
2012 No. 1909
National Health Service, England
The National Health Service (Pharmaceutical Services) Regulations 2012 (revoked)
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
Regulation 4(1)
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
Regulation 10(6)
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
Regs 10(7), 45(3), 63(6), 77(4), 98(9)
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 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Notification of decisions and subsequent action by the Primary Care Trust
10 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Effect of decisions by the Secretary of State
11 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SCHEDULE 4
Terms of service of NHS pharmacists
Regulation 11(1)(a)(i)
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
Regulation 11(2)(a)(i)
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
Regulation 47(1)(a)(i)
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
Regulation 103
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
Regulation 104
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 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .