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

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

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 authorisation

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 Authorisations, Registrations, Licences or Certificates and for Associated Inspections

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

12

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

Fee for applications for additional copy certificates

13

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

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

14

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

PART 4 — Capital Fees for Assistance in Obtaining Marketing Authorisations 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 Authorisations, Registrations and Licences and for Associated Compliance Activities

Fees for variations of authorisations, registrations and licences

18

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

Fees for amendments to clinical trial authorisations

19

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

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

20

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

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

21

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

Applications for multiple variations

22

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

PART 6 — Capital Fees for Assessment of Labels and Leaflets

Meaning of “set of proposed changes”

23

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

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

24

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

Time for payment of fees under regulation 24

25

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

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

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

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

27

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

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

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

PART 9 — Capital Fees for Inspections

Fees for inspections

29

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

Fees for inspections of pharmacovigilance service providers

30

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

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

31

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

Inspections in connection with multiple applications

32

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

Fees for inspections relating to good clinical practice in clinical trials

33

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

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

34

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

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

35

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

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

36

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

PART 10 — Periodic Fees for Authorisations, Registrations and Licences

Periodic fees

37

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

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

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

Fees for applications for membership and certificates

39

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

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

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

Time for payment under regulation 40

41

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

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

Interpretation

42

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

Fees for applications made at the invitation of the licensing authority

43

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

Fees for applications for certificates

44

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

Fees for variations of certificates

45

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

Time for payment of fees

46

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

PART 14 — Administration

Payment of fees to Ministers

47

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

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

48

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

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

49

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

Payment of fees in respect of a traditional herbal registration

50

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

Time for payment of periodic fees

51

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

Penalty fees for late payment of periodic fees

52

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

Daily penalty fees for late payment of periodic fees

53

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

Refund or waiver of fees under regulation 52 or 53

54

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

Adjustment, waiver, reduction or refund of fees

55

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

Suspension of licences and authorisations

56

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

Civil proceedings to recover unpaid fees

57

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

PART 15 — Consequential Amendments

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

58

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

PART 16 — Revocations and Savings

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

59

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

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

60

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

Other Revocations

61

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

SCHEDULE 1 — General interpretation provisions

1

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

2

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

3

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

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

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

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 Authorisations, Licences, Registrations and Certificates

Marketing authorisations

24

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

Fees where application includes reclassification

25

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

Fees where person holds clinical trial certificate

26

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

Joint development

27

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

Application for multiple authorisations

28

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

Authorisation for a national homoeopathic product

29

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

Manufacturer's licences and authorisations

30

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

Wholesale dealer's licences

31

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

Broker's registrations

32

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

Active substance registrations

33

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

Clinical trial authorisations

34

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

Traditional herbal registrations

35

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

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

Outgoing mutual recognition applications

36

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

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

Marketing authorisations

37

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

Variation of marketing authorisations

38

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

Reclassification of marketing authorisations

39

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

Variation of marketing authorisation: national homoeopathic products

40

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

Variation of parallel import licence

41

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

Manufacturer's authorisations and licences

42

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

Variation of manufacturer's authorisations and licences

43

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

Wholesale dealer's licences

44

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

Variation of wholesale dealer's licence

45

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

Variation of a broker's registration

46

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

Variation of an active substance registration

47

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

Clinical trial authorisations

48

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

Traditional herbal registrations

49

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

Identical variations

50

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

Complex Variation Applications

51

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

Multiple reclassification variation applications

52

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

PART 5 — Capital Fees for Assessment of Labels and Leaflets

A set of changes

53

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

More than one set of changes proposed

54

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

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

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

Regulatory assistance – same manufacturer

56

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

PART 7 — Relevant Substances

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

57

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

SCHEDULE 3 — Fees for inspections

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

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

Broker's registrations

8

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

Active substance registrations

9

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

Office-based inspections

10

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

SCHEDULE 4 — Periodic fees for licences

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 Authorisations and Licences

Marketing authorisations

5

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

Marketing authorisation: where Part 2 of the Act applies

6

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

Marketing authorisation: 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: special medicinal products

14

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

Additional amount for manufacturer's licences and wholesale dealer's licences which relate to special medicinal products

15

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

Traditional herbal registrations

16

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

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

Parallel import licences

17

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

SCHEDULE 5 — Fees for certificates of registration

Column (1)	Column (1)	Column (1)	Column 2	Column 3
Type of application	Type of application	Type of application	Fees for applications in respect of products prepared from not more than 5 homoeopathic stocks	Fees for other applications
1	An application in respect of a product which is both prepared solely from repeat stocks and is of a repeat formulation.	An application in respect of a product which is both prepared solely from repeat stocks and is of a repeat formulation.	£177	£437
2	An application in respect of a product which is either—	An application in respect of a product which is either—	£531	£782
	(a)	prepared solely from repeat stocks; or
	(b)	is of a repeat formulation.
3	A mutual recognition procedure incoming application.	A mutual recognition procedure incoming application.	£557	£709
4	A mutual recognition outgoing application (regulatory assistance).	A mutual recognition outgoing application (regulatory assistance).	£319	£416
5	A decentralised procedure application where the UK is a concerned member State.	A decentralised procedure application where the UK is a concerned member State.	£478	£625
6	A decentralised procedure application where the UK is the reference member State.	A decentralised procedure application where the UK is the reference member State.	£956	£1,251
7	Any other application.	Any other application.	£878	£1,149

SCHEDULE 6 — Time for payment of capital fees: small companies

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

Interruptions of manufacture, assembly, sale or supply

1

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

Reclassification

2

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

Variation of a traditional herbal registration

3

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

Withdrawal of application in relation to marketing authorisation, 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, manufacturer's licence, broker's registration or active substance registration

6

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

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

7

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

Parallel import licence

8

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

Surrender of marketing authorisation 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

Refund on surrender or revocation of authorisation, registration or licence

1

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

Adjustment and refund: licences relating to imported special medicinal products

2

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

Refunds: treated as having been paid on account

3

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

SCHEDULE 9 — Further revocations

Instrument	Extent of repeal or revocation
Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 1998 (S.I. 1998/574)	The whole of the Regulations
Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 1999 (S.I. 1999/566)	The whole of the Regulations
Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 1999 (S.I. 2000/592)	The whole of the Regulations
Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2003 (S.I. 2003/625)	The whole of the Regulations
Medicines for Human Use (Fees Amendments) Regulations 2006 (S.I. 2006/2125)	The whole of the Regulations
Medicines (Products for Human Use) (Amendments Relating to Fees for Variations) Regulations 2009 (S.I. 2009/3222)	The whole of the Regulations

Signed

Signed by authority of the Secretary of State for Health.

Earl Howe — Parliamentary Under-Secretary of State, — 1st March 2013

Edwin Poots — Minister for Health, Social Services and Public Safety — 7th March 2013

Robert Goodwill — Desmond Swayne — Two of the Lords Commissioners of Her Majesty's Treasury — 7th March 2013

Explanatory note

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

Footnotes

[^f00001]: 1971 c.69; as amended by regulation 45(2) of S.I. 2008/2297 and section 21 of the Health and Medicines Act 1988 (c.49). By virtue of section 1(3) of the Medicines Act 1971 (“the 1971 Act”), expressions used in that section have the same meaning as in the Medicines Act 1968 (c.67) (“the 1968 Act”). See therefore section 1 of the 1968 Act, as substituted by paragraph 2 of Schedule 34 to the Human Medicines Regulations 2012 (S.I. 2012/1916) (“the 2012 Regulations”) which provides the meaning of the expression “the Ministers”, which is relevant to the powers being exercised in the making of these Regulations. By virtue of regulation 348 of, and paragraph 36 of Schedule 34 to, the 2012 Regulations, references in section 1(1) and (2)(b) of the 1971 Act to an application for a licence, or for the variation or renewal of such a licence under Part 2 of the 1968 Act, shall have effect as a reference to any application under Parts 3 to 8 of the 2012 Regulations.

[^f00002]: In the case of the Secretary of State, by virtue of article 2(1) of S.I. 1999/3142. In the case of the Minister for Health, Social Services and Public Safety, by virtue of section 95(5) of, and paragraph 10 of Schedule 12 to, the Northern Ireland Act 1998 (c.47); the Department for which the Minister is responsible was renamed by virtue of Article 3(6) of S.I. 1999/283 (N.I.1).

[^f00003]: 1972 c.68. Section 2(2) was amended by section 27(1)(a) of the Legislative Reform Act (2006 c.51) and section 3(3) of and Part 1 of the Schedule to the European Union (Amendment) Act 2008 (2008 c.7).

[^f00004]: 1973 c.51.

[^f00005]: See article 2(1) of and Schedule 1 to the European Communities (Designation) Order 1972 (S.I. 1972/1811).

[^f00006]: Section 129(6) was extended by section 1(3)(b) of the Medicines Act 1971.

[^f00007]: OJ No L 311, 28.11.2001, p67. Articles 52a and 85b were inserted into Directive 2001/83/EC by Article 1(10) and (19) of Directive 2011/62/EU of the European Parliament and of the Council (OJ No L 174, 1.7.2011, p74) and are expected to be implemented shortly after the commencement of these Regulations.

[^f00008]: OJ No L 169, 12.7.1993, p1. This Directive has been amended by Directive 98/79/EC of the European Parliament and of the Council (OJ No L 331, 7.12.1998, p1), Directive 2000/70/EC of the European Parliament and of the Council (OJ No L 313, 13.12.2000, p22), Directive 2001/104/EC of the European Parliament and of the Council (OJ No L 6, 10.1.2002, p50), Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ No L 284, 31.10.2003, p1) and Directive 2007/47/EC of the European Parliament and of the Council (OJ No L 247, 21.9.2007, p21).

[^f00009]: Regulation 3 has been amended by S.I. 2006/1928.

[^f00010]: Regulation 44 has been amended by S.I. 2006/1928.

[^f00011]: Regulation 24 has been amended by S.I. 2006/1928.

[^f00012]: OJ No L 209, 4.8.2012, p4.

[^f00013]: OJ No L 22, 9.2.1965, P 369/65. This Directive has been codified and assembled with others into Directive 2001/83/EC.

[^f00014]: OJ No L 15, 17.1.1987, p38. This Directive has been repealed by Council Directive 93/41/EEC, OJ No L 214, 24.8.1993, p40.

[^f00015]: Schedule 5 was substituted by regulation 4 of, and paragraph 5 of Schedule 3 to, S.I. 2005/2754.

[^f00016]: Paragraph 4 of Schedule 8 was substituted by regulation 4 of, and paragraph 6 of Schedule 3 to, S.I. 2005/2754.

[^f00017]: Article 28 has been substituted by Article 1(26) of Directive 2004/27/EC of the European Parliament and of the Council (OJ No L 136, 30.4.2004, p34).

[^f00018]: Article 29 has been substituted by article 1(26) of Directive 2004/27/EC of the European Parliament and of the Council (OJ No L 136, 30.4.2004, p34).

[^f00019]: 2006 c.46. A relevant amendment was made by S.I. 2008/393.

[^f00020]: S.I. 2004/1031; relevant amendments are made by S.I. 2006/1928, 2012/504.

[^f00021]: S.I. 2012/504.

[^f00022]: S.I. 2012/2546.

[^f00023]: OJ No L 311, 28.11.2001, p67; relevant amending instruments are Directive 2002/98/EC of the European Parliament and of the Council (OJ No L 33, 8.2.2003, p30), Commission Directive 2003/63/EC (OJ No L 159, 27.6.2003, p46), Directive 2004/24/EC of the European Parliament and of the Council (OJ No L 136, 30.4.2004, p85), Directive 2004/27/EC of the European Parliament and of the Council (OJ No L 136, 30.4.2004, p34), Regulation (EC) No 1901/2006 of the European Parliament and of the Council (OJ No L 378, 27.12.2006, p1), Regulation (EC) No 1394/2007 of the European Parliament and of the Council (OJ No L 324, 10.12.2007, p121), Directive 2008/29/EC of the European Parliament and of the Council (OJ No L 81, 20.3.2008, p51), Directive 2009/53/EC of the European Parliament and of the Council (OJ No L 168, 30.6.2009, p33), Commission Directive 2009/120/EC (OJ No L 242, 15.9.2009, p3), Directive 2010/84/EU of the European Parliament and of the Council (OJ No L 348, 31.12.2010, p74), Directive 2011/62/EU of the European Parliament and of the Council (OJ No L 174, 1.7.2011, p74) and Directive 2012/26/EU of the European Parliament and of the Council (OJ No L 299, 27.10.2012, p1).

[^f00024]: 1968 c.67.

[^f00025]: Article 52a was inserted into Directive 2001/83/EC by Article 1(10) of Directive 2011/62/EU of the European Parliament and of the Council (OJ No L 174, 1.7.2011, p74).

[^f00026]: Article 85b was inserted into Directive 2001/83/EC by Article 1(19) of Directive 2011/62/EU of the European Parliament and of the Council (OJ No L 174, 1.7.2011, p74).

[^f00027]: S.I. 2004/1031; relevant amending instruments are S.I. 2004/3224, 2005/2754 and 2759, 2006/562, 1928 and 2984, 2007/289 and 3101, 2008/941, 2009/1164, 2010/1882 and 2012/1916.

[^f00028]: OJ No L 334, 12.12.2008, p7. Commission Regulation (EC) No 1234/2008 has been amended by Commission Regulation (EC) No 712/2012 (OJ No L 209, 4.8.2012, p4).

[^f00029]: S.I. 1971/972; relevant amending instruments are S.I. 1992/2846, 1994/2852, 2004/1031 and 2005/2789.

[^f00030]: OJ No L 262, 14.10.2003, p22.

[^f00031]: OJ No L 147, 9.6.1975, p13. This Directive has been codified and assembled with others into Directive 2001/83/EC.

[^f00032]: OJ No L 214, 24.8.1993, p1. This Regulation has been amended by Commission Regulation (EC) No 649/98 (OJ No L 88, 24.3.1998, p7), Council Regulation (EC) No 807/2003 (OJ No L 122, 16.5.2003, p36) and Council Regulation (EC) No 1647/2003 (OJ No L 245, 29.9.2003, p19).

[^f00033]: S.I. 2012/1916.

[^f00034]: Section 104 has been amended by S.I. 2004/1031, 2006/2407, 2012/1916.

[^f00035]: Relevant amending instrument is S.I. 2012/1916.

[^f00036]: OJ No L 18, 22.1.2000, p1, as amended by Regulation (EC) No 596/2009 of the European Parliament and of the Council (OJ No L 188, 18.7.2009, p14).

[^f00037]: OJ No L 136, 30.4.2004, p1; relevant amending instruments are Regulation (EC) No 1901/2006 of the European Parliament and of the Council (OJ No L 378, 27.12.2006, p1), Regulation (EC) No 1394/2007 of the European Parliament and of the Council (OJ No L 324, 10.12.2007, p121), Regulation (EC) No 219/2009 of the European Parliament and of the Council (OJ No L 87, 31.3.2009, p109), Regulation (EC) No 470/2009 of the European Parliament and of the Council (OJ No L 152, 16.6.2009, p11), Regulation (EU) No 1235/2010 of the European Parliament and of the Council (OJ No L 348, 31.12.2010, p1) and Corrigendum (OJ L 201, 27.7.2012, p.138).

[^f00038]: Revocations and amendments to regulation 31 have been made by S.I. 2005/2754 and 2006/1928.

[^f00039]: 2006 c.46.

[^f00040]: See Article 1 of the Regulation as amended by Commission Regulation (EU) No 712/2012 (OJ No L 209, 4.8.2012, p4).

[^f00041]: Chapter IIa of the Regulation was inserted by Commission Regulation (EU) No 712/2012 (OJ No L 209, 4.8.2012, p4).

[^f00042]: A copy of the guidance can be downloaded from the licensing authority’s website at www.mhra.gov.uk or obtained by writing to the licensing authority at 151 Buckingham Palace Road, London, SW1W 9SZ or by sending an email to info@mhra.gsi.gov.uk.

[^f00043]: Paragraph 9 of the Regulation was inserted by Commission Regulation (EU) No 712/2012 (OJ No L 209, 4.8.2012, p4).

[^f00044]: OJ No L 209, 4.8.2012, p4.

[^f00045]: Copies of the documents can be downloaded from the licensing authority’s website at www.mhra.gov.uk or obtained by writing to the licensing authority at 151 Buckingham Palace Road, London, SW1W 9SZ or by sending an email to info@mhra.gsi.gov.uk.

[^f00046]: S.I. 1971/1267: Part 2 of the Act is applied by article 3 of the Order which has been amended by S.I. 1994/3119, 2004/1031 and 2006/2407. Provisions of Part 2 of the Act that were repealed under Schedule 35 (repeals and revocations) to the Human Medicines Regulations 2012 are applied to the extent provided for under paragraph 1 of Schedule 32 (transitional provisions and savings) to those Regulations.

[^f00047]: Article 11 has been amended by Directive 2004/27/EC of the European Parliament and of the Council (OJ No L 136, 30.4.2004, p34) and Directive 2010/84/EU of the European Parliament and of the Council (OJ No L 348, 31.12.2010, p74).

[^f00048]: OJ No L 152, 16.6.2009, p1.

Editorial notes

[^key-6b65471f042cbeb2b5a8c5a033f347d4]: Regulations revoked (1.4.2016) by The Medicines (Products for Human Use) (Fees) Regulations 2016 (S.I. 2016/190), reg. 63(1) (with reg. 63(2)-(4))

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

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

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