Information requirements
- Provide total value of product sold/supplied and auditor's certificate if required Manufacturer
Northern Ireland Statutory Rule
2012
United Kingdom
The Medicines (Products for Human Use) (Fees) Regulations 2012
At a glance
What's here
1 compliance obligation
Who this Act binds
Business-side actors with duties under this Act, ranked by how often they appear.
- Manufacturer 1
Other Acts binding the same actors
For each actor bound by this Act, the other UK Acts that bind them most often. Useful for understanding the full compliance landscape facing each role.
Manufacturers also bound by 472 other Acts (top 5 shown)
- Pressure Equipment (Safety) Regulations 2016 2016 91 duties
- Lifts Regulations 2016 2016 70 duties
- The Ecodesign for Energy-Related Products and Energy Information Regulations 2021 2021 70 duties
- Non-Automatic Weighing Instruments Regulations 2016 2016 67 duties
- Pyrotechnic Articles (Safety) Regulations 2015 2015 64 duties
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 104 other Schedules — structural / supplementary
Interpretation
For the purposes of these Regulations, a clinical trial authorisation...
In these Regulations any reference to an application for the...
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 authorizations
Fees where application includes reclassification
Fees where person holds clinical trial certificate
Joint development
Application for multiple authorizations
Authorisation for a national homoeopathic product
Administrative variation application
Manufacturer’s licences and authorisations
Wholesale dealer’s licences
Clinical trial authorisations
Traditional herbal registrations
Outgoing mutual recognition applications
Marketing authorizations
Variation of marketing authorizations
Reclassification of marketing authorizations
Variation of marketing authorization: national homoeopathic products
Variation of parallel import licence
Extension application
Manufacturer’s authorisations and licences
Variation of manufacturer’s authorisations and licences
Wholesale dealer’s licences
Variation of wholesale dealer’s licence
Clinical trial authorisations
Traditional herbal registrations
Identical variations
Complex Variation Applications
Multiple reclassification variation applications
A set of changes
Complex application
More than one set of changes proposed
Regulatory assistance
Regulatory assistance – same manufacturer
Complex registration application
Complex variation application
Decentralised procedure application
Extended Type II Complex Variation Application
General provisions relating to fees for 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
Office-based inspections
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: exempt imported products
Additional amount for manufacturer’s licences and wholesale dealer’s licences which relate to exempt imported products
Clinical trial authorisations
Traditional herbal registrations
Parallel import licences
Determining the total value of the product
Manufacturer’s prices
Marketing authorizations
Marketing authorization: where Part 2 of
Marketing authorization: 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 authorization, 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 or manufacturer’s licence
Refusal of application for grant of marketing authorization, traditional herbal registration or clinical trial authorisation
Parallel import licence
Surrender of marketing authorization at same time as a variation application
Refund on surrender or revocation of authorization, registration or licence
Adjustment and refund: licences relating to exempt imported products
Refunds: treated as having been paid on account
Browse 58 other sections — procedural / definitional / commencement
Citation and commencement
Interpretation
Interpretation of Part 2
Fee for scientific advice: application for, or variation to, EU marketing authorization
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
Time for payment of fees under regulations 4 to 10
Fees for applications for authorizations, licences or certificates
Fee for applications for copy certificates of good manufacturing practice
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 16
Fees for variations of authorizations, registrations, licences and authorisations
Fees for amendments to clinical trial authorisations
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 22
Fees for renewals of certain manufacturer’s licences
Fees for renewals in terms which are not identical to the existing authorization, licence or registration
Fees for regulatory assistance for certain marketing authorizations
Fees for inspections
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
Periodic fees
Periodic fees for clinical trial authorisations
Meaning of “good clinical practice accreditation scheme”
Fees for applications for membership and certificates
Fee for a person appointed hearing
Time for payment under regulation 37
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 49 or 50
Adjustment, waiver, reduction or refund of fees
Suspension of licences and authorisations
Civil proceedings to recover unpaid fees
Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004
Amendment of the
The Medicines (Products for Human Use) (Fees) Regulations 2010
The Homoeopathic Regulations
Explore more
Browse legislation
Find other UK business legislation with related guidance.