The National Health Service (Pharmaceutical Services) Regulations 2012
PART 1Introductory
1Citation and commencement
2Interpretation
PART 2Pharmaceutical needs assessments
3Pharmaceutical needs assessments
4Information to be contained in pharmaceutical needs assessments
5Date by which the first pharmaceutical needs assessment is to be published
6Subsequent assessments
7Temporary extension of pharmaceutical needs assessments
8Consultation on pharmaceutical needs assessments
9Matters for consideration when making assessments
PART 3General matters relating to pharmaceutical lists and applications in respect of them
10Pharmaceutical lists and EPS lists
11Terms of service of NHS chemists: general
12Routine applications for inclusion in or amendment to a pharmaceutical list
13Current needs: additional matters to which the Primary Care Trust must have regard
14Current needs: consequences of additional matters
15Future needs: additional matters to which the Primary Care Trust must have regard
16Future needs: consequences of additional matters
17Improvements or better access in the pharmaceutical needs assessment: additional matters to which the Primary Care Trust must have regard
18Unforeseen benefits applications: additional matters to which the Primary Care Trust must have regard
19Applications to which regulation 17 or 18 applies: consequences of additional matters
20Future improvements or better access: additional matters to which the Primary Care Trust must have regard
21Future improvements or better access: consequences of additional matters
22Refusal of routine applications that are based on neither a pharmaceutical needs assessment nor unforeseen benefits
PART 4Excepted applications
23Applications from NHS chemists in respect of providing directed services
24Relocations that do not result in significant change to pharmaceutical services provision
25Distance selling premises applications
26Change of ownership applications
27Applications for temporary listings arising out of suspensions
28Applications from persons exercising a right of return to a pharmaceutical list
29Applications relating to emergencies requiring the flexible provision of pharmaceutical services
PART 5Specific grounds for refusal or deferral of applications under Parts 3 and 4 which are not linked to fitness grounds
30Refusal: language requirement for some NHS pharmacists
31Refusal: same or adjacent premises
32Deferrals arising out of LPS designations
PART 6Refusal, deferral and conditional inclusion in pharmaceutical lists of chemists on fitness grounds
33Refusal of applications for inclusion in a pharmaceutical list on fitness grounds
34Deferral of consideration of applications for inclusion in a pharmaceutical list on fitness grounds
35Granting applications for inclusion in a pharmaceutical list subject to efficiency conditions and conditions to combat fraud
PART 7Areas that are controlled localities and reserved locations, and new pharmacies within them
36Determination that an area is a controlled locality
37Process for determining controlled localities: preliminary matters
38Process for determining controlled localities: local notification and deferment of routine applications
39Process of determining controlled localities: formulation of the Primary Care Trust’s decision
40Applications for new pharmacy premises in controlled localities: refusals because of preliminary matters
41Applications for new pharmacy premises in controlled localities: reserved locations
42Second and subsequent determinations of reserved location status
43Determinations of reserved locations: supplemental matters
44Prejudice test in respect of routine applications for new pharmacy premises in a part of a controlled locality that is not a reserved location
45Appeals against decisions under Part 7
PART 8Dispensing doctors
46Dispensing doctor lists
47Terms of service of dispensing doctors: general
48Arrangements for the provision of pharmaceutical services by doctors: applications by patients
49Necessary services for temporary patients
50Discontinuation of arrangements for the provision of pharmaceutical services by doctors
51Outline consent and premises approval: applications by doctors
52Notification of applications for outline consent and premises approval
53Decisions on outline consent and premises approval applications and the taking effect of grants
54Premises approval: relocations of practice premises which are not significant before outline consent takes effect
55Premises approval: relocations of practice premises which are not significant after outline consent has taken effect
56Taking effect of premises approval where there is no related application for outline consent
57Gradual introduction of premises approval
58Temporary provision in cases of relocations or additional premises where premises approval has not taken effect
59Practice amalgamations
60Lapse of outline consent and premises approval
61Temporary arrangements during an emergency requiring the flexible provision of pharmaceutical services
62Persons barred from taking part in decision making with regard to applications for outline consent or premises approval
63Appeals against decisions under Part 8
PART 9Conditional inclusion in pharmaceutical lists: certain specific conditions that do not relate to fitness or performance
64Distance selling premises: specific conditions
65Core opening hours conditions
66Conditions relating to providing directed services
67Conditions relating to voluntary closure of premises
68Conditions relating to local resolution of disputes over terms of service
PART 10Performance related sanctions and market exit
69Local dispute resolution before serving remedial notices or breach notices
70Breaches of terms of service: remedial notices
71Breaches of terms of service: breach notices
72Payment withholdings: supplementary matters
73Removal of listings: cases relating to remedial notices and breach notices
74Removal of listings: cases relating to death, incapacity or cessation of service
75Voluntary and automatic removal of listings: change of ownership, relocation, temporary provision and voluntary closure
76Limitation on withdrawal from pharmaceutical lists while fitness investigations or proceedings are ongoing
77Appeals against decisions under Part 10
PART 11Enforcement, reviews and appeals relating to fitness matters
78Extended meaning of “health scheme” in fraud cases
79Review of decisions to impose fitness conditions originally imposed on grants of applications
80Removal for breach of fitness conditions imposed under regulation 35 or 79
81Mandatory removal in suitability cases
82Fitness cases: procedures for removal or contingent removal from pharmaceutical lists
83Procedure for suspensions in fitness cases
84Procedure for reviewing some suspensions and contingent removal conditions
85General power to revoke suspensions in appropriate circumstances
86Evidence of unsuitability, fraud or inefficiency in service provision: specific matters
87Review periods for national disqualifications
88Wider notifications of fitness decisions
PART 12Remuneration, charges and refunds
89The Drug Tariff and section 164: general provisions
90Data to be provided to assist Drug Tariff determinations
91Remuneration in respect of enhanced services
92Dispensing doctor remuneration
93The taking effect of determinations
94Overpayments
95Free supply of drugs, appliances and containers where the drug or appliance is supplied under pharmaceutical services
96Refunds of prescription charges
97Reward scheme
98Payments to suspended chemists
PART 13Miscellaneous
99Sharing of information by home Primary Care Trusts
100Notification by a Primary Care Trust of changes to its pharmaceutical lists
101Proceedings with regard to overridden arrangements during an emergency requiring the flexible provision of pharmaceutical services
102Authorised persons to apply for services
103Transitional provisions
104Amendments and revocations
105Review of these Regulations
SCHEDULE 1Information to be contained in pharmaceutical needs assessments
1Necessary services: current provision
2Necessary services: gaps in provision
3Other relevant services: current provision
4Improvements and better access: gaps in provision
5Other NHS services
6How the assessment was carried out
7Map of provision
SCHEDULE 2Applications in respect of pharmaceutical lists and the procedures to be followed
PART 1Information to be included in routine and excepted applications
1Information to be included in all routine and excepted applications
2Information to be included in all routine and excepted applications for inclusion in a pharmaceutical list
3Fitness information about individuals: routine and excepted applications for inclusion in a pharmaceutical list
4Fitness information about corporate bodies: routine and excepted applications for inclusion in a pharmaceutical list
5Providing fitness information instead to a home Primary Care Trust
6Applications seeking the listing of premises that are already, or are in close proximity to, listed chemist premises
7Additional information to be included with routine applications
8Additional information to be included with excepted applications
9Undertakings
10Nature of details to be supplied
PART 2Preliminary matters
11Relevant information or documentation
12Failure to provide undertakings
13Functions of a home Primary Care Trust in relation to certain applications
14Deferral of notifiable applications prior to notification
15Refusal of notifiable applications prior to notification because of the language requirement for some NHS pharmacists
16Refusal of notifiable applications on fitness grounds prior to notification
17Proposed new pharmacy premises in controlled localities: refusal of routine applications because of preliminary matters prior to notification
PART 3Notification of certain applications
18Applications requiring notifications
19Notification procedure for notifiable applications
20Parallel notifications
21Content of notifications
PART 4Determination and deferral of applications
22Flexibility with regard to determining or deferring applications
23Additional matters for consideration in relation to applications for inclusion in a pharmaceutical list
24Action following deferrals
25Oral hearings
26Persons barred from taking part in decision making on routine and excepted applications
27Timetable for determining applications
PART 5Notification, taking effect of decisions and rights of appeal to the Secretary of State
28Notification of decisions on routine and excepted applications
29Template notice of commencement to be included with a notice of decision
30Third party rights of appeal to the Secretary of State where an application is granted
31Conditional grant of applications where the address of the premises is unknown
32Changes to the premises specified in an application after its grant but before the listing of the premises
33Conditional grant in cases relating to future needs or future improvements or better access
34Taking effect of listing decisions: general
35Notice requiring the commencement of pharmaceutical services
36Appeals to the Secretary of State by the applicant
SCHEDULE 3Appeals to the Secretary of State
PART 1Preliminary matters
1Determination of third party appeal rights in certain cases
2Misconceived appeals
PART 2Notification of appeals
3Notification of appeals notices under paragraph 30, 32(5) or 36 of Schedule 2
4Notification of appeals relating to notices under regulation 45
5Notification of appeals relating to decisions under Part 8 of these Regulations
6Non notification of appeals relating to notices under regulation 77 or 98
PART 3Determination of appeals
7Flexibility with regard to the manner of determining appeals
8Oral hearings
9Decisions of the Secretary of State
10Notification of decisions and subsequent action by the Primary Care Trust
11Effect of decisions by the Secretary of State
SCHEDULE 4Terms of service of NHS pharmacists
PART 1General
1Responsibilities of NHS pharmacists and pharmacy staff
2Breaches by directors and superintendents
PART 2Essential services
3Essential services
4Dispensing services
5Dispensing of drugs and appliances
6Urgent supply without a prescription
7Preliminary matters before providing ordered drugs or appliances
8Providing ordered drugs or appliances
9Refusal to provide drugs or appliances ordered
10Further activities to be carried out in connection with the provision of dispensing services
11Additional requirements in relation to electronic prescribing
12Additional requirements in relation to specified appliances
13Disposal service in respect of unwanted drugs
14Basic procedure in respect of unwanted drugs
15Further activities to be carried out in connection with the disposal of unwanted drugs
16Promotion of healthy lifestyles
17Prescription linked intervention
18Public health campaigns
19Signposting
20Service outline in respect of signposting
21Support for self-care
22Service outline in respect of support for self-care
PART 3Hours of opening
23Pharmacy opening hours: general
24Matters to be considered when issuing directions in respect of pharmacy premises core opening hours
25Determination of pharmacy premises core opening hours instigated by the Primary Care Trust
26Determination of pharmacy premises core opening hours instigated by the NHS pharmacist
27Temporary opening hours and closures during an emergency requiring the flexible provision of pharmaceutical services
PART 4Other terms of service
28Clinical governance
29Professional Standards
30Inducements etc.
31Duty to provide information about fitness matters as they arise
32Other information to be supplied
33Home Primary Care Trust of bodies corporate
34Complaints
35Inspections and access to information
SCHEDULE 5Terms of service of NHS appliance contractors
1Division of responsibilities between individuals and corporate bodies
2Breaches by directors
3Dispensing services
4Dispensing of appliances
5Urgent supply without a prescription
6Preliminary matters before providing appliances
7Providing appliances
8Refusal to provide appliances ordered
9Further activities to be carried out in connection with the provision of dispensing services
10Additional requirements in relation to electronic prescribing
11Additional requirements in relation to specified appliances
12Signposting
13Opening hours: general
14Matters to be considered when issuing directions in respect of core opening hours
15Determination of core opening hours instigated by the Primary Care Trust
16Determination of core opening hours instigated by the NHS appliance contractor
17Temporary open hours and closures during an emergency requiring the flexible provision of pharmaceutical services
18Clinical governance
19Professional Standards
20Inducements etc.
21Duty to provide information about fitness matters as they arise
22Other information to be supplied
23Home Primary Care Trust of bodies corporate
24Complaints
25Inspections and access to information
SCHEDULE 6Terms of service of dispensing doctors
1Persons duly authorised to dispense on behalf of dispensing doctors
2Dispensing of drugs and appliances ordered by another prescriber
3Dispensing of drugs and appliances ordered by the dispensing doctor
4Preliminary matters before providing ordered drugs or appliances
5Provision of Scheduled drugs
6Refusal to provide drugs or appliances ordered
7Dispensing doctors issuing prescription forms which may be presented to an NHS chemist
8Complaints procedures
9Inspections and access to information
10Voluntary closure of premises
SCHEDULE 7Transitional provisions
1Pharmaceutical needs assessments
2Listing applications: NHS chemists
3Listing applications: dispensing doctors
4Approved retail areas
5Controlled localities
6Reserved locations
7Gradual discontinuation of the provision of pharmaceutical services by doctors
8Gradual introduction of the provision of pharmaceutical services by doctors
9Giving effect to listing decisions taken under the 2005 Regulations
10Dispensing contractor lists
11Continuing matters: periods of time
12Other continuing matters: NHS chemists
13Other continuing matters: dispensing doctors
14Continuing operation of SCAT arrangements
15The application of Group 12 of Schedule 8 to the Value Added Tax Act 1994
16Terms of service for distance selling premises
SCHEDULE 8Amendments and revocations
1Revocation of the National Health Service (Service Committees and Tribunal) Regulations 1992, and of amendments to and measures relating to those Regulations
2Amendment to the National Health Service (Indicative Amounts) Regulations 1997
3Amendment to the National Health Service (Payments by Local Authorities to NHS Bodies) (Prescribed Functions) Regulations 2000
4Amendments to the National Health Service (Charges for Drugs and Appliances) Regulations 2000
5Amendments to the National Health Service (Local Pharmaceutical Services and Pharmaceutical Services) Regulations 2002
6Amendments to the National Health Service (Local Pharmaceutical Services and Pharmaceutical Services) (No. 2) Regulations 2002
7Amendments to the National Health Service (General Medical Services Contracts) Regulations 2004
8Amendments to the National Health Service (Personal Medical Services Agreements) Regulations 2004
9Revocation of the National Health Service (Pharmaceutical Services) Regulations 2005 and of amendments to those Regulations
10Amendments to the National Health Service (Local Pharmaceutical Services etc.) Regulations 2006
11Amendments to the Local Authority Social Services and National Health Service Complaints (England) Regulations 2009

2012 No. 1909

National Health Service, England

The National Health Service (Pharmaceutical Services) Regulations 2012

Made

Laid before Parliament

Coming into force

The Secretary of State makes the following Regulations in exercise of the powers conferred by sections 8, 22, 126, 128A, 129, 130, 132, 148, 150A, 151(5) and (7), 154, 159(9), 160, 162, 163(3), 164, 172, 182 and 272(7) and (8) of the National Health Service Act 20061 and section 37(1) of the Health Act 20092.