The National Health Service (Pharmaceutical Services) Regulations 2012

Made: 18th July 2012

Laid before Parliament: 23rd July 2012

Coming into force: 1st September 2012

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

PART 1 — Introductory

Citation and commencement

1

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

Interpretation

2

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

PART 2 — Pharmaceutical needs assessments

Pharmaceutical needs assessments

3

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

Information to be contained in pharmaceutical needs assessments

4

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

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

5

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

Subsequent assessments

6

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

Temporary extension of pharmaceutical needs assessments

7

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

Consultation on pharmaceutical needs assessments

8

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

Matters for consideration when making assessments

9

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

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

Pharmaceutical lists and EPS lists

10

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

Terms of service of NHS chemists: general

11

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

Routine applications for inclusion in or amendment to a pharmaceutical list

12

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

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

13

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

Current needs: consequences of additional matters

14

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

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

15

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

Future needs: consequences of additional matters

16

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

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

17

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

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

18

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

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

19

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

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

20

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

Future improvements or better access: consequences of additional matters

21

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

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

22

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

PART 4 — Excepted applications

Applications from NHS chemists in respect of providing directed services

23

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

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

24

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

Distance selling premises applications

25

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

Change of ownership applications

26

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

Applications for temporary listings arising out of suspensions

27

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

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

28

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

Applications relating to emergencies requiring the flexible provision of pharmaceutical services

29

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

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

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

Refusal: same or adjacent premises

31

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

Deferrals arising out of LPS designations

32

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

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

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

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

34

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

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

35

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

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

Determination that an area is a controlled locality

36

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

Process for determining controlled localities: preliminary matters

37

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

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

38

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

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

39

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

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

40

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

Applications for new pharmacy premises in controlled localities: reserved locations

41

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

Second and subsequent determinations of reserved location status

42

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

Determinations of reserved locations: supplemental matters

43

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

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

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

Appeals against decisions under Part 7

45

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

PART 8 — Dispensing doctors

Dispensing doctor lists

46

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

Terms of service of dispensing doctors: general

47

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

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

48

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

Necessary services for temporary patients

49

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

Discontinuation of arrangements for the provision of pharmaceutical services by doctors

50

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

Outline consent and premises approval: applications by doctors

51

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

Notification of applications for outline consent and premises approval

52

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

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

53

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

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

54

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

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

55

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

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

56

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

Gradual introduction of premises approval

57

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

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

58

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

Practice amalgamations

59

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

Lapse of outline consent and premises approval

60

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

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

61

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

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

62

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

Appeals against decisions under Part 8

63

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

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

Distance selling premises: specific conditions

64

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

Core opening hours conditions

65

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

Conditions relating to providing directed services

66

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

Conditions relating to voluntary closure of premises

67

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

Conditions relating to local resolution of disputes over terms of service

68

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

PART 10 — Performance related sanctions and market exit

Local dispute resolution before serving remedial notices or breach notices

69

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

Breaches of terms of service: remedial notices

70

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

Breaches of terms of service: breach notices

71

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

Payment withholdings: supplementary matters

72

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

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

73

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

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

74

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

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

75

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