Statutory guidance

Current MHRA fees

Updated 1 April 2025

MHRA fees for 2025 - 2027 are applicable from 1 April 2025.

Fees Consultation Response

How to make a payment to the MHRA

1. Active pharmaceutical ingredients manufacturers and importers registration: fees

Fee name	Fee	Notes
New Applications
1.  Active pharmaceutical ingredients manufacturers and importers registration: fees - Manufacturer - New applications - New application for registration as a manufacturer of active substances	£8,687	£3,763 application fee plus £4,924 assessment fee
1.  Active pharmaceutical ingredients manufacturers and importers registration: fees - Importer or distributor - New applications - New application for registration as an importer or distributor of active substances	£5,969	£2,159 application fee plus £3,810 assessment fee
1.  Active pharmaceutical ingredients manufacturers and importers registration: fees - Importer or distributor - New applications - Additional fee if the risk assessment of the initial application triggers an inspection	£697
1.  Active pharmaceutical ingredients manufacturers and importers registration: fees - Importer or distributor - New applications - Inspection fee (per site if required)	£2,898	Charged for inspections conducted post registration
Variations
1.  Active pharmaceutical ingredients manufacturers and importers registration: fees - Importer or distributor - Variations - Notification of changes (variation)	£309
1.  Active pharmaceutical ingredients manufacturers and importers registration: fees - Importer or distributor - Variations - Inspection fee (per site if required)	£2,898
Annual Compliance report
1.  Active pharmaceutical ingredients manufacturers and importers registration: fees - Importer or distributor - Annual compliance report - Annual compliance report where a variation is required	£688
1.  Active pharmaceutical ingredients manufacturers and importers registration: fees - Importer or distributor - Annual compliance report - Assessment of the annual compliance report	£345	Subsequent to 2013, 30 April of each reporting year

2. Active substance importers or distributors: fees

Fee name	Fee
2.  Active substance importers or distributors: fees - Application for registration	£2,159
2.  Active substance importers or distributors: fees - Assessment of initial application: active substance importer / distributor	£3,810
2.  Active substance importers or distributors: fees - Additional fee for the first day of inspection if triggered following risk-assessment of the application	£697
2.  Active substance importers or distributors: fees - Assessment of the Annual Compliance Report: Active Substance Importer / Distributor	£309
2.  Active substance importers or distributors: fees - Notification of changes	£309
2.  Active substance importers or distributors: fees - Standard daily rate for Inspection	£2,898
2.  Active substance importers or distributors: fees - Persons appointed appeals procedure fee	£11,974

3. Active substance manufacturers: fees

Fee name	Fee
3.  Active substance manufacturers: fees - Application for registration	£3,763
3.  Active substance manufacturers: fees - Assessment of Initial Application	£4,924
3.  Active substance manufacturers: fees - Additional fee for the first day of an inspection if triggered following risk-assessment of the application	£949
3.  Active substance manufacturers: fees - Assessment of the Annual Compliance Report	£309
3.  Active substance manufacturers: fees - Notification of Changes	£309
3.  Active substance manufacturers: fees - Inspection days	£3,975

4. Blood banks: application fees for a Review Panel hearing

NB: These fees are scheduled to increase during Q1 of FY25-26

Fee name	Fee
4.  Blood banks: application fees for a Review Panel hearing - Fee	£11,000

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 (60%) will be made. If the application is withdrawn after the panel has been appointed, no refund will be applicable.

5. Blood banks and other blood establishments: fees

NB: These fees are scheduled to increase during Q1 of FY25-26

Blood establishments

Fee name	Fee
New Applications
5.  Blood banks and other blood establishments: fees - Blood Establishments - New Applications - Standard application plus full inspection fee	£6,933
5.  Blood banks and other blood establishments: fees - Blood Establishments - New Applications - Inspection fee (per additional site if required)	£3,552
Variations
5.  Blood banks and other blood establishments: fees - Blood Establishments - Variations - Standard variation	£570
Periodic Fee
5.  Blood banks and other blood establishments: fees - Blood Establishments - Periodic Fee - Annual fee	£509

Hospital Blood Banks and facilities ^{[footnote 1]}

Fee name	Fee	Notes
Inspections
5.  Blood banks and other blood establishments: fees - Blood Establishments - Inspections - Standard Inspection Fee: daily rate	£3,552
Haemovigilance
5.  Blood banks and other blood establishments: fees - Blood Establishments - Haemovigilance - Annual fee	£967	Cost to the MHRA of operating the system for receiving and assessing reports of serious adverse events and reactions [footnote 2]
Compliance
5.  Blood banks and other blood establishments: fees - Hospital Blood Banks and facilities - Compliance - Annual fee	£751	In respect of receipt and assessment of annual compliance reports[footnote 3] submitted by hospital blood banks to the MHRA

6. Blood facilities: contract laboratories fees

NB: These fees are scheduled to increase during Q1 of FY25-26

Fee name	Fee
6.  Blood facilities: contract laboratories fees - Inspections - Inspection fee* (per additional site if required)	£3,552

*For contract laboratories that test blood components on behalf of blood establishments or hospital blood banks

7. Broker registration fees

Fee name	Fee	Notes
New Applications
7.  Broker registration fees - New Applications - Additional fee if the risk assessment of the initial application triggers an inspection	£780
7.  Broker registration fees - New Applications - Inspection Fee (per site if required)	£3,241	Charged for inspections conducted post registration
7.  Broker registration fees - New Applications - New application for registration as a broker	£5,793	£1,983 application fee plus £3,810 assessment fee
Variations
7.  Broker registration fees - Variations - Notification of Changes (Variation)	£345
Annual Compliance Report
7.  Broker registration fees - Annual Compliance Report - Annual Compliance where a variation is required	£688
7.  Broker registration fees - Annual Compliance Report - Assessment of the Annual Compliance Report	£345	Subsequent to 2013, 30 April of each reporting year

8. Clinical trials: application fees

Fee name	Fee
8.  Clinical trials: application fees - Applications with an IMP dossier - Higher fee (Phase 1, Full and Simplified IMPD)	£4,656
8.  Clinical trials: application fees - Applications without an IMP dossier - Lower fee (Phase IV, Cross referral, Additional protocol)	£343
8.  Clinical trials: application fees - CT variations/amendments	£343
8.  Clinical trials: application fees - Assessment of annual safety reports	£343

Notes:

There is no annual Clinical Trials fee and no fee for Phase IV notifications. For a cross-referral or additional protocol submission, no new Investigational Medical Product Dossier (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.

9. Clinical investigations for devices: fees

NB: These fees are scheduled to increase during Q1 of FY25-26

The fee depends on the class of your device.

Fee name	Fee
Notification of a clinical investigation
9.  Clinical investigations for devices: fees - Notification of a clinical investigation - Class I, IIa, or IIb other than implantable or long-term invasive devices (Initial submission)	£7,472
9.  Clinical investigations for devices: fees - Notification of a clinical investigation - Class I, IIa, or IIb other than implantable or long-term invasive devices (Resubmission)	£5,711
9.  Clinical investigations for devices: fees - Notification of a clinical investigation - Class IIb implantable or long-term invasive, Class III, and active implantable devices (Initial submission)	£15,627
9.  Clinical investigations for devices: fees - Notification of a clinical investigation - Class IIb implantable or long-term invasive, Class III, and active implantable devices (Resubmission)	£11,069
Amendment fees
9.  Clinical investigations for devices: fees - Amendment fees - High risk device amendment	£331
9.  Clinical investigations for devices: fees - Amendment fees - Low risk device amendment	£207
Consultation
9.  Clinical investigations for devices: fees - Consultation - Device Regulatory Advice meeting	£906
9.  Clinical investigations for devices: fees - Consultation - Clinical Investigations statistical review	£782

10. Drug-device combination products: fees

Fee name	Fee
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	£4,953
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	£980
10.  Drug-device combination products: fees - Initial consultation for a Device which incorporates one or more known medicinal substances from a new source	£11,543
10.  Drug-device combination products: fees - Further consultation of a Device which incorporates one or more known medicinal substances from a new source	£2,668
10.  Drug-device combination products: fees - Initial consultation for a Device which incorporates a new active substance	£50,644
10.  Drug-device combination products: fees - Further consultation of a Device which incorporates a new active substance	£12,574

Notes:

• 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.

Conformity Assessment Body Designation Applications

Fee name	Fee
10.  Drug-device combination products: fees - Conformity Assessment Body Designation Applications - Extension to scope, which extends the body’s designation to carry out certain tasks that were not previously within the scope of the body’s designation and where the Secretary of State considers that an additional assessment of the body’s procedures is required.	£19,824
10.  Drug-device combination products: fees - Conformity Assessment Body Designation Applications - Extension to scope, to carry out tasks under Part 2, Part 3 or Part 4, which extends the body’s designation in relation to a Part under which they have already been designated.	£13,684
10.  Drug-device combination products: fees - Conformity Assessment Body Designation Applications - Subsidiary audit* subject to additional fees calculated by hourly rate and travel rates (covers both Approved Body and Notified Body)	£24,806

11. Homoeopathic National Rules Scheme: fees

Fee name	Fee
Standard
11.  Homoeopathic National Rules Scheme: fees - Standard - 5 stocks or fewer	£1,325
11.  Homoeopathic National Rules Scheme: fees - Standard - more than 5 stocks	£1,598
Reduced
11.  Homoeopathic National Rules Scheme: fees - Reduced - stock already assessed - 5 stocks or fewer	£984
11.  Homoeopathic National Rules Scheme: fees - Reduced - stock already assessed - more than 5 stocks	£1,235
11.  Homoeopathic National Rules Scheme: fees - Formulation already assessed - 5 stocks or fewer	£984
11.  Homoeopathic National Rules Scheme: fees - Formulation already assessed - more than 5 stocks	£1,235
11.  Homoeopathic National Rules Scheme: fees - Both stock and formulation already assessed - 5 stocks or fewer	£630
11.  Homoeopathic National Rules Scheme: fees - Both stock and formulation already assessed - more than 5 stocks	£892
Supplementary fees
11.  Homoeopathic National Rules Scheme: fees - Supplementary fees - New method of sterilisation (non-pharmacopoeial)	£2,622
11.  Homoeopathic National Rules Scheme: fees - Supplementary fees - New excipients	£8,746
11.  Homoeopathic National Rules Scheme: fees - Supplementary fees - New sources TSE risk actives/excipients (non-CEP)	£773

12. Homeopathic National Rules Scheme: fees for inspections

Inspections are charged at a daily rate

Fee name	Fee
12.  Homeopathic National Rules Scheme: fees for inspections - All GMP, GCP and pharmacovigilance inspections	£5,251
12.  Homeopathic National Rules Scheme: fees for inspections - Office-based risk assessments	£4,924
GDP (wholesale dealers* including homeopathic wholesalers)
12.  Homeopathic National Rules Scheme: fees for inspections - Full day rate	£4,136
12.  Homeopathic National Rules Scheme: fees for inspections - Reduced rate (see notes below)	£2,068
12.  Homeopathic National Rules Scheme: fees for inspections - Office based risk assessments (see notes below)	£3,810

*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.

Before applying for an office-based risk assessment, please read the following:

• Minimum fee of one day (with the exception of the GDP inspections)
• 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.
• 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.
• 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.
• 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.
• 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.
• The office based risk assessment fee will be charged where a risk assessment is conducted which does not lead to an inspection

13. Inspection: fees

Please note: 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.

From 1 April 2023 fees for inspections will continue to be charged at a daily rate as follows:

Fee name	Fee
13.  Inspection: fees - All GMP, GCP and Pharmacovigilance inspections including (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 inspection, clinical trials, contract laboratories, homeopathic manufacturers	£5,251
13.  Inspection: fees - Office based evaluation and risk assessments (see notes below)	£4,924
GDP (wholesale dealers including homeopathic wholesalers)
13.  Inspection: fees - GDP (wholesale dealers including homeopathic wholesalers) - Full day rate	£4,136
13.  Inspection: fees - GDP (wholesale dealers including homeopathic wholesalers) - Reduced rate (see notes below)	£2,068

Notes:

• There is a minimum fee of 1 day (with the exception of the GDP inspections).
• 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.
• The daily rate fee includes pre-inspection preparation, reporting of inspections, resolving issues and may include travel time. It also incorporates activities such as evaluation of compliance assessment report and other support functions and directly related overheads.
• 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 £35,000 of total turnover only where an inspector spends less than 3.5 hours on site.
• The MHRA Inspectorate charge a daily fee for each accredited inspector that conducts the inspection. If an inspector is undergoing accreditation and is only qualified to perform specific aspects of the inspection, a partial fee will be charged.
• The office based inspection evaluation and risk assessment fee will be charged where a risk assessment of documentation not involving an inspection of a site is conducted which is in connection with the monitoring of GMP, GDP, GCP or GPvP. It can also be used in conjunction with or instead of an on-site inspection as notified to the site prior to the start of the inspection.

14. Licence applications: marketing authorisation fees

Fee name	Fee
Major
14.  Licence applications: marketing authorisation fees - Major - Major Orphan (reduced in exceptional circumstances)	£39,811
14.  Licence applications: marketing authorisation fees - Major - Incoming mutual recognition procedure for sale or supply in Northern Ireland and any subsequent Unfettered access route for UKMA(GB)	£83,580
14.  Licence applications: marketing authorisation fees - Major - European reference product application for sale or supply in Northern Ireland	£83,580
14.  Licence applications: marketing authorisation fees - Major - Decentralised procedure for sale or supply in Northern Ireland and any subsequent Unfettered access route for UKMA(GB)	£83,580
14.  Licence applications: marketing authorisation fees - Major - Major: (Previously granted by EU) - unfettered access route to GB	£24,688
14.  Licence applications: marketing authorisation fees - Major - Major International Recognition Type B application for GB or UK	£83,580
14.  Licence applications: marketing authorisation fees - Major - Major International Recognition Type A application for GB or UK	£24,688
14.  Licence applications: marketing authorisation fees - Major - National fee (any other case including hybrid applications)	£124,194
Abridged complex
14.  Licence applications: marketing authorisation fees - Abridged complex - Incoming mutual recognition procedure for sale or supply in Northern Ireland and any subsequent Unfettered access route for UKMA(GB)	£23,205
14.  Licence applications: marketing authorisation fees - Abridged complex - European reference product application for sale or supply in Northern Ireland	£23,205
14.  Licence applications: marketing authorisation fees - Abridged complex - Decentralised procedure for the sale or supply in Northern Ireland and any subsequent Unfettered access route for UKMA(GB)	£23,205
14.  Licence applications: marketing authorisation fees - Abridged complex - Complex: (Previously granted by EU) - unfettered access route to GB	£13,983
14.  Licence applications: marketing authorisation fees - Abridged complex - Complex International Recognition Type B application for GB or UK	£23,205
14.  Licence applications: marketing authorisation fees - Abridged complex - Complex International Recognition Type A application for GB or UK	£13,983
14.  Licence applications: marketing authorisation fees - Abridged complex - National fee (any other case including hybrid applications)	£34,335
Abridged standard
14.  Licence applications: marketing authorisation fees - Abridged standard - Incoming mutual recognition procedure for sale or supply in Northern Ireland and any subsequent Unfettered access route for a UKMA(GB)	£8,503
14.  Licence applications: marketing authorisation fees - Abridged standard - European reference product application for sale or supply in Northern Ireland	£8,503
14.  Licence applications: marketing authorisation fees - Abridged standard - Decentralised procedure for sale or supply in Northern Ireland and any subsequent Unfettered access route for UKMA(GB)	£8,503
14.  Licence applications: marketing authorisation fees - Abridged standard - Standard International Recognition Type B application for GB or UK	£8,503
14.  Licence applications: marketing authorisation fees - Abridged standard - Standard International Recognition Type A application for GB or UK	£7,743
14.  Licence applications: marketing authorisation fees - Abridged standard - Standard: (Previously granted by EU) - unfettered access route to GB	£7,743
14.  Licence applications: marketing authorisation fees - Abridged standard - National fee (all other cases)	£12,589
Abridged simple
14.  Licence applications: marketing authorisation fees - Abridged simple - Incoming mutual recognition procedure for sale or supply in Northern Ireland and Unfettered access route for UKMA(GB)	£3,433
14.  Licence applications: marketing authorisation fees - Abridged simple - Decentralised procedure for sale or supply in Northern Ireland and Unfettered access route for UKMA(GB)	£3,433
14.  Licence applications: marketing authorisation fees - Abridged simple - Simple: (Previously granted by EU) - unfettered access route to GB	£3,433
14.  Licence applications: marketing authorisation fees - Abridged simple - National fee (all other cases)	£3,433

15. 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

Fee name	Fee
15.  Licence applications: manufacturers licence (including THMPD and homeopathic medicinal products)* fees - Standard	£4,209
15.  Licence applications: manufacturers licence (including THMPD and homeopathic medicinal products)* fees - Non-orthodox practitioner (NOP)	£245
15.  Licence applications: manufacturers licence (including THMPD and homeopathic medicinal products)* fees - Change of ownership	£461

16. Licence applications: parallel imports fees

Fee name	Fee
16.  Licence applications: parallel imports fees - Complex application*	£24,343
16.  Licence applications: parallel imports fees - Standard application*	£10,617
16.  Licence applications: parallel imports fees - Simple application	£2,400

*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.

17. Licence applications: Phase 1 Accreditation Scheme fees

Fee name	Fee
17.  Licence applications: Phase 1 Accreditation Scheme fees - Phase I Accreditation Scheme - Accreditation of Phase 1 units	£141
17.  Licence applications: Phase 1 Accreditation Scheme fees - Phase I Accreditation Scheme - Certificate of accreditation	£75

18. Medicines export certificates: fees

Fee name	Fee
18.  Medicines export certificates: fees - Urgent request: two working days - Electronic copy	£182
18.  Medicines export certificates: fees - Standard request: ten working days - Electronic copy	£82

19. Periodic fees for holding a marketing authorisation

Fee name	Fee
Type of licence
19.  Periodic fees for holding a marketing authorisation - New active substance[footnote 4]	£11,627
19.  Periodic fees for holding a marketing authorisation - Derivatives with a different route of administration[footnote 4] or complex abridged[footnote 5]	£11,627
19.  Periodic fees for holding a marketing authorisation - Other derivatives[footnote 4]	£7,847
Legal status/sale category	Fee type[footnote 6]
Prescription only medicine (POM)
19.  Periodic fees for holding a marketing authorisation - Prescription Only Medicine (POM) - Standard fee[footnote 6]	£2,908
19.  Periodic fees for holding a marketing authorisation - Prescription Only Medicine (POM) - Reduced rate fee	£1,450
19.  Periodic fees for holding a marketing authorisation - Prescription Only Medicine (POM) - ‘Maintenance’ fee	£368
19.  Periodic fees for holding a marketing authorisation - Prescription Only Medicine (POM) - All others (P, GSL, PLPI and None)	£368
Type of licence
19.  Periodic fees for holding a marketing authorisation - Herbal	£92
19.  Periodic fees for holding a marketing authorisation - Homeopathic and Anthroposophic PLRs (per PLR)	£92
19.  Periodic fees for holding a marketing authorisation - Simplified Homeopathic Authorisation	No fee
19.  Periodic fees for holding a marketing authorisation - National Rules Homeopathic Authorisation	£92
19.  Periodic fees for holding a marketing authorisation - Manufacturer’s licence	£561
19.  Periodic fees for holding a marketing authorisation - Wholesale dealer’s licence	£346
19.  Periodic fees for holding a marketing authorisation - Wholesale dealer’s licence (reduced rate or GSL) [footnote 7]	£206
19.  Periodic fees for holding a marketing authorisation - THMPD registration	£92

All other legal status medicinal products

If you no longer require your licence and do not want to be charged a periodic fee in April, you are required to formally cancel your licence before 31 December 2024.

Holders of Manufacturers and Wholesale Dealer’s licences are required to notify the MHRA at pcl@mhra.gov.uk by 31 December 2024. If you do not formally cancel your licence by this date, you will be charged a periodic fee for the period 1 April 2025 to 31 March 2026.

20. 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

Fee name	Fee	Notes
Licence renewal applications
20.  Licence renewals, reclassifications and assessment of labels and leaflets: fees - Licence Renewal Applications - Manufacturers’ licences Non-orthodox practitioner (NOP)	£214
First renewal of a market authorisation granted with a new active substance
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	£1,239	[footnote 8] [footnote 9]
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)	£1,239	[footnote 8] [footnote 9]
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 International Recognition	£1,239	[footnote 8] [footnote 9]
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	£16,042	[footnote 8] [footnote 9]
Reclassification
20.  Licence renewals, reclassifications and assessment of labels and leaflets: fees - Reclassification - POM to P - Additional for MA or PI application with reclassification element from POM to P[footnote 10], [footnote 11]	£40,173
20.  Licence renewals, reclassifications and assessment of labels and leaflets: fees - Reclassification - Reclassification variation application POM to P[footnote 10],[footnote 11]	£40,173
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[footnote 10],[footnote 11]	£10,929
20.  Licence renewals, reclassifications and assessment of labels and leaflets: fees - Reclassification - Reclassification variation application P to GSL	£10,929
20.  Licence renewals, reclassifications and assessment of labels and leaflets: fees - Reclassification - Reclassification variation application (MA) (analogous product) [footnote 11]	£1,593
20.  Licence renewals, reclassifications and assessment of labels and leaflets: fees - Reclassification - Reclassification Type IB variation application (MA) (analogous product) [footnote 11]	£419
Assessment of labels and leaflets
20.  Licence renewals, reclassifications and assessment of labels and leaflets: fees - Assessment of labels and leaflets - National (BROMI) notification/self-certification[footnote 13]	£224
20.  Licence renewals, reclassifications and assessment of labels and leaflets: fees - Assessment of labels and leaflets - Parallel imports	£440
20.  Licence renewals, reclassifications and assessment of labels and leaflets: fees - Assessment of labels and leaflets - Single or first application[footnote 12]	£992

21. Orphan Marketing Products: fees

Fee name	Fee
21.  Orphan Marketing Products: fees - Orphan Major (Full fee)	£124,194
21.  Orphan Marketing Products: fees - Orphan Major (exceptional circumstances in which point G of Part IV of Annex 1 in the 2001 Directive applies)	£39,811
21.  Orphan Marketing Products: fees - Orphan Complex (Full Fee)	£34,335
21.  Orphan Marketing Products: fees - Orphan Standard (Full Fee)	£12,589

Notes:

Where the licensing authority grants an orphan marketing authorisation, the following percentage of the fee otherwise payable under regulation 12(1)(a) in connection with the application for that authorisation shall be refunded, if it has not yet paid, shall be waived

(a) Small and medium (SME) company: 100%

(b) Applications not made on behalf of SME but which point G of Part IV of Annex 1 to the 2001 Directive applies: 50%

(c) Any other case: 10%

22. Pharmacovigilance (PV) Safety Review: fees

Fee name	Fee
22.  Pharmacovigilance (PV) Safety Review: fees - PV Major Safety Review (1-2 active ingredients)	£61,408
22.  Pharmacovigilance (PV) Safety Review: fees - PV Major Safety Review (3 active ingredients)	£71,357
22.  Pharmacovigilance (PV) Safety Review: fees - PV Major Safety Review (4 active ingredients)	£81,305
22.  Pharmacovigilance (PV) Safety Review: fees - PV Major Safety Review (5 or more active ingredients)	£91,254
22.  Pharmacovigilance (PV) Safety Review: fees - PV Periodic Safety Update Report (PSUR) single assessment: Full Fee	£1,066
22.  Pharmacovigilance (PV) Safety Review: fees - PV Periodic Safety Update Report (PSUR) single assessment: Half Fee	£534
22.  Pharmacovigilance (PV) Safety Review: fees - PV Post Authorisation Safety Study (PASS) protocol	£9,949
22.  Pharmacovigilance (PV) Safety Review: fees - Assessment of PASS Results	£9,949

23. Plasma Master File (PMF) & Vaccine Antigen Master File certification or certified annual update work: fees

Fee name	Fee
23.  Plasma Master File (PMF) & Vaccine Antigen Master File certification or certified annual update work: fees - Certification of new PMF (for scientific & technical evaluation)	£11,126
23.  Plasma Master File (PMF) & Vaccine Antigen Master File certification or certified annual update work: fees - Certified Annual Update of a PMF (epidemiology update only)	£419
23.  Plasma Master File (PMF) & Vaccine Antigen Master File certification or certified annual update work: fees - Certified Annual Update of a PMF (significant changes to safety information)	£1,593
23.  Plasma Master File (PMF) & Vaccine Antigen Master File certification or certified annual update work: fees - Vaccine Antigen Master File (VAMF) certification	£11,126

24. Pre-Assessment (Rolling Review): fees

Fee name	Fee
24.  Pre-Assessment (Rolling Review): fees - Application by pre-assessment (NAS) - Module 3 (chemical, pharmaceutical and biological information)	£31,049
24.  Pre-Assessment (Rolling Review): fees - Application by pre-assessment (NAS) - Module 4 (non-clinical reports)	£31,049
24.  Pre-Assessment (Rolling Review): fees - Application by pre-assessment (NAS) - Module 5 (clinical study reports)	£31,049
24.  Pre-Assessment (Rolling Review): fees - Application by pre-assessment (Biosimilar) - Module 3 (chemical, pharmaceutical and biological information)	£5,802
24.  Pre-Assessment (Rolling Review): fees - Application by pre-assessment (Biosimilar) - Module 4 (non-clinical reports)	£5,802
24.  Pre-Assessment (Rolling Review): fees - Application by pre-assessment (Biosimilar) - Module 5 (clinical study reports)	£5,802

25. Safety and quality vetting of unlicenced imported medicines fees

Fee name	Fee
25.  Safety and quality vetting of unlicenced imported medicines fees - Number of annual Notifications - 1 – 20	£86
25.  Safety and quality vetting of unlicenced imported medicines fees - Number of annual Notifications - 21 – 100	£427
25.  Safety and quality vetting of unlicenced imported medicines fees - Number of annual Notifications - 101 to 500	£2,131
25.  Safety and quality vetting of unlicenced imported medicines fees - Number of annual Notifications - 501 to 1000	£4,261
25.  Safety and quality vetting of unlicenced imported medicines fees - Number of annual Notifications - 1,001-2,000	£8,521
25.  Safety and quality vetting of unlicenced imported medicines fees - Number of annual Notifications - 2,001-5,000	£17,042
25.  Safety and quality vetting of unlicenced imported medicines fees - Number of annual Notifications - 5,001-10,000	£34,083
25.  Safety and quality vetting of unlicenced imported medicines fees - Number of annual Notifications - 10,001-15,000	£51,125
25.  Safety and quality vetting of unlicenced imported medicines fees - Number of annual Notifications - 15,001-20,000	£68,166
25.  Safety and quality vetting of unlicenced imported medicines fees - Number of annual Notifications - 20,001-25,000	£85,208
25.  Safety and quality vetting of unlicenced imported medicines fees - Number of annual Notifications - 25,001-30,000	£102,249
25.  Safety and quality vetting of unlicenced imported medicines fees - Number of annual Notifications - 30,001-35,000	£119,291
25.  Safety and quality vetting of unlicenced imported medicines fees - Number of annual Notifications - 35,001-40,000	£136,333
25.  Safety and quality vetting of unlicenced imported medicines fees - Number of annual Notifications - 40,001-45,000	£153,375
25.  Safety and quality vetting of unlicenced imported medicines fees - Number of annual Notifications - 45,001-50,000	£170,417
25.  Safety and quality vetting of unlicenced imported medicines fees - Number of annual Notifications - Per additional bracket of 5,000 notifications above 50,000	£17,042
25.  Safety and quality vetting of unlicenced imported medicines fees - Number of annual Product Codes - 11– 20	£487
25.  Safety and quality vetting of unlicenced imported medicines fees - Number of annual Product Codes - 21 – 50	£1,218
25.  Safety and quality vetting of unlicenced imported medicines fees - Number of annual Product Codes - 51 – 100	£2,435
25.  Safety and quality vetting of unlicenced imported medicines fees - Number of annual Product Codes - 101 – 200	£4,869
25.  Safety and quality vetting of unlicenced imported medicines fees - Number of annual Product Codes - Per additional 100 codes above 200	£2,435

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

26. Scientific advice meetings: fees

Fee name	Fee
26.  Scientific Advice Meeting - High complexity	£17,516
26.  Scientific Advice Meeting - Medium complexity	£13,137
26.  Scientific Advice Meeting - Low complexity	£8,758
26.  Scientific Advice Meeting – Simple complexity	£986
26.  Scientific advice meetings: fees - Pharmacovigilance advice meetings - Advice on labels and leaflets	£3,757
26.  Scientific advice meetings: fees - Reclassification advice meetings - Pharmacy to General Sales List switch	£8,758
26.  Scientific advice meetings: fees - Reclassification advice meetings - Prescription Only Medicine to Pharmacy switch	£8,758

27. Simplified Homeopathic Registration Scheme: fees

Fee name	Fee
Standard
27.  Simplified Homeopathic Registration Scheme: fees - Standard - 5 stocks or fewer	£962
27.  Simplified Homeopathic Registration Scheme: fees - Standard - more than 5 stocks	£1,259
Reduced
27.  Simplified Homeopathic Registration Scheme: fees - Reduced - 5 stocks or fewer	£582
27.  Simplified Homeopathic Registration Scheme: fees - Reduced - more than 5 stocks	£857
27.  Simplified Homeopathic Registration Scheme: fees - Formulation already assessed - 5 stocks or fewer	£582
27.  Simplified Homeopathic Registration Scheme: fees - Formulation already assessed - more than 5 stocks	£857
27.  Simplified Homeopathic Registration Scheme: fees - Both stock and formulation already assessed - 5 stocks or fewer	£194
27.  Simplified Homeopathic Registration Scheme: fees - Both stock and formulation already assessed - more than 5 stocks	£479

28. Simplified Homeopathic Registration Scheme: Decentralised Procedure applications: fees

Fee name	Fee
28.  Simplified Homeopathic Registration Scheme: Decentralised Procedure applications: fees - Decentralised Procedure for sale or supply in Northern Ireland and Unfettered access route for UKHR(GB) - 5 stocks or fewer	£524
28.  Simplified Homeopathic Registration Scheme: Decentralised Procedure applications: fees - Decentralised Procedure for sale or supply in Northern Ireland and Unfettered access route for UKHR(GB) - more than 5 stocks	£686

29. Simplified Homoeopathic Registration Scheme: Mutual Recognition Procedures: fees

Fee name	Fee
29.  Simplified Homoeopathic Registration Scheme: Mutual Recognition Procedures: fees - Incoming Mutual Recognition for sale or supply in Northern Ireland and Unfettered access route for UKHR(GB) - 5 stocks or fewer	£610
29.  Simplified Homoeopathic Registration Scheme: Mutual Recognition Procedures: fees - Incoming Mutual Recognition for sale or supply in Northern Ireland and Unfettered access route for UKHR(GB) - more than 5 stocks	£777

30. Testing of samples: fees

Fee name	Fee
30.  Control Testing - Daily rate	£5,093

31. Traditional Herbal Registration Scheme: fees

Fee name	Fee
Standard
31.  Traditional Herbal Registration Scheme: fees - Standard - 3 or fewer existing herbal active ingredients	£2,950
31.  Traditional Herbal Registration Scheme: fees - Standard - more than 3 existing herbal active ingredients	£4,424
Reduced
31.  Traditional Herbal Registration Scheme: fees - Reduced - Category I - 3 or fewer existing herbal active ingredients	£657
31.  Traditional Herbal Registration Scheme: fees - Reduced - Category I - more than 3 existing herbal active ingredients	£983
31.  Traditional Herbal Registration Scheme: fees - Reduced - Category II - 3 or fewer existing herbal active ingredients	£983
31.  Traditional Herbal Registration Scheme: fees - Reduced - Category II - more than 3 existing herbal active ingredients	£1,476
Complex
31.  Traditional Herbal Registration Scheme: fees - Complex - single new herbal active ingredient	£5,899
31.  Traditional Herbal Registration Scheme: fees - Complex - 2 or more new herbal active ingredients	£8,849
Traditional Herbal Registration Scheme
31.  Traditional Herbal Registration Scheme: fees - Traditional Herbal Registration Scheme: supplementary fees - Ancillary vitamins / minerals - Existing Sources plus CEP	£1,311
31.  Traditional Herbal Registration Scheme: fees - Traditional Herbal Registration Scheme: supplementary fees - Ancillary vitamins / minerals - New sources (non-CEP)	£2,622
31.  Traditional Herbal Registration Scheme: fees - Traditional Herbal Registration Scheme: supplementary fees - Ancillary vitamins / minerals - New excipients	£8,748
31.  Traditional Herbal Registration Scheme: fees - Traditional Herbal Registration Scheme: supplementary fees - Ancillary vitamins / minerals - New sources TSE risk excipients (non-CEP)	£777
31.  Traditional Herbal Registration Scheme: fees - Traditional Herbal Registration Scheme: supplementary fees - Ancillary vitamins / minerals - Sterile products	£2,622

*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”

32. Variation: Homeopathic National Rules Scheme fees

Fee name	Fee
32.  Variation: Homeopathic National Rules Scheme fees - Standard variation application	£296
32.  Variation: Homeopathic National Rules Scheme fees - Indication	£456
32.  Variation: Homeopathic National Rules Scheme fees - Other applications (for up to 30 variations where no further medical, technical or scientific assessment is required)	£149
32.  Variation: Homeopathic National Rules Scheme fees - Other applications (for any subsequent variations where no further medical, technical or scientific assessment is required)	£75

33. Variations: Homeopathic Simplified Scheme fees

Fee name	Fee
33.  Variations: Homeopathic Simplified Scheme fees - New technical	£296
33.  Variations: Homeopathic Simplified Scheme fees - Other applications (where further medical, technical or scientific assessment is required)	£296
33.  Variations: Homeopathic Simplified Scheme fees - Other applications (for up to 30 variations where no further medical, technical or scientific assessment is required)	£149
33.  Variations: Homeopathic Simplified Scheme fees - Other applications (for any subsequent variations where no further medical, technical or scientific assessment is required)	£75

34. Variations: licence variations application fees

The following fees also apply to international recognition.

Fee name	Fee
34.  Variations: licence variations application fees - Applications for variations of marketing authorisations falling within the scope of Chapter II of Commission Regulation (EC) No 1234/2008. - Single kind variation - Type IB	£419
34.  Variations: licence variations application fees - Applications for variations of marketing authorisations falling within the scope of Chapter II of Commission Regulation (EC) No 1234/2008. - Single kind variation - Type II	£419
34.  Variations: licence variations application fees - Applications for variations of marketing authorisations falling within the scope of Chapter II of Commission Regulation (EC) No 1234/2008. - Single kind variation - Type II Complex Variation	£3,338
34.  Variations: licence variations application fees - Applications for variations of marketing authorisations falling within the scope of Chapter II of Commission Regulation (EC) No 1234/2008. - Single kind variation - Extended Type II Complex Variation	£10,301

Applications for variations of marketing authorisations falling within the scope of Chapter IIa of Commission Regulation (EC) No 1234/2008 and of marketing authorisations in force in Great Britain.

Fee name	Fee
34.  Variations: National Type 1A variation	No fee
34.  Variations: licence variations application fees - Applications for variations of marketing authorisations falling within the scope of Chapter IIa of Commission Regulation (EC) No 1234/2008 and of marketing authorisations in force in Great Britain. - National Type 1B Variation	£419
34.  Variations: licence variations application fees - Applications for variations of marketing authorisations falling within the scope of Chapter IIa of Commission Regulation (EC) No 1234/2008 and of marketing authorisations in force in Great Britain. - National Type II Variation	£1,593
34.  Variations: licence variations application fees - Applications for variations of marketing authorisations falling within the scope of Chapter IIa of Commission Regulation (EC) No 1234/2008 and of marketing authorisations in force in Great Britain. - National Type II Complex Variation	£11,126
34.  Variations: licence variations application fees - Applications for variations of marketing authorisations falling within the scope of Chapter IIa of Commission Regulation (EC) No 1234/2008 and of marketing authorisations in force in Great Britain. - National Type II Extended Complex Variation	£40,173

35. Variations: licence variations applications groups fees

The following fees also apply to international recognition.

Fee name	Fee
35.  Variations: licence variations applications groups fees - Applications for variations of marketing authorisations falling within the scope of Chapter II of Commission Regulation (EC) No 1234/2008. - Minor variation (Type IB) Group	£419
35.  Variations: licence variations applications groups fees - Applications for variations of marketing authorisations falling within the scope of Chapter II of Commission Regulation (EC) No 1234/2008. - Major Variation (Type II) Group	£1,528
35.  Variations: licence variations applications groups fees - Applications for variations of marketing authorisations falling within the scope of Chapter II of Commission Regulation (EC) No 1234/2008. - Major Variation (Type II) Complex Group	£3,619
35.  Variations: licence variations applications groups fees - Applications for variations of marketing authorisations falling within the scope of Chapter II of Commission Regulation (EC) No 1234/2008. - Major Variation (Type II) Extended Complex Group	£10,555
35.  Variations: licence variations applications groups fees - Applications for variations of marketing authorisations falling within the scope of Chapter IIa of Commission Regulation (EC) No 1234/2008 and of marketing authorisations in force in Great Britain. - National Type IB Minor Variation Group	£833
35.  Variations: licence variations applications groups fees - Applications for variations of marketing authorisations falling within the scope of Chapter IIa of Commission Regulation (EC) No 1234/2008 and of marketing authorisations in force in Great Britain. - National Type II Major Variation Group	£2,212
35.  Variations: licence variations applications groups fees - Applications for variations of marketing authorisations falling within the scope of Chapter IIa of Commission Regulation (EC) No 1234/2008 and of marketing authorisations in force in Great Britain. - National Type II Major Variation Complex Group	£12,065
35.  Variations: licence variations applications groups fees - Applications for variations of marketing authorisations falling within the scope of Chapter IIa of Commission Regulation (EC) No 1234/2008 and of marketing authorisations in force in Great Britain. - National Type II Major Variation Extended Complex Group	£35,184

36. Variations: other licence variations applications fees

Fee name	Fee
Parallel import (PI)
36.  Variations: other licence variations applications fees - Parallel import (PI) - Standard	£479
36.  Variations: other licence variations applications fees - Parallel import (PI) - Administrative	No Fee
Manufacturer’s licences (including traditional herbal medicines)
36.  Variations: other licence variations applications fees - Manufacturer’s licences (including traditional herbal medicines) - Standard	£688
36.  Variations: other licence variations applications fees - Manufacturer’s licences (including traditional herbal medicines) - Administrative	£345
Wholesale dealers’ licences (includes THMPD)
36.  Variations: other licence variations applications fees - Wholesale dealers’ licences (includes THMPD) - Standard	£652
36.  Variations: other licence variations applications fees - Wholesale dealers’ licences (includes THMPD) - Administrative	£345
Clinical trial authorisations
36.  Variations: other licence variations applications fees - Clinical trial authorisations - Amendments to 1 part of dossier	£302
36.  Variations: other licence variations applications fees - Clinical trial authorisations - Amendments to 2 parts of dossier	£302
36.  Variations: other licence variations applications fees - Clinical trial authorisations - Amendments to 3 parts of dossier	£302
36.  Variations: other licence variations applications fees - Clinical trial authorisations - Protocol	£302

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.

37. Variations: Traditional Herbal Registration Scheme fees

Fee name	Fee
37.  Variations: Traditional Herbal Registration Scheme fees - Standard	£293
37.  Variations: Traditional Herbal Registration Scheme fees - Complex	£773
37.  Variations: Traditional Herbal Registration Scheme fees - New excipient	£8,748
37.  Variations: Traditional Herbal Registration Scheme fees - Administrative	£186

Notes:

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.

37.1 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 or CMS).

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: Mutual Recognition Procedure

CMS major variation (type II) Grouped lead case

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 or CMS).

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 or CMS).

38. Wholesale distribution authorisations: fees

Fee name	Fee	Notes
New Applications
38.  Wholesale distribution authorisations: fees - New Applications - Standard application plus full inspection fee	£6,295	£2,159 application fee plus £4,136 inspection fee
38.  Wholesale distribution authorisations: fees - New Applications - Inspection Fee (per additional site if required)	£2,898
38.  Wholesale distribution authorisations: fees - New Applications - Reduced application* plus full inspection fee	£5,216	£1,080 application fee plus £4,136 inspection fee
38.  Wholesale distribution authorisations: fees - New Applications - Reduced application plus reduced Inspection fee - General Sales List (GSL) only	£3,148	£1,080 application fee plus £2,068 inspection fee
38.  Wholesale distribution authorisations: fees - New Applications - Change of ownership	£478
Variations
38.  Wholesale distribution authorisations: fees - Variations - Standard variation	£583
38.  Wholesale distribution authorisations: fees - Variations - Administrative variation	£309
Inspections
38.  Wholesale distribution authorisations: fees - Inspections - Standard Inspection Fee (per site)	£4,136
38.  Wholesale distribution authorisations: fees - Inspections - Reduced rate Inspection fee	£2,068
38.  Wholesale distribution authorisations: fees - Inspections - Inspection fee THMP/Homeopathic only	£2,047
38.  Wholesale distribution authorisations: fees - Inspections - Inspection fee reduced rate THMP/Homeopathic only	£1,114
38.  Wholesale distribution authorisations: fees - Inspections - Office Based Risk Assessments	£3,810

Notes:

Special reduced rates to apply to:

• Wholesale dealers handling GSL products only.
• Registered retail pharmacies where wholesaling of licensed products does not exceed 15% of total turnover in licensed products.
• Small wholesale dealers where wholesaling of licensed products does not exceed £35,000 of total turnover in licensed products.
• See also fees for registration of Active Pharmaceutical Ingredient Manufacturers

39. Early Access to Medicines Scheme (EAMS)

Fee name	Fee
39.  Early Access to Medicines Scheme (EAMS) - Promising Innovative Medicine (PIM) designation	£4,852
39.  Early Access to Medicines Scheme (EAMS) - Scientific opinion for new medicinal products	£31,214
39.  Early Access to Medicines Scheme (EAMS) - Renewal fee for new medicinal products	£15,607
39.  Early Access to Medicines Scheme (EAMS) - Scientific opinion for new indications	£10,115
39.  Early Access to Medicines Scheme (EAMS) - Renewal fee for new indications	£5,057

40. Change of Ownership for Product Licenses

Fee name	Fee
40. Change of Ownership for Product Licenses - Change of ownership (including THMPD registrations)	£592

41. Innovative Licensing and Access Pathway (ILAP)

Fee name	Fee	Notes
41. Innovation Passport	£3,945	The Innovation Passport fee is not refundable if the application is not successful
41. Target Development Profile (TDP)	£4,845

42. Medical Device Approved Body Fees

NB: These fees are scheduled to increase during Q1 of FY25-26

Fee name	Fee
42. Medical Device Approved Body Fees - Initial application for designation	£35,672
42. Medical Device Approved Body Fees - Re-application	£8,918
42. Medical Device Approved Body Fees - Initial designation audit	£58,341
42. Medical Device Approved Body Fees - Surveillance	£45,675
42. Medical Device Approved Body Fees - Witnessed Audit	£10,072
42. Medical Device Approved Body Fees - Re-designation application fee	£35,672
42. Medical Device Approved Body Fees - Re-designation audit	£58,341
42. Medical Device Approved Body Fees - Follow up Audit - Major Closure	£22,789
42. Medical Device Approved Body Fees - Follow up Audit - Special Clinical	£18,583
42. Medical Device Approved Body Fees - Follow up Audit - Process Specific	£22,789
42. Medical Device Approved Body Fees - TSE Applications UK Conformity Assessment Bodies	£1,297
42. Medical Device Approved Body Fees - Extension to scope - new UKCA codes or Annex	£18,212
42. Medical Device Approved Body Fees - Extension to scope - Extension to scope, where codes are limited	£12,571
42. Medical Device Approved Body Fees - Subsidiary audit	£22,789
42. Medical Device Approved Body Fees - Day rate for auditing	£1,262

43. Distance selling logo application

Fee name	Fee
43. Distance selling logo application - Registration fee	£100
43. Distance selling logo application - Annual renewal fee	£97

44. Periodic Safety Update Reports (PSURs) for medicinal products

Fee name	Fee
45. Periodic Safety Update Reports (PSURs) for medicinial products - Actives/ combinations currently listed on the EURD or future UKRD	£979
45. Periodic Safety Update Reports (PSURs) for medicinial products - Reduced fee (where more than one Marketing Authorisation Holder is involved in the procedure)	£490

45. Fees: additional information

The medicines (products for human use) (fees) regulations 2016

The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020

The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023

The Blood Safety and Quality Regulations 2005

The Medical Devices Regulations 2002

The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (legislation.gov.uk)

Medicines and Medical Devices Act 2021

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

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 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.

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

The Agency’s fees legislation currently has provision for some payment easements for small companies and payment waivers for small and medium companies (SME).

1. ‘Facility’ is defined 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. Payment of the annual haemovigilance fee is exempt from 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 ↩

4. 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 prescription-only medicine. ↩ ↩² ↩³

5. Payable for first three complete fee periods following the year of grant. ↩

6. 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. Maintenance 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 ↩ ↩²

7. 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. ↩

8. Where the application: relates to a medicinal product which, at the time the marketing authorisation was granted, contained a new active ingredient; and is the first renewal in relation to that product. ↩ ↩² ↩³ ↩⁴

9. 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 lower renewal fee will be payable in respect of each of the other applications. ↩ ↩² ↩³ ↩⁴

10. 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. ↩ ↩² ↩³

11. 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 the analogous product fee 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 as for analogous products, or half of that for PLPI variations in the case of other applications where there is an analogous product already with the same legal status. ↩ ↩² ↩³ ↩⁴ ↩⁵

12. See more on national leaflets and labels. ↩

13. 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%. ↩