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

W.S.I. 2013/898 · made 17 April 2013 · revised to 1 October 2021

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PDFs: Printed copy https://openlegislation.uk/national-health-service-pharmaceutical-services-wales-regulations-2013-revoked/pdf/wsi_20130898_mi.pdf

## Introductory text

NATIONAL HEALTH SERVICE, WALES
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

## 1 Title, commencement and application

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## 2 Interpretation

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## Part 2: Pharmaceutical lists and dispensing doctor lists

## 3 Preparation and maintenance of pharmaceutical lists

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## 4 Preparation and maintenance of dispensing doctor lists

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## 5 Terms of service

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## Part 3: Determination of controlled localities

## 6 Areas that are controlled localities

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## 7 Appeals against decisions under Part 3

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## Part 4: Applications by NHS pharmacists and NHS appliance contractors for inclusion in or amendment to pharmaceutical lists

## 8 Applications to be included in or for amendment to a pharmaceutical list

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## 9 Determination of applications to be included in or for amendment to a pharmaceutical list

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

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## 11 Locations in controlled localities that are reserved locations

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## 12 Applications for preliminary consent and effect of preliminary consent

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## 13 Applications involving minor relocation within a Local Health Board’s area

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## 14 Applications involving minor relocation between neighbouring Local Health Board areas

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## 15 Applications involving temporary relocation

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## 16 Applications involving a change of ownership

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## 17 Procedure following grant of an application

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## 18 Application to extend the relevant period

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## 19 Appeals

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## Part 5: Applications by doctors for inclusion in or amendment to dispensing doctor lists

## 20 Arrangements for the provision of pharmaceutical services by doctors

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## 21 Necessary services for temporary patients

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## 22 Provision of pharmaceutical services for immediate treatment or personal administration

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## 23 Discontinuation of arrangements for the provision of pharmaceutical services by doctors

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## 24 Outline consent and premises approval

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## 25 Taking effect of outline consent and premises approval

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## 26 Lapse of outline consent and premises approval

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## 27 Premises approval: change of premises before outline consent takes effect

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## 28 Premises approval: additional and new premises after outline consent has taken effect

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## 29 Premises approval: practice amalgamations

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## 30 Appeals

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## Part 6: Fitness grounds and inclusion in and removal from pharmaceutical lists

## 31 Deferral of applications on fitness grounds

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## 32 Refusal of applications on fitness grounds

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## 33 Conditional inclusion relating to fitness grounds

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## 34 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

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## 35 Removal from a pharmaceutical list for other reasons

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## 36 Suspension from a pharmaceutical list

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## 37 Notification of decision to impose conditions

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## 38 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

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## 39 Review of a decision to impose conditions

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## 40 Appeals

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## Part 7: Payments to NHS pharmacists and NHS appliance contractors

## 41 The Drug Tariff and remuneration of NHS pharmacists and NHS appliance contractors

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## 42 Local Health Boards as determining authorities

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## 43 Overpayments

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## 44 Reward scheme

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## 45 Payments to suspended NHS pharmacists and NHS appliance contractors

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## Part 8: Miscellaneous

## 46 Home Local Health Board

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## 47 Publication of particulars

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## 48 Exercise of choice in certain cases

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## 49 Transitional provisions

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## 50 Minor and consequential amendments and revocations

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## Signature

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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

## 1 Details of the application

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## 2 Details of the application

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## 3 Details of the application

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## 4 Details of the applicant

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## 5 Details of the applicant

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## 6 Details of the applicant

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## 7 Details of the premises and opening hours

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## 8 Details of the premises and opening hours

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## 9 Details of the premises and opening hours

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## 10 Pharmaceutical services to be provided

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## 11 Pharmaceutical services to be provided

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## 12 Pharmaceutical services to be provided

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## 13 Information relating to the necessary or expedient test

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## 14 Information relating to the prejudice test

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## 15 Information relating to applications involving relocations

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## 16 Information relating to applications involving relocations

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## 17 Information relating to applications involving relocations

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## 18 Information relating to applications involving relocations

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## 19 Information relating to applications involving a change of ownership

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## 20 Information relating to applications involving a change of ownership

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## 21 Applicant’s undertaking

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### Part 2: Information and undertakings for applications for inclusion in a pharmaceutical list

## 22 Applicant’s details

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## 23 Investigations, proceedings and convictions

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## 24 Investigations, proceedings and convictions

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## 25 Pharmaceutical qualifications, referees etc.

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## 26 Pharmaceutical qualifications, referees etc.

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## 27 Pharmaceutical qualifications, referees etc.

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## 28 Pharmaceutical qualifications, referees etc.

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## 29 Pharmaceutical qualifications, referees etc.

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## 30 Undertakings

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### Part 3: Notification of commencement date

## 31 Information to be provided prior to the commencement of the provision of pharmaceutical services

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### Part 4: Applications for outline consent and premises approval

## 32 Details of the application

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## 33 Details of the application

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## 34 Details of the applicant

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## 35 Details of the applicant

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## 36 Application for outline consent

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## 37 Application for outline consent

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## 38 Application for premises approval

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## 39 Application for premises approval

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## 40 Application for premises approval

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## 41 Application for premises approval

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## 42 Application for premises approval

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## 43 Application for premises approval

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## 44 Pharmaceutical services to be provided

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## 45 Prejudice test

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## 46 Necessary or expedient

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## 47 Applicant’s undertaking

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## Schedule 2: Procedures to be followed by Local Health Boards to determine applications under the Regulations

### Part 1: Preliminary matters

## 1 General principles

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## 2 Timetable for determining applications

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## 3 Persons prohibited from taking part in decision-making on applications

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### Part 2: Determination of controlled localities

## 4 Notice of proposed determination in respect of controlled localities

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## 5 Deferral of applications

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## 6 Imposition of conditions

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## 7 Notification of determinations and action following determinations

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### Part 3: Applications for inclusion in or amendment to pharmaceutical lists and dispensing doctor lists

## 8 Notice of certain applications

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## 9 Persons and bodies to be notified

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## 10 Content of notifications

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## 11 Oral hearings

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## 12 Information to which a Local Health Board must have regard

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## 13 Imposition of conditions

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## 14 Notification of decisions: applications for inclusion in or amendment to pharmaceutical lists

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## 15 Notification of decisions: applications for inclusion in or amendment to dispensing doctor lists

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## 16 Notification of decisions: applications under regulation 18 for extension of the relevant period

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## 17 Notification of decisions: applications under regulation 11(2)

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## 18 Action following determination in respect of reserved locations

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## Schedule 3: Appeals to the Welsh Ministers

### Part 1: Preliminary matters

## 1 General principles

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## 2 Oral hearings

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### Part 2: Appeals against decisions determining controlled localities

## 3 Right of appeal to the Welsh Ministers

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## 4 Notification of appeals

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## 5 Decision on appeals

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### Part 3: Appeals against decisions for inclusion in or amendment to pharmaceutical lists and dispensing doctor lists

## 6 Right of appeal to the Welsh Ministers

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## 7 Notification of appeals

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## 8 Decision on appeals

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## 9 Effect of decisions by the Welsh Ministers

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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

## 1 Interpretation

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## 2 Incorporation of provisions

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### Part 2: Essential Services

## 3 Essential services

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## 4 Dispensing services

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## 5 Dispensing of drugs and appliances

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## 5A Supply in accordance with a SSP

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## 6 Urgent supply without a prescription

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## 7 Preliminary matters before providing ordered drugs or appliances

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## 8 Providing ordered drugs or appliances

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## 9 Refusal to provide drugs or appliances ordered

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## 10 Further activities to be carried out in connection with the provision of dispensing services

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## 11 Additional requirements in relation to specified appliances

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## 12 Disposal service in respect of unwanted drugs

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## 13 Basic procedure in respect of unwanted drugs

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## 14 Further activities to be carried out in connection with the disposal of unwanted drugs

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## 15 Promotion of healthy lifestyles

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## 16 Prescription linked intervention

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## 17 Public health campaigns

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## 18 Signposting

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## 19 Service outline in respect of signposting

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## 20 Support for self-care

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## 21 Service outline in respect of support for self-care

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### Part 3: Pharmacy Opening Hours

## 22 Pharmacy opening hours: general

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## 23 Matters to be considered when issuing directions in respect of pharmacy opening hours

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## 24 Determination of pharmacy opening hours instigated by the Local Health Board

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## 25 Determination of pharmacy opening hours instigated by the NHS pharmacist

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## 26 Temporary opening hours and closures during an emergency requiring the flexible provision of pharmaceutical services

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### Part 4: Clinical Governance and Complaints

## 27 Clinical governance

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## 28 Professional standards

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## 29 Inducements

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

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## 31 Duty to provide information about fitness matters as they arise

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## 32 Home Local Health Board of bodies corporate

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## 33 Complaints

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### Part 5: Other terms of service

## 34 Directed services

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## 35 Information to be supplied

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## 35A Welsh Language

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## 36 Withdrawal from pharmaceutical lists

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## 37 Charges for drugs and refunds

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## 38 Inspections and access to information

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

## 1 Incorporation of provisions

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## 2 Division of responsibilities between individuals and corporate bodies

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## 3 Dispensing services

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## 4 Dispensing of appliances

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

## 4A Supply in accordance with a SSP

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

## 5 Urgent supply without a prescription

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

## 6 Preliminary matters before providing appliances

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

## 7 Providing appliances

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

## 8 Refusal to provide appliances ordered

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

## 9 Further activities to be carried out in connection with the provision of dispensing services

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

## 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 opening hours

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

## 14 Determination of opening hours instigated by the Local Health Board

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

## 15 Determination of opening hours instigated by the NHS appliance contractor

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

## 16 Clinical governance

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

## 17 Professional Standards

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

## 18 Inducements

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

## 19 Duty to provide information about fitness to practise matters as they arise

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

## 20 Home Local Health Board of bodies corporate

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

## 21 Complaints

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

## 22 Directed Services

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

## 23 Information to be supplied

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

## 23A Welsh Language

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

## 24 Withdrawal from pharmaceutical lists

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

## 25 Charges for appliances

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

## 26 Inspections and access to information

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

## Schedule 6: Terms of service for doctors providing pharmaceutical services

## 1 Interpretation

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

## 2 Incorporation of provisions

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

## 3 Persons duly authorised to dispense on behalf of dispensing doctors

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

## 4 Dispensing of drugs and appliances ordered by another prescriber

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

## 5 Dispensing of drugs and appliances ordered by the dispensing doctor

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

## 6 Preliminary matters before providing ordered drugs or appliances

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

## 7 Provision of Scheduled drugs

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

## 8 Refusal to provide drugs or appliances ordered

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

## 9 Fees and charges

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

## 10 Complaints and concerns

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

## 11 Inspections and access to information

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

## 12 Welsh Language

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

## Schedule 7: Minor and consequential amendments

## 1 The National Health Service (Service Committees and Tribunal) Regulations 1992

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

## 2 The National Health Service (Indicative Amounts) Regulations 1997

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

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

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

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

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

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

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

## 6 The Single Use Carrier Bags Charge (Wales) Regulations 2010

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

## 1 Revocations

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

## 2 Revocations

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

## 3 Revocations

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

## 4 Revocations

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

## 5 Revocations

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

## 6 Revocations

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

## 7 Revocations

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

## 8 Revocations

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

## 9 Revocations

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

## 10 Revocations

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

## 11 Revocations

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

## 12 Revocations

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

## 13 Revocations

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

## 14 Revocations

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

## 15 Revocations

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

## 16 Revocations

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

## 17 Revocations

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## 18 Revocations

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

## 19 Revocations

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## 20 Revocations

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## 21 Revocations

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

## 22 Revocations

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

## 23 Revocations

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

## 24 Revocations

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

## 25 Revocations

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

## Explanatory note

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

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Source: https://www.legislation.gov.uk/wsi/2013/898 (the official version)
Page: https://openlegislation.uk/national-health-service-pharmaceutical-services-wales-regulations-2013-revoked
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.

