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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Manufacturer's licences or manufacturing authorisations

11

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Wholesale dealer's licences

12

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Wholesale dealer's licences: evidence

13

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Wholesale dealer's licences: exempt imported products

14

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

15

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Clinical trial authorisations

16

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Traditional herbal registrations

17

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

Parallel import licences

18

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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.	£172	£425
2	An application in respect of a product which is either—	An application in respect of a product which is either—	£517	£761
	(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.	£542	£690
4	A mutual recognition outgoing application (regulatory assistance).	A mutual recognition outgoing application (regulatory assistance).	£310	£405
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.	£465	£608
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.	£930	£1,217
7	Any other application.	Any other application.	£854	£1,118

SCHEDULE 6 — TIME FOR PAYMENT OF CAPITAL FEES: SMALL COMPANIES

Interpretation

1

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Major application

2

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Complex application

3

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Multiple application

4

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Outgoing mutual recognition application

5

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Application for traditional herbal registration

6

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Traditional herbal registration: complex variation

7

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

8

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Inspection fees in connection with applications

9

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SCHEDULE 7 — WAIVER, REDUCTION OR REFUND OF CAPITAL FEES

Interruptions of manufacture, assembly, sale or supply

1

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Reclassification

2

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Variation of a traditional herbal registration

3

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

4

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Withdrawal of application in relation to a certificate of registration

5

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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

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

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

Signed

Signed by authority of the Secretary of State for Health.

Earl Howe — Parliamentary Under-Secretary of State, — 2012-02-20

Edwin Poots — Minister for Health, Social Services and Public Safety — 2012-02-23

Michael Fabricant — Brooks Newmark — Two of the Lords Commissioners of Her Majesty's Treasury — 2012-02-22

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(1) of the 1968 Act, as amended by article 2(2) of, and Schedule 1 to, S.I. 1969/388, by article 5 of, and the Schedule to, S.I. 1999/3142, by article 5(1) of, and paragraph 15 of Schedule 1 to, S.I. 2002/794 and by regulation 44 of, and Schedule 8 to, S.I. 2006/2407. Section 1(1) of the 1968 Act contains a definition of the expression “the Ministers”, which is relevant to the powers being exercised in the making of these Regulations. See also regulation 9(12) of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (S.I. 1994/3144) (“the 1994 Regulations”), by virtue of which the 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 include reference to an application for a marketing authorization under the 1994 Regulations or for the variation or renewal of such an authorization.

[^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.

[^f00004]: 1973 c.51.

[^f00005]: S.I. 1972/1811.

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

[^f00007]: Amendments have been made to section 51 by S.I. 2006/2407.

[^f00008]: OJ No. L 169, 12.7.1993, p.1. 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, p.1), Directive 2000/70/EC of the European Parliament and of the Council (OJ No. L 313, 13.12.2000, p.22), Directive 2001/104/EC of the European Parliament and of the Council (OJ No. L 6, 10.1.2002, p.50), Regulation (EC) No. 1882/2003 of the European Parliament and of the Council (OJ No. L 284, 31.10.2003, p.1) and Directive 2007/47/EC of the European Parliament and of the Council (OJ No. L 247, 21.9.2007, p.21).

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

[^f00010]: Section 50 has been amended by S.I. 2004/1031.

[^f00011]: Regulation 4 has been amended by S.I. 2001/795, 2002/236, 2005/2759, 2006/1952.

[^f00012]: Section 30 was substituted by S.I. 2005/2789.

[^f00013]: Regulation 44 has been amended by S.I. 2006/1928, 2010/551.

[^f00014]: Regulation 24 has been amended by S.I. 2006/1928, 2010/551.

[^f00015]: S.I. 1971/1450, to which amendments which are not relevant to these Regulations have been made.

[^f00016]: OJ No. L 22, 9.2.1965, p.369. This Directive has been codified and assembled with others into Directive 2001/83/EC.

[^f00017]: OJ No. L 15, 17.1.1987, p.38. This Directive has been repealed by Council Directive 93/41/EEC, OJ No. L 214, 24.8.1993, p.40.

[^f00018]: Regulation 19 has been amended by S.I. 2005/2754, 2010/1882.

[^f00019]: Sections 21 and 22 were substituted by regulation 8 of, and paragraphs 2 and 3 of Schedule 1 to, S.I. 2005/1094.

[^f00020]: Schedule 5 was substituted by regulation 4 of, and paragraph 5 of Schedule 3 to, S.I. 2005/2754.

[^f00021]: Paragraph 4 was substituted by regulation 4 of, and paragraph 6 of Schedule 3 to, S.I. 2005/2754.

[^f00022]: Schedule 2 was substituted by regulation 9 of, and paragraph 4 of Schedule 2 to, S.I. 2005/1094.

[^f00023]: Schedule 5 was inserted by regulation 20 of S.I. 2005/2753.

[^f00024]: 2006 c.46. A relevant amendment was made by S.I. 2008/393.

[^f00025]: S.I. 2004/1031; relevant amendments are made by S.I. 2006/1928, 2010/551.

[^f00026]: The definition of “administrative variation” was inserted by S.I. 1998/574. The definitions of “concerned member state” and “set of applications” were inserted by S.I. 2005/2753. The definition of “standard variation” was inserted by S.I. 1998/574 and amended by S.I. 2001/795.

[^f00027]: S.I. 2010/551.

[^f00028]: Paragraph (4) was inserted by S.I. 1996/482.

[^f00029]: Regulation 13 was amended by S.I. 2005/2753. Regulation 14 was substituted by S.I. 1998/574 and amended by S.I. 1999/566, 2010/551. Regulation 15 was amended by S.I. 2010/551. Regulation 15A was inserted by S.I. 2009/389. Regulation 16 was amended by S.I. 2005/2573. Schedule 2 was substituted by S.I. 1996/482 and amended by S.I. 2005/2753, 2006/2125, 2010/551. Schedule 2A was inserted by S.I. 2005/2753 and amended by S.I. 2010/551.

[^f00030]: OJ No. L 311, 28.11.2001, p.67; relevant amending instruments are Directive 2002/98/EC of the European Parliament and of the Council (OJ No. L 33, 8.2.2003, p.30), Commission Directive 2003/63/EC (OJ No. L 159, 27.6.2003, p.46), Directive 2004/24/EC of the European Parliament and of the Council (OJ No. L 136, 30.4.2004, p.85), Directive 2004/27/EC of the European Parliament and of the Council (OJ No. L 136, 30.4.2004, p.34), Regulation (EC) No. 1901/2006 of the European Parliament and of the Council (OJ No. L 378, 27.12.2006, p.1), Regulation (EC) No. 1394/2007 of the European Parliament and of the Council (OJ No. L 324, 10.12.2007, p.121), Directive 2008/29/EC of the European Parliament and of the Council (OJ No. L 81, 20.3.2008, p.51), Directive 2009/53/EC of the European Parliament and of the Council (OJ No. L 168, 30.6.2009, p.33) and Commission Directive 2009/120/EC (OJ No. L 242, 15.9.2009, p.3), Directive 2010/84/EU of the European Parliament and of the Council (OJ No. L 348, 31.12.2010, p.74), Directive 2011/62/EU of the European Parliament and of the Council (OJ No. L 174, 1.7.2011, p.74).

[^f00031]: 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 and 2009/1164.

[^f00032]: S.I. 1971/972; relevant amending instruments are S.I. 1992/2846, 1994/2852, 2004/1031 and 2005/2789.

[^f00033]: OJ No. L 214, 24.8.1993. This Regulation has been replaced by Regulation (EC) No. 726/2004.

[^f00034]: OJ No. L 262, 14.10.2003, p.22.

[^f00035]: OJ No. L 147, 9.6.1975, p.13. This Directive has been codified and assembled with others into Directive 2001/83/EC.

[^f00036]: OJ No. L 334, 12.12.2008, p.7.

[^f00037]: S.I. 2005/2750, as amended by S.I. 2006/914.

[^f00038]: S.I. 1994/105; relevant amending instruments are S.I. 1994/899, 1996/482, 1998/574, 1999/566, 2001/795, 2002/236 and 254, 2003/625 and 2321, 2005/2753, 2006/2125 and 2407, 2007/803 and 2009/389.

[^f00039]: S.I. 1994/3144; relevant amending instruments are S.I. 1996/1499, 1998/3105, 2000/292, 2001/795, 2002/236 and 542, 2003/1618, 2317 and 2321, 2004/856 (as regards England), 1016 (as regards Wales), 1031, 2290 and 3224, 2005/50, 768, 1094, 1520, 1710, 2754 and 2759, 2006/562 (as regards England), 914, 1952 and 2407, 2007/289, 2008/3097 and 2009/1164, 2820, 3063 and 3222.

[^f00040]: Amendments have been made to these sections by S.I. 2004/1031 and 2006/2407.

[^f00041]: OJ No. L 18, 22.1.2000, p.1, as amended by Regulation (EC) No. 596/2009 of the European Parliament and of the Council (OJ No. L 188, 18.7.2009, p.14).

[^f00042]: Repeals and amendments to section 7 have been made by S.I. 1977/1050, 1983/1724, 1992/604, 1994/276, 2004/1031, 2005/50 and 2753 and 2006/2407.

[^f00043]: OJ No. L 136, 30.4.2004, p.1; relevant amending instruments are Regulation (EC) No. 1901/2006 of the European Parliament and of the Council (OJ No. L 378, 27.12.2006, p.1), Regulation (EC) No. 1394/2007 of the European Parliament and of the Council (OJ No. L 324, 10.12.2007, p.121), Regulation (EC) No. 219/2009 of the European Parliament and of the Council (OJ No. L 87, 31.3.2009, p.109) and Regulation (EC) No. 470/2009 of the European Parliament and of the Council (OJ No. L 168, 16.6.2009, p.11).

[^f00044]: S.I. 2005/2789.

[^f00045]: Revocations and amendments to regulation 31 have been made by S.I. 2005/2754 and 2006/1928.

[^f00046]: 2006 c.46.

[^f00047]: S.I. 1971/1450 to which there are no relevant amendments.

[^f00048]: Section 51(1) has been amended by S.I. 2006/2407.

[^f00049]: OJ No. L 121, 1.5.2001, p.34. This Directive has been amended by Regulation (EC) No. 1901/2006 (OJ No. L 378, 27.12.2006, p.1), to which amendments which are not relevant to these Regulations have been made.

[^f00050]: See Article 1 of the Regulation.

[^f00051]: 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.

[^f00052]: 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.

[^f00053]: S.I. 1971/1267; Part II 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.

[^f00054]: Amendments and substitutions to section 4 have been made by S.I. 2004/1031, 2005/1094 and 2754 and 2006/2407.

[^f00055]: Section 2A was inserted by S.I. 2005/1094.

[^f00056]: Section 44 has been amended by S.I. 2005/1094, 2006/2407.

[^f00057]: Article 11 has been amended by Directive 2004/27/EC (OJ L 136, 30.4.2004, p.34).

[^f00058]: OJ L 152, 16.6.2009, p.1.

Editorial notes

[^key-85916a0a8585089198c48ad09111fcc9]: 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))

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