The National Health Service (Pharmaceutical Services) (Wales) Regulations 2020

1. Introductory Text

2. PART 1 Introductory

   1. 1. Title, commencement and application

   2. 2. Interpretation

3. PART 2 Pharmaceutical needs assessments

   1. 3. Pharmaceutical needs assessments

   2. 4. Information to be contained in pharmaceutical needs assessments

   3. 5. Date by which the first pharmaceutical needs assessment is to be published

   4. 6. Subsequent assessments

   5. 7. Consultation on pharmaceutical needs assessments

   6. 8. Matters for consideration when making assessments

   7. 9. Publication of pharmaceutical needs assessments

4. PART 3 Pharmaceutical lists and dispensing doctor lists

   1. 10. Preparation and maintenance of pharmaceutical lists

   2. 11. Preparation and maintenance of dispensing doctor lists

   3. 12. Terms of service

5. PART 4 Determination of controlled localities

   1. 13. Areas that are controlled localities

   2. 14. Appeals against decisions under Part 4

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

   1. 15. Applications to be included in or make amendment to a pharmaceutical list

   2. 16. Determination of applications to be included in or to make amendment to a pharmaceutical list

   3. 17. Locations in controlled localities that are reserved locations

   4. 18. Applications for preliminary consent and effect of preliminary consent

   5. 19. Applications involving relocation within a Local Health Board’s area

   6. 20. Applications involving relocation between neighbouring Local Health Board areas

   7. 21. Applications involving temporary relocation

   8. 22. Applications involving a change of ownership

   9. 23. Procedure following grant of an application

   10. 24. Application to extend the relevant period

   11. 25. Appeals

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

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

   2. 27. Necessary services for temporary patients

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

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

   5. 30. Outline consent and premises approval

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

   7. 32. Lapse of outline consent and premises approval

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

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

   10. 35. Premises approval: practice amalgamations

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

   1. 36. Deferral of applications on fitness grounds

   2. 37. Refusal of applications on fitness grounds

   3. 38. Conditional inclusion on fitness grounds

   4. 39. 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. 40. Removal from a pharmaceutical list for other reasons

   6. 41. Suspension from a pharmaceutical list

   7. 42. Notification of a decision to impose conditions

   8. 43. 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. 44. Review of a decision to impose conditions

   10. 45. Appeals

9. PART 8 Conditional inclusion in pharmaceutical lists: certain specific conditions that do not relate to fitness or performance

   1. 46. Core opening hours conditions

   2. 47. Conditions relating to providing directed services

   3. 48. Conditions relating to local resolution of disputes over terms of service

10. PART 9 Performance related sanctions and Market Exit

    1. 49. Local dispute resolution before serving remedial notices or breach notices

    2. 50. Breaches of terms of service: remedial notices

    3. 51. Breaches of terms of service: breach notices

    4. 52. Payment withholdings: supplementary matters

    5. 53. Removal of listings: cases relating to remedial notices and breach notices

    6. 54. Appeals against decisions under Part 9

11. PART 10 Payments to NHS pharmacists and NHS appliance contractors

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

    2. 55A. Zero or nominal product reimbursement for coronavirus vaccines, coronavirus antivirals and influenza virus vaccines

    3. 56. Local Health Boards as determining authorities

    4. 57. Overpayments

    5. 58. Reward scheme

    6. 59. Payments to suspended NHS pharmacists and NHS appliance contractors

12. PART 11 Miscellaneous

    1. 60. Home Local Health Board

    2. 61. Publication of particulars

    3. 62. Exercise of choice in certain cases

    4. 63. Transitional provisions

    5. 64. Minor and consequential amendments

    6. 65. Revocation

13. Signature

14. 1. SCHEDULE 1

       Information to be contained in pharmaceutical needs assessments

       1. 1. Current provision of pharmaceutical services

       2. 2. Other NHS services

       3. 3. Gaps in provision of pharmaceutical services

       4. 4. How the assessment was carried out

       5. 5. Map of provision

    2. SCHEDULE 2

       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; relocation within a...

             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 pharmaceutical services of a...

          2. Information relating to applications to be included in, or amend, a pharmaceutical list

             1. 13. Where regulation 16 applies to the determination of an application,...

          3. Information relating to the prejudice test

             1. 14. Where the prejudice test in regulation 16 applies to the...

          4. Information relating to applications involving relocations

             1. 15. Where the applicant applies to relocate (whether within the Local...

             2. 16. Where the application involves a relocation between neighbouring Local Health...

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

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

          5. Information relating to applications involving a change of ownership

             1. 19. Name of the person included in the pharmaceutical list currently...

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

          6. Applicant’s undertaking

             1. 21. The applicant must give an undertaking that if the application...

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

          1. 22. Applicant’s details

          2. 23. Investigation, 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. Meeting identified needs

          16. 47. Applicant’s undertaking

    3. SCHEDULE 3

       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 determination and action following determination

       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 notification

          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 to make an amendment to a pharmaceutical list

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

          9. 16. Notification of decisions: applications under regulation 24 for extension of the relevant period

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

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

    4. SCHEDULE 4

       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

    5. SCHEDULE 5

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

       1. PART 1 General

          1. 1. Interpretation

          2. 2. Incorporation of provisions

          3. 2A. Code of practice on access to premises An NHS pharmacist...

       2. PART 2 Essential services

          1. 3. Essential services

          2. 4. Dispensing services

          3. 5. Dispensing of drugs and appliances

          4. 6. Supply in accordance with a SSP

          5. 7. Urgent supply without a prescription

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

          7. 9. Providing ordered drugs or appliances

          8. 10. Refusal to provide drugs or appliances ordered

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

          10. 12. Additional requirements in relation to specified appliances

          11. 13. Disposal service in respect of unwanted drugs

          12. 14. Basic procedure in respect of unwanted drugs

          13. 15. Further activities to be carried out in connection with the disposal of unwanted drugs

          14. 16. Promotion of healthy lifestyles

          15. 17. Prescription linked intervention

          16. 18. Public health campaigns

          17. 19. Signposting

          18. 20. Service outline in respect of signposting

          19. 21. Support for self-care

          20. 22. Service outline in respect of support for self-care

       3. PART 3 Pharmacy opening hours

          1. 23. Pharmacy opening hours: general

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

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

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

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

       4. PART 4 Clinical governance and complaints

          1. 28. Clinical governance

          2. 29. Professional standards

          3. 30. Inducements

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

          5. 32. Home Local Health Board of bodies corporate

          6. 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

          6. 39. Welsh language

    6. SCHEDULE 6

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

       1. 1. Incorporation of provisions

       2. 1A. Code of practice on access to premises An NHS appliance...

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

       4. 3. Dispensing services

       5. 4. Dispensing of appliances

       6. 5. Supply in accordance with a SSP

       7. 6. Urgent supply without a prescription

       8. 7. Preliminary matters before providing appliances

       9. 8. Providing appliances

       10. 9. Refusal to provide appliances ordered

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

       12. 11. Additional requirements in relation to specified appliances

       13. 12. Signposting

       14. 13. Opening hours: general

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

       16. 15. Determination of opening hours instigated by the Local Health Board

       17. 16. Determination of opening hours instigated by the NHS appliance contractor

       18. 17. Clinical governance

       19. 18. Professional standards

       20. 19. Inducements

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

       22. 21. Home Local Health Board of bodies corporate

       23. 22. Complaints

       24. 23. Directed services

       25. 24. Information to be supplied

       26. 25. Withdrawal from pharmaceutical services

       27. 26. Charges for appliances

       28. 27. Inspections and access to information

       29. 28. Welsh language

    7. SCHEDULE 7

       Terms of service for doctors providing pharmaceutical services

       1. 1. Interpretation

       2. 2. Incorporation of provisions

       3. 2A. Code of practice on access to premises A doctor who...

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

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

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

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

       8. 7. Provision of Scheduled drugs

       9. 8. Refusal to provide drugs or appliances ordered

       10. 9. Fees and charges

       11. 10. Complaints and concerns

       12. 11. Inspections and access to information

       13. 12. Welsh language

    8. SCHEDULE 8

       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

15. Explanatory Note