Information requirements
- Provide sales-value information and auditor's certificate to the MHRA if requested
UK Statutory Instrument
2016
United Kingdom
The Medicines (Products for Human Use) (Fees) Regulations 2016
At a glance
What's here
1 compliance obligation
What this Act requires
Sections that create concrete duties on businesses or carry penalties. Procedural and definitional sections are folded into the “Browse other sections” expander at the bottom of each group. Click any section title to read the source text on legislation.gov.uk.
Schedules
Browse 123 other Schedules — structural / supplementary
In these Regulations— “the 2001 Directive” means Directive 2001/83/EC of...
For the purposes of these Regulations, a clinical trial authorisation...
In these Regulations any reference to an application for the...
In these Regulations any reference to an application to be...
(1) For the purpose of these Regulations, a company is...
Interpretation
Major application
Mutual recognition procedure incoming application
New excipient variation application
New indication variation application
Parallel Import Licence application
Reclassification variation application
Reduced registration application
Simple application
Standard application
Standard registration application
General: categories of Applications and Variations
Standard variation application
Standard variation application for a homoeopathic medicinal product
Type IB and Type II Applications
Type II Complex Variation Application
Marketing authorisations
Fees where an application for a European Union marketing authorisation had been made before IP completion day
Fees where application includes reclassification
Fees where person holds clinical trial certificate
Joint development
Application for multiple authorisations
Application by pre-assessment of modules
Authorisation for a national homoeopathic product
Administrative variation application
Manufacturer's licences and authorisations
Wholesale dealer's licences
Broker's registrations
Active substance registrations
Clinical trial authorisations
Traditional herbal registrations
Early Access to Medicines Scheme fees
Online sellers of medicines
Outgoing mutual recognition applications
Marketing authorisations
Variation of marketing authorisations
Variation of orphan marketing authorisations: small and medium companies
Extension application
Reclassification of marketing authorisations
Fees where an application for a variation or an extension of a European Union marketing authorisation had been made before IP completion day
Variation of marketing authorisation: national homoeopathic products
Variation of parallel import licence
Manufacturer's authorisations and licences
Variation of manufacturer's authorisations and licences
Wholesale dealer's licences
Variation of wholesale dealer's licence
Variation of a broker's registration
Variation of an active substance registration
Clinical trial authorisations
Complex application
Traditional herbal registrations
Identical variations
Complex Variation Applications
Multiple reclassification variation applications
A set of changes
More than one set of changes proposed
Renewal of a marketing authorisation
Renewal of multiple marketing authorisations
The fee payable under regulation 19D(1) in connection with the...
(1) The fee payable under regulation 19F(1) in connection with...
Substances listed for the purposes of paragraph 24(2)(b) and (4)(b) and 38(2)(b)
Complex registration application
Complex variation application
Decentralised procedure application
Extended Type II Complex Variation Application
General provisions relating to fees for inspections
Office-based inspections
Fees: general
Traditional herbal medicinal products
Sites concerned with starting materials for traditional herbal medicinal products
Wholesale dealer's licence: general
Wholesale dealer's licence: traditional herbal medicinal products
Wholesale dealer's licences: inspection of short duration
Broker's registrations
Active substance registrations
In this Schedule— “anthroposophic product” means a medicinal product prepared...
Reduced fees
Manufacturer's licences or manufacturing authorisations
Wholesale dealer's licences
Wholesale dealer's licences: evidence
Wholesale dealer's licences: special medicinal products
Additional amount for manufacturer's licences and wholesale dealer's licences which relate to special medicinal products
Traditional herbal registrations
Online sellers of medicines
Parallel import licences
Determining the total value of the product
Manufacturer's prices
Marketing authorisations
Marketing authorisation: where Part 2 of the Act applies
Marketing authorisation: derivatives
Number of fee periods
Authorisation for two or more kinds of medicinal product
Interpretation
Major application
Complex application
Multiple application
Outgoing mutual recognition application
Application for traditional herbal registration
Traditional herbal registration: complex variation
Application for manufacturer's licence, manufacturing authorisation or wholesale dealer's licence
Inspection fees in connection with applications
Interruptions of manufacture, assembly, sale or supply
Clinical trial authorisation
Scientific advice: paediatric indications
Refunds: treated as having been paid on account
Reclassification
Variation of a traditional herbal registration
Withdrawal of application in relation to marketing authorisation, traditional herbal registration or clinical trial authorisation
Withdrawal of application in relation to a certificate of registration
Withdrawal of application in relation to manufacturing authorisation, wholesale dealer's licence, manufacturer's licence, broker's registration or active substance registration
Refusal of application for grant of marketing authorisation, traditional herbal registration or clinical trial authorisation
Orphan marketing authorisation
Parallel import licence
Surrender of marketing authorisation at same time as a variation application
Refund on surrender or revocation of authorisation, registration or licence
Adjustment and refund: licences relating to imported special medicinal products
Waiver or refund: converted EU marketing authorisations
Refunds: treated as having been paid on account
Browse 74 other sections — procedural / definitional / commencement
Citation and commencement
Interpretation
Interpretation of Part 2
Fee for scientific or other advice
Fee for scientific advice: application for, or variation to, EU marketing authorisation
Fee for scientific advice: classification of a medicinal product
Fee for advertising advice
Fee for pharmacovigilance advice
Fee for advice on labelling or leaflets
Fee for regulatory advice
Fee for advice for other purposes
Waiver for advice given to small and medium companies
Time for payment of fees under regulations 3A to 8
Fees for applications for authorisations, registrations, licences or certificates etc.
Fee for application to be included on the list of online sellers of medicines
Fee for applications for additional copy certificates
Fees for applications for certificates and copy certificates by exporters of medicinal products
Meaning of “set of applications”
Fees for applications for regulatory assistance under the mutual recognition procedure
Time for payment of fees under regulation 17
Fees for variations of authorisations, registrations and licences
Fees for certification of plasma master files
Fee for certification of vaccine antigen master files
Fees for assessment of post-authorisation safety studies
Fee for carrying out a major safety review
Fee for assessment of periodic safety update reports
Fee for assessment of clinical trial annual safety reports
Fee for testing of samples by the appropriate authority
Time for payment of fees under regulations 19A to 19F
Fees for modifications to clinical trial authorisations
Fees for notification of changes and reports for broker's registrations
Fees for notification of changes and compliance Reports for active substance registrations
Applications for multiple variations
Meaning of “set of proposed changes”
Fees for assessment of a set of proposed changes to labels and leaflets
Time for payment of fees under regulation 25
Fees for renewals of certain manufacturer's licences
Fee for renewals of a marketing authorisation
Fees for renewals in terms which are not identical to the existing authorisation, licence or registration
Fees for regulatory assistance for certain marketing authorisations
Fees for inspections
Fees for inspections of pharmacovigilance service providers
Payer of inspection fee (contract laboratories and API manufacturing sites)
Inspections in connection with multiple applications
Fees for inspections relating to good clinical practice in clinical trials
Amount, and time for payment, of inspection fees in respect of an application for a wholesale dealer's licence
Adjustment and refund of inspection fees in respect of a wholesale dealer's licence
Amount, and time for payment, of inspection fees in respect of an application for a broker's registration or an active substance registration
Periodic fees
Periodic fee for persons included on the list of online sellers of medicines
Meaning of “good clinical practice accreditation scheme”
Fees for applications for membership and certificates
Fee for a review upon oral representations or a person appointed hearing
Time for payment under regulation 42
Interpretation
Fees for applications made at the invitation of the licensing authority
Fees for applications for certificates
Fees for variations of certificates
Time for payment of fees
Payment of fees to Ministers
Time for payment of capital fees in connection with applications or inspections
Time for payment of capital fees – applications made by small companies
Payment of fees in respect of a traditional herbal registration
Time for payment of periodic fees
Penalty fees for late payment of periodic fees
Daily penalty fees for late payment of periodic fees
Refund or waiver of fees under regulation 54 or 55
Adjustment, waiver, reduction or refund of fees
Suspension of licences and authorisations
Civil proceedings to recover unpaid fees
Amendment of the Medical Devices (Consultation Requirements) (Fees) Regulations 1995
Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004
Amendment of the Human Medicines Regulations 2012
The Medicines (Products for Human Use) (Fees) Regulations 2013
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