The Medicines (Products for Human Use) (Fees) Regulations 2013

Made: 7th March 2013

Laid before Parliament: 11th March 2013

Coming into force in accordance with regulation 1

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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 authorisation

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 Authorisations, Registrations, Licences or Certificates and for Associated Inspections

Fees for applications for authorisations, registrations, licences or certificates etc.

12

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Fee for applications for additional copy certificates

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 Authorisations 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 Authorisations, Registrations and Licences and for Associated Compliance Activities

Fees for variations of authorisations, registrations and licences

18

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Fees for amendments to clinical trial authorisations

19

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Fees for notification of changes and reports for broker's registrations

20

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Fees for notification of changes and compliance Reports for active substance registrations

21

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Applications for multiple variations

22

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PART 6 — Capital Fees for Assessment of Labels and Leaflets

Meaning of “set of proposed changes”

23

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

24

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Time for payment of fees under regulation 24

25

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

Fees for renewals of certain manufacturer's licences

26

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

27

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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 Authorisations

Fees for regulatory assistance for certain marketing authorisations

28

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PART 9 — Capital Fees for Inspections

Fees for inspections

29

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Fees for inspections of pharmacovigilance service providers

30

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

31

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Inspections in connection with multiple applications

32

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Fees for inspections relating to good clinical practice in clinical trials

33

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

34

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

35

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Amount, and time for payment, of inspection fees in respect of an application for a broker's registration or an active substance registration

36

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PART 10 — Periodic Fees for Authorisations, Registrations and Licences

Periodic fees

37

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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”

38

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Fees for applications for membership and certificates

39

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PART 12 — Capital Fee for a Review Upon Oral Representations or a Person Appointed Hearing

Fee for a review upon oral representations or a person appointed hearing

40

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Time for payment under regulation 40

41

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PART 13 — Fees in relation to the Part 6 of the Human Medicines Regulations (certification of homoeopathic medicinal products)

Interpretation

42

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Fees for applications made at the invitation of the licensing authority

43

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Fees for applications for certificates

44

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Fees for variations of certificates

45

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Time for payment of fees

46

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PART 14 — Administration

Payment of fees to Ministers

47

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

48

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

49

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Payment of fees in respect of a traditional herbal registration

50

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Time for payment of periodic fees

51

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Penalty fees for late payment of periodic fees

52

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Daily penalty fees for late payment of periodic fees

53

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Refund or waiver of fees under regulation 52 or 53

54

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Adjustment, waiver, reduction or refund of fees

55

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Suspension of licences and authorisations

56

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Civil proceedings to recover unpaid fees

57

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PART 15 — Consequential Amendments

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

58

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PART 16 — Revocations and Savings

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

59

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

60

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Other Revocations

61

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SCHEDULE 1 — General interpretation provisions

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 authorisations, licences, 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 Authorisations, Licences, Registrations and Certificates

Marketing authorisations

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 authorisations

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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Broker's registrations

32

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Active substance registrations

33

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Clinical trial authorisations

34

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Traditional herbal registrations

35

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

Outgoing mutual recognition applications

36

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

Marketing authorisations

37

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Variation of marketing authorisations

38

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Reclassification of marketing authorisations

39

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Variation of marketing authorisation: national homoeopathic products

40

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Variation of parallel import licence

41

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Manufacturer's authorisations and licences

42

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Variation of manufacturer's authorisations and licences

43

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Wholesale dealer's licences

44

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Variation of wholesale dealer's licence

45

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Variation of a broker's registration

46

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Variation of an active substance registration

47

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Clinical trial authorisations

48

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Traditional herbal registrations

49

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Identical variations

50

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Complex Variation Applications

51

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Multiple reclassification variation applications

52

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PART 5 — Capital Fees for Assessment of Labels and Leaflets

A set of changes

53

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More than one set of changes proposed

54

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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 Authorisations

Regulatory assistance

55

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Regulatory assistance – same manufacturer

56

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PART 7 — Relevant Substances

Substances listed for the purposes of paragraph 24(2)(b) and (4)(b) and 37(2)(b)

57

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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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Broker's registrations

8

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Active substance registrations

9