Updates of current MHRA fees

Updates of current MHRA fees

Below are the list of Updated MHRA Fees relating to Pharmaceutical Industry

 

  • Active pharmaceutical ingredients manufacturers and importers registration: fees

New application for registration as a manufacturer of active substances £5006 £3143 application fee + £1863 assessment fee
New application for registration as an importer or distributor of active substances £3157 £1803 application fee + £1354 assessment fee
Additional fee if the risk assessment of the initial application triggers an inspection £582
Inspection fee (per site if required) £1936
  • 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
  • Clinical trials: application fees

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
  • Clinical investigations for devices: fees

    • Class I, IIa, or IIb other than implantable or long-term invasive devices
Notification of a clinical investigation £3,820 (£2,920)
Notification of a clinical investigation amendment £207
  • Class IIb implantable or long-term invasive, Class III, and active implantable devices

Notification of a clinical investigation £5,040 (£3,570)
Notification of a clinical investigation amendment £331
  • 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
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
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
  • Homoeopathic National Rules Scheme: fees

5 stocks or fewer £1,088
more than 5 stocks £1,312
Supplementary fees
New method of sterilisation (non-pharmacopoeial) £2,154
New excipients £7,185
New sources TSE risk actives/excipients (non-CEP) £635
  • Homoeopathic National Rules Scheme: fees for inspections

All GMP, GCP and pharmacovigilance inspections £2,655 (daily rate)
Office-based risk assessments £1,863
Full day rate £1936
  • Inspection: fees

All GMP, GCP and Pharmacovigilance inspections including: 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 risk assessments: £1,863
Full day rate £1,936
  • 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
  • Licence applications: marketing authorisations (including extension applications) fees

    • Abridged Complex
National fee (including hybrid applications) £25,643
Decentralised procedure where the UK is a concerned member state (CMS) £24,760
  • Decentralised procedure where UK is RMS

Major £121,664
Abridged complex £35,634
Abridged standard £15,659
  • Licence applications: manufacturers licence (including THMPD and homeopathic medicinal products) fees

Standard £3,143
Non-orthodox practitioner (NOP) £183
Change of ownership £344
  • Licence applications: parallel imports fees

Complex application £18,180
Standard application £6,663
Simple application £1,792
Change of ownership (including THMPD registrations) £442
  • Licence applications: Phase 1 Accreditation Scheme fees

Phase I Accreditation Scheme Fee
Accreditation of Phase 1 units £117
Certificate of accreditation £62
  • 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
  • Periodic fees from 1 April 2017: per licence fee period

Type of licence Fee
New active substance £9,710
Derivatives with a different route of administration or complex abridged £9,710
Other derivatives £6,554
Legal status/sale category Fee type – see note 3
POM
Standard fee £2,428
Reduced rate fee £1,211
‘Maintenance’ fee £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) £172
THMPD registration £76
  • Licence renewals, reclassifications and assessment of labels and leaflets: fees

Licence Renewal Applications Fee
Manufacturers’ licences Non-orthodox practitioner (NOP) £178
Outgoing mutual recognition First renewal of a major application
All others £747

 

Reclassification Fee
POM to P – Additional for MA or PI application with reclassification element from POM to P £11,992
Reclassification variation application POM to P £11,992
P to GSL – Additional fee for MA or PI application with reclassification element from P to GSL £8,162
Reclassification variation application P to GSL £8,162
Reclassification variation application (MA) (analogous product) £734
Reclassification Type IB variation application (MA) (analogous product) £277
Reclassification variation application (PI) (analogous product) £176
  • Simplified Homoeopathic Registration Scheme: fees

5 stocks or fewer £790
Stock already assessed
5 stocks or fewer £478
Formulation already assessed
5 stocks or fewer £ 478
  • 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
  • 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
  • Traditional Herbal Registration Scheme: fees

Standard
3 or fewer existing herbal active ingredient £2,423
more than 3 existing herbal active ingredients £3,634
Complex
single new herbal active ingredient £4,846
2 or more new herbal active ingredients £7,269
  • 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
  • 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
  • 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
  • Variations: licence variations applications groups fees

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
  • Variations: other licence variations applications fees

Manufacturer’s licences (including traditional herbal medicines)
Standard £514
Administrative £257
Wholesale dealers’ licences (includes THMPD)
Standard £486
Administrative £257
  • Variations: Traditional Herbal Registration Scheme fees

Standard £240
Complex £635
New excipient £7,186
Administrative £152
  • Wholesale distribution authorisations: fees

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
Standard application plus full inspection fee £3739 (£1803 application fee plus £1936 inspection fee)

 

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The technical inputs, quality of work and translation output provided by M/s. InClinition, Dombivli, Mumbai, India were found satisfactory and meeting the latest standards. We recommend them for any kind of translation projects in future.

Dr. Ashish Mungantiwar
Dr. Ashish MungantiwarPresident-Medical Services, Mcleods Pharmaceuticals Ltd.

We found their suggestions and guidelines appropriate to our formulation range. InClinition Team has expert domain knowledge. They involved all our staff during conduction of audit and created positive approach towards audit. We strongly recommend their services and wish a continued support from them.

Mr. Nandkishor Deshpande
Mr. Nandkishor DeshpandeDirector, Debco Homeopathic Pharmaceuticals

On occasion of InClinition's 1st International Scientific Conference, we wish a grand success to conference.

Mr. Pranab Mukherjee
Mr. Pranab MukherjeePresident, Republic of India
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