MHRA fees for 2018/19 are remaining the same as 2017/18
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
Notes:
This fee will be payable on application for a Review Panel hearing and applies to all Review Panel proceedings related to an applicant who disagrees with a decision of the licensing authority and who has made an application to be heard pursuant to the relevant sections of the Human Medicines Regulations 2012 and subordinate legislation. A fee will be payable in respect of requests for hearings relating to marketing authorisations, manufacturer’s licences and authorisations, clinical trials applications, herbal and homeopathic registration and blood establishments and blood banks.
If the outcome of the hearing is positive for the company and the original advice is overturned, the fee will be refunded. If an application is made and subsequently withdrawn before a panel has been appointed to consider the case, a partial refund will be made (60%). If the application is withdrawn after the panel has been appointed, no refund will be applicable
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 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. Homoeopathic National Rules Scheme: fees for inspections
Inspections are charged at a daily rate |
|
Type of inspection |
|
All GMP, GCP and pharmacovigilance inspections |
£2,655 (daily rate) |
These include the following (this is not an exhaustive list)
- intermediate biological sites
- manufacturers of active pharmaceutical ingredients (API)
- sterile, non-sterile and assembly sites
- non-routine inspections
- pharmacovigilance inspections, including those of service providers
- clinical trials
- contract laboratories
- homoeopathic manufacturers
- blood banks
- blood establishments
Office-based risk assessments |
£1,863 |
(see notes below) |
GDP (wholesale dealers* including homeopathic wholesalers) |
|
|
*A reduced rate fee for a wholesale dealer inspection will be payable by wholesale dealers who handle GSL products only and for registered retail pharmacies and small wholesale dealers where wholesaling of licensed products does not exceed 15% or £35,000 of total turnover ONLY where an inspector spends less than 3.5 hours on site. This fee will be £1,328 |
|
|
Full day rate £1,936 |
|
|
Reduced rate (see notes below) |
£968 |
|
Office based risk assessments (see notes below) 1,354 |
|
|
Notes: read before applying for an office-based risk assessment:
- 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, eg 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 sitesmanufacturers of active pharmaceutical ingredients (API)sterile, non-sterile and assembly sitesnon-routine inspectionspharmacovigilance inspectionclinical trialscontract laboratorieshomeopathic manufacturers |
2,655 |
Office based 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, 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 £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.
- All accredited inspectors attending an inspection will be charged for, but inspectors in training will not. The status of the inspectors should be made clear to the company at the start of the inspection.
- The office based inspection risk assessment fee will be charged where a risk assessment is conducted which does not lead to an inspection.
14. Licence applications: marketing authorisations (including extension applications) fees
Major |
|
National fee (including hybrid applications) |
£92,753 |
Decentralised procedure where the UK is a concerned member state (CMS) |
£89,556 |
Major (reduced in exceptional circumstances or orders under Section 104/105) |
£29,732 |
Outgoing mutual recognition where the UK is the reference member state (RMS) |
|
1st wave |
£41,573 |
2nd wave |
£27,308 |
Incoming mutual recognition with the UK as a CMS and European reference products |
£62,421 |
Abridged complex |
|
National fee (including hybrid applications) |
£25,643 |
Decentralised procedure where the UK is a concerned member state (CMS) |
£24,760 |
Outgoing mutual recognition where the UK is the reference member state (RMS) |
|
1st wave |
£10,753 |
2nd wave |
£7,133 |
Incoming mutual recognition (UK CMS) and European reference products |
£17,330 |
Abridged standard |
|
National fee |
£9,402 |
Decentralised procedure (UK CMS) |
£9,078 |
Outgoing mutual recognition (UK RMS) |
|
1st wave |
£4,282 |
2nd wave |
£3,567 |
Incoming mutual recognition (UK CMS) and European reference products |
£6,350 |
Abridged simple |
|
National fee |
£2,564 |
Decentralised procedure where the UK is a CMS |
£2,564 |
Outgoing mutual recognition where the UK is an RMS |
£2,564 |
Outgoing mutual recognition (informed consent) |
£2,564 |
1st wave |
£2,564 |
2nd wave |
£2,564 |
Duplicates for all of the above outgoing mutual recognition applications when undertaken at the same time as the lead application |
£2,564 |
Decentralised procedure where UK is RMS |
|
Major |
£121,664 |
Abridged complex |
£35,634 |
Abridged standard |
£15,659 |
Abridged simple |
£8,105 |
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 RMS |
£35,634 |
Decentralised procedure where the UK is CMS |
£24,760 |
Outgoing mutual recognition (UK RMS) |
|
1st wave |
£10,753 |
2nd wave |
£7,133 |
Incoming mutual recognition (UK CMS) |
£17,330 |
Extension application group bulk |
|
Decentralised procedure where the UK is RMS |
£15,659 |
Decentralised procedure where the UK is CMS |
£9,078 |
Outgoing mutual recognition (UK RMS) |
|
1st wave |
£4,282 |
2nd wave |
£3,567 |
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 |
£344 |
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 from 1 April 2017: per licence fee period
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 POM.
- 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.
*Reminder to cancel licences by the end of December 2017
Holders of Manufacturers and Wholesale Dealer’s licences are required to notify the MHRA at pcl@mhra.gsi.gov.uk by 31 December, this will ensure that you are not liable for a periodic fee for the period 1 April 2018 to 31 March 2019.
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 |
|
Outgoing mutual recognition First renewal of a major application (1) |
|
£9,682 |
All others (2) |
£747 |
|
Fees are currently not applicable to national and mutual recognition decentralised procedure (MR-DC) authorisations where the UK is a concerned member state (CMS).
Reclassification |
Fee |
POM to P - Additional for MA or PI application with reclassification element from POM to P (3), (4) |
£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:
- 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.
- If a number of such renewal applications are made at the same time and in relation to products with the same active ingredient, dosage form, indications, PSUR and renewal date, the full fee is charged for the first application, but a 50% “discount” applies to each other application.
- 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. Safety and quality vetting of unlicenced imported medicines fees
Number of notifications estimated for coming year |
Additional sum to be paid* |
1 – 20 |
£130 |
21 – 100 |
£519 |
21 – 1,000 |
£2,077 |
1,001 – 5,000 |
£10,383 |
5,001 – 20,000 |
£25,957 |
20,001 – 50,000 |
£51,914 |
50,001 – 100,000 |
£103,828 |
100,001 + |
£155,742 |
*Additional sum to be paid with annual periodic fee for Manufacturers Licence holders and wholesale dealer licence holders
22. 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.
23. Simplified Homoeopathic 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 |
24. Simplified Homoeopathic Registration Scheme: Decentralised Procedure applications: fees
Where the UK is CMS |
5 stocks or fewer |
£430 |
more than 5 stocks |
£563 |
Where the UK is RMS |
5 stocks or fewer |
£813 |
more than 5 stocks |
£1,063 |
25. 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 |
26. 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”
27. Variation: Homoeopathic 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 |
28. Variations: Homoeopathic 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 |
29. Variations: licence variations application fees
Type 1A |
National/CMS |
No fee |
Type 1A |
RMS |
No fee |
Type 1B |
National/CMS |
£277 |
Type 1B |
RMS or reference authority for worksharing |
£550 |
Type II |
National/CMS |
£734 |
Type II |
RMS or reference authority for worksharing |
£890 |
Type II complex |
National/CMS |
£8,309 |
Type II complex |
RMS or reference authority for worksharing |
£14,406 |
Extended type II complex |
National/CMS |
£25,643 |
Extended type II complex |
RMS or reference authority for worksharing |
£35,846 |
Type IB and II variations following invalidation incur a 10% invalidation fee
30. 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 1B) group fee where the UK is: |
|
Concerned member state (CMS) |
£622 |
Reference member state (RMS) or Reference authority for worksharing |
£1,225 |
Major variation (Type II) group fee where the UK is: |
|
CMS |
£1,652 |
RMS or Reference authority for work sharing |
£1,996 |
Major variation (Type II) complex group fee where UK is: |
|
CMS |
£9,010 |
RMS or Reference authority for work sharing |
£15,233 |
Major variation (Type II) Extended complex group fee where UK is: |
|
CMS |
£26,276 |
RMS or Reference authority for work sharing |
£36,724 |
Minor variation (Type IB) group fee (national) |
£622 |
Major vatiation (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 |
31. 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
32. 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 [LINK]
32.1 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, CMS or RMS).
IMPORTANT: Type IB or Type II variations that include any Type IA changes require a grouped fee according the highest classification of change. Variations in this format supported by a proof of payment for a single fee (or other lesser fee) will be invalidated.
Example 1: National Procedures
Type IB National CMS - lead case - £308, each bulk case - £154
Minor variation (type IB) grouped - lead case - £691, each bulk case £346
Example 2: Mutual Recognition Procedure.
RMS major variation (type II) Grouped lead case – £2,218, each bulk case - £1,109
Complex Variations
The lead case incurs a type II complex or extended complex fee, each bulk member is charged at the relevant single type II fee (national/CMS or RMS).
Grouped Complex Variations
The lead case incurs a ‘type II grouped complex’ or ‘extended grouped complex fee’ and each bulk member is charged at the type II group major bulk fee (national/CMS or RMS).
Worksharing procedures:
- If UK is the ‘Reference Authority’ the same reductions apply for when the UK is Reference Member State in an MRP
- If UK is the recipient of a ‘Reference Authority’ assessment the same reductions apply for when the UK is Concerned Member State in an MRP
- Where all of the affected authorisations are held only in the UK then of course the usual ‘bulk’ submissions can be made in the UK without recourse to appointing a ‘Reference Authority’
All Workshare procedures must obtain prior approval from variationqueries@mhra.gsi.gov.uk before submission and the confirmatory email included in the variation submission cover letter.
33. 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
The medicines (products for human use) (fees) regulations 2016
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 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 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.
-
Payment easements for small companies - definition of a small company: the Agency’s fees legislation currently has provision for some payment easements for small companies in relation to a number of capital fees. See the extract from MHRA fees legislation for further information.