Northern Ireland Statutory Rule SI 2012/134 United Kingdom

The Medicines (Products for Human Use) (Fees) Regulations 2012

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.

Manufacturer1

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

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.

58 other provisions — procedural and definitional
s.001 Citation and commencement
s.002 Interpretation
s.003 Interpretation of Part 2
s.004 Fee for scientific advice: application for, or variation to, EU marketing authorization
s.005 Fee for scientific advice: classification of a medicinal product
s.006 Fee for advertising advice
s.007 Fee for pharmacovigilance advice
s.008 Fee for advice on labelling or leaflets
s.009 Fee for regulatory advice
s.010 Fee for advice for other purposes
s.011 Time for payment of fees under regulations 4 to 10
s.012 Fees for applications for authorizations, licences or certificates
s.013 Fee for applications for copy certificates of good manufacturing practice
s.014 Fees for applications for certificates and copy certificates by exporters of medicinal products
s.015 Meaning of “set of applications”
s.016 Fees for applications for regulatory assistance under the mutual recognition procedure
s.017 Time for payment of fees under regulation 16
s.018 Fees for variations of authorizations, registrations, licences and authorisations
s.019 Fees for amendments to clinical trial authorisations
s.020 Applications for multiple variations
s.021 Meaning of “set of proposed changes”
s.022 Fees for assessment of a set of proposed changes to labels and leaflets
s.023 Time for payment of fees under regulation 22
s.024 Fees for renewals of certain manufacturer’s licences
s.025 Fees for renewals in terms which are not identical to the existing authorization, licence or registration
s.026 Fees for regulatory assistance for certain marketing authorizations
s.027 Fees for inspections
s.028 Payer of inspection fee (contract laboratories and API manufacturing sites)
s.029 Inspections in connection with multiple applications
s.030 Fees for inspections relating to good clinical practice in clinical trials
s.031 Amount, and time for payment, of inspection fees in respect of an application for a wholesale dealer’s licence
s.032 Adjustment and refund of inspection fees in respect of a wholesale dealer’s licence
s.033 Periodic fees
s.034 Periodic fees for clinical trial authorisations
s.035 Meaning of “good clinical practice accreditation scheme”
s.036 Fees for applications for membership and certificates
s.037 Fee for a person appointed hearing
s.038 Time for payment under regulation 37
s.039 Interpretation
s.040 Fees for applications made at the invitation of the licensing authority
s.041 Fees for applications for certificates
s.042 Fees for variations of certificates
s.043 Time for payment of fees
s.044 Payment of fees to Ministers
s.045 Time for payment of capital fees in connection with applications or inspections
s.046 Time for payment of capital fees – applications made by small companies
s.047 Payment of fees in respect of a traditional herbal registration
s.048 Time for payment of periodic fees
s.049 Penalty fees for late payment of periodic fees
s.050 Daily penalty fees for late payment of periodic fees
s.051 Refund or waiver of fees under regulation 49 or 50
s.052 Adjustment, waiver, reduction or refund of fees
s.053 Suspension of licences and authorisations
s.054 Civil proceedings to recover unpaid fees
s.055 Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004
s.056 Amendment of the
s.057 The Medicines (Products for Human Use) (Fees) Regulations 2010
s.058 The Homoeopathic Regulations
Schedules

Schedules

1 of 105 shown
s.sch004 Information requirements Regulated
  • Provide total value of product sold/supplied and auditor's certificate if requiredManufacturer
104 other schedules
s.sch001 Interpretation
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.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 authorizations
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 authorizations
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 Clinical trial authorisations
s.sch002 Traditional herbal registrations
s.sch002 Outgoing mutual recognition applications
s.sch002 Marketing authorizations
s.sch002 Variation of marketing authorizations
s.sch002 Reclassification of marketing authorizations
s.sch002 Variation of marketing authorization: national homoeopathic products
s.sch002 Variation of parallel import licence
s.sch002 Extension application
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 Clinical trial authorisations
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 Complex application
s.sch002 More than one set of changes proposed
s.sch002 Regulatory assistance
s.sch002 Regulatory assistance – same manufacturer
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 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 Office-based inspections
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: exempt imported products
s.sch004 Additional amount for manufacturer’s licences and wholesale dealer’s licences which relate to exempt imported products
s.sch004 Clinical trial authorisations
s.sch004 Traditional herbal registrations
s.sch004 Parallel import licences
s.sch004 Determining the total value of the product
s.sch004 Manufacturer’s prices
s.sch004 Marketing authorizations
s.sch004 Marketing authorization: where Part 2 of
s.sch004 Marketing authorization: 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 authorization, 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 or manufacturer’s licence
s.sch007 Refusal of application for grant of marketing authorization, traditional herbal registration or clinical trial authorisation
s.sch007 Parallel import licence
s.sch007 Surrender of marketing authorization at same time as a variation application
s.sch008 Refund on surrender or revocation of authorization, registration or licence
s.sch008 Adjustment and refund: licences relating to exempt imported products
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.