Statutory Instruments
2012 No. 504
Medicines
Fees And Charges
The Medicines (Products for Human Use) (Fees) Regulations 2012 (revoked)
Regulations revoked (1.4.2013) by The Medicines (Products for Human Use) (Fees) Regulations 2013 (S.I. 2013/532), reg. 59(1) (with reg. 59(2)-(4))
Made 23rd February 2012
Laid before Parliament 29th February 2012
Coming into force 1st April 2012

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PART 1 General

Citation and commencement
1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Interpretation
2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 2 Capital Fees for Pre-Application Meetings

Interpretation of Part 2
3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Fee for scientific advice: application for, or variation to, EU marketing authorization
4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Fee for scientific advice: classification of a medicinal product
5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Fee for advertising advice
6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Fee for pharmacovigilance advice
7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Fee for advice on labelling or leaflets
8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Fee for regulatory advice
9. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Fee for advice for other purposes
10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Time for payment of fees under regulations 4 to 10
11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 3 Capital Fees for Applications for Authorizations, Registrations, Licences, Certificates or Authorisations and for Associated Inspections

Fees for applications for authorizations, licences or certificates etc.
12. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Fee for applications for copy certificates of good manufacturing practice
13. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Fees for applications for certificates and copy certificates by exporters of medicinal products
14. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 4 Capital Fees for Assistance in Obtaining Marketing Authorizations in Other EEA States

Meaning of “set of applications”
15. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Fees for applications for regulatory assistance under the mutual recognition procedure
16. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Time for payment of fees under regulation 16
17. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 5 Capital Fees for Applications for Variations of Authorizations, Registrations, Licences and Authorisations and for Associated Inspections

Fees for variations of authorizations, registrations, licences and authorisations
18. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Fees for amendments to clinical trial authorisations
19. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Applications for multiple variations
20. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 6 Capital Fees for Assessment of Labels and Leaflets

Meaning of “set of proposed changes”
21. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Fees for assessment of a set of proposed changes to labels and leaflets
22. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Time for payment of fees under regulation 22
23. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 7 Capital Fees for Applications for Renewals of Certain Licences, Authorizations and Registrations and for Associated Inspections

Fees for renewals of certain manufacturer's licences
24. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Fees for renewals in terms which are not identical to the existing authorization, licence or registration
25. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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 Authorizations

Fees for regulatory assistance for certain marketing authorizations
26. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 9 Capital Fees for Inspections

Fees for inspections
27. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Payer of inspection fee (contract laboratories and API manufacturing sites)
28. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Inspections in connection with multiple applications
29. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Fees for inspections relating to good clinical practice in clinical trials
30. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amount, and time for payment, of inspection fees in respect of an application for a wholesale dealer's licence
31. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Adjustment and refund of inspection fees in respect of a wholesale dealer's licence
32. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 10 Periodic Fees for Authorizations, Registrations, Licences and Authorisations

Periodic fees
33. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Periodic fees for clinical trial authorisations
34. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 11 Capital Fees For Application For Membership of Good Clinical Practice Accreditation Scheme and for Certificate of Membership

Meaning of “good clinical practice accreditation scheme”
35. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Fees for applications for membership and certificates
36. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 12 Capital Fee for a Person Appointed Hearing

Fee for a person appointed hearing
37. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Time for payment under regulation 37
38. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 13 Fees in relation to the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994

Interpretation
39. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Fees for applications made at the invitation of the licensing authority
40. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Fees for applications for certificates
41. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Fees for variations of certificates
42. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Time for payment of fees
43. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 14 Administration

Payment of fees to Ministers
44. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Time for payment of capital fees in connection with applications or inspections
45. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Time for payment of capital fees – applications made by small companies
46. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Payment of fees in respect of a traditional herbal registration
47. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Time for payment of periodic fees
48. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Penalty fees for late payment of periodic fees
49. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Daily penalty fees for late payment of periodic fees
50. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Refund or waiver of fees under regulation 49 or 50
51. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Adjustment, waiver, reduction or refund of fees
52. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Suspension of licences and authorisations
53. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Civil proceedings to recover unpaid fees
54. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 15 Consequential Amendments

Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004
55. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendment of the Homoeopathic Regulations
56. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 16 Revocations and Savings

The Medicines (Products for Human Use) (Fees) Regulations 2010
57. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The Homoeopathic Regulations
58. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SCHEDULE 1 INTERPRETATION
Regulation 2

Interpretation
1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SCHEDULE 2 CAPITAL FEES FOR APPLICATIONS FOR, AND VARIATIONS TO, MARKETING AUTHORIZATIONS, LICENCES, AUTHORISATIONS, REGISTRATIONS AND CERTIFICATES
Regulations 12(1)(a), 16,18(1), 19(1), 22(1), 26(1)

PART 1 General: interpretation and categories of applications and variations

Interpretation
1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

General: categories of Applications and Variations
2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Administrative variation application
3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Extension application
4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Complex application
5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Complex registration application
6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Complex variation application
7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Decentralised procedure application
8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Extended Type II Complex Variation Application
9. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Major application
10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Mutual recognition procedure incoming application
11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

New excipient variation application
12. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

New indication variation application
13. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Parallel Import Licence application
14. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Reclassification variation application
15. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Reduced registration application
16. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Simple application
17. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Standard application
18. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Standard registration application
19. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Standard variation application
20. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Standard variation application for a homoeopathic medicinal product
21. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Type IB and Type II Applications
22. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Type II Complex Variation Application
23. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 2 Capital Fees for Applications for Authorizations, Licences, Registrations and Certificates

Marketing authorizations
24. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Fees where application includes reclassification
25. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Fees where person holds clinical trial certificate
26. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Joint development
27. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Application for multiple authorizations
28. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Authorisation for a national homoeopathic product
29. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Manufacturer's licences and authorisations
30. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Wholesale dealer's licences
31. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Clinical trial authorisations
32. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Traditional herbal registrations
33. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 3 Capital Fees for Assistance in Obtaining Marketing Authorizations in Other EEA States

Outgoing mutual recognition applications
34. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 4 Capital Fees for Applications for Variations of Authorizations, Licences and Registrations

Marketing authorizations
35. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Variation of marketing authorizations
36. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Reclassification of marketing authorizations
37. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Variation of marketing authorization: national homoeopathic products
38. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Variation of parallel import licence
39. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Manufacturer's authorisations and licences
40. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Variation of manufacturer's authorisations and licences
41. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Wholesale dealer's licences
42. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Variation of wholesale dealer's licence
43. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Clinical trial authorisations
44. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Traditional herbal registrations
45. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Identical variations
46. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Complex Variation Applications
47. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Multiple reclassification variation applications
48. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 5 Capital Fees for Assessment of Labels and Leaflets

A set of changes
49. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

More than one set of changes proposed
50. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

Regulatory assistance
51. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Regulatory assistance – same manufacturer
52. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SCHEDULE 3 FEES FOR INSPECTIONS
Regulations 27(1), 30,31(2), 32(1)

General provisions relating to fees for inspections
1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Fees: general
2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Traditional herbal medicinal products
3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Sites concerned with starting materials for traditional herbal medicinal products
4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Wholesale dealer's licence: general
5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Wholesale dealer's licence: traditional herbal medicinal products
6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Wholesale dealer's licences: inspection of short duration
7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Office-based inspections
8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SCHEDULE 4 PERIODIC FEES FOR LICENCES
Regulation 33(2) and (3), 34(2)

PART 1 Interpretation
1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 2 Value of the Product Sold or Supplied

Determining the total value of the product
2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Manufacturer's prices
3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Information requirements
4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 3 Periodic Fees for Marketing Authorizations and Licences

Marketing authorizations
5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Marketing authorization: where Part 2 of the Act applies
6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Marketing authorization: derivatives
7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Number of fee periods
8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Authorisation for two or more kinds of medicinal product
9. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Reduced fees
10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Manufacturer's licences or manufacturing authorisations
11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Wholesale dealer's licences
12. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Wholesale dealer's licences: evidence
13. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Wholesale dealer's licences: exempt imported products
14. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Additional amount for manufacturer's licences and wholesale dealer's licences which relate to exempt imported products
15. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Clinical trial authorisations
16. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Traditional herbal registrations
17. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 4 Types of Marketing Authorization for which only One Periodic Fee is Payable

Parallel import licences
18. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SCHEDULE 5 FEES FOR CERTIFICATES OF REGISTRATION
Regulation 42(1) and (2)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SCHEDULE 6 TIME FOR PAYMENT OF CAPITAL FEES: SMALL COMPANIES
Regulation 46(1)

Interpretation
1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Major application
2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Complex application
3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Multiple application
4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Outgoing mutual recognition application
5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Application for traditional herbal registration
6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Traditional herbal registration: complex variation
7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Application for manufacturer's licence, manufacturing authorisation or wholesale dealer's licence
8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Inspection fees in connection with applications
9. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SCHEDULE 7 WAIVER, REDUCTION OR REFUND OF CAPITAL FEES
Regulation 52(2)

Interruptions of manufacture, assembly, sale or supply
1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Reclassification
2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Variation of a traditional herbal registration
3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Withdrawal of application in relation to marketing authorization, traditional herbal registration or clinical trial authorisation
4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Withdrawal of application in relation to a certificate of registration
5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Withdrawal of application in relation to manufacturing authorisation, wholesale dealer's licence or manufacturer's licence
6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Refusal of application for grant of marketing authorization, traditional herbal registration or clinical trial authorisation
7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Parallel import licence
8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Surrender of marketing authorization at same time as a variation application
9. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Clinical trial authorisation
10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Scientific advice: paediatric indications
11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Refunds: treated as having been paid on account
12. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SCHEDULE 8 ADJUSTMENT, REDUCTION OR REFUND OF PERIODIC FEES
Regulation 52(2)

Refund on surrender or revocation of authorization, registration or licence
1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Adjustment and refund: licences relating to exempt imported products
2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Refunds: treated as having been paid on account
3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Regulations revoked (1.4.2013) by The Medicines (Products for Human Use) (Fees) Regulations 2013 (S.I. 2013/532), reg. 59(1) (with reg. 59(2)-(4))