Introductory Text
PART 1 General
1.Citation and commencement
2.Interpretation
PART 2 Capital Fees for Pre-Application Meetings
3.Interpretation of Part 2
4.Fee for scientific advice: application for, or variation to, EU marketing authorisation
5.Fee for scientific advice: classification of a medicinal product
6.Fee for advertising advice
7.Fee for pharmacovigilance advice
8.Fee for advice on labelling or leaflets
9.Fee for regulatory advice
10.Fee for advice for other purposes
11.Time for payment of fees under regulations 4 to 10
PART 3 Capital Fees for Applications for Authorisations, Registrations, Licences or Certificates and for Associated Inspections
12.Fees for applications for authorisations, registrations, licences or certificates etc.
13.Fee for applications for additional copy certificates
14.Fees for applications for certificates and copy certificates by exporters of medicinal products
PART 4 Capital Fees for Assistance in Obtaining Marketing Authorisations in Other EEA States
15.Meaning of “set of applications”
16.Fees for applications for regulatory assistance under the mutual recognition procedure
17.Time for payment of fees under regulation 16
PART 5 Capital Fees for Applications for Variations of Authorisations, Registrations and Licences and for Associated Compliance Activities
18.Fees for variations of authorisations, registrations and licences
19.Fees for amendments to clinical trial authorisations
20.Fees for notification of changes and reports for broker’s registrations
21.Fees for notification of changes and compliance Reports for active substance registrations
22.Applications for multiple variations
PART 6 Capital Fees for Assessment of Labels and Leaflets
23.Meaning of “set of proposed changes”
24.Fees for assessment of a set of proposed changes to labels and leaflets
25.Time for payment of fees under regulation 24
PART 7 Capital Fees for Applications for Renewals of Certain Licences, Authorisations and Registrations and for Associated Inspections
26.Fees for renewals of certain manufacturer’s licences
27.Fees for renewals in terms which are not identical to the existing authorisation, licence or registration
PART 8 Capital Fees for Regulatory Assistance Given by the United Kingdom Acting as Reference Member State Relating to the Assessment of Applications for the Renewal of Specified Marketing Authorisations
28.Fees for regulatory assistance for certain marketing authorisations
PART 9 Capital Fees for Inspections
29.Fees for inspections
30.Fees for inspections of pharmacovigilance service providers
31.Payer of inspection fee (contract laboratories and API manufacturing sites)
32.Inspections in connection with multiple applications
33.Fees for inspections relating to good clinical practice in clinical trials
34.Amount, and time for payment, of inspection fees in respect of an application for a wholesale dealer’s licence
35.Adjustment and refund of inspection fees in respect of a wholesale dealer’s licence
36.Amount, and time for payment, of inspection fees in respect of an application for a broker’s registration or an active substance registration
PART 10 Periodic Fees for Authorisations, Registrations and Licences
37.Periodic fees
PART 11 Capital Fees for Application for Membership of Good Clinical Practice Accreditation Scheme and for Certificate of Membership
38.Meaning of “good clinical practice accreditation scheme”
39.Fees for applications for membership and certificates
PART 12 Capital Fee for a Review Upon Oral Representations or a Person Appointed Hearing
40.Fee for a review upon oral representations or a person appointed hearing
41.Time for payment under regulation 40
PART 13 Fees in relation to the Part 6 of the Human Medicines Regulations (certification of homoeopathic medicinal products)
42.Interpretation
43.Fees for applications made at the invitation of the licensing authority
44.Fees for applications for certificates
45.Fees for variations of certificates
46.Time for payment of fees
PART 14 Administration
47.Payment of fees to Ministers
48.Time for payment of capital fees in connection with applications or inspections
49.Time for payment of capital fees – applications made by small companies
50.Payment of fees in respect of a traditional herbal registration
51.Time for payment of periodic fees
52.Penalty fees for late payment of periodic fees
53.Daily penalty fees for late payment of periodic fees
54.Refund or waiver of fees under regulation 52 or 53
55.Adjustment, waiver, reduction or refund of fees
56.Suspension of licences and authorisations
57.Civil proceedings to recover unpaid fees
PART 15 Consequential Amendments
58.Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004
PART 16 Revocations and Savings
59.The Medicines (Products for Human Use) (Fees) Regulations 2012
60.The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2012
61.Other Revocations
Signature
SCHEDULES
SCHEDULE 1
General interpretation provisions
1.In these Regulations, unless the context requires otherwise— “the 2001...
2.For the purposes of these Regulations, a clinical trial authorisation...
3.In these Regulations any reference to an application for the...
SCHEDULE 2
Capital fees for applications for, and variations to, marketing authorisations, licences, registrations and certificates
PART 1 General: interpretation and categories of applications and variations
1.Interpretation
2.General: categories of applications and variations
3.Administrative variation application
4.Extension application
5.Complex application
6.Complex registration application
7.Complex variation application
8.Decentralised procedure application
9.Extended Type II Complex Variation Application
10.Major application
11.Mutual recognition procedure incoming application
12.New excipient variation application
13.New indication variation application
14.Parallel import licence application
15.Reclassification variation application
16.Reduced registration application
17.Simple application
18.Standard application
19.Standard registration application
20.Standard variation application
21.Standard variation application for a homoeopathic medicinal product
22.Type IB and Type II Applications
23.Type II Complex Variation Application
PART 2 Capital Fees for Applications for Authorisations, Licences, Registrations and Certificates
24.Marketing authorisations
25.Fees where application includes reclassification
26.Fees where person holds clinical trial certificate
27.Joint development
28.Application for multiple authorisations
29.Authorisation for a national homoeopathic product
30.Manufacturer’s licences and authorisations
31.Wholesale dealer’s licences
32.Broker’s registrations
33.Active substance registrations
34.Clinical trial authorisations
35.Traditional herbal registrations
PART 3 Capital Fees for Assistance in Obtaining Marketing Authorisations in Other EEA States
36.Outgoing mutual recognition applications
PART 4 Capital Fees for Applications for Variations of Authorisations, Licences and Registrations
37.Marketing authorisations
38.Variation of marketing authorisations
39.Reclassification of marketing authorisations
40.Variation of marketing authorisation: national homoeopathic products
41.Variation of parallel import licence
42.Manufacturer’s authorisations and licences
43.Variation of manufacturer’s authorisations and licences
44.Wholesale dealer’s licences
45.Variation of wholesale dealer’s licence
46.Variation of a broker’s registration
47.Variation of an active substance registration
48.Clinical trial authorisations
49.Traditional herbal registrations
50.Identical variations
51.Complex Variation Applications
52.Multiple reclassification variation applications
PART 5 Capital Fees for Assessment of Labels and Leaflets
53.A set of changes
54.More than one set of changes proposed
PART 6 Capital Fees for Regulatory Assistance Given by the United Kingdom Acting as Reference Member State Relating to the Assessment of Applications for the Renewal of Specified Marketing Authorisations
55.Regulatory assistance
56.Regulatory assistance – same manufacturer
PART 7 Relevant Substances
57.Substances listed for the purposes of paragraph 24(2)(b) and (4)(b) and 37(2)(b)
SCHEDULE 3
Fees for inspections
1.General provisions relating to fees for inspections
2.Fees: general
3.Traditional herbal medicinal products
4.Sites concerned with starting materials for traditional herbal medicinal products
5.Wholesale dealer’s licence: general
6.Wholesale dealer’s licence: traditional herbal medicinal products
7.Wholesale dealer’s licences: inspection of short duration
8.Broker’s registrations
9.Active substance registrations
10.Office-based inspections
SCHEDULE 4
Periodic fees for licences
PART 1 Interpretation
1.In this Schedule— “anthroposophic product” means a medicinal product prepared...
PART 2 Value of the Product Sold or Supplied
2.Determining the total value of the product
3.Manufacturer’s prices
4.Information requirements
PART 3 Periodic Fees for Marketing Authorisations and Licences
5.Marketing authorisations
6.Marketing authorisation: where Part 2 of the Act applies
7.Marketing authorisation: derivatives
8.Number of fee periods
9.Authorisation for two or more kinds of medicinal product
10.Reduced fees
11.Manufacturer’s licences or manufacturing authorisations
12.Wholesale dealer’s licences
13.Wholesale dealer’s licences: evidence
14.Wholesale dealer’s licences: special medicinal products
15.Additional amount for manufacturer’s licences and wholesale dealer’s licences which relate to special medicinal products
16.Traditional herbal registrations
PART 4 Types of Marketing Authorisation for which only One Periodic Fee is Payable
17.Parallel import licences
SCHEDULE 5
Fees for certificates of registration
SCHEDULE 6
Time for payment of capital fees: small companies
1.Interpretation
2.Major application
3.Complex application
4.Multiple application
5.Outgoing mutual recognition application
6.Application for traditional herbal registration
7.Traditional herbal registration: complex variation
8.Application for manufacturer’s licence, manufacturing authorisation or wholesale dealer’s licence
9.Inspection fees in connection with applications
SCHEDULE 7
Waiver, reduction or refund of capital fees
1.Interruptions of manufacture, assembly, sale or supply
2.Reclassification
3.Variation of a traditional herbal registration
4.Withdrawal of application in relation to marketing authorisation, traditional herbal registration or clinical trial authorisation
5.Withdrawal of application in relation to a certificate of registration
6.Withdrawal of application in relation to manufacturing authorisation, wholesale dealer’s licence, manufacturer’s licence, broker’s registration or active substance registration
7.Refusal of application for grant of marketing authorisation, traditional herbal registration or clinical trial authorisation
8.Parallel import licence
9.Surrender of marketing authorisation at same time as a variation application
10.Clinical trial authorisation
11.Scientific advice: paediatric indications
12.Refunds: treated as having been paid on account
SCHEDULE 8
Adjustment, reduction or refund of periodic fees
1.Refund on surrender or revocation of authorisation, registration or licence
2.Adjustment and refund: licences relating to imported special medicinal products
3.Refunds: treated as having been paid on account
SCHEDULE 9
Further revocations
Explanatory Note