Welsh Statutory Instrument SI 2020/1073 United Kingdom

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

Read it on legislation.gov.uk (opens in a new tab)
Status
In Force
Penalty ceiling
Regulated

Does it bind you?

Business-side roles with duties under this instrument.

Any Person28 Contractor26 Trader6 Self-Employed Person3 Employer2 Director or Officer2

Plus 6 duties on the regulator, Crown ministers and public bodies — folded into the section list below.

Other Acts binding the same actors

If a role above is yours, these are the other instruments that most often bind it.

Any Person — also bound by 2340 other Acts
Contractor — also bound by 173 other Acts
Trader — also bound by 825 other Acts
Companies Act 2006 243 duties
Companies Act 1985 85 duties
Self-Employed Person — also bound by 80 other Acts
Employer — also bound by 682 other Acts
TULRCA 1992 72 duties
Director or Officer — also bound by 429 other Acts
Companies Act 2006 126 duties

What it requires

Regulations creating concrete business duties or carrying penalties, grouped as the instrument is structured. Titles link to the source text — blue means you’re leaving for legislation.gov.uk.

s.029 Discontinuation of arrangements for the provision of pharmaceutical services by doctors Regulated
Other duties (1) — Crown / regulator
  • Local Health Board must notify doctors to stop providing pharmaceutical servicesLocal authority
s.035 Premises approval: practice amalgamations Regulated
  • Notify Local Health Boards of your practice amalgamationAny Person
s.046 Core opening hours conditions Regulated
Other duties (1) — Crown / regulator
  • Local Health Board must direct opening hours for pharmacy and appliance contractors who agreed extended hoursLocal authority
s.050 Breaches of terms of service: remedial notices Regulated
  • Respond to a remedial notice from your Local Health BoardContractor
62 other provisions — procedural and definitional
s.001 Title, commencement and application
s.002 Interpretation
s.003 Pharmaceutical needs assessments
s.004 Information to be contained in pharmaceutical needs assessments
s.005 Date by which the first pharmaceutical needs assessment is to be published
s.006 Subsequent assessments
s.007 Consultation on pharmaceutical needs assessments
s.008 Matters for consideration when making assessments
s.009 Publication of pharmaceutical needs assessments
s.010 Preparation and maintenance of pharmaceutical lists
s.011 Preparation and maintenance of dispensing doctor lists
s.012 Terms of service
s.013 Areas that are controlled localities
s.014 Appeals against decisions under Part 4
s.015 Applications to be included in or make amendment to a pharmaceutical list
s.016 Determination of applications to be included in or to make amendment to a pharmaceutical list
s.017 Locations in controlled localities that are reserved locations
s.018 Applications for preliminary consent and effect of preliminary consent
s.019 Applications involving relocation within a Local Health Board’s area
s.020 Applications involving relocation between neighbouring Local Health Board areas
s.021 Applications involving temporary relocation
s.022 Applications involving a change of ownership
s.023 Procedure following grant of an application
s.024 Application to extend the relevant period
s.025 Appeals
s.026 Arrangements for the provision of pharmaceutical services by doctors
s.027 Necessary services for temporary patients
s.028 Provision of pharmaceutical services for immediate treatment or personal administration
s.030 Outline consent and premises approval
s.031 Taking effect of outline consent and premises approval
s.032 Lapse of outline consent and premises approval
s.033 Premises approval: change of premises before outline consent takes effect
s.034 Premises approval: additional and new premises after outline consent has taken effect
s.036 Deferral of applications on fitness grounds
s.037 Refusal of applications on fitness grounds
s.038 Conditional inclusion on fitness grounds
s.039 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
s.040 Removal from a pharmaceutical list for other reasons
s.041 Suspension from a pharmaceutical list
s.042 Notification of a decision to impose conditions
s.043 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
s.044 Review of a decision to impose conditions
s.045 Appeals
s.047 Conditions relating to providing directed services
s.048 Conditions relating to local resolution of disputes over terms of service
s.049 Local dispute resolution before serving remedial notices or breach notices
s.051 Breaches of terms of service: breach notices
s.052 Payment withholdings: supplementary matters
s.053 Removal of listings: cases relating to remedial notices and breach notices
s.054 Appeals against decisions under Part 9
s.055 The Drug Tariff and remuneration of NHS pharmacists and NHS appliance contractors
s.055 Zero or nominal product reimbursement for coronavirus vaccines, coronavirus antivirals and influenza virus vaccines
s.056 Local Health Boards as determining authorities
s.057 Overpayments
s.058 Reward scheme
s.059 Payments to suspended NHS pharmacists and NHS appliance contractors
s.060 Home Local Health Board
s.061 Publication of particulars
s.062 Exercise of choice in certain cases
s.063 Transitional provisions
s.064 Minor and consequential amendments
s.065 Revocation
Schedules

Schedules

69 of 169 shown
s.sch005 Refusal to provide drugs or appliances ordered Regulated
  • Follow rules for refusing or supplying NHS prescriptions in WalesTrader
s.sch005 Additional requirements in relation to specified appliances Regulated
  • Provide home delivery and supplementary services for specified appliancesAny Person
s.sch005 Disposal service in respect of unwanted drugs Regulated
  • Accept and dispose of unwanted drugs presented to your pharmacyAny Person
s.sch005 Basic procedure in respect of unwanted drugs Regulated
  • Accept and dispose of unwanted prescription drugs brought in from homes or care homesAny Person
s.sch005 Further activities to be carried out in connection with the disposal of unwanted drugs Regulated
  • Ensure staff awareness and protective equipment for handling waste drugsEmployer
s.sch005 Promotion of healthy lifestyles Regulated
  • Promote public health messages when appropriateEmployer
s.sch005 Prescription linked intervention Regulated
  • Provide health advice and keep records when presenting a prescriptionAny Person
s.sch005 Public health campaigns Regulated
  • Participate in up to four public health campaigns per year when requested by the Local Health BoardAny Person
s.sch005 Signposting Regulated
  • Provide signposting information to pharmacy users about other health and social care providersTrader
s.sch005 Service outline in respect of signposting Regulated
  • Provide signposting and referral services when unable to supply a serviceAny Person
s.sch005 Support for self-care Regulated
  • Provide self-care advice and support to patientsAny Person
s.sch005 Service outline in respect of support for self-care Regulated
  • Provide self-care advice and record clinically significant interventionsContractor
s.sch005 Pharmacy opening hours: general Regulated
  • Ensure pharmacy opening hours comply with minimum 40 hours/week and associated dutiesAny Person
s.sch005 Determination of pharmacy opening hours instigated by the Local Health Board Regulated
Other duties (1) — Crown / regulator
  • Local Health Board must assess and decide pharmacy opening hoursLocal authority
s.sch005 Determination of pharmacy opening hours instigated by the NHS pharmacist Regulated
Other duties (1) — Crown / regulator
  • Local Health Board must determine pharmacy opening hours change applications within 60 days and notify the pharmacistLocal authority
s.sch005 Clinical governance Regulated
  • Establish and operate a clinical governance system for your pharmacyAny Person
s.sch005 Professional standards Regulated
  • Provide NHS pharmaceutical services in line with professional standardsAny Person
s.sch005 Code of practice on access to premises An NHS pharmacist... Regulated
  • Consider code of practice on accessible pharmacy premisesAny Person
s.sch005 Inducements Regulated
  • Do not offer gifts or rewards to induce prescription ordersTrader
s.sch005 Duty to provide information about fitness to practice matters as they arise Regulated
  • Report fitness-to-practice matters to the Local Health Board within 7 daysDirector or Officer
s.sch005 Home Local Health Board of bodies corporate Regulated
  • Body corporate NHS pharmacist must report to home Local Health BoardAny Person
s.sch005 Complaints Regulated
  • Have a compliant complaints handling procedureTrader
s.sch005 Directed services Regulated
  • Comply with terms and conditions of directed services arrangementAny Person
s.sch005 Information to be supplied Regulated
  • Notify Local Health Board of changes to pharmacy list information and related mattersAny Person
s.sch005 Withdrawal from pharmaceutical lists Regulated
  • Notify Local Health Board 3 months before withdrawing from pharmaceutical listSelf-Employed Person
s.sch005 Charges for drugs and refunds Regulated
  • NHS pharmacists must refund overpaid charges on valid claimAny Person
s.sch005 Inspections and access to information Regulated
  • Allow Local Health Board inspections and provide requested informationAny Person
s.sch005 Welsh language Regulated
  • Provide Welsh language services and encourage Welsh language useAny Person
s.sch005 Dispensing services Regulated
  • Provide proper and sufficient drugs and appliances to valid prescriptionsAny Person
s.sch005 Dispensing of drugs and appliances Regulated
  • Provide prescribed drugs and appliances with reasonable promptnessAny Person
s.sch005 Dispensing ophthalmic listed appliances and ophthalmic listed medicines ordered by qualifying optometrists Regulated
  • Dispense ophthalmic appliances and medicines ordered by optometristsTrader
s.sch005 Supply in accordance with a SSP Regulated
  • Consider and, if appropriate, supply under a Serious Shortage Protocol; endorse and notify the GPAny Person
s.sch005 Preliminary matters before providing ordered drugs or appliances Regulated
  • Provide time estimates and verify exemption evidence before dispensingAny Person
s.sch005 Providing ordered drugs or appliances Regulated
  • Provide drugs or appliances only in accordance with valid prescriptionsAny Person
s.sch006 Further activities to be carried out in connection with the provision of dispensing services Regulated
  • Provide safe and appropriate dispensing services to patientsContractor
s.sch006 Additional requirements in relation to specified appliances Regulated
  • Provide home delivery service and supplementary support for specified appliancesContractor
s.sch006 Signposting Regulated
  • Refer patients or provide alternative contractor details when unable to supply applianceContractor
s.sch006 Opening hours: general Regulated
  • You must provide appliance services for at least 30 hours per weekContractor
s.sch006 Matters to be considered when issuing directions in respect of opening hours Regulated
Other duties (1) — Crown / regulator
  • Local Health Board must ensure pharmacy hours meet local needsLocal authority
s.sch006 Determination of opening hours instigated by the Local Health Board Regulated
Other duties (1) — Crown / regulator
  • Local Health Board must consult and notify before changing opening hoursLocal authority
s.sch006 Determination of opening hours instigated by the NHS appliance contractor Regulated
  • Apply to change your opening hours with 90 days' noticeContractor
s.sch006 Clinical governance Regulated
  • Participate in an acceptable system of clinical governanceContractor
s.sch006 Professional standards Regulated
  • NHS appliance contractors must meet professional pharmaceutical standardsContractor
s.sch006 Inducements Regulated
  • Do not offer inducements for appliance prescriptionsContractor
s.sch006 Code of practice on access to premises An NHS appliance... Regulated
  • Have regard to the code of practice on access to premisesContractor
s.sch006 Division of responsibilities between individuals and corporate bodies Regulated
  • Ensure only registered pharmacists perform tasks requiring a natural personContractor
s.sch006 Duty to provide information about fitness to practise matters as they arise Regulated
  • Notify Local Health Board of fitness-to-practise and criminal matters within 7 daysDirector or Officer
s.sch006 Home Local Health Board of bodies corporate Regulated
  • Provide details of all Local Health Boards when using home LHB routeContractor
s.sch006 Complaints Regulated
  • Have compliant complaints handling arrangements in placeContractor
s.sch006 Directed services Regulated
  • Comply with terms and conditions of directed services arrangementContractor
s.sch006 Information to be supplied Regulated
  • Notify Local Health Board of changes to your information and supply requested detailsContractor
s.sch006 Withdrawal from pharmaceutical services Regulated
  • Notify Local Health Board of withdrawal from pharmaceutical list at least 3 months in advanceContractor
s.sch006 Inspections and access to information Regulated
  • Allow inspections and access to information by Local Health BoardContractor
s.sch006 Welsh language Regulated
  • Comply with Welsh language requirements for pharmaceutical servicesContractor
s.sch006 Dispensing services Regulated
  • Supply proper and sufficient appliances when prescribedContractor
s.sch006 Dispensing of appliances Regulated
  • Provide prescribed appliances promptly on valid prescriptionContractor
s.sch006 Supply in accordance with a SSP Regulated
  • Consider and supply in accordance with Serious Shortage Protocol (SSP) when applicableContractor
s.sch006 Preliminary matters before providing appliances Regulated
  • Provide time estimates and verify exemption evidence before supplying appliancesContractor
s.sch006 Providing appliances Regulated
  • Provide NHS appliances correctly — signed valid prescription, and measure/fit if neededContractor
s.sch006 Refusal to provide appliances ordered Regulated
  • Know when you can or must refuse to supply NHS appliancesContractor
s.sch007 Inspections and access to information Regulated
  • Allow inspections and provide information to the Local Health BoardSelf-Employed Person
s.sch007 Welsh language Regulated
  • Provide Welsh language pharmaceutical services and notify the Local Health BoardContractor
s.sch007 Code of practice on access to premises A doctor who... Regulated
  • Doctors providing pharmaceutical services must consider the code of practice on access to premisesAny Person
s.sch007 Persons duly authorised to dispense on behalf of dispensing doctors Regulated
  • Ensure authorised staff follow dispensing rulesAny Person
s.sch007 Dispensing of drugs and appliances ordered by another prescriber Regulated
  • Dispense drugs and appliances ordered by another prescriber promptlyAny Person
s.sch007 Dispensing of drugs and appliances ordered by the dispensing doctor Regulated
  • Follow dispensing rules for drugs and appliances you order as a dispensing doctorSelf-Employed Person
s.sch007 Preliminary matters before providing ordered drugs or appliances Regulated
  • Ask for proof of exemption or remission from prescription chargesTrader
s.sch007 Provision of Scheduled drugs Regulated
  • Do not provide Scheduled drugs to patients except under specified conditionsAny Person
s.sch007 Refusal to provide drugs or appliances ordered Regulated
  • Refuse or restrict repeat prescription supplies when conditions not metAny Person
100 other schedules
s.sch001 Current provision of pharmaceutical services
s.sch001 Other NHS services
s.sch001 Gaps in provision of pharmaceutical services
s.sch001 How the assessment was carried out
s.sch001 Map of provision
s.sch002 Details of the application
s.sch002 Pharmaceutical services to be provided
s.sch002 Details of directed services that the applicant applies to provide....
s.sch002 If the application is to provide pharmaceutical services of a...
s.sch002 Where regulation 16 applies to the determination of an application,...
s.sch002 Where the prejudice test in regulation 16 applies to the...
s.sch002 Where the applicant applies to relocate (whether within the Local...
s.sch002 Where the application involves a relocation between neighbouring Local Health...
s.sch002 The applicant must provide details of whether—
s.sch002 If the application is for a temporary relocation, the applicant...
s.sch002 Name of the person included in the pharmaceutical list currently...
s.sch002 Type of consent applied for (full or preliminary).
s.sch002 The applicant must provide details of whether—
s.sch002 The applicant must give an undertaking that if the application...
s.sch002 Applicant’s details
s.sch002 Investigation, proceedings and convictions
s.sch002 If the applicant (and where the applicant is a body...
s.sch002 Pharmaceutical qualifications, referees etc.
s.sch002 Where the applicant (or where the applicant is a body...
s.sch002 Where the applicant is a body corporate, the name and...
s.sch002 The applicant must supply the name of any Local Health...
s.sch002 If the applicant is the director or superintendent of a...
s.sch002 Type of application (for example: new inclusion; relocation within a...
s.sch002 Undertakings
s.sch002 Information to be provided prior to the commencement of the provision of pharmaceutical services
s.sch002 Details of the application
s.sch002 Type of application (outline consent, premises approval or both).
s.sch002 Details of the applicant
s.sch002 The General Medical Council reference number under which the applicant...
s.sch002 Application for outline consent
s.sch002 Address of any pharmacy within the area described and delineated...
s.sch002 Application for premises approval
s.sch002 Distance between those premises and the nearest pharmacy (and the...
s.sch002 Details of the applicant
s.sch002 Whether the application is for premises approval for additional premises...
s.sch002 Whether the application arises because a practice amalgamation has taken...
s.sch002 If outline consent has already been granted a description and...
s.sch002 Details of any other medical practice premises which have been...
s.sch002 Pharmaceutical services to be provided
s.sch002 Prejudice test
s.sch002 Meeting identified needs
s.sch002 Applicant’s undertaking
s.sch002 If the applicant is an individual or a partnership carrying...
s.sch002 If the applicant is a body corporate carrying on a...
s.sch002 Details of the premises and opening hours
s.sch002 Whether the applicant is currently in possession of the premises...
s.sch002 The days on which the pharmacy will be open for...
s.sch003 General principles
s.sch003 Content of notification
s.sch003 Oral hearings
s.sch003 Information to which a Local Health Board must have regard
s.sch003 Imposition of conditions
s.sch003 Notification of decisions: applications for inclusion in or to make an amendment to a pharmaceutical list
s.sch003 Notification of decisions: applications for inclusion in or amendment to dispensing doctor lists
s.sch003 Notification of decisions: applications under regulation 24 for extension of the relevant period
s.sch003 Notification of decisions: applications under regulation 17(2)
s.sch003 Action following determination in respect of reserved locations
s.sch003 Timetable for determining applications
s.sch003 Persons prohibited from taking part in decision-making on applications
s.sch003 Notice of proposed determination in respect of controlled localities
s.sch003 Deferral of applications
s.sch003 Imposition of conditions
s.sch003 Notification of determination and action following determination
s.sch003 Notice of certain applications
s.sch003 Persons and bodies to be notified
s.sch004 General principles
s.sch004 Oral hearings
s.sch004 Right of appeal to the Welsh Ministers
s.sch004 Notification of appeals
s.sch004 Decision on appeals
s.sch004 Right of appeal to the Welsh Ministers
s.sch004 Notification of appeals
s.sch004 Decision on appeals
s.sch004 Effect of decisions by the Welsh Ministers
s.sch005 Interpretation
s.sch005 Further activities to be carried out in connection with the provision of dispensing services
s.sch005 Incorporation of provisions
s.sch005 Matters to be considered when issuing directions in respect of pharmacy opening hours
s.sch005 Temporary opening hours and closures during an emergency requiring the flexible provision of pharmaceutical services
s.sch005 Essential services
s.sch005 Workforce reporting
s.sch005 Urgent supply without a prescription
s.sch006 Incorporation of provisions
s.sch006 Charges for appliances
s.sch006 Urgent supply without a prescription
s.sch007 Interpretation
s.sch007 Complaints and concerns
s.sch007 Incorporation of provisions
s.sch007 Fees and charges
s.sch008 The National Health Service (Service Committees and Tribunal) Regulations 1992
s.sch008 The National Health Service (Indicative Amounts) Regulations 1997
s.sch008 The National Health Service (Payments by Local Authorities to Health Authorities) (Prescribed Functions) (Wales) Regulations 2001
s.sch008 The National Health Service (General Medical Services Contracts) (Wales) Regulations 2004
s.sch008 The National Health Service (Free Prescriptions and Charges for Drugs and Appliances) (Wales) Regulations 2007
s.sch008 The Single Use Carrier Bags Charge (Wales) Regulations 2010

Duty extraction and severity labels are Guvnor’s analysis of the instrument, not the instrument itself. Always verify against the linked source text.