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 application to be included on the list of online sellers of medicines
14.Fee for applications for additional copy certificates
15.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
16.Meaning of “set of applications”
17.Fees for applications for regulatory assistance under the mutual recognition procedure
18.Time for payment of fees under regulation 17
PART 5 Capital Fees for Applications for Variations of Authorisations, Registrations and Licences and for Associated Compliance Activities
19.Fees for variations of authorisations, registrations and licences
20.Fees for amendments to clinical trial authorisations
21.Fees for notification of changes and reports for broker’s registrations
22.Fees for notification of changes and compliance Reports for active substance registrations
23.Applications for multiple variations
PART 6 Capital Fees for Assessment of Labels and Leaflets
24.Meaning of “set of proposed changes”
25.Fees for assessment of a set of proposed changes to labels and leaflets
26.Time for payment of fees under regulation 25
PART 7 Capital Fees for Applications for Renewals of Certain Licences, Authorisations and Registrations and for Associated Inspections
27.Fees for renewals of certain manufacturer’s licences
28.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
29.Fees for regulatory assistance for certain marketing authorisations
PART 9 Capital Fees for Inspections
30.Fees for inspections
31.Fees for inspections of pharmacovigilance service providers
32.Payer of inspection fee (contract laboratories and API manufacturing sites)
33.Inspections in connection with multiple applications
34.Fees for inspections relating to good clinical practice in clinical trials
35.Amount, and time for payment, of inspection fees in respect of an application for a wholesale dealer’s licence
36.Adjustment and refund of inspection fees in respect of a wholesale dealer’s licence
37.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
38.Periodic fees
39.Periodic fee for persons included on the list of online sellers of medicines
PART 11 Capital Fees for Application for Membership of Good Clinical Practice Accreditation Scheme and for Certificate of Membership
40.Meaning of “good clinical practice accreditation scheme”
41.Fees for applications for membership and certificates
PART 12 Capital Fee for a Review Upon Oral Representations or a Person Appointed Hearing
42.Fee for a review upon oral representations or a person appointed hearing
43.Time for payment under regulation 42
PART 13 Fees in relation to the Part 6 of the Human Medicines Regulations (certification of homoeopathic medicinal products)
44.Interpretation
45.Fees for applications made at the invitation of the licensing authority
46.Fees for applications for certificates
47.Fees for variations of certificates
48.Time for payment of fees
PART 14 Administration
49.Payment of fees to Ministers
50.Time for payment of capital fees in connection with applications or inspections
51.Time for payment of capital fees – applications made by small companies
52.Payment of fees in respect of a traditional herbal registration
53.Time for payment of periodic fees
54.Penalty fees for late payment of periodic fees
55.Daily penalty fees for late payment of periodic fees
56.Refund or waiver of fees under regulation 54 or 55
57.Adjustment, waiver, reduction or refund of fees
58.Suspension of licences and authorisations
59.Civil proceedings to recover unpaid fees
PART 15 Amendments to Other Legislation
60.Amendment of the Medical Devices (Consultation Requirements) (Fees) Regulations 1995
61.Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004
62.Amendment of the Human Medicines Regulations 2012
PART 16 Revocations and Savings
63.The Medicines (Products for Human Use) (Fees) Regulations 2013
Signature
SCHEDULES
SCHEDULE 1
General interpretation provisions
1.In these Regulations— “the 2001 Directive” means Directive 2001/83/EC of...
2.For the purposes of these Regulations, a clinical trial authorisation...
3.In these Regulations any reference to an application for the...
4.In these Regulations any reference to an application to be...
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
36.Online sellers of medicines
PART 3 Capital Fees for Assistance in Obtaining Marketing Authorisations in Other EEA States
37.Outgoing mutual recognition applications
PART 4 Capital Fees for Applications for Variations of Authorisations, Licences and Registrations
38.Marketing authorisations
39.Variation of marketing authorisations
40.Reclassification of marketing authorisations
41.Variation of marketing authorisation: national homoeopathic products
42.Variation of parallel import licence
43.Manufacturer’s authorisations and licences
44.Variation of manufacturer’s authorisations and licences
45.Wholesale dealer’s licences
46.Variation of wholesale dealer’s licence
47.Variation of a broker’s registration
48.Variation of an active substance registration
49.Clinical trial authorisations
50.Traditional herbal registrations
51.Identical variations
52.Complex Variation Applications
53.Multiple reclassification variation applications
PART 5 Capital Fees for Assessment of Labels and Leaflets
54.A set of changes
55.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
56.Regulatory assistance
57.Regulatory assistance – same manufacturer
PART 7 Relevant Substances
58.Substances listed for the purposes of paragraph 24(2)(b) and (4)(b) and 38(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
17.Online sellers of medicines
PART 4 Types of Marketing Authorisation for which only One Periodic Fee is Payable
18.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
Explanatory Note