The Medicines (Products for Human Use) (Fees) Regulations 2012

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

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Interpretation

2

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PART 2 — Capital Fees for Pre-Application Meetings

Interpretation of Part 2

3

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

4

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Fee for scientific advice: classification of a medicinal product

5

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Fee for advertising advice

6

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Fee for pharmacovigilance advice

7

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Fee for advice on labelling or leaflets

8

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Fee for regulatory advice

9

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Fee for advice for other purposes

10

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Time for payment of fees under regulations 4 to 10

11

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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

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Fee for applications for copy certificates of good manufacturing practice

13

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

14

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

Meaning of “set of applications”

15

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Fees for applications for regulatory assistance under the mutual recognition procedure

16

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Time for payment of fees under regulation 16

17

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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

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Fees for amendments to clinical trial authorisations

19

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Applications for multiple variations

20

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PART 6 — Capital Fees for Assessment of Labels and Leaflets

Meaning of “set of proposed changes”

21

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

22

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Time for payment of fees under regulation 22

23

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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

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

25

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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

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PART 9 — Capital Fees for Inspections

Fees for inspections

27

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

28

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Inspections in connection with multiple applications

29

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Fees for inspections relating to good clinical practice in clinical trials

30

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

31

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

32

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

Periodic fees

33

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Periodic fees for clinical trial authorisations

34

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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

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Fees for applications for membership and certificates

36

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PART 12 — Capital Fee for a Person Appointed Hearing

Fee for a person appointed hearing

37

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Time for payment under regulation 37

38

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

Interpretation

39

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Fees for applications made at the invitation of the licensing authority

40

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Fees for applications for certificates

41

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Fees for variations of certificates

42

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Time for payment of fees

43

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PART 14 — Administration

Payment of fees to Ministers

44

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

45

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

46

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Payment of fees in respect of a traditional herbal registration

47

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Time for payment of periodic fees

48

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Penalty fees for late payment of periodic fees

49

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Daily penalty fees for late payment of periodic fees

50

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Refund or waiver of fees under regulation 49 or 50

51

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Adjustment, waiver, reduction or refund of fees

52

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Suspension of licences and authorisations

53

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Civil proceedings to recover unpaid fees

54

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PART 15 — Consequential Amendments

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

55

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Amendment of the Homoeopathic Regulations

56

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PART 16 — Revocations and Savings

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

57

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The Homoeopathic Regulations

58

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SCHEDULE 1 — INTERPRETATION

Interpretation

1

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2

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3

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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

Interpretation

1

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General: categories of Applications and Variations

2

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Administrative variation application

3

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Extension application

4

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Complex application

5

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Complex registration application

6

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Complex variation application

7

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Decentralised procedure application

8

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Extended Type II Complex Variation Application

9

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Major application

10

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Mutual recognition procedure incoming application

11

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New excipient variation application

12

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New indication variation application

13

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Parallel Import Licence application

14

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Reclassification variation application

15

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Reduced registration application

16

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Simple application

17

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Standard application

18

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Standard registration application

19

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Standard variation application

20

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Standard variation application for a homoeopathic medicinal product

21

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Type IB and Type II Applications

22

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Type II Complex Variation Application

23

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

Marketing authorizations

24

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Fees where application includes reclassification

25

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Fees where person holds clinical trial certificate

26

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Joint development

27

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Application for multiple authorizations

28

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Authorisation for a national homoeopathic product

29

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Manufacturer's licences and authorisations

30

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Wholesale dealer's licences

31

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Clinical trial authorisations

32

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Traditional herbal registrations

33

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

Outgoing mutual recognition applications

34

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

Marketing authorizations

35

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Variation of marketing authorizations

36

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Reclassification of marketing authorizations

37

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Variation of marketing authorization: national homoeopathic products

38

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Variation of parallel import licence

39

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Manufacturer's authorisations and licences

40

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Variation of manufacturer's authorisations and licences

41

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Wholesale dealer's licences

42

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Variation of wholesale dealer's licence

43

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Clinical trial authorisations

44

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Traditional herbal registrations

45

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Identical variations

46

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Complex Variation Applications

47

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Multiple reclassification variation applications

48

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PART 5 — Capital Fees for Assessment of Labels and Leaflets

A set of changes

49

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More than one set of changes proposed

50

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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

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Regulatory assistance – same manufacturer

52

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SCHEDULE 3 — FEES FOR INSPECTIONS

General provisions relating to fees for inspections

1

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Fees: general

2

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Traditional herbal medicinal products

3

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Sites concerned with starting materials for traditional herbal medicinal products

4

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Wholesale dealer's licence: general

5

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Wholesale dealer's licence: traditional herbal medicinal products

6

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Wholesale dealer's licences: inspection of short duration

7

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Office-based inspections

8

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SCHEDULE 4 — PERIODIC FEES FOR LICENCES

PART 1 — Interpretation

1

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PART 2 — Value of the Product Sold or Supplied

Determining the total value of the product

2

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Manufacturer's prices

3

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Information requirements

4

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PART 3 — Periodic Fees for Marketing Authorizations and Licences

Marketing authorizations

5

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Marketing authorization: where Part 2 of the Act applies

6

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Marketing authorization: derivatives

7

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Number of fee periods

8

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Authorisation for two or more kinds of medicinal product

9

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Reduced fees

10

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