Consultation outcome

Annex B - MHRA Statutory fee proposals

Updated 31 January 2023

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Proposed statutory fees from 1 April 2023

Table 1 – 10% Indexation increase in line with increased pay costs

Level 1 Descriptor Level 2 Descriptor Level 3 Descriptor Fee Name Current Fee (£) Proposed Fee (£)
1. Active pharmaceutical ingredients manufacturers and importers registration: fees Fees for registration of active substance manufacturers New applications New application for registration as a manufacturer of active substances 5,006 5,507
1. Active pharmaceutical ingredients manufacturers and importers registration: fees Fees for registration of active substance importer or distributor New applications New application for registration as an importer or distributor of active substances 3,157 3,473
1. Active pharmaceutical ingredients manufacturers and importers registration: fees Fees for registration of active substance importer or distributor New applications Additional fee if the risk assessment of the initial application triggers an inspection 582 640
1. Active pharmaceutical ingredients manufacturers and importers registration: fees Fees for registration of active substance importer or distributor Variations Notification of changes (variation) 257 283
1. Active pharmaceutical ingredients manufacturers and importers registration: fees Fees for registration of active substance importer or distributor Annual compliance report Assessment of the annual compliance report 257 283
1. Active pharmaceutical ingredients manufacturers and importers registration: fees Fees for registration of active substance importer or distributor Annual compliance report Annual compliance report where a variation is required 514 565
2. Active substance importers or distributors: fees     Application for registration 1,803 1,983
2. Active substance importers or distributors: fees     Assessment of initial application: active substance importer / distributor 1,354 1,489
2. Active substance importers or distributors: fees     Additional fee for the first day of inspection if triggered following risk-assessment of the application 582 640
2. Active substance importers or distributors: fees     Persons appointed appeals procedure fee 10,000 11,000
3. Active substance manufacturers: fees     Application for registration 3,143 3,457
3. Active substance manufacturers: fees     Assessment of Initial Application 1,863 2,049
3. Active substance manufacturers: fees     Additional fee for the first day of an inspection if triggered following risk-assessment of the application 792 871
4. Blood banks: application fees for a Review Panel hearing     Fee 10,000 11,000
5. Blood banks and other blood establishments: fees Blood Establishments New Applications Standard application 3,074 3,381
5. Blood banks and other blood establishments: fees Blood Establishments Variations Standard variation 518 570
5. Blood banks and other blood establishments: fees Blood Establishments Periodic Fee Annual fee 463 509
5. Blood banks and other blood establishments: fees Hospital Blood Banks and facilities Compliance Annual fee 683 751
7. Broker registration fees Broker registration fees New Applications New application for registration as a broker 3,157 3,473
7. Broker registration fees Broker registration fees New Applications Additional fee if the risk assessment of the initial application triggers an inspection 582 640
7. Broker registration fees Broker registration fees Annual Compliance Report Annual Compliance where a variation is required 514 565
8. Clinical trials: application fees   Applications with an IMP dossier Higher fee (Phase 1, Full and Simplified IMPD) 3,060 3,366
8. Clinical trials: application fees   Applications without an IMP dossier Lower fee (Phase IV, Cross referral, Additional protocol) 225 248
8. Clinical trials: application fees   CT variations/amendments   225 248
10. Drug-device combination products: fees     Initial Consultation for a Device which incorporates one or more known medicinal substances from an approved manufacturer of that substance 4,136 4,550
10. Drug-device combination products: fees     Further consultation of a Device which incorporates one or more known medicinal substances from an approved manufacturer of that substance 818 900
10. Drug-device combination products: fees     Initial Consultation for a Device which incorporates one or more known medicinal substances from a new source 9,640 10,604
10. Drug-device combination products: fees     Further consultation of a Device which incorporates one or more known medicinal substances from a new source 2,228 2,451
10. Drug-device combination products: fees     Initial consultation for a Device which incorporates a new active substance 42,296 46,526
10. Drug-device combination products: fees     Further consultation of a Device which incorporates a new active substance 10,501 11,551
12. Homeopathic National Rules Scheme: fees for inspections     GDP (wholesale dealers including homeopathic wholesalers) 1,328 1,461
14. Licence applications: marketing authorisations (including extension applications) fees Major   Major Orphan (reduced in exceptional circumstances) 29,732 32,705
14. Licence applications: marketing authorisations (including extension applications) fees Major   Incoming mutual recognition procedure for sale or supply in Northern Ireland and any subsequent Unfettered access route for UKMA(GB) 62,421 68,663
14. Licence applications: marketing authorisations (including extension applications) fees Major   European reference product application for sale or supply in Northern Ireland 62,421 68,663
14. Licence applications: marketing authorisations (including extension applications) fees Major   Decentralised procedure for sale or supply in Northern Ireland and any subsequent Unfettered access route for UKMA(GB) 62,421 68,663
14. Licence applications: marketing authorisations (including extension applications) fees Major   Major: (Previously granted by EU) - unfettered access route to GB 18,437 20,281
14. Licence applications: marketing authorisations (including extension applications) fees Major   Major: (Previously granted by EEA) – application for GB or UK, excluding GB unfettered access route (MRDC reliance procedure) 62,421 68,663
14. Licence applications: marketing authorisations (including extension applications) fees Major   Major: (Previously granted by EU) - automatic recognition application (EC Decision reliance procedure) 18,437 20,281
14. Licence applications: marketing authorisations (including extension applications) fees Major   National fee (any other case including hybrid applications) 92,753 102,028
14. Licence applications: marketing authorisations (including extension applications) fees Abridged complex   Incoming mutual recognition procedure for sale or supply in Northern Ireland and any subsequent Unfettered access route for UKMA(GB) 17,330 19,063
14. Licence applications: marketing authorisations (including extension applications) fees Abridged complex   European reference product application for sale or supply in Northern Ireland 17,330 19,063
14. Licence applications: marketing authorisations (including extension applications) fees Abridged complex   Decentralised procedure for the sale or supply in Northern Ireland and any subsequent Unfettered access route for UKMA(GB) 17,330 19,063
14. Licence applications: marketing authorisations (including extension applications) fees Abridged complex   Complex: (Previously granted by EU) - unfettered access route to GB 10,443 11,487
14. Licence applications: marketing authorisations (including extension applications) fees Abridged complex   Complex: (Previously granted by EEA) – application for GB or UK, excluding GB unfettered access route (MRDC reliance procedure) 17,330 19,063
14. Licence applications: marketing authorisations (including extension applications) fees Abridged complex   Complex: (Previously granted by EU) - automatic recognition application (EC Decision reliance procedure) 10,443 11,487
14. Licence applications: marketing authorisations (including extension applications) fees Abridged complex   National fee (any other case including hybrid applications) 25,643 28,207
14. Licence applications: marketing authorisations (including extension applications) fees Abridged standard   Incoming mutual recognition procedure for sale or supply in Northern Ireland and any subsequent Unfettered access route for a UKMA(GB) 6,350 6,985
14. Licence applications: marketing authorisations (including extension applications) fees Abridged standard   European reference product application for sale or supply in Northern Ireland 6,350 6,985
14. Licence applications: marketing authorisations (including extension applications) fees Abridged standard   Decentralised procedure for sale or supply in Northern Ireland and any subsequent Unfettered access route for UKMA(GB) 6,350 6,985
14. Licence applications: marketing authorisations (including extension applications) fees Abridged standard   Standard: (Previously granted by EU) - unfettered access route to GB 5,783 6,361
14. Licence applications: marketing authorisations (including extension applications) fees Abridged standard   Standard: (Previously granted by EEA) – application for GB or UK, excluding GB unfettered access route (MRDC reliance procedure) 6,350 6,985
14. Licence applications: marketing authorisations (including extension applications) fees Abridged standard   Standard: (Previously granted by EU) - automatic recognition application (EC Decision reliance procedure) 5,783 6,361
14. Licence applications: marketing authorisations (including extension applications) fees Abridged standard   National fee (all other cases) 9,402 10,342
14. Licence applications: marketing authorisations (including extension applications) fees Abridged simple   Incoming mutual recognition procedure for sale or supply in Northern Ireland and any subsequent Unfettered access route for UKMA(GB) 2,564 2,820
14. Licence applications: marketing authorisations (including extension applications) fees Abridged simple   Decentralised procedure for sale or supply in Northern Ireland and any subsequent Unfettered access route for UKMA(GB) 2,564 2,820
14. Licence applications: marketing authorisations (including extension applications) fees Abridged simple   Simple: (Previously granted by EU) - unfettered access route to GB 2,564 2,820
14. Licence applications: marketing authorisations (including extension applications) fees Abridged simple   Simple: (Previously granted by EEA) – application for GB or UK, excluding GB unfettered access route (MRDC reliance procedure) 2,564 2,820
14. Licence applications: marketing authorisations (including extension applications) fees Abridged simple   Simple: (Previously granted by EU) - automatic recognition application (EC Decision reliance procedure) 2,564 2,820
14. Licence applications: marketing authorisations (including extension applications) fees Abridged simple   National fee (all other cases) 2,564 2,820
14. Licence applications: marketing authorisations (including extension applications) fees Extension application group   Incoming mutual recognition (UK CMS) 17,330 19,063
14. Licence applications: marketing authorisations (including extension applications) fees Extension application group bulk   Decentralised procedure where the UK is CMS 9,078 9,986
14. Licence applications: marketing authorisations (including extension applications) fees Extension application group bulk   Incoming mutual recognition (UK CMS) 6,350 6,985
15. Licence applications: manufacturers licence (including THMPD and homeopathic medicinal products) fees     Standard 3,143 3,457
15. Licence applications: manufacturers licence (including THMPD and homeopathic medicinal products) fees     Non-orthodox practitioner (NOP) 183 201
15. Licence applications: manufacturers licence (including THMPD and homeopathic medicinal products) fees     Change of ownership 344 378
16. Licence applications: parallel imports fees     Complex application 18,180 19,998
16. Licence applications: parallel imports fees     Simple application 1,792 1,971
16. Licence applications: parallel imports fees     Change of ownership (including THMPD registrations) 442 486
17. Licence applications: Phase 1 Accreditation Scheme fees   Phase I Accreditation Scheme Accreditation of Phase 1 units 117 129
17. Licence applications: Phase 1 Accreditation Scheme fees   Phase I Accreditation Scheme Certificate of accreditation 62 68
18. Medicines export certificates: fees   Urgent request: two working days per set Original and two copies 152 167
18. Medicines export certificates: fees   Standard request: ten working days per set Original and two copies 68 75
18. Medicines export certificates: fees   Standard request: ten working days per set Each additional copy 34 37
19. Periodic fees for holding a marketing authorisation     New active substance (1) 9,710 10,681
19. Periodic fees for holding a marketing authorisation     Derivatives with a different route of administration (1) or complex abridged (2) 9,710 10,681
19. Periodic fees for holding a marketing authorisation     Other derivatives (1) 6,554 7,209
19. Periodic fees for holding a marketing authorisation   Prescription only medicine Standard fee 2,428 2,671
19. Periodic fees for holding a marketing authorisation   Prescription only medicine Reduced rate fee 1,211 1,332
19. Periodic fees for holding a marketing authorisation   Prescription only medicine ‘Maintenance’ fee 307 338
19. Periodic fees for holding a marketing authorisation   Prescription only medicine All others (P, GSL, PLPI and None) 307 338
19. Periodic fees for holding a marketing authorisation     Herbal 76 84
19. Periodic fees for holding a marketing authorisation     Homeopathic and Anthroposophic PLRs (per PLR) 76 84
19. Periodic fees for holding a marketing authorisation     National Rules Homeopathic Authorisation 76 84
19. Periodic fees for holding a marketing authorisation     Manufacturer’s licence 468 515
19. Periodic fees for holding a marketing authorisation     Wholesale dealer’s licence 288 317
19. Periodic fees for holding a marketing authorisation     Wholesale dealer’s licence (reduced rate or GSL) (4) 172 189
19. Periodic fees for holding a marketing authorisation     THMPD registration 76 84
20. Licence renewals, reclassifications and assessment of labels and leaflets: fees   Licence Renewal Applications Manufacturers’ licences Non-orthodox practitioner (NOP) 178 196
20. Licence renewals, reclassifications and assessment of labels and leaflets: fees   First renewal of a market authorisation granted with a new active substance UKMA(GB) granted under the unfettered access route 747 822
20. Licence renewals, reclassifications and assessment of labels and leaflets: fees   First renewal of a market authorisation granted with a new active substance UKMA(GB) previously granted by EU (automatic recognition) 747 822
20. Licence renewals, reclassifications and assessment of labels and leaflets: fees   First renewal of a market authorisation granted with a new active substance All other cases 9,682 10,650
20. Licence renewals, reclassifications and assessment of labels and leaflets: fees   Reclassification P to GSL - Additional fee for MA or PI application with reclassification element from P to GSL (3), (4) 8,162 8,978
20. Licence renewals, reclassifications and assessment of labels and leaflets: fees   Reclassification Reclassification variation application P to GSL 8,162 8,978
20. Licence renewals, reclassifications and assessment of labels and leaflets: fees   Reclassification Reclassification variation application (PI) (analogous product) 176 194
20. Licence renewals, reclassifications and assessment of labels and leaflets: fees   Assessment of labels and leaflets Single or first application (5) 518 570
20. Licence renewals, reclassifications and assessment of labels and leaflets: fees   Assessment of labels and leaflets National (BROMI) - Article 61 (3) Notification (6) 186 205
20. Licence renewals, reclassifications and assessment of labels and leaflets: fees   Assessment of labels and leaflets Parallel imports 328 361
21. Orphan Marketing Products: fees     Orphan Major (Full fee) 92,753 102,028
21. Orphan Marketing Products: fees     Orphan Major (exceptional circumstances in which point 6 pf Part II of Annex 1 in the 2001 Directive applies) 29,732 32,705
21. Orphan Marketing Products: fees     Orphan Complex (Full Fee) 25,643 28,207
21. Orphan Marketing Products: fees     Orphan Standard (Full Fee) 9,402 10,342
22. Pharmacovigilance (PV) Safety Review: fees     PV Major Safety Review (1-2 active ingredients) 51,286 56,415
22. Pharmacovigilance (PV) Safety Review: fees     PV Major Safety Review (3 active ingredients) 59,595 65,555
22. Pharmacovigilance (PV) Safety Review: fees     PV Major Safety Review (4 active ingredients) 67,904 74,694
22. Pharmacovigilance (PV) Safety Review: fees     PV Major Safety Review (5 or more active ingredients) 76,213 83,834
22. Pharmacovigilance (PV) Safety Review: fees     PV Periodic Safety Update Report (PSUR) single assessment: Full Fee 890 979
22. Pharmacovigilance (PV) Safety Review: fees     PV Periodic Safety Update Report (PSUR) single assessment: Half Fee 445 490
22. Pharmacovigilance (PV) Safety Review: fees     PV Post Authorisation Safety Study (PASS) protocol 8,309 9,140
22. Pharmacovigilance (PV) Safety Review: fees     Assessment of PASS Results 8,309 9,140
23. Plasma Master File (PMF) & Vaccine Antigen Master File certification or certified annual update work: fees     Certification of new PMF (for scientific & technical evaluation) 8,309 9,140
23. Plasma Master File (PMF) & Vaccine Antigen Master File certification or certified annual update work: fees     Vaccine Antigen Master File (VAMF) certification 8,309 9,140
24. Pre-Assessment (Rolling Review): fees     Application by pre-assessment (NAS) - Module 3 (chemical, pharmaceutical and biological information) 23,188 25,507
24. Pre-Assessment (Rolling Review): fees     Application by pre-assessment (NAS) - Module 4 (non-clinical reports) 23,188 25,507
24. Pre-Assessment (Rolling Review): fees     Application by pre-assessment (NAS) - Module 5 (clinical study reports) 23,188 25,507
24. Pre-Assessment (Rolling Review): fees     Application by pre-assessment (Biosimilar) - Module 3 (chemical, pharmaceutical and biological information) 4,333 4,766
24. Pre-Assessment (Rolling Review): fees     Application by pre-assessment (Biosimilar) - Module 4 (non-clinical reports) 4,333 4,766
24. Pre-Assessment (Rolling Review): fees     Application by pre-assessment (Biosimilar) - Module 5 (clinical study reports) 4,333 4,766
26. Scientific advice meetings: fees     Quality development only 2,201 2,421
26. Scientific advice meetings: fees     Safety development only 2,201 2,421
26. Scientific advice meetings: fees     Quality and safety development 3,061 3,367
26. Scientific advice meetings: fees     Clinical development only 2,763 3,039
26. Scientific advice meetings: fees     Quality and clinical development 3,624 3,986
26. Scientific advice meetings: fees     Safety and clinical development 3,624 3,986
26. Scientific advice meetings: fees     Quality, safety and clinical development 4,487 4,936
26. Scientific advice meetings: fees Pre-consultation application meetings on devices incorporating an ancillary medicinal substance   Quality development only 749 824
26. Scientific advice meetings: fees Pre-consultation application meetings on devices incorporating an ancillary medicinal substance   Safety development only 749 824
26. Scientific advice meetings: fees Pre-consultation application meetings on devices incorporating an ancillary medicinal substance   Quality and safety development 949 1,044
26. Scientific advice meetings: fees Pre-consultation application meetings on devices incorporating an ancillary medicinal substance   Clinical development only 949 1,044
26. Scientific advice meetings: fees Pre-consultation application meetings on devices incorporating an ancillary medicinal substance   Quality and clinical development 1,299 1,429
26. Scientific advice meetings: fees Pre-consultation application meetings on devices incorporating an ancillary medicinal substance   Safety and clinical development 1,299 1,429
26. Scientific advice meetings: fees Pre-consultation application meetings on devices incorporating an ancillary medicinal substance   Quality, safety and clinical development 1,648 1,813
26. Scientific advice meetings: fees Pre-consultation application meetings on devices incorporating an ancillary medicinal substance   Broader scope meetings 4,451 4,896
26. Scientific advice meetings: fees Pharmacovigilance advice meetings   Standard meeting 3,061 3,367
26. Scientific advice meetings: fees Pharmacovigilance advice meetings   Major meeting 3,624 3,986
26. Scientific advice meetings: fees Pharmacovigilance advice meetings   Post-authorisation regulatory advice meetings 2,763 3,039
26. Scientific advice meetings: fees Pharmacovigilance advice meetings   Advertising advice 2,201 2,421
26. Scientific advice meetings: fees Pharmacovigilance advice meetings   Advice on labels and leaflets 2,201 2,421
26. Scientific advice meetings: fees Reclassification advice meetings   Pharmacy to General Sales List switch 2,763 3,039
26. Scientific advice meetings: fees Reclassification advice meetings   Prescription Only Medicine to Pharmacy switch 3,624 3,986
30. Testing of samples: fees   Plasma pools which require three or fewer tests Fee payable where the licensing authority carries out a full assessment 180 198
30. Testing of samples: fees   Plasma pools which require three or fewer tests Fee payable where the licensing authority carries out a paper-based assessment 90 99
30. Testing of samples: fees   Plasma pools which require four or five tests Fee payable where the licensing authority carries out a full assessment 215 237
30. Testing of samples: fees   Plasma pools which require four or five tests Fee payable where the licensing authority carries out a paper-based assessment 90 99
30. Testing of samples: fees   Plasma pools which require six or more tests Fee payable where the licensing authority carries out a full assessment 230 253
30. Testing of samples: fees   Plasma pools which require six or more tests Fee payable where the licensing authority carries out a paper-based assessment 90 99
30. Testing of samples: fees   Band A – single component product, other than Botulinum toxin. requiring five or fewer in vitro tests Fee payable where the licensing authority carries out a full assessment 1,660 1,826
30. Testing of samples: fees   Band B – Factor VIII, Factor VIX or intravenous Immunoglobin Fee payable where the licensing authority carries out a full assessment 1,910 2,101
30. Testing of samples: fees   Band C – Multi-component product, or Botulinum toxin, requiring five or fewer in vitro tests Fee payable where the licensing authority carries out a full assessment 2,340 2,574
30. Testing of samples: fees   Band D – product requiring six to nine in vitro tests Fee payable where the licensing authority carries out a full assessment 3,690 4,059
30. Testing of samples: fees   Band E – product requiring (a) ten or more in vitro tests, or (b) one or more in vivo tests Fee payable where the licensing authority carries out a full assessment 6,410 7,051
30. Testing of samples: fees   Band F – one or more tests that must be carried out under containment measures applicable to hazard Group 3 or 4 biological agents under Control of Substances Hazardous to Health Regulations 2002 (123) or requires use of human tissue cells as part of testing Fee payable where the licensing authority carries out a full assessment 10,350 11,385
34. Variations: licence variations application fees   Type II complex National 8,309 9,140
34. Variations: licence variations application fees   Extended type II complex National 25,643 28,207
34. Variations: licence variations application fees   Chapter II of Commission Regulation (EC) /1234/2008 (as amended for CMS). In addition, variations submitted under the relevant National reliance/recognition routes. Single kind variation - Type II Complex Variation 2,493 2,742
34. Variations: licence variations application fees   Chapter II of Commission Regulation (EC) /1234/2008 (as amended for CMS). In addition, variations submitted under the relevant National reliance/recognition routes. Single kind variation - Extended Type II Complex Variation 7,693 8,462
35. Variations: licence variations applications groups fees     Minor variation (Type IB) group fee (national) 622 684
35. Variations: licence variations applications groups fees     Major variation (Type II) group fee (national) 1,652 1,817
35. Variations: licence variations applications groups fees     Major variation (Type II) complex group fee (national) 9,010 9,911
35. Variations: licence variations applications groups fees     Major variation (Type II) extended complex group fee (national) 26,276 28,904
35. Variations: licence variations applications groups fees   Chapter II of Commission Regulation (EC) /1234/2008 (as amended for CMS). In addition, variations submitted under the relevant National reliance/recognition routes. Major Variation (Type II) Complex Group Application 2,703 2,973
35. Variations: licence variations applications groups fees   Chapter II of Commission Regulation (EC) /1234/2008 (as amended for CMS). In addition, variations submitted under the relevant National reliance/recognition routes. Major Variation (Type II) Extended Complex Group Application 7,883 8,671
36. Variations: other licence variations applications fees   Parallel import (PI) Standard 357 393
36. Variations: other licence variations applications fees   Manufacturer’s licences (including traditional herbal medicines) Standard 514 565
36. Variations: other licence variations applications fees   Manufacturer’s licences (including traditional herbal medicines) Administrative 257 283
36. Variations: other licence variations applications fees   Wholesale dealers’ licences (includes Traditional Herbal Medicinal Products) Standard 486 535
36. Variations: other licence variations applications fees   Wholesale dealers’ licences (includes Traditional Herbal Medicinal Products) Administrative 257 283
36. Variations: other licence variations applications fees   Clinical trial authorisations Amendments to 1 part of dossier 225 248
36. Variations: other licence variations applications fees   Clinical trial authorisations Amendments to 2 parts of dossier 225 248
36. Variations: other licence variations applications fees   Clinical trial authorisations Amendments to 3 parts of dossier 225 248
36. Variations: other licence variations applications fees   Clinical trial authorisations Protocol 225 248
38. Wholesale distribution authorisations: fees   New Applications Change of ownership 399 439
38. Wholesale distribution authorisations: fees   New Applications Standard variation 486 535
38. Wholesale distribution authorisations: fees   New Applications Administrative variation 257 283
38. Wholesale distribution authorisations: fees   Inspections Issue of Good Distribution Practice Certificates 68 75

Table 2 – Fees that increase above indexation to achieve cost-based recovery

Fee Name Current Fee (£) Proposed Fee (£)
Inspection - Full day rate (Good Manufacturing Practice, Good Clinical Practice and Pharmacovigilance) 2,655 3,651
Inspection - Full day rate (Good Distribution Practice) 1,936 2,662
Inspection - Full day rate (Blood banks and other blood establishments) 2,583 3,552
Inspection - Half day rate (Good Manufacturing Practice, Good Clinical Practice and Pharmacovigilance) 1,328 1,825
Inspection - Half day rate (Good Distribution Practice) 968 1,331
Inspection - Half day rate (Blood banks and other blood establishments) 1,292 1,776
Inspection - Office based evaluation and risk assessments (Good Manufacturing Practice, Good Clinical Practice and Pharmacovigilance) 1,863 2,562
Inspection - Office based risk assessments (Wholesale distribution authorisations) 1,354 1,862
Inspection – Traditional Herbal Medicinal Product/Homeopathic only (Wholesale distribution authorisations) 1,367 1,880
Inspection - reduced rate Traditional Herbal Medicinal Product/Homeopathic only (Wholesale distribution authorisations) 744 1,023
Inspection - Standard application plus full inspection fee (Wholesale distribution authorisations) 3,739 4,645
Inspection - Reduced application plus full inspection fee (Wholesale distribution authorisations) 2,838 3,654
Inspection - Reduced application plus reduced Inspection fee - General Sales List (GSL) only (Wholesale distribution authorisations) 1,870 2,323
Variation - Extended application group (National fee) 25,643 33,003
Variation - Single kind variation - Type IB (Falling under scope of Chapter II Commission Regulation 1234/2008) 277 344
Variation - Single kind variation - Type II (Falling under scope of Chapter II Commission Regulation 1234/2008) 277 344
Variation - Type IB National 277 344
Variation - Reclassification Type IB 277 344
Variation - Minor Variation (Type IB) Group Application (Falling under scope of Chapter II Commission Regulation 1234/2008) 277 344
Certified Annual Update of a Plasma Master File (PMF) 277 344
Variation - Major (Type II) Group Application (Falling under scope of Chapter II Commission Regulation 1234/2008) 496 1,255
Variation - Type II Standard National 734 1,308
Variation - Reclassification variation application (MA) (analogous product) 734 1,308
Certified Annual Update of a Plasma Master File (PMF) - significant changes to safety information 734 1,308
Parallel imports fees - standard application 6,663 8,722
Reclassification – Prescription Only Medicine to Pharmacy (Additional for MA or PI application) 11,992 33,003
Reclassification – Prescription Only Medicine to Pharmacy (variation application) 11,992 33,003
     
Safety and quality vetting of unlicensed imported medicines fees:    
Number of annual notifications: 1 - 20 130 70
Number of annual notifications: 21 - 100 519 350
Number of annual notifications: 101 - 1,000 2,077 2,400
Number of annual notifications: 1,001 - 5,000 10,383 12,000
Number of annual notifications: 5,001 - 20,000 25,957 30,000
Number of annual notifications: 20,001 - 50,000 51,914 60,000
Number of annual notifications: 50,001 - 100,000 103,828 120,000
Number of annual notifications: 100,001 + 155,742 200,000
     
Band A – single component product, other than Botulinum toxin. requiring five or fewer in vitro tests 305 367
Band B – Factor VIII, Factor VIX or intravenous Immunoglobin 305 367
Band C – Multi-component product, or Botulinum toxin, requiring five or fewer in vitro tests 305 992
Band D – product requiring six to nine in vitro tests 677 992
Band E – product requiring (a) ten or more in vitro tests, or (b) one or more in vivo tests 677 1,849
Band F – one or more tests that must be carried out under containment measures applicable to hazard Group 3 or 4 biological agents under Control of Substances Hazardous to Health Regulations 2002 (123) or requires use of human tissues or cells as part of testing 677 1,849
Initial application for designation (covers both Approved Body and Notified Body) 8,252 35,672
Re-application to address ground for rejection of a previous application 2,063 8,918
Initial designation audit 15,904 58,341
Surveillance 10,160 45,675
Witnessed Audit 4,404 10,072
Re-designation application fee 8,252 35,672
Re-designation audit 15,904 58,341
Follow up Audit - Major Closure 3,876 22,789
Follow up Audit - Special Clinical 2,586 18,583
Follow up Audit - Process Specific 3,876 22,789
TSE Applications UK Conformity Assessment Bodies 532 1,297
In addition to each of the above, the below two fees are for time spent on audit and travel:    
Half day rate for auditing 361 631
Hourly rate for travel 90 171
     
Class I, IIa, or IIb other than implantable or long-term invasive devices: Notification 3,820 7,472
Class I, IIa, or IIb other than implantable or long-term invasive devices: Notification - re-notification in the event of an objection 2,920 5,711
Class IIb implantable or long-term invasive, Class III, and active implantable devices: Notification 5,040 15,627
Class IIb implantable or long-term invasive, Class III, and active implantable devices: Notification - re-notification in the event of an objection 3,570 11,069
Devices Registration 100 240
Devices Registration amendment 100 240
Devices Blood bank annual fee 492 967

Table 3 – New Fees

Fee Name Proposed Fee (£)
Conformity Assessment Body Designation Applications – Extension to scope, new UKCA codes or Annex (covers both Approved Body and Notified Body) 18,212  
Conformity Assessment Body Designation Applications – Extension to scope, where codes are limited (covers both Approved Body and Notified Body) 12,571  
Conformity Assessment Body Audits – Subsidiary audit subject to additional fees calculated by hourly rate and travel rates (covers both Approved Body and Notified Body) 22,789  
Clinical investigations consultation fee (optional) – Device Regulatory Advice meeting 906  
Clinical Investigations consultation fee optional service – Clinical Investigations statistical review 782  
In Vitro Diagnostic (IVD) Performance Report (also known as IVD performance evaluation report) 7,472  
Scientific Advice - aligned to the Innovative Licensing and Access Pathway (ILAP) Innovation Passport 9,895  
Scientific Advice - aligned to the ILAP Target Development Profile 23,948  
Early Access to Medicines Scheme (EAMS) – Promising Innovative Medicine (PIM) designation 3,986  
EAMS - fee for the assessment of the scientific opinion for new chemical or biological medicinal products 25,643  
EAMS renewal fee for new chemical or biological medicinal products (if applicable) 12,821  
EAMS - fee for the assessment of the scientific opinion for new indications 8,309  
EAMS renewal fee for new indications (if applicable) 4,154  
Safety and quality vetting of unlicensed imported medicines fees:    
Number of annual product codes: 1-5 100  
Number of annual product codes: 6-10 200  
Number of annual product codes: 11-20 400  
Number of annual product codes: 21-50 1,000  
Number of annual product codes: 51-100 2,000  
Number of annual product codes: 101-200 4,000  
Number of annual product codes: per additional 100 product codes above 200 2,000  
     
Clinical Trials - Assessment of annual safety reports 248  
Clinical Trials - Complex amendments 1,800  
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