Statutory guidance

Current MHRA fees

Updated 3 August 2018

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

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 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:

1. Minimum fee of one day (with the exception of the GDP inspections)
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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:

1. There is a minimum fee of 1 day (with the exception of the GDP inspections).
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. The office based inspection evaluation and risk assessment fee will be charged where a risk assessment is conducted which does not lead to an inspection. It can also be used in conjunction with or instead of an on site inspection if agreed with the site prior to the start of the 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:

1. To which Section G of Part IV of the Annex to Council Directive 75/318/EEC refers.
2. 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:

1. 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.
2. Payable for first three complete fee periods following the year of grant.

3. 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

4. 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:

1. 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.
2. 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.
3. 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.
4. 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.
5. 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%.
6. 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

34. 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.

1. 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.

2. 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.

3. 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.