UK Statutory Instrument SI 2016/190 United Kingdom

The Medicines (Products for Human Use) (Fees) Regulations 2016

Read it on legislation.gov.uk (opens in a new tab)
Status
In Force
Penalty ceiling
Regulated

Does it bind you?

Business-side roles with duties under this instrument.

Manufacturer3 Any Person1

Other Acts binding the same actors

If a role above is yours, these are the other instruments that most often bind it.

Manufacturer — also bound by 502 other Acts
Any Person — also bound by 2340 other Acts

What it requires

Regulations creating concrete business duties or carrying penalties, grouped as the instrument is structured. Titles link to the source text — blue means you’re leaving for legislation.gov.uk.

s.008 Fee for advice on labelling or leaflets Regulated
  • Pay the £3,757 fee for labelling or leaflet advice meetingsManufacturer
s.019 Fee for assessment of clinical trial annual safety reports Regulated
  • Pay £343 fee when submitting a clinical trial annual safety reportAny Person
72 other provisions — procedural and definitional
s.001 Citation and commencement
s.002 Interpretation
s.003 Interpretation of Part 2
s.003 Fee for scientific or other advice
s.004 Fee for scientific advice: application for, or variation to, EU marketing authorisation
s.005 Fee for scientific advice: classification of a medicinal product
s.006 Fee for advertising advice
s.007 Fee for pharmacovigilance advice
s.009 Fee for regulatory advice
s.010 Fee for advice for other purposes
s.010 Waiver for advice given to small and medium companies
s.011 Time for payment of fees under regulations 3A to 8
s.012 Fees for applications for authorisations, registrations, licences or certificates etc.
s.013 Fee for application to be included on the list of online sellers of medicines
s.014 Fee for applications for additional copy certificates
s.015 Fees for applications for certificates and copy certificates by exporters of medicinal products
s.016 Meaning of “set of applications”
s.017 Fees for applications for regulatory assistance under the mutual recognition procedure
s.018 Time for payment of fees under regulation 17
s.019 Fees for variations of authorisations, registrations and licences
s.019 Fees for certification of plasma master files
s.019 Fee for certification of vaccine antigen master files
s.019 Fees for assessment of post-authorisation safety studies
s.019 Fee for carrying out a major safety review
s.019 Fee for assessment of periodic safety update reports
s.019 Fee for testing of samples by the appropriate authority
s.019 Time for payment of fees under regulations 19A to 19F
s.020 Fees for modifications to clinical trial authorisations
s.021 Fees for notification of changes and reports for broker's registrations
s.022 Fees for notification of changes and compliance Reports for active substance registrations
s.023 Applications for multiple variations
s.024 Meaning of “set of proposed changes”
s.025 Fees for assessment of a set of proposed changes to labels and leaflets
s.026 Time for payment of fees under regulation 25
s.027 Fees for renewals of certain manufacturer's licences
s.027 Fee for renewals of a marketing authorisation
s.028 Fees for renewals in terms which are not identical to the existing authorisation, licence or registration
s.029 Fees for regulatory assistance for certain marketing authorisations
s.030 Fees for inspections
s.031 Fees for inspections of pharmacovigilance service providers
s.032 Payer of inspection fee (contract laboratories and API manufacturing sites)
s.033 Inspections in connection with multiple applications
s.034 Fees for inspections relating to good clinical practice in clinical trials
s.035 Amount, and time for payment, of inspection fees in respect of an application for a wholesale dealer's licence
s.036 Adjustment and refund of inspection fees in respect of a wholesale dealer's licence
s.037 Amount, and time for payment, of inspection fees in respect of an application for a broker's registration or an active substance registration
s.038 Periodic fees
s.039 Periodic fee for persons included on the list of online sellers of medicines
s.040 Meaning of “good clinical practice accreditation scheme”
s.041 Fees for applications for membership and certificates
s.042 Fee for a review upon oral representations or a person appointed hearing
s.043 Time for payment under regulation 42
s.044 Interpretation
s.045 Fees for applications made at the invitation of the licensing authority
s.046 Fees for applications for certificates
s.047 Fees for variations of certificates
s.048 Time for payment of fees
s.049 Payment of fees to Ministers
s.050 Time for payment of capital fees in connection with applications or inspections
s.051 Time for payment of capital fees – applications made by small companies
s.052 Payment of fees in respect of a traditional herbal registration
s.053 Time for payment of periodic fees
s.054 Penalty fees for late payment of periodic fees
s.055 Daily penalty fees for late payment of periodic fees
s.056 Refund or waiver of fees under regulation 54 or 55
s.057 Adjustment, waiver, reduction or refund of fees
s.058 Suspension of licences and authorisations
s.059 Civil proceedings to recover unpaid fees
s.060 Amendment of the Medical Devices (Consultation Requirements) (Fees) Regulations 1995
s.061 Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004
s.062 Amendment of the Human Medicines Regulations 2012
s.063 The Medicines (Products for Human Use) (Fees) Regulations 2013
Schedules

Schedules

2 of 124 shown
s.sch004 Information requirements Regulated
  • Provide sales-value information and auditor's certificate to the MHRA if requestedManufacturer
s.sch004 Marketing authorisations Regulated
  • Pay the fee for holding a marketing authorisationManufacturer
122 other schedules
s.sch001 In these Regulations— “the 2001 Directive” means Directive 2001/83/EC of...
s.sch001 For the purposes of these Regulations, a clinical trial authorisation...
s.sch001 In these Regulations any reference to an application for the...
s.sch001 In these Regulations any reference to an application to be...
s.sch001 (1) For the purpose of these Regulations, a company is...
s.sch002 Interpretation
s.sch002 Major application
s.sch002 Mutual recognition procedure incoming application
s.sch002 New excipient variation application
s.sch002 New indication variation application
s.sch002 Parallel Import Licence application
s.sch002 Reclassification variation application
s.sch002 Reduced registration application
s.sch002 Simple application
s.sch002 Standard application
s.sch002 Standard registration application
s.sch002 General: categories of Applications and Variations
s.sch002 Standard variation application
s.sch002 Standard variation application for a homoeopathic medicinal product
s.sch002 Type IB and Type II Applications
s.sch002 Type II Complex Variation Application
s.sch002 Marketing authorisations
s.sch002 Fees where an application for a European Union marketing authorisation had been made before IP completion day
s.sch002 Fees where application includes reclassification
s.sch002 Fees where person holds clinical trial certificate
s.sch002 Joint development
s.sch002 Application for multiple authorisations
s.sch002 Application by pre-assessment of modules
s.sch002 Authorisation for a national homoeopathic product
s.sch002 Administrative variation application
s.sch002 Manufacturer's licences and authorisations
s.sch002 Wholesale dealer's licences
s.sch002 Broker's registrations
s.sch002 Active substance registrations
s.sch002 Clinical trial authorisations
s.sch002 Traditional herbal registrations
s.sch002 Early Access to Medicines Scheme fees
s.sch002 Online sellers of medicines
s.sch002 Outgoing mutual recognition applications
s.sch002 Marketing authorisations
s.sch002 Variation of marketing authorisations
s.sch002 Variation of orphan marketing authorisations: small and medium companies
s.sch002 Extension application
s.sch002 Reclassification of marketing authorisations
s.sch002 Fees where an application for a variation or an extension of a European Union marketing authorisation had been made before IP completion day
s.sch002 Variation of marketing authorisation: national homoeopathic products
s.sch002 Variation of parallel import licence
s.sch002 Manufacturer's authorisations and licences
s.sch002 Variation of manufacturer's authorisations and licences
s.sch002 Wholesale dealer's licences
s.sch002 Variation of wholesale dealer's licence
s.sch002 Variation of a broker's registration
s.sch002 Variation of an active substance registration
s.sch002 Clinical trial authorisations
s.sch002 Complex application
s.sch002 Traditional herbal registrations
s.sch002 Identical variations
s.sch002 Complex Variation Applications
s.sch002 Multiple reclassification variation applications
s.sch002 A set of changes
s.sch002 More than one set of changes proposed
s.sch002 Renewal of a marketing authorisation
s.sch002 Renewal of multiple marketing authorisations
s.sch002 The fee payable under regulation 19D(1) in connection with the...
s.sch002 (1) The fee payable under regulation 19F(1) in connection with...
s.sch002 Substances listed for the purposes of paragraph 24(2)(b) and (4)(b) and 38(2)(b)
s.sch002 Complex registration application
s.sch002 Complex variation application
s.sch002 Decentralised procedure application
s.sch002 Extended Type II Complex Variation Application
s.sch003 General provisions relating to fees for inspections
s.sch003 Office-based inspections
s.sch003 Fees: general
s.sch003 Traditional herbal medicinal products
s.sch003 Sites concerned with starting materials for traditional herbal medicinal products
s.sch003 Wholesale dealer's licence: general
s.sch003 Wholesale dealer's licence: traditional herbal medicinal products
s.sch003 Wholesale dealer's licences: inspection of short duration
s.sch003 Broker's registrations
s.sch003 Active substance registrations
s.sch004 In this Schedule— “anthroposophic product” means a medicinal product prepared...
s.sch004 Reduced fees
s.sch004 Manufacturer's licences or manufacturing authorisations
s.sch004 Wholesale dealer's licences
s.sch004 Wholesale dealer's licences: evidence
s.sch004 Wholesale dealer's licences: special medicinal products
s.sch004 Additional amount for manufacturer's licences and wholesale dealer's licences which relate to special medicinal products
s.sch004 Traditional herbal registrations
s.sch004 Online sellers of medicines
s.sch004 Parallel import licences
s.sch004 Determining the total value of the product
s.sch004 Manufacturer's prices
s.sch004 Marketing authorisation: where Part 2 of the Act applies
s.sch004 Marketing authorisation: derivatives
s.sch004 Number of fee periods
s.sch004 Authorisation for two or more kinds of medicinal product
s.sch006 Interpretation
s.sch006 Major application
s.sch006 Complex application
s.sch006 Multiple application
s.sch006 Outgoing mutual recognition application
s.sch006 Application for traditional herbal registration
s.sch006 Traditional herbal registration: complex variation
s.sch006 Application for manufacturer's licence, manufacturing authorisation or wholesale dealer's licence
s.sch006 Inspection fees in connection with applications
s.sch007 Interruptions of manufacture, assembly, sale or supply
s.sch007 Clinical trial authorisation
s.sch007 Scientific advice: paediatric indications
s.sch007 Refunds: treated as having been paid on account
s.sch007 Reclassification
s.sch007 Variation of a traditional herbal registration
s.sch007 Withdrawal of application in relation to marketing authorisation, traditional herbal registration or clinical trial authorisation
s.sch007 Withdrawal of application in relation to a certificate of registration
s.sch007 Withdrawal of application in relation to manufacturing authorisation, wholesale dealer's licence, manufacturer's licence, broker's registration or active substance registration
s.sch007 Refusal of application for grant of marketing authorisation, traditional herbal registration or clinical trial authorisation
s.sch007 Orphan marketing authorisation
s.sch007 Parallel import licence
s.sch007 Surrender of marketing authorisation at same time as a variation application
s.sch008 Refund on surrender or revocation of authorisation, registration or licence
s.sch008 Adjustment and refund: licences relating to imported special medicinal products
s.sch008 Waiver or refund: converted EU marketing authorisations
s.sch008 Refunds: treated as having been paid on account

Duty extraction and severity labels are Guvnor’s analysis of the instrument, not the instrument itself. Always verify against the linked source text.