The Medicines (Products for Human Use) (Fees) Regulations 2012 No. 134 xmlns:atom="http://www.w3.org/2005/Atom"
Introductory Text
PART 1
1.Citation and commencement
2.Interpretation
PART 2
3.Interpretation of Part 2
4.Fee for scientific advice: application for, or variation to, EU marketing authorization
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
12.Fees for applications for authorizations, licences or certificates etc.
13.Fee for applications for copy certificates of good manufacturing practice
14.Fees for applications for certificates and copy certificates by exporters of medicinal products
PART 4 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
18.Fees for variations of authorizations, registrations, licences and authorisations
19.Fees for amendments to clinical trial authorisations
20.Applications for multiple variations
PART 6
21.Meaning of “set of proposed changes”
22.Fees for assessment of a set of proposed changes to labels and leaflets
23.Time for payment of fees under regulation 22
PART 7
24.Fees for renewals of certain manufacturer’s licences
25.Fees for renewals in terms which are not identical to the existing authorization, licence or registration
PART 8
26.Fees for regulatory assistance for certain marketing authorizations
PART 9
27.Fees for inspections
28.Payer of inspection fee (contract laboratories and API manufacturing sites)
29.Inspections in connection with multiple applications
30.Fees for inspections relating to good clinical practice in clinical trials
31.Amount, and time for payment, of inspection fees in respect of an application for a wholesale dealer’s licence
32.Adjustment and refund of inspection fees in respect of a wholesale dealer’s licence
PART 10
33.Periodic fees
34.Periodic fees for clinical trial authorisations
PART 11
35.Meaning of “good clinical practice accreditation scheme”
36.Fees for applications for membership and certificates
PART 12
37.Fee for a person appointed hearing
38.Time for payment under regulation 37
PART 13
39.Interpretation
40.Fees for applications made at the invitation of the licensing authority
41.Fees for applications for certificates
42.Fees for variations of certificates
43.Time for payment of fees
PART 14
44.Payment of fees to Ministers
45.Time for payment of capital fees in connection with applications or inspections
46.Time for payment of capital fees – applications made by small companies
47.Payment of fees in respect of a traditional herbal registration
48.Time for payment of periodic fees
49.Penalty fees for late payment of periodic fees
50.Daily penalty fees for late payment of periodic fees
51.Refund or waiver of fees under regulation 49 or 50
52.Adjustment, waiver, reduction or refund of fees
53.Suspension of licences and authorisations
54.Civil proceedings to recover unpaid fees
PART 15
55.Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004
56.Amendment of the Homoeopathic Regulations
PART 16
57.The Medicines (Products for Human Use) (Fees) Regulations 2010
58.The Homoeopathic Regulations
Signature
SCHEDULE 1
INTERPRETATION
1.Interpretation
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 AUTHORIZATIONS, LICENCES, AUTHORISATIONS, 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 Authorizations, Licences, Registrations and Certificates
24.Marketing authorizations
25.Fees where application includes reclassification
26.Fees where person holds clinical trial certificate
27.Joint development
28.Application for multiple authorizations
29.Authorisation for a national homoeopathic product
30.Manufacturer’s licences and authorisations
31.Wholesale dealer’s licences
32.Clinical trial authorisations
33.Traditional herbal registrations
PART 3 Capital Fees for Assistance in Obtaining Marketing Authorizations in Other EEA States
34.Outgoing mutual recognition applications
PART 4 Capital Fees for Applications for Variations of Authorizations, Licences and Registrations
35.Marketing authorizations
36.Variation of marketing authorizations
37.Reclassification of marketing authorizations
38.Variation of marketing authorization: national homoeopathic products
39.Variation of parallel import licence
40.Manufacturer’s authorisations and licences
41.Variation of manufacturer’s authorisations and licences
42.Wholesale dealer’s licences
43.Variation of wholesale dealer’s licence
44.Clinical trial authorisations
45.Traditional herbal registrations
46.Identical variations
47.Complex Variation Applications
48.Multiple reclassification variation applications
PART 5 Capital Fees for Assessment of Labels and Leaflets
49.A set of changes
50.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 Authorizations
51.Regulatory assistance
52.Regulatory assistance – same manufacturer
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.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 Authorizations and Licences
5.Marketing authorizations
6.Marketing authorization: where Part 2 of the Act applies
7.Marketing authorization: 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: exempt imported products
15.Additional amount for manufacturer’s licences and wholesale dealer’s licences which relate to exempt imported products
16.Clinical trial authorisations
17.Traditional herbal registrations
PART 4 Types of Marketing Authorization 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 authorization, 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 or manufacturer’s licence
7.Refusal of application for grant of marketing authorization, traditional herbal registration or clinical trial authorisation
8.Parallel import licence
9.Surrender of marketing authorization 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 authorization, registration or licence
2.Adjustment and refund: licences relating to exempt imported products
3.Refunds: treated as having been paid on account
Explanatory Note