The National Health Service (Pharmaceutical Services) (Wales) Regulations 2013
Made: 17 April 2013
Laid before the National Assembly for Wales: 18 April 2013
Coming into force: 10 May 2013
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PART 1 — Introduction
Title, commencement and application
1
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Interpretation
2
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PART 2 — Pharmaceutical lists and dispensing doctor lists
Preparation and maintenance of pharmaceutical lists
3
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Preparation and maintenance of dispensing doctor lists
4
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Terms of service
5
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PART 3 — Determination of controlled localities
Areas that are controlled localities
6
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Appeals against decisions under Part 3
7
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PART 4 — Applications by NHS pharmacists and NHS appliance contractors for inclusion in or amendment to pharmaceutical lists
Applications to be included in or for amendment to a pharmaceutical list
8
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Determination of applications to be included in or for amendment to a pharmaceutical list
9
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Determination of applications to be included in or for amendment to a pharmaceutical list: effect of earlier determinations
10
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Locations in controlled localities that are reserved locations
11
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Applications for preliminary consent and effect of preliminary consent
12
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Applications involving minor relocation within a Local Health Board’s area
13
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Applications involving minor relocation between neighbouring Local Health Board areas
14
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Applications involving temporary relocation
15
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Applications involving a change of ownership
16
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Procedure following grant of an application
17
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Application to extend the relevant period
18
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Appeals
19
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PART 5 — Applications by doctors for inclusion in or amendment to dispensing doctor lists
Arrangements for the provision of pharmaceutical services by doctors
20
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Necessary services for temporary patients
21
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Provision of pharmaceutical services for immediate treatment or personal administration
22
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Discontinuation of arrangements for the provision of pharmaceutical services by doctors
23
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Outline consent and premises approval
24
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Taking effect of outline consent and premises approval
25
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Lapse of outline consent and premises approval
26
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Premises approval: change of premises before outline consent takes effect
27
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Premises approval: additional and new premises after outline consent has taken effect
28
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Premises approval: practice amalgamations
29
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Appeals
30
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PART 6 — Fitness grounds and inclusion in and removal from pharmaceutical lists
Deferral of applications on fitness grounds
31
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Refusal of applications on fitness grounds
32
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Conditional inclusion relating to fitness grounds
33
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Removal from a pharmaceutical list for breach of conditions on fitness grounds or imposition or variation or imposition of new conditions under section 108 of the 2006 Act
34
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Removal from a pharmaceutical list for other reasons
35
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Suspension from a pharmaceutical list
36
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Notification of decision to impose conditions
37
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Review of decision to impose a suspension under section 110 of the 2006 Act or a contingent removal under section 108 of the 2006 Act
38
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Review of a decision to impose conditions
39
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Appeals
40
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PART 7 — Payments to NHS pharmacists and NHS appliance contractors
The Drug Tariff and remuneration of NHS pharmacists and NHS appliance contractors
41
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Local Health Boards as determining authorities
42
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Overpayments
43
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Reward scheme
44
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Payments to suspended NHS pharmacists and NHS appliance contractors
45
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PART 8 — Miscellaneous
Home Local Health Board
46
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Publication of particulars
47
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Exercise of choice in certain cases
48
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Transitional provisions
49
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Minor and consequential amendments and revocations
50
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SCHEDULE 1 — Information to be included in applications to provide pharmaceutical services
PART 1 — Application for inclusion in or for amendment to a pharmaceutical list
Information required from all applicants
Details of the application
1
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2
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3
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Details of the applicant
4
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5
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6
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Details of the premises and opening hours
7
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8
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9
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Pharmaceutical services to be provided
10
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11
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12
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Information relating to the necessary or expedient test
13
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Information relating to the prejudice test
14
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Information relating to applications involving relocations
15
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16
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17
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18
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Information relating to applications involving a change of ownership
19
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20
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Applicant’s undertaking
21
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PART 2 — Information and undertakings for applications for inclusion in a pharmaceutical list
Applicant’s details
22
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Investigations, proceedings and convictions
23
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24
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Pharmaceutical qualifications, referees etc.
25
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26
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27
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28
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29
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Undertakings
30
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PART 3 — Notification of commencement date
Information to be provided prior to the commencement of the provision of pharmaceutical services
31
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PART 4 — Applications for outline consent and premises approval
Details of the application
32
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33
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Details of the applicant
34
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35
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Application for outline consent
36
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37
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Application for premises approval
38
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39
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40
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41
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42
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43
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Pharmaceutical services to be provided
44
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Prejudice test
45
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Necessary or expedient
46
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Applicant’s undertaking
47
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SCHEDULE 2 — Procedures to be followed by Local Health Boards to determine applications under the Regulations
PART 1 — Preliminary matters
General principles
1
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Timetable for determining applications
2
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Persons prohibited from taking part in decision-making on applications
3
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PART 2 — Determination of controlled localities
Notice of proposed determination in respect of controlled localities
4
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Deferral of applications
5
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Imposition of conditions
6
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Notification of determinations and action following determinations
7
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PART 3 — Applications for inclusion in or amendment to pharmaceutical lists and dispensing doctor lists
Notice of certain applications
8
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Persons and bodies to be notified
9
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Content of notifications
10
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Oral hearings
11
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Information to which a Local Health Board must have regard
12
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Imposition of conditions
13
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Notification of decisions: applications for inclusion in or amendment to pharmaceutical lists
14
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Notification of decisions: applications for inclusion in or amendment to dispensing doctor lists
15
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Notification of decisions: applications under regulation 18 for extension of the relevant period
16
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Notification of decisions: applications under regulation 11(2)
17
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Action following determination in respect of reserved locations
18
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SCHEDULE 3 — Appeals to the Welsh Ministers
PART 1 — Preliminary matters
General principles
1
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Oral hearings
2
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PART 2 — Appeals against decisions determining controlled localities
Right of appeal to the Welsh Ministers
3
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Notification of appeals
4
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Decision on appeals
5
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PART 3 — Appeals against decisions for inclusion in or amendment to pharmaceutical lists and dispensing doctor lists
Right of appeal to the Welsh Ministers
6
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Notification of appeals
7
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Decision on appeals
8
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Effect of decisions by the Welsh Ministers
9
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SCHEDULE 4 — Terms of service for NHS pharmacists who provide pharmaceutical services in particular by the provision of drugs
PART 1 — General
Interpretation
1
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Incorporation of provisions
2
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PART 2 — Essential Services
Essential services
3
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Dispensing services
4
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Dispensing of drugs and appliances
5
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Urgent supply without a prescription
6
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Preliminary matters before providing ordered drugs or appliances
7
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Providing ordered drugs or appliances
8
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Refusal to provide drugs or appliances ordered
9
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Further activities to be carried out in connection with the provision of dispensing services
10
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Additional requirements in relation to specified appliances
11
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Disposal service in respect of unwanted drugs
12
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Basic procedure in respect of unwanted drugs
13
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Further activities to be carried out in connection with the disposal of unwanted drugs
14
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Promotion of healthy lifestyles
15
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Prescription linked intervention
16
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Public health campaigns
17
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Signposting
18
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Service outline in respect of signposting
19
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