2013 No. 898 (W.102)

NATIONAL HEALTH SERVICE, WALES

The National Health Service (Pharmaceutical Services) (Wales) Regulations 2013 (revoked)F1

Made

Laid before the National Assembly for Wales

Coming into force

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Annotations:
Amendments (Textual)
F1

Regulations revoked (1.10.2020 for the revocation of Pts. 1-3, 7, 8; 31.2.2021 for the revocation of regs. 8(1), 20; and 1.10.2021 in so far as not already in force) ) by The National Health Service (Pharmaceutical Services) (Wales) Regulations 2020 (S.I. 2020/1073), reg. 65 (with reg. 63)

F1PART 1Introduction

Title, commencement and applicationF11

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InterpretationF12

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F1PART 2Pharmaceutical lists and dispensing doctor lists

Preparation and maintenance of pharmaceutical listsF13

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Preparation and maintenance of dispensing doctor listsF14

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Terms of serviceF15

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F1PART 3Determination of controlled localities

Areas that are controlled localitiesF16

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Appeals against decisions under Part 3F17

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F1PART 4Applications 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 listF18

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Determination of applications to be included in or for amendment to a pharmaceutical listF19

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Determination of applications to be included in or for amendment to a pharmaceutical list: effect of earlier determinationsF110

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Locations in controlled localities that are reserved locationsF111

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Applications for preliminary consent and effect of preliminary consentF112

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Applications involving minor relocation within a Local Health Board’s areaF113

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Applications involving minor relocation between neighbouring Local Health Board areasF114

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Applications involving temporary relocationF115

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Applications involving a change of ownershipF116

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Procedure following grant of an applicationF117

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Application to extend the relevant periodF118

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AppealsF119

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F1PART 5Applications by doctors for inclusion in or amendment to dispensing doctor lists

Arrangements for the provision of pharmaceutical services by doctorsF120

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Necessary services for temporary patientsF121

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Provision of pharmaceutical services for immediate treatment or personal administrationF122

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Discontinuation of arrangements for the provision of pharmaceutical services by doctorsF123

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Outline consent and premises approvalF124

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Taking effect of outline consent and premises approvalF125

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Lapse of outline consent and premises approvalF126

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Premises approval: change of premises before outline consent takes effectF127

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Premises approval: additional and new premises after outline consent has taken effectF128

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Premises approval: practice amalgamationsF129

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AppealsF130

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F1PART 6Fitness grounds and inclusion in and removal from pharmaceutical lists

Deferral of applications on fitness groundsF131

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Refusal of applications on fitness groundsF132

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Conditional inclusion relating to fitness groundsF133

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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 ActF134

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Removal from a pharmaceutical list for other reasonsF135

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Suspension from a pharmaceutical listF136

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Notification of decision to impose conditionsF137

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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 ActF138

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Review of a decision to impose conditionsF139

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AppealsF140

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F1PART 7Payments to NHS pharmacists and NHS appliance contractors

The Drug Tariff and remuneration of NHS pharmacists and NHS appliance contractorsF141

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Local Health Boards as determining authoritiesF142

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OverpaymentsF143

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Reward schemeF144

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Payments to suspended NHS pharmacists and NHS appliance contractorsF145

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F1PART 8Miscellaneous

Home Local Health BoardF146

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Publication of particularsF147

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Exercise of choice in certain casesF148

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Transitional provisionsF149

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Minor and consequential amendments and revocationsF150

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F1SCHEDULE 1Information to be included in applications to provide pharmaceutical services

Regulations 8, 12, 17, 23, 26 and 27

F1PART 1Application for inclusion in or for amendment to a pharmaceutical list

F1Information required from all applicants

Details of the application

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F12

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F13

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Details of the applicant

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F15

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F16

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Details of the premises and opening hours

F17

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F18

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F19

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Pharmaceutical services to be provided

F110

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F111

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F112

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Information relating to the necessary or expedient testF113

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Information relating to the prejudice testF114

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Information relating to applications involving relocations

F115

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F116

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F117

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F118

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Information relating to applications involving a change of ownership

F119

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F120

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Applicant’s undertakingF121

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F1PART 2Information and undertakings for applications for inclusion in a pharmaceutical list

Applicant’s detailsF122

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Investigations, proceedings and convictions

F123

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F124

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Pharmaceutical qualifications, referees etc.

F125

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F126

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F127

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F128

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F129

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UndertakingsF130

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F1PART 3Notification of commencement date

Information to be provided prior to the commencement of the provision of pharmaceutical servicesF131

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F1PART 4Applications for outline consent and premises approval

Details of the application

F132

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F133

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Details of the applicant

F134

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F135

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Application for outline consent

F136

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F137

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Application for premises approval

F138

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F139

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F140

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F141

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F142

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F143

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Pharmaceutical services to be providedF144

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Prejudice testF145

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Necessary or expedientF146

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Applicant’s undertakingF147

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F1SCHEDULE 2Procedures to be followed by Local Health Boards to determine applications under the Regulations

Regulations 6, 8 and 24

F1PART 1Preliminary matters

General principlesF11

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Timetable for determining applicationsF12

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Persons prohibited from taking part in decision-making on applicationsF13

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F1PART 2Determination of controlled localities

Notice of proposed determination in respect of controlled localitiesF14

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Deferral of applicationsF15

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Imposition of conditionsF16

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Notification of determinations and action following determinationsF17

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F1PART 3Applications for inclusion in or amendment to pharmaceutical lists and dispensing doctor lists

Notice of certain applicationsF18

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Persons and bodies to be notifiedF19

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Content of notificationsF110

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Oral hearingsF111

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Information to which a Local Health Board must have regardF112

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Imposition of conditionsF113

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Notification of decisions: applications for inclusion in or amendment to pharmaceutical listsF114

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Notification of decisions: applications for inclusion in or amendment to dispensing doctor listsF115

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Notification of decisions: applications under regulation 18 for extension of the relevant periodF116

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Notification of decisions: applications under regulation 11(2)F117

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Action following determination in respect of reserved locationsF118

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F1SCHEDULE 3Appeals to the Welsh Ministers

Regulations 7, 19 and 30

F1PART 1Preliminary matters

General principlesF11

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Oral hearingsF12

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F1PART 2Appeals against decisions determining controlled localities

Right of appeal to the Welsh MinistersF13

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Notification of appealsF14

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Decision on appealsF15

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F1PART 3Appeals against decisions for inclusion in or amendment to pharmaceutical lists and dispensing doctor lists

Right of appeal to the Welsh MinistersF16

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Notification of appealsF17

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Decision on appealsF18

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Effect of decisions by the Welsh MinistersF19

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F1SCHEDULE 4Terms of service for NHS pharmacists who provide pharmaceutical services in particular by the provision of drugs

Regulation 5

F1PART 1General

InterpretationF11

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Incorporation of provisionsF12

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F1PART 2Essential Services

Essential servicesF13

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Dispensing servicesF14

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Dispensing of drugs and appliancesF15

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Supply in accordance with a SSPF15A

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Urgent supply without a prescriptionF16

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Preliminary matters before providing ordered drugs or appliancesF17

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Providing ordered drugs or appliancesF18

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Refusal to provide drugs or appliances orderedF19

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Further activities to be carried out in connection with the provision of dispensing servicesF110

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Additional requirements in relation to specified appliancesF111

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Disposal service in respect of unwanted drugsF112

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Basic procedure in respect of unwanted drugsF113

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Further activities to be carried out in connection with the disposal of unwanted drugsF114

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Promotion of healthy lifestylesF115

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Prescription linked interventionF116

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Public health campaignsF117

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SignpostingF118

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Service outline in respect of signpostingF119

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Support for self-careF120

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Service outline in respect of support for self-careF121

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F1PART 3Pharmacy Opening Hours

Pharmacy opening hours: generalF122

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Matters to be considered when issuing directions in respect of pharmacy opening hoursF123

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Determination of pharmacy opening hours instigated by the Local Health BoardF124

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Determination of pharmacy opening hours instigated by the NHS pharmacistF125

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Temporary opening hours and closures during an emergency requiring the flexible provision of pharmaceutical servicesF126

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F1PART 4Clinical Governance and Complaints

Clinical governanceF127

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Professional standardsF128

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InducementsF129

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Duty to provide information about fitness to practise matters: NHS pharmacists on pharmaceutical lists on 10 May 2013F130

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Duty to provide information about fitness matters as they ariseF131

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Home Local Health Board of bodies corporateF132

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ComplaintsF133

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F1PART 5Other terms of service

Directed servicesF134

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Information to be suppliedF135

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Welsh LanguageF135A

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Withdrawal from pharmaceutical listsF136

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Charges for drugs and refundsF137

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Inspections and access to informationF138

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F1SCHEDULE 5Terms of service for NHS appliance contractors who provide pharmaceutical services only by the provision of appliances

Regulation 5

Incorporation of provisionsF11

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Division of responsibilities between individuals and corporate bodiesF12

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Dispensing servicesF13

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Dispensing of appliancesF14

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

Supply in accordance with a SSPF14A

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

Urgent supply without a prescriptionF15

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

Preliminary matters before providing appliancesF16

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

Providing appliancesF17

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

Refusal to provide appliances orderedF18

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

Further activities to be carried out in connection with the provision of dispensing servicesF19

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

Additional requirements in relation to specified appliancesF110

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

SignpostingF111

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Opening hours: generalF112

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

Matters to be considered when issuing directions in respect of opening hoursF113

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

Determination of opening hours instigated by the Local Health BoardF114

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

Determination of opening hours instigated by the NHS appliance contractorF115

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

Clinical governanceF116

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

Professional StandardsF117

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

InducementsF118

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

Duty to provide information about fitness to practise matters as they ariseF119

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

Home Local Health Board of bodies corporateF120

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

ComplaintsF121

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

Directed ServicesF122

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

Information to be suppliedF123

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Welsh LanguageF123A

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Withdrawal from pharmaceutical listsF124

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Charges for appliancesF125

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Inspections and access to informationF126

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F1SCHEDULE 6Terms of service for doctors providing pharmaceutical services

Regulation 5

InterpretationF11

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Incorporation of provisionsF12

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

Persons duly authorised to dispense on behalf of dispensing doctorsF13

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

Dispensing of drugs and appliances ordered by another prescriberF14

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

Dispensing of drugs and appliances ordered by the dispensing doctorF15

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

Preliminary matters before providing ordered drugs or appliancesF16

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

Provision of Scheduled drugsF17

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Refusal to provide drugs or appliances orderedF18

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

Fees and chargesF19

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

Complaints and concernsF110

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

Inspections and access to informationF111

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

Welsh LanguageF112

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F1SCHEDULE 7Minor and consequential amendments

Regulation 50

The National Health Service (Service Committees and Tribunal) Regulations 1992F11

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The National Health Service (Indicative Amounts) Regulations 1997F12

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The National Health Service (Payments by Local Authorities to Health Authorities) (Prescribed Functions) (Wales) Regulations 2001F13

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

The National Health Service (General Medical Services Contracts) (Wales) Regulations 2004F14

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

The National Health Service (Free Prescriptions and Charges for Drugs and Appliances) (Wales) Regulations 2007F15

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

The Single Use Carrier Bags Charge (Wales) Regulations 2010F16

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F1SCHEDULE 8

Regulation 50

Revocations

F11

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F12

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F13

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F14

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F15

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F16

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F17

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F18

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F19

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F110

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F111

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F112

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F113

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F114

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F115

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F116

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F117

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F118

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F119

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F120

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F121

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F122

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F123

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F124

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F125

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F1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .