The National Health Service (Pharmaceutical Services) Regulations 2012

Made: 18th July 2012

Laid before Parliament: 23rd July 2012

Coming into force: 1st September 2012

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PART 1 — Introductory

Citation and commencement

1

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Interpretation

2

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PART 2 — Pharmaceutical needs assessments

Pharmaceutical needs assessments

3

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Information to be contained in pharmaceutical needs assessments

4

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Date by which the first pharmaceutical needs assessment is to be published

5

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Subsequent assessments

6

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Temporary extension of pharmaceutical needs assessments

7

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Consultation on pharmaceutical needs assessments

8

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Matters for consideration when making assessments

9

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PART 3 — General matters relating to pharmaceutical lists and applications in respect of them

Pharmaceutical lists and EPS lists

10

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Terms of service of NHS chemists: general

11

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Routine applications for inclusion in or amendment to a pharmaceutical list

12

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Current needs: additional matters to which the Primary Care Trust must have regard

13

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Current needs: consequences of additional matters

14

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Future needs: additional matters to which the Primary Care Trust must have regard

15

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Future needs: consequences of additional matters

16

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Improvements or better access in the pharmaceutical needs assessment: additional matters to which the Primary Care Trust must have regard

17

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Unforeseen benefits applications: additional matters to which the Primary Care Trust must have regard

18

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Applications to which regulation 17 or 18 applies: consequences of additional matters

19

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Future improvements or better access: additional matters to which the Primary Care Trust must have regard

20

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Future improvements or better access: consequences of additional matters

21

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Refusal of routine applications that are based on neither a pharmaceutical needs assessment nor unforeseen benefits

22

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PART 4 — Excepted applications

Applications from NHS chemists in respect of providing directed services

23

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Relocations that do not result in significant change to pharmaceutical services provision

24

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Distance selling premises applications

25

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Change of ownership applications

26

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Applications for temporary listings arising out of suspensions

27

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Applications from persons exercising a right of return to a pharmaceutical list

28

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Applications relating to emergencies requiring the flexible provision of pharmaceutical services

29

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PART 5 — Specific grounds for refusal or deferral of applications under Parts 3 and 4 which are not linked to fitness grounds

Refusal: language requirement for some NHS pharmacists

30

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Refusal: same or adjacent premises

31

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Deferrals arising out of LPS designations

32

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PART 6 — Refusal, deferral and conditional inclusion in pharmaceutical lists of chemists on fitness grounds

Refusal of applications for inclusion in a pharmaceutical list on fitness grounds

33

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Deferral of consideration of applications for inclusion in a pharmaceutical list on fitness grounds

34

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Granting applications for inclusion in a pharmaceutical list subject to efficiency conditions and conditions to combat fraud

35

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PART 7 — Areas that are controlled localities and reserved locations, and new pharmacies within them

Determination that an area is a controlled locality

36

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Process for determining controlled localities: preliminary matters

37

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Process for determining controlled localities: local notification and deferment of routine applications

38

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Process of determining controlled localities: formulation of the Primary Care Trust’s decision

39

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Applications for new pharmacy premises in controlled localities: refusals because of preliminary matters

40

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Applications for new pharmacy premises in controlled localities: reserved locations

41

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Second and subsequent determinations of reserved location status

42

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Determinations of reserved locations: supplemental matters

43

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Prejudice test in respect of routine applications for new pharmacy premises in a part of a controlled locality that is not a reserved location

44

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Appeals against decisions under Part 7

45

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PART 8 — Dispensing doctors

Dispensing doctor lists

46

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Terms of service of dispensing doctors: general

47

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Arrangements for the provision of pharmaceutical services by doctors: applications by patients

48

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Necessary services for temporary patients

49

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Discontinuation of arrangements for the provision of pharmaceutical services by doctors

50

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Outline consent and premises approval: applications by doctors

51

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Notification of applications for outline consent and premises approval

52

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Decisions on outline consent and premises approval applications and the taking effect of grants

53

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Premises approval: relocations of practice premises which are not significant before outline consent takes effect

54

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Premises approval: relocations of practice premises which are not significant after outline consent has taken effect

55

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Taking effect of premises approval where there is no related application for outline consent

56

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Gradual introduction of premises approval

57

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Temporary provision in cases of relocations or additional premises where premises approval has not taken effect

58

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Practice amalgamations

59

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Lapse of outline consent and premises approval

60

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Temporary arrangements during an emergency requiring the flexible provision of pharmaceutical services

61

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Persons barred from taking part in decision making with regard to applications for outline consent or premises approval

62

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Appeals against decisions under Part 8

63

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PART 9 — Conditional inclusion in pharmaceutical lists: certain specific conditions that do not relate to fitness or performance

Distance selling premises: specific conditions

64

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Core opening hours conditions

65

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Conditions relating to providing directed services

66

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Conditions relating to voluntary closure of premises

67

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Conditions relating to local resolution of disputes over terms of service

68

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PART 10 — Performance related sanctions and market exit

Local dispute resolution before serving remedial notices or breach notices

69

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Breaches of terms of service: remedial notices

70

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Breaches of terms of service: breach notices

71

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Payment withholdings: supplementary matters

72

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Removal of listings: cases relating to remedial notices and breach notices

73

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Removal of listings: cases relating to death, incapacity or cessation of service

74

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Voluntary and automatic removal of listings: change of ownership, relocation, temporary provision and voluntary closure

75

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Limitation on withdrawal from pharmaceutical lists while fitness investigations or proceedings are ongoing

76

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Appeals against decisions under Part 10

77

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PART 11 — Enforcement, reviews and appeals relating to fitness matters

Extended meaning of “health scheme” in fraud cases

78

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Review of decisions to impose fitness conditions originally imposed on grants of applications

79

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Removal for breach of fitness conditions imposed under regulation 35 or 79

80

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Mandatory removal in suitability cases

81

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Fitness cases: procedures for removal or contingent removal from pharmaceutical lists

82

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Procedure for suspensions in fitness cases

83

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Procedure for reviewing some suspensions and contingent removal conditions

84

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General power to revoke suspensions in appropriate circumstances

85

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Evidence of unsuitability, fraud or inefficiency in service provision: specific matters

86

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Review periods for national disqualifications

87

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Wider notifications of fitness decisions

88

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PART 12 — Remuneration, charges and refunds

The Drug Tariff and section 164: general provisions

89

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Data to be provided to assist Drug Tariff determinations

90

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Remuneration in respect of enhanced services

91

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Dispensing doctor remuneration

92

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The taking effect of determinations

93

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Overpayments

94

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Free supply of drugs, appliances and containers where the drug or appliance is supplied under pharmaceutical services

95

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Refunds of prescription charges

96

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Reward scheme

97

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Payments to suspended chemists

98

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PART 13 — Miscellaneous

Sharing of information by home Primary Care Trusts

99

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Notification by a Primary Care Trust of changes to its pharmaceutical lists

100

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Proceedings with regard to overridden arrangements during an emergency requiring the flexible provision of pharmaceutical services

101

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Authorised persons to apply for services

102

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Transitional provisions

103

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Amendments and revocations

104

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Review of these Regulations

105

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SCHEDULE 1 — Information to be contained in pharmaceutical needs assessments

Necessary services: current provision

1

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Necessary services: gaps in provision

2

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Other relevant services: current provision

3

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Improvements and better access: gaps in provision

4

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Other NHS services

5

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How the assessment was carried out

6

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Map of provision

7

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SCHEDULE 2 — Applications in respect of pharmaceutical lists and the procedures to be followed

PART 1 — Information to be included in routine and excepted applications

Information to be included in all routine and excepted applications

1

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Information to be included in all routine and excepted applications for inclusion in a pharmaceutical list

2

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Fitness information about individuals: routine and excepted applications for inclusion in a pharmaceutical list

3

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Fitness information about corporate bodies: routine and excepted applications for inclusion in a pharmaceutical list

4

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Providing fitness information instead to a home Primary Care Trust

5

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Applications seeking the listing of premises that are already, or are in close proximity to, listed chemist premises

6

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Additional information to be included with routine applications

7

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Additional information to be included with excepted applications

8

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Undertakings

9

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Nature of details to be supplied

10

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PART 2 — Preliminary matters

Relevant information or documentation

11

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Failure to provide undertakings

12

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Functions of a home Primary Care Trust in relation to certain applications

13

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Deferral of notifiable applications prior to notification

14

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Refusal of notifiable applications prior to notification because of the language requirement for some NHS pharmacists

15

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Refusal of notifiable applications on fitness grounds prior to notification

16

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Proposed new pharmacy premises in controlled localities: refusal of routine applications because of preliminary matters prior to notification

17

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PART 3 — Notification of certain applications

Applications requiring notifications

18

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Notification procedure for notifiable applications

19

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Parallel notifications

20

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Content of notifications

21

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PART 4 — Determination and deferral of applications

Flexibility with regard to determining or deferring applications

22

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Additional matters for consideration in relation to applications for inclusion in a pharmaceutical list

23

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Action following deferrals

24

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Oral hearings

25

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Persons barred from taking part in decision making on routine and excepted applications

26

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Timetable for determining applications

27

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PART 5 — Notification, taking effect of decisions and rights of appeal to the Secretary of State

Notification of decisions on routine and excepted applications

28

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Template notice of commencement to be included with a notice of decision

29

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Third party rights of appeal to the Secretary of State where an application is granted

30

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Conditional grant of applications where the address of the premises is unknown

31

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Changes to the premises specified in an application after its grant but before the listing of the premises

32

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Conditional grant in cases relating to future needs or future improvements or better access

33

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Taking effect of listing decisions: general

34

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Notice requiring the commencement of pharmaceutical services

35

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Appeals to the Secretary of State by the applicant

36

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SCHEDULE 3 — Appeals to the Secretary of State

PART 1 — Preliminary matters

Determination of third party appeal rights in certain cases

1

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Misconceived appeals

2

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PART 2 — Notification of appeals

Notification of appeals notices under paragraph 30, 32(5) or 36 of Schedule 2

3

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Notification of appeals relating to notices under regulation 45

4

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Notification of appeals relating to decisions under Part 8 of these Regulations

5

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Non notification of appeals relating to notices under regulation 77 or 98

6

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PART 3 — Determination of appeals

Flexibility with regard to the manner of determining appeals

7

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Oral hearings

8

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Decisions of the Secretary of State

9

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Notification of decisions and subsequent action by the Primary Care Trust

10

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Effect of decisions by the Secretary of State

11

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

SCHEDULE 4 — Terms of service of NHS pharmacists

PART 1 — General

Responsibilities of NHS pharmacists and pharmacy staff

1

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

Breaches by directors and superintendents

2

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

PART 2 — Essential services

Essential services

3

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

Dispensing services

4

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

Dispensing of drugs and appliances

5

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

Urgent supply without a prescription

6

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

Preliminary matters before providing ordered drugs or appliances

7

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

Providing ordered drugs or appliances

8

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

Refusal to provide drugs or appliances ordered

9

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

Further activities to be carried out in connection with the provision of dispensing services

10

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

Additional requirements in relation to electronic prescribing

11

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

Additional requirements in relation to specified appliances

12

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

Disposal service in respect of unwanted drugs

13

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

Basic procedure in respect of unwanted drugs

14

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

Further activities to be carried out in connection with the disposal of unwanted drugs

15

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

Promotion of healthy lifestyles

16

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

Prescription linked intervention

17

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

Public health campaigns

18

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

Signposting

19

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

Service outline in respect of signposting

20

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

Support for self-care

21

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

Service outline in respect of support for self-care

22

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

PART 3 — Hours of opening

Pharmacy opening hours: general

23

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

Matters to be considered when issuing directions in respect of pharmacy premises core opening hours

24

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

Determination of pharmacy premises core opening hours instigated by the Primary Care Trust

25

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

Determination of pharmacy premises core opening hours instigated by the NHS pharmacist

26

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

Temporary opening hours and closures during an emergency requiring the flexible provision of pharmaceutical services

27

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

PART 4 — Other terms of service

Clinical governance

28

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

Professional Standards

29

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

Inducements etc.

30

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

Duty to provide information about fitness matters as they arise

31

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

Other information to be supplied

32

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

Home Primary Care Trust of bodies corporate

33

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

Complaints

34

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

Inspections and access to information

35

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

SCHEDULE 5 — Terms of service of NHS appliance contractors

Division of responsibilities between individuals and corporate bodies

1

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

Breaches by directors

2

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

Dispensing services

3

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

Dispensing of appliances

4

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

Urgent supply without a prescription

5

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

Preliminary matters before providing appliances

6

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

Providing appliances

7

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

Refusal to provide appliances ordered

8

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

Further activities to be carried out in connection with the provision of dispensing services

9

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

Additional requirements in relation to electronic prescribing

10

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

Additional requirements in relation to specified appliances

11

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

Signposting

12

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

Opening hours: general

13

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

Matters to be considered when issuing directions in respect of core opening hours

14

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

Determination of core opening hours instigated by the Primary Care Trust

15

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

Determination of core opening hours instigated by the NHS appliance contractor

16

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

Temporary open hours and closures during an emergency requiring the flexible provision of pharmaceutical services

17

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

Clinical governance

18

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

Professional Standards

19

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

Inducements etc.

20

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

Duty to provide information about fitness matters as they arise

21

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

Other information to be supplied

22

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

Home Primary Care Trust of bodies corporate

23

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

Complaints

24

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

Inspections and access to information

25

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

SCHEDULE 6 — Terms of service of dispensing doctors

Persons duly authorised to dispense on behalf of dispensing doctors

1

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

Dispensing of drugs and appliances ordered by another prescriber

2

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

Dispensing of drugs and appliances ordered by the dispensing doctor

3

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

Preliminary matters before providing ordered drugs or appliances

4

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

Provision of Scheduled drugs

5

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

Refusal to provide drugs or appliances ordered

6

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

Dispensing doctors issuing prescription forms which may be presented to an NHS chemist

7

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

Complaints procedures

8

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

Inspections and access to information

9

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

Voluntary closure of premises

10

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

SCHEDULE 7 — Transitional provisions

Pharmaceutical needs assessments

1

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

Listing applications: NHS chemists

2

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

Listing applications: dispensing doctors

3

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

Approved retail areas

4

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

Controlled localities

5

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

Reserved locations

6

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

Gradual discontinuation of the provision of pharmaceutical services by doctors

7

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

Gradual introduction of the provision of pharmaceutical services by doctors

8

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

Giving effect to listing decisions taken under the 2005 Regulations

9

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

Dispensing contractor lists

10

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

Continuing matters: periods of time

11

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

Other continuing matters: NHS chemists

12

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

Other continuing matters: dispensing doctors

13

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

Continuing operation of SCAT arrangements

14

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

The application of Group 12 of Schedule 8 to the Value Added Tax Act 1994

15

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

Terms of service for distance selling premises

16

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

SCHEDULE 8 — Amendments and revocations

Revocation of the National Health Service (Service Committees and Tribunal) Regulations 1992, and of amendments to and measures relating to those Regulations

1

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

Amendment to the National Health Service (Indicative Amounts) Regulations 1997

2

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

Amendment to the National Health Service (Payments by Local Authorities to NHS Bodies) (Prescribed Functions) Regulations 2000

3

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

Amendments to the National Health Service (Charges for Drugs and Appliances) Regulations 2000

4

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

Amendments to the National Health Service (Local Pharmaceutical Services and Pharmaceutical Services) Regulations 2002

5

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

Amendments to the National Health Service (Local Pharmaceutical Services and Pharmaceutical Services) (No. 2) Regulations 2002

6

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

Amendments to the National Health Service (General Medical Services Contracts) Regulations 2004

7

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

Amendments to the National Health Service (Personal Medical Services Agreements) Regulations 2004

8

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

Revocation of the National Health Service (Pharmaceutical Services) Regulations 2005 and of amendments to those Regulations

9

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

Amendments to the National Health Service (Local Pharmaceutical Services etc.) Regulations 2006

10

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

Amendments to the Local Authority Social Services and National Health Service Complaints (England) Regulations 2009

11

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

Signed

Signed by authority of the Secretary of State for Health.

Earl Howe — Parliamentary Under-Secretary of State — Department of Health — 18th July 2012

Explanatory note

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

Footnotes

[^f00001]: 2006 c.41. Section 128A was inserted by the Health Act 2009 (c.21), section 25; section 129 has been amended by the Health Act 2009, sections 26 and 27 and Schedule 6, the Health and Social Care Act 2012 (c. 7), section 207(8), and by S.I. 2010/231; section 130 has been amended by the Health and Social Care Act 2012, section 207(10), and by S.I. 2010/22; section 132 has been amended by S.I. 2007/289 and 2010/22 and 231; section 148 has been amended by S.I. 2010/22; section 150A was inserted by the Health Act 2009, section 28; section 154 has been amended by S.I. 2010/22; and section 164 has been amended (although the amendments are not yet fully in force) by the Health and Social Care Act 2008 (c. 14), section 141(1), and Schedule 15, Part 4. By virtue of section 271(1) of the 2006 Act, the functions of the Secretary of State being exercised in the making of these Regulations are exercisable only in relation to England. See also section 275(1) of the 2006 Act, which contains definitions of “prescribed” and “regulations” that are relevant to the powers being exercised.

[^f00002]: 2009 c. 21.

[^f00003]: 1968 c. 67.

[^f00004]: 1992/662; revoked by S.I. 2005/641.

[^f00005]: 2005/641; revoked by Schedule 7 to these Regulations.

[^f00006]: The amendments made to section 164 by the Health and Social Care Act 2008 (c. 14), section 141, and Schedule 15, Part 4, are not yet fully in force.

[^f00007]: See section 126(9) of that Act, which provides a definition of “listed” that includes the power for the Secretary of State to approve lists for the purposes of section 126.

[^f00008]: 2006 c. 52.

[^f00009]: 1971 c.80.

[^f00010]: S.I. 2000/620.

[^f00011]: 2000 c.7. The definition of “electronic communication” has been amended by the Communications Act 2003 (c. 21), Schedule 17, paragraph 158.

[^f00012]: Inserted by the Health Act 2009 (c. 21), section 26(3).

[^f00013]: S.I. 2004/291.

[^f00014]: S.I. 2010/231.

[^f00015]: 1978 c. 29. Section 2 has been amended by: the Health and Social Services and Social Security Adjudications Act 1983 (c.41), Schedule 7, paragraph 1; the National Health Service and Community Care Act 1990 (c.19), section 28, Schedule 9, paragraph 19(1), and Schedule 10; the National Health Service Reform (Scotland) Act 2004 (asp 7), Schedule 1, paragraph 1(2); the Smoking, Health and Social Care (Scotland) Act 2005 (asp 13), Schedule 2, paragraph 2(2); and the Health Boards (Membership and Elections) (Scotland) Act 2009 (asp 5), section 2(1).

[^f00016]: Section 25 has been amended by: the Health and Social Care Act 2008 (c. 14), section 113, Schedule 10, paragraph 17, and Schedule 15, Part 2; and by S.I. 2010/231.

[^f00017]: 2006 c. 42.

[^f00018]: Section 134(2) has been amended by the Health Act 2009 (c. 21), Schedule 1, paragraph 8.

[^f00019]: S.I. 2006/552.

[^f00020]: S.I. 2004/585; regulation 3 has been amended by S.I. 2008/1187.

[^f00021]: Section 159 has been amended by S.I. 2010/22.

[^f00022]: S.I. 2011/2237.

[^f00023]: S.I. 2005/2414.

[^f00024]: The British Pharmacopoeia Commission was originally established by S.I. 1970/1256 and is at 151 Buckingham Palace Road, London SW1 9SZ.

[^f00025]: S.I. 2002/253; amended by S.I. 2009/1182.

[^f00026]: 1989 c.44; amended by S.I. 2005/848.

[^f00027]: 2007 c.28.

[^f00028]: S.I. 2004/906. See regulation 2(2) of those Regulations.

[^f00029]: S.I. 1976/1213 (N.I. 22).

[^f00030]: Section 72A was inserted by the Health Act 2006 (c. 28), section 30, and has been amended by S.I. 2006/2407.

[^f00031]: S.I. 2004/627.

[^f00032]: S.I. 2004/629.

[^f00033]: Paragraph 42 has been amended by S.I. 2005/893 and 2009/2230.

[^f00034]: Schedule 2 has been amended by S.I. 2004/3215, 2009/2230, 2010/2389 and 2011/680.

[^f00035]: 2010 c. 15.

[^f00036]: 2009 c. 1 (N.I.).

[^f00037]: S.I. 2003/2382.

[^f00038]: Prior to its repeal, regulation 35 was amended by S.I. 2005/1501.

[^f00039]: S.I. 1992/664. These Regulations, together with the amendments to them, are revoked by paragraph 1 of Schedule 8.

[^f00040]: Schedule 2 has been amended by S.I. 2004/3215, 2009/2230, 2010/2389 and 2011/680.

[^f00041]: Section 71 was substituted by the Health Act 2006 (c. 28), section 28, and has been subsequently amended by S.I. 2007/3101 and 2010/231.

[^f00042]: S.I. 2002/254; article 5 has been amended by S.I. 2009/1182. This Order was so renamed by section 213(4) and (6) of the Health and Social Care Act 2012 (c. 7).

[^f00043]: Inserted by the Health Act 2009 (c. 21), section 25.

[^f00044]: Section 129(2) has been amended by the Health Act 2009 (c. 21), section 26(2).

[^f00045]: 2007 c.28.

[^f00046]: 2010 c. 15.

[^f00047]: S.I. 2008/915.

[^f00048]: Section 129(2A) was inserted by the Health Act 2009 (c. 21), section 26(3).

[^f00049]: Section 129(2A) was inserted by the Health Act 2009 (c. 21), section 26(3).

[^f00050]: Section 129(2B) was inserted by the Health Act 2009 (c. 21), section 26(3).

[^f00051]: Section 129(2B) was inserted by the Health Act 2009 (c. 21), section 26(3).

[^f00052]: Section 129(2B) was inserted by the Health Act 2009 (c. 21), section 26(3).

[^f00053]: Section 129(2A) and (2B) were inserted by the Health Act 2009 (c. 21), section 26(3).

[^f00054]: Prior to its repeal, the heading of regulation 13 was amended by S.I. 2009/2205.

[^f00055]: Prior to its repeal, regulation 16 was amended by S.I. 2005/1501.

[^f00056]: Prior to their repeal, regulations 6 and 7 were both amended by S.I. 2005/1501 and 2006/3373.

[^f00057]: Section 129(2A) and (2B) were inserted by the Health Act 2009 (c. 21), section 26(3).

[^f00058]: Section 129(2A) and (2B) were inserted by the Health Act 2009 (c. 21), section 26(3).

[^f00059]: Section 129(2A) and (2B) were inserted by the Health Act 2009 (c. 21), section 26(3).

[^f00060]: S.I. 2002/2016.

[^f00061]: S.I. 2006/552.

[^f00062]: Section 129(2A) and (2B) were inserted by the Health Act 2009 (c. 21), section 26(3).

[^f00063]: Regulation 4 has been amended by S.I. 2009/599 and 2010/914.

[^f00064]: 2003 c. 42.

[^f00065]: S.I. 2008/2699 (L 16); see rule 19 of those Rules.

[^f00066]: Prior to its repeal, regulation 18ZA was inserted by S.I. 2005/1501.

[^f00067]: Prior to its repeal, regulation 20 was amended by S.I. 2006/552.

[^f00068]: S.I. 2008/915.

[^f00069]: Prior to its repeal, regulation 18(2) was amended by S.I. 2005/1501 and 2010/914.

[^f00070]: Prior to its repeal, regulation 65 was amended by S.I. 2006/3373.

[^f00071]: Prior to its repeal, regulation 20 was amended by S.I. 2006/552.

[^f00072]: Prior to its repeal, regulation 14 was amended by S.I. 2006/3373.

[^f00073]: Section 72 has been amended by: the Insolvency Act 1985 (c. 65), Schedule 8, paragraph 15; the Insolvency Act 1986 (c. 45), Schedule 14; the Adults with Incapacity (Scotland) Act 2000 (asp 4), Schedule 5, paragraph 12, and Schedule 6; the Mental Incapacity Act 2005 (c. 9), Schedule 6, paragraph 14; the Health Act 2006 (c. 28), section 29; and S.I. 1989/ 2405, 2007/289 and 2010/231

[^f00074]: Section 154 has been amended by S.I. 2010/22.

[^f00075]: S.I. 2008/2699 (L 16); see rule 19 of those Rules.

[^f00076]: Section 158 has been amended by S.I. 2010/22.

[^f00077]: S.I. 2008/2699 (L 16); see rule 19 of those Rules.

[^f00078]: Section 157 has been amended by S.I. 2010/22.

[^f00079]: Sections 154 and 155 have been amended by S.I. 2010/22.

[^f00080]: Section 157 has been amended by S.I. 2010/22.

[^f00081]: Section 158 has been amended by S.I. 2010/22.

[^f00082]: See rule 19 of those Rules.

[^f00083]: Sections 154 and 155 have been amended by S.I. 2010/22.

[^f00084]: 2003 c. 42.

[^f00085]: Section 159 has been amended by S.I. 2010/22.

[^f00086]: Sections 154 and 155 have been amended by S.I. 2010/22.

[^f00087]: Section 164 has been amended by the Health and Social Care Act 2008 (c. 14), section 141(1), and Schedule 15, Part 4.

[^f00088]: Section 164 has been amended by the Health and Social Care Act 2008 (c. 14), section 141(1), and Schedule 15, Part 4.

[^f00089]: Section 164 has been amended by the Health and Social Care Act 2008 (c. 14), section 141(1), and Schedule 15, Part 4.

[^f00090]: Regulation 10 has been amended by S.I. 2000/3189, 2002/2352 and 2004/696.

[^f00091]: 1989 c. 41.

[^f00092]: Section 69 has been amended by the Statute Law (Repeals) Act 1993 (c. 50), Schedule 1, Part 12, and by S.I. 1976/1213, 2007/289 and 3101 and 2010/231.

[^f00093]: 1995 c. 46. Section 302 has been amended by: the Communications Act 2003 (c. 21), Schedule 17, paragraph 133; the Wireless Telegraphy Act 2006 (c. 36), Schedule 7, paragraph 16; and the Criminal Proceedings etc. (Reform) (Scotland) Act 2007 (asp 6), section 50(1).

[^f00094]: 1992 c. 5. Section 115A was inserted by the Social Security Administration (Fraud) Act 1997 (c. 47), section 15, and has been amended by the Social Security Fraud Act 2001 (c. 11), section 14.

[^f00095]: Amended by S.I. 1968/1699 and 2010/231.

[^f00096]: Section 129(2A) and (2B) were inserted by the Health Act 2006 (c. 21), section 26(3).

[^f00097]: Schedule 2 has been amended by S.I. 2004/3215, 2009/2230, 2010/2389 and 2011/680.

[^f00098]: 1971 c.38; see section 2(1)(a) of that Act, which defines “controlled drug” for the purposes of that Act.

[^f00099]: S.I. 2001/3998. Schedule 4 has been amended by S.I. 2003/1432, 2005/3372, 2007/2154 and 2009/3136, and Schedule 5 has been amended by S.I. 2005/2864.

[^f00100]: Regulation 3 has been amended by S.I. 2002/2352, 2003/1084, 2004/865, 2005/578, 2008/571, 2009/411, 2010/1727 and 2011/518.

[^f00101]: Regulation 7 has been amended by S.I. 2000/3189, 2002/2352, 2004/696, 2005/578 and 2009/29.

[^f00102]: Regulation 5 has been amended by S.I. 2004/663 and 936, 2006/562, 2008/1697 and 2009/411.

[^f00103]: 1985 c.72.

[^f00104]: Established by S.I. 2007/478.

[^f00105]: 2010 c. 15.

[^f00106]: The Medicines and Healthcare Products Regulatory Agency, which is an executive agency of the Department of Health, issues safety advice, warnings, alerts and recalls in respect of medical devices on behalf of the Secretary of State, and also safety advice, warnings, alerts and recalls in respect of medicines on behalf of the Secretary of State and the Minister for Health, Social Services and Public Safety, acting jointly. The Department of Health also, separately, issues other communications concerning patient safety, on behalf of the Secretary of State.

[^f00107]: 2006 c. 47; section 59 has been amended by: the Education and Skills Act 2008 (c. 25), section 147(8); the Health Act 2009 (c. 21), Schedule 1, paragraphs 12 and 15, and Schedule 6; and S.I. 2008/912.

[^f00108]: 1974 c. 37.

[^f00109]: 1996 c. 18; section 43A was inserted by the Public Interest Disclosure Act 1998 (c. 23), section 1. See also section 43K(1)(c) (i) of the Employment Rights Act 1996 (inserted by the Public Interest Disclosure Act 1998, section 1, and amended by: the National Health Service Reform and Health Care Professions Act 2002 (c. 17), Schedule 2, paragraph 63; the National Health Service (Consequential Provisions) Act 2006 (c. 43), Schedule 1, paragraphs 177 and 178(b); and S.I. 2007/961), which extends the meaning of “worker” for the Part of that Act that deals with protected disclosures so that it covers all individuals who provide pharmaceutical services in accordance with arrangements made by a Primary Care Trust under section 126 of the National Health Service Act 2006.

[^f00110]: 1995 c. 46. Section 302 has been amended by: the Communications Act 2003 (c. 21), Schedule 17, paragraph 133; the Wireless Telegraphy Act 2006 (c. 36), Schedule 7, paragraph 16; and the Criminal Proceedings etc. (Reform) (Scotland) Act 2007 (asp 6), section 50(1).

[^f00111]: 1992 c. 5. Section 115A was inserted by the Social Security Administration (Fraud) Act 1997 (c. 47), section 15, and has been amended by the Social Security Fraud Act 2001 (c. 11), section 14.

[^f00112]: S.I. 2009/309; amended by S.I. 2009/1768.

[^f00113]: Regulation 3 has been amended by S.I. 2002/2352, 2003/1084, 2004/865, 2005/578, 2008/571, 2009/411, 2010/1727 and 2011/518.

[^f00114]: Regulation 7 has been amended by S.I. 2000/3189, 2002/2352, 2004/696, 2005/578 and 2009/29.

[^f00115]: Regulation 5 has been amended by S.I. 2004/663 and 936, 2006/562, 2008/1697 and 2009/411.

[^f00116]: 1985 c. 72.

[^f00117]: Established by S.I. 2007/478.

[^f00118]: 2010 c. 15.

[^f00119]: 1974 c. 37.

[^f00120]: 1995 c. 46. Section 302 has been amended by: the Communications Act 2003 (c. 21), Schedule 17, paragraph 133; the Wireless Telegraphy Act 2006 (c. 36), Schedule 7, paragraph 16; and the Criminal Proceedings etc. (Reform) (Scotland) Act 2007 (asp 6), section 50(1).

[^f00121]: 1992 c. 5. Section 115A was inserted by the Social Security Administration (Fraud) Act 1997 (c. 47), section 15, and has been amended by the Social Security Fraud Act 2001 (c. 11), section 14.

[^f00122]: S.I. 2009/309; amended by S.I. 2009/1768.

[^f00123]: Schedule 2 has been amended by S.I. 2004/3215, 2009/2230, 2010/2389 and 2011/680.

[^f00124]: 1971 c.38; see section 2(1)(a) of that Act, which defines “controlled drug” for the purposes of that Act.

[^f00125]: S.I. 2001/3998. Schedule 4 has been amended by S.I. 2003/1432, 2005/3372, 2007/2154 and 2009/3136, and Schedule 5 has been amended by S.I. 2005/2864.

[^f00126]: Paragraph 39 has been amended by S.I. 2005/893, 2007/3491 and 2009/2230.