
2013 No. 898 (W.102)
NATIONAL HEALTH SERVICE, WALES
The National Health Service (Pharmaceutical Services) (Wales) Regulations 2013 (revoked)
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
Regulations 8, 12, 17, 23, 26 and 27
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
Regulations 6, 8 and 24
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
Regulations 7, 19 and 30
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
Regulation 5
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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Supply in accordance with a SSP
5A. 
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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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Support for self-care
20 
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Service outline in respect of support for self-care
21 
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PART 3 Pharmacy Opening Hours
Pharmacy opening hours: general
22 
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Matters to be considered when issuing directions in respect of pharmacy opening hours
23 
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Determination of pharmacy opening hours instigated by the Local Health Board
24 
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Determination of pharmacy opening hours instigated by the NHS pharmacist
25 
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Temporary opening hours and closures during an emergency requiring the flexible provision of pharmaceutical services
26 
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PART 4 Clinical Governance and Complaints
Clinical governance
27 
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Professional standards
28 
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Inducements
29 
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Duty to provide information about fitness to practise matters: NHS pharmacists on pharmaceutical lists on 10 May 2013
30 
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Duty to provide information about fitness matters as they arise
31 
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Home Local Health Board of bodies corporate
32 
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Complaints
33 
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PART 5 Other terms of service
Directed services
34 
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Information to be supplied
35 
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Welsh Language
35A. 
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Withdrawal from pharmaceutical lists
36 
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Charges for drugs and refunds
37 
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Inspections and access to information
38 
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SCHEDULE 5
Terms of service for NHS appliance contractors who provide pharmaceutical services only by the provision of appliances
Regulation 5
Incorporation of provisions
1 
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Division of responsibilities between individuals and corporate bodies
2 
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Dispensing services
3 
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Dispensing of appliances
4 
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Supply in accordance with a SSP
4A. 
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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 specified appliances
10 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Signposting
11 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Opening hours: general
12 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Matters to be considered when issuing directions in respect of opening hours
13 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Determination of opening hours instigated by the Local Health Board
14 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Determination of opening hours instigated by the NHS appliance contractor
15 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Clinical governance
16 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Professional Standards
17 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inducements
18 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Duty to provide information about fitness to practise matters as they arise
19 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Home Local Health Board of bodies corporate
20 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Complaints
21 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Directed Services
22 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Information to be supplied
23 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Welsh Language
23A. 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Withdrawal from pharmaceutical lists
24 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Charges for appliances
25 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inspections and access to information
26 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SCHEDULE 6
Terms of service for doctors providing pharmaceutical services
Regulation 5
Interpretation
1 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Incorporation of provisions
2 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Persons duly authorised to dispense on behalf of dispensing doctors
3 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Dispensing of drugs and appliances ordered by another prescriber
4 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Dispensing of drugs and appliances ordered by the dispensing doctor
5 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Preliminary matters before providing ordered drugs or appliances
6 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Provision of Scheduled drugs
7 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Refusal to provide drugs or appliances ordered
8 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fees and charges
9 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Complaints and concerns
10 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inspections and access to information
11 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Welsh Language
12. 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SCHEDULE 7
Minor and consequential amendments
Regulation 50
The National Health Service (Service Committees and Tribunal) Regulations 1992
1 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The National Health Service (Indicative Amounts) Regulations 1997
2 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The National Health Service (Payments by Local Authorities to Health Authorities) (Prescribed Functions) (Wales) Regulations 2001
3 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The National Health Service (General Medical Services Contracts) (Wales) Regulations 2004
4 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The National Health Service (Free Prescriptions and Charges for Drugs and Appliances) (Wales) Regulations 2007
5 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The Single Use Carrier Bags Charge (Wales) Regulations 2010
6 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SCHEDULE 8
Regulation 50
Revocations
1 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
9 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
11 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
13 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
14 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
15 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
16 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
17 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
18 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
19 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
20 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
21 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
22 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
23 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
24 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
25 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .