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

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  1. Introductory Text

  2. PART 1 Introduction

    1. 1.Title, commencement and application

    2. 2.Interpretation

  3. PART 2 Pharmaceutical lists and dispensing doctor lists

    1. 3.Preparation and maintenance of pharmaceutical lists

    2. 4.Preparation and maintenance of dispensing doctor lists

    3. 5.Terms of service

  4. PART 3 Determination of controlled localities

    1. 6.Areas that are controlled localities

    2. 7.Appeals against decisions under Part 3

  5. PART 4 Applications by NHS pharmacists and NHS appliance contractors for inclusion in or amendment to pharmaceutical lists

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

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

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

    4. 11.Locations in controlled localities that are reserved locations

    5. 12.Applications for preliminary consent and effect of preliminary consent

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

    7. 14.Applications involving minor relocation between neighbouring Local Health Board areas

    8. 15.Applications involving temporary relocation

    9. 16.Applications involving a change of ownership

    10. 17.Procedure following grant of an application

    11. 18.Application to extend the relevant period

    12. 19.Appeals

  6. PART 5 Applications by doctors for inclusion in or amendment to dispensing doctor lists

    1. 20.Arrangements for the provision of pharmaceutical services by doctors

    2. 21.Necessary services for temporary patients

    3. 22.Provision of pharmaceutical services for immediate treatment or personal administration

    4. 23.Discontinuation of arrangements for the provision of pharmaceutical services by doctors

    5. 24.Outline consent and premises approval

    6. 25.Taking effect of outline consent and premises approval

    7. 26.Lapse of outline consent and premises approval

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

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

    10. 29.Premises approval: practice amalgamations

    11. 30.Appeals

  7. PART 6 Fitness grounds and inclusion in and removal from pharmaceutical lists

    1. 31.Deferral of applications on fitness grounds

    2. 32.Refusal of applications on fitness grounds

    3. 33.Conditional inclusion relating to fitness grounds

    4. 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

    5. 35.Removal from a pharmaceutical list for other reasons

    6. 36.Suspension from a pharmaceutical list

    7. 37.Notification of decision to impose conditions

    8. 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

    9. 39.Review of a decision to impose conditions

    10. 40.Appeals

  8. PART 7 Payments to NHS pharmacists and NHS appliance contractors

    1. 41.The Drug Tariff and remuneration of NHS pharmacists and NHS appliance contractors

    2. 42.Local Health Boards as determining authorities

    3. 43.Overpayments

    4. 44.Reward scheme

    5. 45.Payments to suspended NHS pharmacists and NHS appliance contractors

  9. PART 8 Miscellaneous

    1. 46.Home Local Health Board

    2. 47.Publication of particulars

    3. 48.Exercise of choice in certain cases

    4. 49.Transitional provisions

    5. 50.Minor and consequential amendments and revocations

  10. Signature

    1. SCHEDULE 1

      Information to be included in applications to provide pharmaceutical services

      1. PART 1 Application for inclusion in or for amendment to a pharmaceutical list

        1. Information required from all applicants

          1. 1.Details of the application

          2. 2.Type of consent applied for (full or preliminary).

          3. 3.Type of application (for example: new inclusion; minor relocation within...

          4. 4.Details of the applicant

          5. 5.If the applicant is an individual or a partnership carrying...

          6. 6.If the applicant is a body corporate carrying on a...

          7. 7.Details of the premises and opening hours

          8. 8.Whether the applicant is currently in possession of the premises...

          9. 9.The days on which the pharmacy will be open for...

          10. 10.Pharmaceutical services to be provided

          11. 11.Details of directed services that the applicant applies to provide....

          12. 12.If the application is to provide services of a different...

          13. 13.Information relating to the necessary or expedient test

          14. 14.Information relating to the prejudice test

          15. 15.Information relating to applications involving relocations

          16. 16.Where the application involves a minor relocation between neighbouring Local...

          17. 17.The applicant must provide details of whether—

          18. 18.If the application is for a temporary relocation, the applicant...

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

          20. 20.The applicant must provide details of whether—

          21. 21.Applicant’s undertaking

      2. PART 2 Information and undertakings for applications for inclusion in a pharmaceutical list

        1. 22.Applicant’s details

        2. 23.Investigations, proceedings and convictions

        3. 24.If the applicant (and where the applicant is a body...

        4. 25.Pharmaceutical qualifications, referees etc.

        5. 26.Where the applicant (or where the applicant is a body...

        6. 27.Where the applicant is a body corporate, the name and...

        7. 28.The applicant must supply the name of any Local Health...

        8. 29.If the applicant is the director or superintendent of a...

        9. 30.Undertakings

      3. PART 3 Notification of commencement date

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

      4. PART 4 Applications for outline consent and premises approval

        1. 32.Details of the application

        2. 33.Type of application (outline consent, premises approval or both).

        3. 34.Details of the applicant

        4. 35.The General Medical Council reference number under which the applicant...

        5. 36.Application for outline consent

        6. 37.Address of any pharmacy within the area described and delineated...

        7. 38.Application for premises approval

        8. 39.Distance between those premises and the nearest pharmacy (and the...

        9. 40.Whether the application is for premises approval, for additional premises...

        10. 41.Whether the application arises because a practice amalgamation has taken...

        11. 42.If outline consent has already been granted a description and...

        12. 43.Details of any other medical practice premises which have been...

        13. 44.Pharmaceutical services to be provided

        14. 45.Prejudice test

        15. 46.Necessary or expedient

        16. 47.Applicant’s undertaking

    2. SCHEDULE 2

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

      1. PART 1 Preliminary matters

        1. 1.General principles

        2. 2.Timetable for determining applications

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

      2. PART 2 Determination of controlled localities

        1. 4.Notice of proposed determination in respect of controlled localities

        2. 5.Deferral of applications

        3. 6.Imposition of conditions

        4. 7.Notification of determinations and action following determinations

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

        1. 8.Notice of certain applications

        2. 9.Persons and bodies to be notified

        3. 10.Content of notifications

        4. 11.Oral hearings

        5. 12.Information to which a Local Health Board must have regard

        6. 13.Imposition of conditions

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

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

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

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

        11. 18.Action following determination in respect of reserved locations

    3. SCHEDULE 3

      Appeals to the Welsh Ministers

      1. PART 1 Preliminary matters

        1. 1.General principles

        2. 2.Oral hearings

      2. PART 2 Appeals against decisions determining controlled localities

        1. 3.Right of appeal to the Welsh Ministers

        2. 4.Notification of appeals

        3. 5.Decision on appeals

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

        1. 6.Right of appeal to the Welsh Ministers

        2. 7.Notification of appeals

        3. 8.Decision on appeals

        4. 9.Effect of decisions by the Welsh Ministers

    4. SCHEDULE 4

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

      1. PART 1 General

        1. 1.Interpretation

        2. 2.Incorporation of provisions

      2. PART 2 Essential Services

        1. 3.Essential services

        2. 4.Dispensing services

        3. 5.Dispensing of drugs and appliances

        4. 6.Urgent supply without a prescription

        5. 7.Preliminary matters before providing ordered drugs or appliances

        6. 8.Providing ordered drugs or appliances

        7. 9.Refusal to provide drugs or appliances ordered

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

        9. 11.Additional requirements in relation to specified appliances

        10. 12.Disposal service in respect of unwanted drugs

        11. 13.Basic procedure in respect of unwanted drugs

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

        13. 15.Promotion of healthy lifestyles

        14. 16.Prescription linked intervention

        15. 17.Public health campaigns

        16. 18.Signposting

        17. 19.Service outline in respect of signposting

        18. 20.Support for self-care

        19. 21.Service outline in respect of support for self-care

      3. PART 3 Pharmacy Opening Hours

        1. 22.Pharmacy opening hours: general

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

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

        4. 25.Determination of pharmacy opening hours instigated by the NHS pharmacist

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

      4. PART 4 Clinical Governance and Complaints

        1. 27.Clinical governance

        2. 28.Professional standards

        3. 29.Inducements

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

        5. 31.Duty to provide information about fitness matters as they arise

        6. 32.Home Local Health Board of bodies corporate

        7. 33.Complaints

      5. PART 5 Other terms of service

        1. 34.Directed services

        2. 35.Information to be supplied

        3. 36.Withdrawal from pharmaceutical lists

        4. 37.Charges for drugs and refunds

        5. 38.Inspections and access to information

    5. SCHEDULE 5

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

      1. 1.Incorporation of provisions

      2. 2.Division of responsibilities between individuals and corporate bodies

      3. 3.Dispensing services

      4. 4.Dispensing of appliances

      5. 5.Urgent supply without a prescription

      6. 6.Preliminary matters before providing appliances

      7. 7.Providing appliances

      8. 8.Refusal to provide appliances ordered

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

      10. 10.Additional requirements in relation to specified appliances

      11. 11.Signposting

      12. 12.Opening hours: general

      13. 13.Matters to be considered when issuing directions in respect of opening hours

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

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

      16. 16.Clinical governance

      17. 17.Professional Standards

      18. 18.Inducements

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

      20. 20.Home Local Health Board of bodies corporate

      21. 21.Complaints

      22. 22.Directed Services

      23. 23.Information to be supplied

      24. 24.Withdrawal from pharmaceutical lists

      25. 25.Charges for appliances

      26. 26.Inspections and access to information

    6. SCHEDULE 6

      Terms of service for doctors providing pharmaceutical services

      1. 1.Interpretation

      2. 2.Incorporation of provisions

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

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

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

      6. 6.Preliminary matters before providing ordered drugs or appliances

      7. 7.Provision of Scheduled drugs

      8. 8.Refusal to provide drugs or appliances ordered

      9. 9.Fees and charges

      10. 10.Complaints and concerns

      11. 11.Inspections and access to information

    7. SCHEDULE 7

      Minor and consequential amendments

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

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

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

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

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

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

    8. SCHEDULE 8

      1. 1.Revocations

      2. 2.The National Health Service (Pharmaceutical Services) Amendment Regulations 1993.

      3. 3.The National Health Service (Pharmaceutical Services and Charges for Drugs...

      4. 4.The National Health Service (Pharmaceutical Services) Amendment Regulations 1995.

      5. 5.The National Health Service (Pharmaceutical Services) Amendment Regulations 1996.

      6. 6.The National Health Service (Pharmaceutical Services) Amendment Regulations 1998.

      7. 7.The National Health Service (Pharmaceutical Services) Amendment Regulations 1999.

      8. 8.The National Health Service (Pharmaceutical Services) and (General Medical Services)...

      9. 9.The National Health Service (General Medical Services) and (Pharmaceutical Services)...

      10. 10.The National Health Service (Pharmaceutical Services) (Amendment) (Wales) Regulations 2003)...

      11. 11.The National Health Service (Amendments concerning Supplementary and Independent Nurse...

      12. 12.The National Health Service (Pharmaceutical Services) (Amendment) (No.2) (Wales) Regulations...

      13. 13.The National Health Service (Pharmaceutical Services etc) (Repeatable Prescriptions) (Amendment)...

      14. 14.The National Health Service (Pharmaceutical Services) (Amendment) (Wales) Regulations 2004....

      15. 15.The National Health Service (Pharmaceutical Services) (Amendment) (Wales) Regulations 2005....

      16. 16.Paragraph 6 of Schedule 1 to the General Dental Services...

      17. 17.The National Health Service (Pharmaceutical Services) (Amendment) (Wales) Regulations 2006....

      18. 18.Paragraph 1 of Schedule 2 to the National Health Service...

      19. 19.Regulation 3 of the National Health Service (Miscellaneous Amendments Concerning...

      20. 20.Regulations 3, 4, 5, 6, 7 and 8 of the...

      21. 21.The National Health Service (Pharmaceutical Services) (Amendment) (Wales) Regulations 2009....

      22. 22.The National Health Service (Pharmaceutical Services) (Amendment) (Wales) Regulations 2010)....

      23. 23.Regulation 2 of the National Health Service (Miscellaneous Amendments Relating...

      24. 24.The National Health Service (Pharmaceutical Services) (Amendment) (Wales) (No.2) Regulations...

      25. 25.Paragraph 2 of Schedule 2 to the National Health Service...

  11. Explanatory Note

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