Current MHRA fees
Updated 1 April 2021
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This publication is available at https://www.gov.uk/government/publications/mhra-fees/current-mhra-fees
MHRA fees for 2022 - 2023 are remaining the same as 2021 - 2022.
How to make a payment to the MHRA.
For further information regarding EU Exit fees seeThe Human Medicines (Amendment etc.) (EU Exit) Regulations 2020
1. Active pharmaceutical ingredients manufacturers and importers registration: fees
| Fees for registration of active substance manufacturers | Fees | Notes |
|---|---|---|
| New applications | ||
| New application for registration as a manufacturer of active substances | £5006 | £3143 application fee plus £1863 assessment fee |
| Fees for registration of active substance importer or distributor | Fees | Notes |
|---|---|---|
| New applications | ||
| New application for registration as an importer or distributor of active substances | £3157 | £1803 application fee plus £1354 assessment fee |
| Additional fee if the risk assessment of the initial application triggers an inspection | £582 | £1936 Inspection fee less £1354 assessment fee |
| Inspection fee (per site if required) | £1936 | Charged for inspections conducted post registration |
| Variations | ||
| Notification of changes (variation) | £257 | |
| Inspection fee (per site if required) | £1936 | |
| Annual compliance report | ||
| Assessment of the annual compliance report | £257 | Subsequent to 2013, 30 April of each reporting year |
| Annual compliance report where a variation is required | £514 | When there have been changes during the year which need to be updated. £257 Notification of changes fee + £257 annual compliance report assessment fee. |
2. Active substance importers or distributors: fees
| Application for registration | £1,803 |
| Assessment of initial application: active substance importer / distributor | £1,354 |
| Additional fee for the first day of inspection if triggered following risk-assessment of the application | £582 |
| Assessment of the Annual Compliance Report: Active Substance Importer / Distributor | £257 |
| Notification of changes | £257 |
| Standard daily rate for Inspection | £1,936 |
| Persons appointed appeals procedure fee | £10,000 |
3. Active substance manufacturers: fees
| Application for registration | £3,143 |
| Assessment of Initial Application | £1,863 |
| Additional fee for the first day of an inspection if triggered following risk-assessment of the application | £792 |
| Assessment of the Annual Compliance Report | £257 |
| Notification of Changes | £257 |
| Inspection days | £2,655 |
4. Blood banks: application fees for a Review Panel hearing
| Fee | £10,000 |
Notes: This fee will be payable on application for a Review Panel hearing and applies to all Review Panel proceedings related to an applicant who disagrees with a decision of the licensing authority and who has made an application to be heard pursuant to the relevant sections of the Human Medicines Regulations 2012 and subordinate legislation. A fee will be payable in respect of requests for hearings relating to marketing authorisations, manufacturer’s licences and authorisations, clinical trials applications, herbal and homeopathic registration and blood establishments and blood banks.
If the outcome of the hearing is positive for the company and the original advice is overturned, the fee will be refunded. If an application is made and subsequently withdrawn before a panel has been appointed to consider the case, a partial refund (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
| Blood Establishments | Fee | Notes |
| New Applications | ||
| Standard application plus full inspection fee | £5,657 | £3074 application fee plus £2583 inspection fee |
| Inspection fee (per additional site if required) | £2,583 | |
| Variations | ||
| Standard variation | £518 | |
| Periodic Fee | ||
| Annual fee | £463 | |
| Inspections | ||
| Standard Inspection Fee: daily rate | £2,583 | |
| Haemovigilance | ||
| Annual fee | £492 | Cost to the MHRA of operating the system for receiving and assessing reports of serious adverse events and reactions |
| Hospital Blood Banks and facilities | Fee | Notes |
| Inspections | ||
| Inspection fee (per additional site if required) | £2,583 | |
| Haemovigilance | ||
| Annual fee | £492 | In respect of cost to the MHRA of operating the system for receiving and assessing reports of serious adverse events and reactions(2) |
| Compliance | ||
| Annual fee | £683 | In respect of receipt and assessment of annual compliance reports submitted by hospital blood banks to the MHRA(3) |
| 1. ‘Facility’ is defined in SI 2006/2013 as: “a hospital, any other facility or service owned or managed by a health service body, a care home, an independent clinic, a manufacturer, or a biomedical research institute” | ||
| 2. SI 2006/2013 exempts from payment of the annual haemovigilance fee a facility that has entered into an arrangement with a hospital blood bank for that hospital blood bank to report serious adverse events or reactions on the facility’s behalf | ||
| 3. The annual compliance fee is only payable by hospital blood banks, not by facilities. It is charged in addition to any inspection fee that may be payable |
6. Blood facilities: contract laboratories fees
| Inspections | |
|---|---|
| Inspection fee* (per additional site if required) | £2,583 |
| *For contract laboratories that test blood components on behalf of blood establishments or hospital blood banks |
7. Broker registration fees
| Broker registration fees | Fees | Notes |
|---|---|---|
| New Applications | ||
| New application for registration as a broker | £3157 | (£1803 application fee + £1354 assessment fee) |
| Additional fee if the risk assessment of the initial application triggers an inspection | £582 | (£1936 Inspection fee less £1354 assessment fee) |
| Inspection Fee (per site if required) | £1936 | Charged for inspections conducted post registration |
| Variations | ||
| Notification of Changes (Variation) | £257 | |
| Annual Compliance Report | ||
| Assessment of the Annual Compliance Report | £257 | Subsequent to 2013, 30 April of each reporting year |
| Annual Compliance where a variation is required | £514 | When there have been changes during the year which need to be updated. £257 Notification of Changes fee + £257 Annual Compliance Report assessment fee. |
8. Clinical trials: application fees
| Fee description | Type of fee | Fee |
|---|---|---|
| Applications with an IMP dossier | Higher fee (Phase 1, Full and Simplified IMPD) | £ 3060 |
| Applications without an IMP dossier | Lower fee (Phase IV, Cross referral, Additional protocol) | £225 |
| CT variations/amendments | £225 |
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
The fee depends on the class of your device. The figure in brackets is the fee for re-notification in the event of an objection.
9.1 Class I, IIa, or IIb other than implantable or long-term invasive devices
| Notification | Fee |
|---|---|
| Notification of a clinical investigation | £3,820 (£2,920) |
| Notification of a clinical investigation amendment | £207 |
9.2 Class IIb implantable or long-term invasive, Class III, and active implantable devices
| Notification | Fee |
|---|---|
| Notification of a clinical investigation | £5,040 (£3,570) |
| Notification of a clinical investigation amendment | £331 |
10. Drug-device combination products: fees
| Device which incorporates a known medicinal substance from a source previously used in medicinal products or in medical devices where the MHRA has previously been consulted | £4,136 |
| Request by a notified body to the MHRA to supply an additional assessment report | £818 |
| Device which incorporates a known medicinal substance from a new source | £9,640 |
| Notified body request to the MHRA to supply an additional assessment report | £2,228 |
| Device incorporating a new active substance | £42,296 |
| Request by a notified body for the MHRA to supply an additional assessment report | £10,501 |
Notes:
- where a half fee is applicable, the sum will always need to be rounded up, e.g if the fee is £599, then the half fee is £300
- if a device incorporates two or more medicinal substances the fee will be for the higher priced substance
- the same fee applies regardless of the strength or concentration of the medicinal substance.
- one fee will apply to multiple applications made at the same time for a range of similar devices (e.g. a range of catheters made of the same material) incorporating the same medicinal substance at the same level
11. Homoeopathic National Rules Scheme: fees
| Standard | |
|---|---|
| 5 stocks or fewer | £1,088 |
| more than 5 stocks | £1,312 |
| Reduced | |
|---|---|
| Stock already assessed | |
| 5 stocks or fewer | £808 |
| more than 5 stocks | £1,014 |
| Formulation already assessed | |
|---|---|
| 5 stocks or fewer | £808 |
| more than 5 stocks | £1,014 |
| Both stock and formulation already assessed | |
|---|---|
| 5 stocks or fewer | £517 |
| more than 5 stocks | £732 |
| Supplementary fees | |
|---|---|
| New method of sterilisation (non-pharmacopoeial) | £2,154 |
| New excipients | £7,185 |
| New sources TSE risk actives/excipients (non-CEP) | £635 |
12. Homeopathic National Rules Scheme: fees for inspections
| Inspections are charged at a daily rate | |
| Type of inspection | |
| All GMP, GCP and pharmacovigilance inspections | £2,655 (daily rate) |
These include the following (this is not an exhaustive list)
- intermediate biological sites
- manufacturers of active pharmaceutical ingredients (API)
- sterile, non-sterile and assembly sites
- non-routine inspections
- pharmacovigilance inspections, including those of service providers
- clinical trials
- contract laboratories
- homoeopathic manufacturers
- blood banks
- blood establishments
| Office-based risk assessments | £1,863 | (see notes below) |
| GDP (wholesale dealers* including homeopathic wholesalers) | ||
| *A reduced rate fee for a wholesale dealer inspection will be payable by wholesale dealers who handle GSL products only and for registered retail pharmacies and small wholesale dealers where wholesaling of licensed products does not exceed 15% or £35,000 of total turnover ONLY where an inspector spends less than 3.5 hours on site. This fee will be £1,328 | ||
| Full day rate £1,936 | ||
| Reduced rate (see notes below) | £968 | |
| Office based risk assessments (see notes below) 1,354 |
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. This fee will be £1,328.
- 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 2015 fees for inspections will continue to be charged at a daily rate as follows:
| Type of inspection | Daily rate £ |
|---|---|
| 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 | 2,655 |
| Office based evaluation and risk assessments (see notes below) | 1,863 |
| GDP (wholesale dealers including homeopathic wholesalers): | |
| Full day rate | 1,936 |
| Reduced rate (see notes below) | 968 |
| Office based risk assessments (see notes below) |
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 authorisations (including extension applications) fees
| Major | |
|---|---|
| Major Orphan (reduced in exceptional circumstances ) | £29,732 |
| Incoming mutual recognition procedure for sale or supply in Northern Ireland and Unfettered access route for UKMA(GB) | £62,421 |
| European reference product application for sale or supply in Northern Ireland | £62,421 |
| Decentralised procedure for sale or supply in Northern Ireland and Unfettered access route for UKMA(GB) | £62,421 |
| Major: (Previously granted by EU) - unfettered access route to GB | £18,437 |
| Major: (Previously granted by EEA) – application for GB or UK, excluding GB unfettered access route (MRDC reliance procedure) | £62,421 |
| Major: (Previously granted by EU) - automatic recognition application (EC Decision reliance procedure) | £18,437 |
| National fee (any other case including hybrid applications) | £92,753 |
| Abridged complex | |
|---|---|
| Incoming mutual recognition procedure for sale or supply in Northern Ireland and Unfettered access route for UKMA(GB) | £17,330 |
| European reference product application for sale or supply in Northern Ireland | £17,330 |
| Decentralised procedure for the sale or supply in Northern Ireland and Unfettered access route for UKMA(GB) | £17,330 |
| Complex: (Previously granted by EU) - unfettered access route to GB | £10,443 |
| Complex: (Previously granted by EEA) – application for GB or UK, excluding GB unfettered access route (MRDC reliance procedure) | £17,330 |
| Complex: (Previously granted by EU) - automatic recognition application (EC Decision reliance procedure) | £10,443 |
| National fee (any other case including hybrid applications) | £25,643 |
| Abridged standard | |
|---|---|
| Incoming mutual recognition procedure for sale or supply in Northern Ireland and Unfettered access route for a UKMA(GB) | £6,350 |
| European reference product application for sale or supply in Northern Ireland | £6,350 |
| Decentralised procedure for sale or supply in Northern Ireland and Unfettered access route for UKMA(GB) | £6,350 |
| Standard: (Previously granted by EU) - unfettered access route to GB | £5,783 |
| Standard: (Previously granted by EEA) – application for GB or UK, excluding GB unfettered access route (MRDC reliance procedure) | £6,350 |
| Standard: (Previously granted by EU) - automatic recognition application (EC Decision reliance procedure) | £5,783 |
| National fee (all other cases) | £9,402 |
| Abridged simple | |
|---|---|
| Incoming mutual recognition procedure for sale or supply in Northern Ireland and Unfettered access route for UKMA(GB) | £2,564 |
| Decentralised procedure for sale or supply in Northern Ireland and Unfettered access route for UKMA(GB) | £2,564 |
| Simple: (Previously granted by EU) - unfettered access route to GB | £2,564 |
| Simple: (Previously granted by EEA) – application for GB or UK, excluding GB unfettered access route (MRDC reliance procedure) | £2,564 |
| Simple: (Previously granted by EU) - automatic recognition application (EC Decision reliance procedure) | £2,564 |
| National fee (all other cases) | £2,564 |
| Extension application | |
|---|---|
| Extension application group (National fee) | £25,643 |
| Extension application group bulk (National fee) | £9,402 |
| Extension application group | |
|---|---|
| Decentralised procedure where the UK is CMS | £24,760 |
| Incoming mutual recognition (UK CMS) | £17,330 |
| Extension application group bulk | |
|---|---|
| Decentralised procedure where the UK is CMS | £9,078 |
| Incoming mutual recognition (UK CMS) | £6,350 |
| (To which Section G of Part IV of the Annex to Council Directive 75/318/EEC refers) | |
| Parallel import complex application (2) | £18,180 |
| Standard application (2) | £6,663 |
| Simple application | £1,792 |
| Change of ownership (including THMPD registrations) | £442 |
| Manufacturers’ licences (including THMPD and homeopathic medicinal products | |
| Standard (3) | £3,143 |
| Non-orthodox practitioner (NOP) | £183 |
| Change of ownership | £442 |
Notes:
- To which Section G of Part IV of the Annex to Council Directive 75/318/EEC refers.
- An application for a Parallel Import licence for a product where there is no common origin between the imported and UK reference product – similar definitions for incoming Mutual Complex and Standard applications apply.
- Where relevant, these standard, rather than complex, fees will be charged where the application is only concerned with the introduction of new suppliers of defined simple Active Pharmaceutical Ingredients (APIs). More information can be found on Fees for New Suppliers of Defined Simple Active Pharmaceutical Ingredients (Updated March 2013) (20Kb)
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
| Standard | £3,143 |
| Non-orthodox practitioner (NOP) | £183 |
| Change of ownership | £344 |
16. Licence applications: parallel imports fees
| Complex application* | £18,180 |
| Standard application* | £6,663 |
| Simple application | £1,792 |
| Change of ownership (including THMPD registrations) | £442 |
| *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
| Phase I Accreditation Scheme | Fee |
| Accreditation of Phase 1 units | £117 |
| Certificate of accreditation | £62 |
18. Medicines/medical devices export certificates: fees
| Urgent request: two working days per set | |
| Original and two copies | £152 |
| Standard request: ten working days per set | |
| Original and two copies | £68 |
| Each additional copy | £34 |
19. Periodic fees
| Type of licence | Fee |
|---|---|
| New active substance (1) | £9,710 |
| Derivatives with a different route of administration (1) or complex abridged (2) | £9,710 |
| Other derivatives (1) | £6,554 |
| Legal status/sale category | Fee type - see note 3 |
| POM | |
| Standard fee* | £2,428 |
| Reduced rate fee | £1,211 |
| ‘Maintenance’ fee | £307 |
| All others (P, GSL, PLPI and None) | £307 |
| Type of licence | Fee |
|---|---|
| Herbal | £76 |
| Homeopathic and Anthroposophic PLRs (per PLR) | £76 |
| Simplified Homeopathic Registration | No fee |
| National Rules Homeopathic Authorisation | £76 |
| Manufacturer’s licence | £468 |
| Wholesale dealer’s licence | £288 |
| Wholesale dealer’s licence (reduced rate or GSL) (4) | £172 |
| THMPD registration | £76 |
Notes:
- 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.
- Payable for first three complete fee periods following the year of grant.
-
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
- Wholesale dealer’s licence (reduced rate or GSL) The reduced fee payable under regulation 37(3) is applicable where the wholesale dealer’s licence— (a) relates to anything done in a registered pharmacy by or under the supervision of a pharmacist and amounts to wholesale dealing, where such dealing constitutes no more than 15% of the total value of the sale of authorised medicinal products carried on at that pharmacy; (b) does not relate to anything done in a registered pharmacy, where the total value of the sale by way of wholesale dealing in authorised medicinal products does not exceed £35,000; or (c) relates to general sale list medicines only.
All other legal status medicinal products
Lower fee - This fee is payable relating to pharmacy medicines, general sale list medicines or ‘none’ status medicines regardless of turnover.
If you no longer require your licence and do not want to be charged a periodic fee in April 2023, you are required to formally cancel your licence before 31 December 2022.
Holders of Manufacturers and Wholesale Dealer’s licences are required to notify the MHRA at pcl@mhra.gov.uk by 31 December 2022. If you do not formally cancel your licence by this date, you will be charged a periodic fee for the period 1 April 2023 to 31 March 2024.
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
| Licence Renewal Applications | Fee |
|---|---|
| Manufacturers’ licences Non-orthodox practitioner (NOP) | £178 |
| First renewal of a market authorisation granted with a new active substance | Fee |
|---|---|
| UKMA(GB) granted under the unfettered access route | £747 (1),(2) |
| UKMA(GB) previously granted by EU (automatic recognition) | £747 (1),(2) |
| All other cases | £9,682 (1),(2) |
| Reclassification | Fee |
|---|---|
| POM to P - Additional for MA or PI application with reclassification element from POM to P (3), (4) | £11,992 |
| Reclassification variation application POM to P (3),(4) | £11,992 |
| P to GSL - Additional fee for MA or PI application with reclassification element from P to GSL (3), (4) | £8,162 |
| Reclassification variation application P to GSL | £8,162 |
| Reclassification variation application (MA) (analogous product) (4) | £734 |
| Reclassification Type IB variation application (MA) (analogous product) (4) | £277 |
| Reclassification variation application (PI) (analogous product) | £176 |
| Assessment of labels and leaflets | |
|---|---|
| Single or first application (5) | £518 |
| National (BROMI) - Article 61 (3) Notification (6) | £186 |
| Parallel imports | £328 |
Notes:
- 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.
-
If a number of such renewal applications are made at the same time and in relation to products with the same active ingredient, dosage form, indications, Periodic Safety Update Report (PSUR) and renewal date, the full fee is charged for the first application, but a fee of £747 will be payable in respect of each of the other applications.
-
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.
-
If multiple MA applications with reclassification elements are made at the same time and in relation to products with the same active ingredient, the full additional fee is charged for one application but only £734 for each other application. If multiple reclassification variation applications are made at the same time and in relation to products with the same active ingredient, the full fee is charged for the one application but in relation to each other application the fee is only £734, or £367 for PLPI variations in the case of other applications where there is an analogous product already with the same legal status.
-
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%.
- See more on national leaflets and labels.
21. Orphan Marketing Products: fees
| Orphan Major (Full fee) | £92,753 |
| Orphan Major (exceptional circumstances in which point 6 pf Part II of Annex 1 in the 2001 Directive applies) | £29,732 |
| Orphan Complex (Full Fee) | £25,643 |
| Orphan Standard (Full Fee) | £9,402 |
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 paragraph 6 of Part II of Annex 1 to the 2001 Directive applies: 50%
(c) Any other case: 10%
22. Pharmacovigilance (PV) Safety Review: fees
| PV Major Safety Review (1-2 active ingredients) | £51,286 |
| PV Major Safety Review (3 active ingredients) | £59,595 |
| PV Major Safety Review (4 active ingredients) | £67,904 |
| PV Major Safety Review (5 or more active ingredients) | £76,213 |
| PV Periodic Safety Update Report (PSUR) single assessment: Full Fee | £890 |
| PV Periodic Safety Update Report (PSUR) single assessment: Half Fee | £445 |
| PV Post Authorisation Safety Study (PASS) protocol | £8,309 |
| Assessment of PASS Results | £8,309 |
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 |
| Certified Annual Update of a PMF (epidemiology update only) | £277 |
| Certified Annual Update of a PMF (significant changes to safety information) | £734 |
| Vaccine Antigen Master File (VAMF) certification | £8,309 |
24. Pre-Assessment (Rolling Review): fees
| Application by pre-assessment (NAS) - Module 3 (chemical, pharmaceutical and biological information) | £23,188 |
| Application by pre-assessment (NAS) - Module 4 (non-clinical reports) | £23,188 |
| Application by pre-assessment (NAS) - Module 5 (clinical study reports) | £23,188 |
| Application by pre-assessment (Biosimilar) - Module 3 (chemical, pharmaceutical and biological information) | £4,333 |
| Application by pre-assessment (Biosimilar) - Module 4 (non-clinical reports) | £4,333 |
| Application by pre-assessment (Biosimilar) - Module 5 (clinical study reports) | £4,333 |
25. Safety and quality vetting of unlicenced imported medicines fees
| Number of notifications estimated for coming year | Additional sum to be paid* |
|---|---|
| 1 – 20 | £130 |
| 21 – 100 | £519 |
| 101 – 1,000 | £2,077 |
| 1,001 – 5,000 | £10,383 |
| 5,001 – 20,000 | £25,957 |
| 20,001 – 50,000 | £51,914 |
| 50,001 – 100,000 | £103,828 |
| 100,001 + | £155,742 |
*Additional sum to be paid with annual periodic fee for Manufacturers Licence holders and wholesale dealer licence holders
26. Scientific advice meetings: fees
| Quality development only | £2,201 |
| Safety development only | £2,201 |
| Quality and safety development | £3,061 |
| Clinical development only | £2,763 |
| Quality and clinical development | £3,624 |
| Safety and clinical development | £3,624 |
| Quality, safety and clinical development | £4,487 |
| Discussion on development of paediatric forms and uses meeting criteria for waiver set down in schedule 5 paragraph 10 of SI 2008 No.552 | No fee |
| Pre-consultation application meetings on devices incorporating an ancillary medicinal substance* | |
| Quality development only | £749 |
| Safety development only | £749 |
| Quality and safety development | £949 |
| Clinical development only | £949 |
| Quality and clinical development | £1,299 |
| Safety and clinical development | £1,299 |
| Quality, safety and clinical development | £1,648 |
| Broader scope meetings | £4,451 |
| Pharmacovigilance advice meetings | |
| Standard meeting | £3,061 |
| Major meeting | £3,624 |
| Post-authorisation regulatory advice meetings | £2,763 |
| Advertising advice | £2,201 |
| Advice on labels and leaflets | £2,201 |
| Reclassification advice meetings | |
| P to GSL switch | £2,763 |
| POM to P switch | £3,624 |
*Scientific advice on the medicinal substance aspects of the device product.
27. Simplified Homeopathic Registration Scheme: fees
| Standard | |||
| 5 stocks or fewer | £790 | more than 5 stocks | £1,034 |
| Reduced | |||
| Stock already assessed | |||
| 5 stocks or fewer | £478 | more than 5 stocks | £704 |
| Formulation already assessed | |||
| 5 stocks or fewer | £ 478 | more than 5 stocks | £704 |
| Both stock and formulation already assessed | |||
| 5 stocks or fewer | £159 | more than 5 stocks | £393 |
28. Simplified Homeopathic Registration Scheme: Decentralised Procedure applications: fees
| Where the UK is CMS | 5 stocks or fewer | £430 | more than 5 stocks | £563 |
29. Simplified Homoeopathic Registration Scheme: Mutual Recognition Procedures: fees
| Mutual recognition outgoing | |
| 5 stocks or fewer | £287 |
| more than 5 stocks | £374 |
| Mutual recognition incoming | |
| 5 stocks or fewer | £501 |
| more than 5 stocks | £638 |
30. Testing of samples: fees
| Product Type | Fee payable where the licensing authority carries out a full assessment | Fee payable where the licensing authority carries out a paper-based assessment |
| Plasma pools which require three or fewer tests | £180 | £90 |
| Plasma pools which require four or five tests | £215 | £90 |
| Plasma pools which require six or more tests | £230 | £90 |
| Band A – single component product, other than Botulinum toxin. requiring five or fewer in vitro tests | £1,660 | £305 |
| Band B – Factor VIII, Factor VIX or intravenous Immunoglobin | £1,910 | £305 |
| Band C – Multi-component product, or Botulinum toxin, requiring five or fewer in vitro tests | £2,340 | £305 |
| Band D – product requiring six to nine in vitro tests | £3,690 | £677 |
| Band E – one to two in vitro tests | £6,410 | £677 |
| 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 | £10,350 | £677 |
31. Traditional Herbal Registration Scheme: fees
| Standard | |
|---|---|
| 3 or fewer existing herbal active ingredient | £2,423 |
| more than 3 existing herbal active ingredients | £3,634 |
| Reduced | |
|---|---|
| Category I | |
| 3 or fewer existing herbal active ingredients | £539 |
| more than 3 existing herbal active ingredients | £807 |
| Category II | |
| 3 or fewer existing herbal active ingredients | £807 |
| more than 3 existing herbal active ingredients | £1,212 |
| Complex | |
|---|---|
| single new herbal active ingredient | £4,846 |
| 2 or more new herbal active ingredients | £7,269 |
| Traditional Herbal Registration Scheme: supplementary fees | |
|---|---|
| Ancillary vitamins / minerals | |
| Existing Sources plus CEP | £1,077 |
| New sources (non-CEP) | £2,154 |
| New excipients | £7,186 |
| New sources TSE risk excipients (non-CEP) | £638 |
| Sterile products | £2,154 |
| Inspection of Manufacturers | |
| Full day | £1,615 |
| Half day | £994 |
| Inspection of Wholesale Dealers | |
| Full day | £1,367 |
| Half day | £744 |
| Inspection of non-orthodox practitioners | £295 |
*Reduced registration application category I” means an application, other than a complex registration application, for a traditional herbal registration relating to a medicinal product which is presented in the form of a herbal tea; “reduced registration application category II” means an application, other than a complex registration application, for a traditional herbal registration where the application falls within one of the descriptions specified in sub-paragraphs (a) to (d) as follows:
(a) the application relates to a medicinal product which is presented in the form of a herbal tincture
(b) the application relates to a medicinal product which is presented in the form of an essential oil
(c) the application relates to a medicinal product which is presented in the form of a fatty oil or
(d) the application relates to a medicinal product which contains only “herbal substances in a capsule”
32. Variation: Homeopathic National Rules Scheme fees
| Standard variation application | £243 |
| Indication | £374 |
| Other applications (for up to 30 variations where no further medical, technical or scientific assessment is required) | £122 |
| Other applications (for any subsequent variations where no further medical, technical or scientific assessment is required) | £61 |
33. Variations: Homeopathic Simplified Scheme fees
| New technical | £243 |
|---|---|
| Other applications (where further medical, technical or scientific assessment is required) | £243 |
| Other applications (for up to 30 variations where no further medical, technical or scientific assessment is required) | £122 |
| Other applications (for any subsequent variations where no further medical, technical or scientific assessment is required) | £61 |
34. Variations: licence variations application fees
| Type 1A | National | No fee |
| Type 1B | National | £277 |
| Type II | National | £734 |
| Type II complex | National | £8,309 |
| Extended type II complex | National | £25,643 |
Applications for variations of marketing authorisations falling within the scope of 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 IB | £277 |
| Single kind variation - Type II | £277 |
| Single kind variation - Type II Complex Variation | £2,493 |
| Single kind variation - Extended Type II Complex Variation | £7,693 |
Type IB and II variations following invalidation incur a 10% invalidation fee
35. Variations: licence variations applications groups fees
Where a half fee is applicable the sum will always be rounded up e.g. if the fee is £599 the half fee is £300
| Minor variation (Type IB) group fee (national) | £622 |
| Major variation (Type II) group fee (national) | £1,652 |
| Major variation (Type II) complex group fee (national) | £9,010 |
| Major variation (Type II) extended complex group fee (national) | £26,276 |
Applications for variations of marketing authorisations falling within the scope of Chapter II of Commission Regulation (EC) /1234/2008 (as amended for CMS). In addition, variations submitted under the relevant National reliance/recognition routes.
| Minor Variation (Type IB) Group Application | £277 |
| Major Variation (Type II) Group Application | £496 |
| Major Variation (Type II) Complex Group Application | £2,703 |
| Major Variation (Type II) Extended Complex Group Application | £7,883 |
36. Variations: other licence variations applications fees
| Parallel import (PI) | |
|---|---|
| Standard | £357 |
| Administrative | No fee |
| Manufacturer’s licences (including traditional herbal medicines) | |
|---|---|
| Standard | £514 |
| Administrative | £257 |
| Wholesale dealers’ licences (includes THMPD) | |
|---|---|
| Standard | £486 |
| Administrative | £257 |
| Clinical trial authorisations | |
|---|---|
| Amendments to 1 part of dossier | £225 |
| Amendments to 2 parts of dossier | £225 |
| Amendments to 3 parts of dossier | £225 |
| Protocol | £225 |
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
| Standard | £240 |
| Complex | £635 |
| New excipient | £7,186 |
| Administrative | £152 |
Notes: 1. Reductions for ‘bulks’ of single or group variations (ie same changes different authorisations belonging to the same company) are available. Further guidance for bulk variations is available at the end of this page
- Standard fees will be charged where the application is concerned with the introduction of new suppliers of defined simple Active Pharmaceutical Ingredients (APIs) only. Further information: Fees for New Suppliers of Defined Simple Active Pharmaceutical Ingredients.
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: National Procedures
Type IB National - lead case - £277, each bulk case - £139 Minor variation (type IB) grouped - lead case - £622, each bulk case £311
Example 2: Mutual Recognition Procedure.
CMS major variation (type II) Grouped lead case – £496, each bulk case - £298
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
| New Applications | ||
|---|---|---|
| Standard application plus full inspection fee | £3739 (£1803 application fee plus £1936 inspection fee) | |
| Inspection Fee (per additional site if required) | £1936 | |
| Reduced application* plus full inspection fee | £2838 | £902 application fee plus £1936 inspection fee |
| Reduced application plus reduced Inspection fee - General Sales List (GSL) only | £1870 | £902 application fee plus £968 inspection fee |
| Change of ownership | £399 | |
| Variations | ||
| Standard variation | £486 | |
| Administrative variation | £257 |
| Inspections | ||
|---|---|---|
| Standard Inspection Fee (per site) | £1936 | ( See: fees for Inspection) |
| Reduced rate Inspection fee | £968 | |
| Inspection fee THMP/Homeopathic only | £1367 | |
| Inspection fee reduced rate THMP/Homeopathic only | £744 | |
| Office Based Risk Assessments | £1354 | |
| Issue of GDP Certificates | £68 + 1 additional copy |
Notes:
Special reduced rates to apply to:
1) Wholesale dealers handling GSL products only.
2) Registered retail pharmacies where wholesaling of licensed products does not exceed 15% of total turnover in licensed products.
3) Small wholesale dealers where wholesaling of licensed products does not exceed £35,000 of total turnover in licensed products.
4) See also fees for registration of Active Pharmaceutical Ingredient Manufacturers
39. Fees: additional information
The medicines (products for human use) (fees) regulations 2016
See information on fees for new suppliers of defined simple active pharmaceutical ingredients.
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Definitions of different types of marketing authorisation applications: one of the most common questions we are asked is about the definitions of the different types of marketing authorisation applications. We are therefore publishing an extract from the MHRA fees legislation the The Medicines (Products for Human Use)(Fees) Regulations 2010 S.I No 551 which defines each of the different types of application: See MHRA fees definitions for information.
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Clarification of terminology relating to periodic fees: you might find it useful to refer to the terminology relating to periodic fees from the The Medicines (Products for Human Use)(Fees) Regulations 2010 S.I No 551. They will help you determine how to calculate turnover and whether you can claim reduced or maintenance rates for any of your products.
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The Agency’s fees legislation currently has provision for some payment easements for small companies and payment waivers for small and medium companies (SME).