. Further guidance for bulk variations is available at the end of this page

  • Standard fees will be charged where the application is concerned with the introduction of new suppliers of defined simple Active Pharmaceutical Ingredients (APIs) only. Further information: Fees for New Suppliers of Defined Simple Active Pharmaceutical Ingredients [LINK]

Bulk fee reductions

Terminology

  • Lead Case: the first Licence listed on the application form of a specific variation
  • Bulk Case: each additional licence included in the application form of a specific variation

Reductions for ‘bulks’ of single or group variations are available. You must meet the following criteria:

  • the changes are to authorisations registered under the same company number
  • the changes are identical across the lead and bulk members, and rely on the same supporting data. (QRD updates to the SPC do not need to meet this requirement)
  • the authorisations included are not a combination of Mutual Recognition and National licences

Complex variations are subject to different bulk fee reductions

Each bulk case included in the variation carries a 50% reduced fee of the full specified fee for the lead case. The fee type for the lead case is dependent upon the type of submission (grouping/single), the category of variation (Type 1A/1B/2) and procedure type of MA (National/MRP, CMS or RMS).

IMPORTANT: Type IB or Type II variations that include any Type IA changes require a grouped fee according the highest classification of change. Variations in this format supported by a proof of payment for a single fee (or other lesser fee) will be invalidated.

Example 1: National Procedures Type IB National CMS - lead case - £308, each bulk case - £154 Minor variation (type IB) grouped - lead case - £691, each bulk case £346

Example 2: Mutual Recognition Procedure. RMS major variation (type II) Grouped lead case – £2,218, each bulk case - £1,109

Complex Variations The lead case incurs a type II complex or extended complex fee, each bulk member is charged at the relevant single type II fee (national/CMS or RMS).

Grouped Complex Variations The lead case incurs a ‘type II grouped complex’ or ‘extended grouped complex fee’ and each bulk member is charged at the type II group major bulk fee (national/CMS or RMS).

Worksharing procedures:

  • If UK is the ‘Reference Authority’ the same reductions apply for when the UK is Reference Member State in an MRP
  • If UK is the recipient of a ‘Reference Authority’ assessment the same reductions apply for when the UK is Concerned Member State in an MRP
  • Where all of the affected authorisations are held only in the UK then of course the usual ‘bulk’ submissions can be made in the UK without recourse to appointing a ‘Reference Authority’

All Workshare procedures must obtain prior approval from variationqueries@mhra.gsi.gov.uk before submission and the confirmatory email included in the variation submission cover letter.

Wholesale distribution authorisations: fees

New Applications    
Standard application plus full inspection fee £3739 (£1803 application fee plus £1936 inspection fee)  
Inspection Fee (per additional site if required) £1936  
Reduced application* plus full inspection fee £2838 £902 application fee plus £1936 inspection fee
Reduced application plus reduced Inspection fee - General Sales List (GSL) only £1870 £902 application fee plus £968 inspection fee
Change of ownership £399  
Variations    
Standard variation £486  
Administrative variation £257  
Inspections    
Standard Inspection Fee (per site) £1936 ( See: fees for Inspection)
Reduced rate Inspection fee £968  
Inspection fee THMP/Homeopathic only £1367  
Inspection fee reduced rate THMP/Homeopathic only £744  
Office Based Risk Assessments £1354  
Issue of GDP Certificates £68 + 1 additional copy  

Notes: Special reduced rates to apply to: 1) Wholesale dealers handling GSL products only. 2) Registered retail pharmacies where wholesaling of licensed products does not exceed 15% of total turnover in licensed products. 3) Small wholesale dealers where wholesaling of licensed products does not exceed £35,000 of total turnover in licensed products. 4) See also fees for registration of Active Pharmaceutical Ingredient Manufacturers

Fees: additional information

The medicines (products for human use) (fees) regulations 2013 No.532

See information on fees for new suppliers of defined simple active pharmaceutical ingredients.

  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: See MHRA fees definitions for information.

  2. Clarification of terminology relating to periodic fees: you might find it useful to refer to the terminology relating to periodic fees 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.

  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. See the extract from MHRA fees legislation for further information.