Consultation outcome
Annex B - MHRA Statutory fee proposals
Updated 31 January 2023
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 |