Refusal to provide drugs or appliances ordered
- Follow rules for refusing or supplying NHS prescriptions in Wales Trader
Welsh Statutory Instrument
2020
United Kingdom
The National Health Service (Pharmaceutical Services) (Wales) Regulations 2020
At a glance
What's here
73 compliance obligations
Who this Act binds
Business-side actors with duties under this Act, ranked by how often they appear.
- Any Person 28
- Contractor 26
- Trader 6
- Self-Employed Person 3
- Employer 2
- Director or Officer 2
Plus 6 non-business duties on Crown ministers, regulators, local authorities or tribunals — shown collapsed under each section below.
Other Acts binding the same actors
For each actor bound by this Act, the other UK Acts that bind them most often. Useful for understanding the full compliance landscape facing each role.
Any Person also bound by 2337 other Acts (top 5 shown)
- Human Medicines Regulations 2012 2012 169 duties
- Merchant Shipping Act 1995 1995 144 duties
- Insolvency (England and Wales) Rules 2016 2016 101 duties
- Road Traffic Act 1988 1988 95 duties
- Air Navigation Order 2016 2016 95 duties
Contractors also bound by 178 other Acts (top 5 shown)
- The National Health Service (Personal Medical Services Agreements) Regulations 2015 2015 137 duties
- The National Health Service (General Medical Services Contracts) Regulations 2015 2015 134 duties
- Construction (Design and Management) Regulations 2015 2015 114 duties
- The National Health Service (General Medical Services Contracts) (Wales) Regulations 2023 2023 93 duties
- The Health and Personal Social Services (General Medical Services Contracts) Regulations (Northern Ireland) 2004 2004 87 duties
Traders also bound by 826 other Acts (top 5 shown)
- Value Added Tax Regulations 1995 1995 413 duties
- Companies Act 2006 2006 243 duties
- The Large and Medium-sized Companies and Groups (Accounts and Reports) Regulations 2008 2008 114 duties
- Insolvency (England and Wales) Rules 2016 2016 62 duties
- Building Societies Act 1986 1986 56 duties
Self-Employed People also bound by 82 other Acts (top 5 shown)
- General Dental Services Regulations (Northern Ireland) 1993 1993 12 duties
- The National Health Service (General Dental Services) (Scotland) Regulations 2010 2010 7 duties
- The General Chiropractic Council (Indemnity Arrangements) Rules Order of Council 2015 2015 5 duties
- Personal Protective Equipment at Work Regulations (Northern Ireland) 1993 1993 5 duties
- The Management of Health and Safety at Work Regulations 1992 1992 4 duties
Employers also bound by 694 other Acts (top 5 shown)
- The Income Tax (Pay As You Earn) Regulations 2003 2003 236 duties
- Provision and Use of Work Equipment Regulations 1998 1998 120 duties
- TULRCA 1992 1992 72 duties
- Employment Rights (Northern Ireland) Order 1996 (current NI employment law) 1996 52 duties
- Income Tax (Earnings and Pensions) Act 2003 2003 50 duties
Directors and Officers also bound by 425 other Acts (top 5 shown)
- Insolvency (England and Wales) Rules 2016 2016 161 duties
- Companies Act 2006 2006 108 duties
- Insolvency Act 1986 1986 72 duties
- The Large and Medium-sized Companies and Groups (Accounts and Reports) Regulations 2008 2008 55 duties
- The Housing Administration (England and Wales) Rules 2018 2018 26 duties
What this Act requires
Sections that create concrete duties on businesses or carry penalties. Procedural and definitional sections are folded into the “Browse other sections” expander at the bottom of each group. Click any section title to read the source text on legislation.gov.uk.
Schedules
Additional requirements in relation to specified appliances
- Provide home delivery and supplementary services for specified appliances Any Person
Disposal service in respect of unwanted drugs
- Accept and dispose of unwanted drugs presented to your pharmacy Any Person
Basic procedure in respect of unwanted drugs
- Accept and dispose of unwanted prescription drugs brought in from homes or care homes Any Person
Further activities to be carried out in connection with the disposal of unwanted drugs
- Ensure staff awareness and protective equipment for handling waste drugs Employer
Promotion of healthy lifestyles
- Promote public health messages when appropriate Employer
Prescription linked intervention
- Provide health advice and keep records when presenting a prescription Any Person
Public health campaigns
- Participate in up to four public health campaigns per year when requested by the Local Health Board Any Person
Signposting
- Provide signposting information to pharmacy users about other health and social care providers Trader
Service outline in respect of signposting
- Provide signposting and referral services when unable to supply a service Any Person
Support for self-care
- Provide self-care advice and support to patients Any Person
Service outline in respect of support for self-care
- Provide self-care advice and record clinically significant interventions Contractor
Pharmacy opening hours: general
- Ensure pharmacy opening hours comply with minimum 40 hours/week and associated duties Any Person
Determination of pharmacy opening hours instigated by the Local Health Board
Other duties (1) — Crown / regulator
- Local Health Board must assess and decide pharmacy opening hours Local authority
Determination of pharmacy opening hours instigated by the NHS pharmacist
Other duties (1) — Crown / regulator
- Local Health Board must determine pharmacy opening hours change applications within 60 days and notify the pharmacist Local authority
Clinical governance
- Establish and operate a clinical governance system for your pharmacy Any Person
Professional standards
- Provide NHS pharmaceutical services in line with professional standards Any Person
Code of practice on access to premises An NHS pharmacist...
- Consider code of practice on accessible pharmacy premises Any Person
Inducements
- Do not offer gifts or rewards to induce prescription orders Trader
Duty to provide information about fitness to practice matters as they arise
- Report fitness-to-practice matters to the Local Health Board within 7 days Director or Officer
Home Local Health Board of bodies corporate
- Body corporate NHS pharmacist must report to home Local Health Board Any Person
Complaints
- Have a compliant complaints handling procedure Trader
Directed services
- Comply with terms and conditions of directed services arrangement Any Person
Information to be supplied
- Notify Local Health Board of changes to pharmacy list information and related matters Any Person
Withdrawal from pharmaceutical lists
- Notify Local Health Board 3 months before withdrawing from pharmaceutical list Self-Employed Person
Charges for drugs and refunds
- NHS pharmacists must refund overpaid charges on valid claim Any Person
Inspections and access to information
- Allow Local Health Board inspections and provide requested information Any Person
Welsh language
- Provide Welsh language services and encourage Welsh language use Any Person
Dispensing services
- Provide proper and sufficient drugs and appliances to valid prescriptions Any Person
Dispensing of drugs and appliances
- Provide prescribed drugs and appliances with reasonable promptness Any Person
Dispensing ophthalmic listed appliances and ophthalmic listed medicines ordered by qualifying optometrists
- Dispense ophthalmic appliances and medicines ordered by optometrists Trader
Supply in accordance with a SSP
- Consider and, if appropriate, supply under a Serious Shortage Protocol; endorse and notify the GP Any Person
Preliminary matters before providing ordered drugs or appliances
- Provide time estimates and verify exemption evidence before dispensing Any Person
Providing ordered drugs or appliances
- Provide drugs or appliances only in accordance with valid prescriptions Any Person
Further activities to be carried out in connection with the provision of dispensing services
- Provide safe and appropriate dispensing services to patients Contractor
Additional requirements in relation to specified appliances
- Provide home delivery service and supplementary support for specified appliances Contractor
Signposting
- Refer patients or provide alternative contractor details when unable to supply appliance Contractor
Opening hours: general
- You must provide appliance services for at least 30 hours per week Contractor
Matters to be considered when issuing directions in respect of opening hours
Other duties (1) — Crown / regulator
- Local Health Board must ensure pharmacy hours meet local needs Local authority
Determination of opening hours instigated by the Local Health Board
Other duties (1) — Crown / regulator
- Local Health Board must consult and notify before changing opening hours Local authority
Determination of opening hours instigated by the NHS appliance contractor
- Apply to change your opening hours with 90 days' notice Contractor
Clinical governance
- Participate in an acceptable system of clinical governance Contractor
Professional standards
- NHS appliance contractors must meet professional pharmaceutical standards Contractor
Inducements
- Do not offer inducements for appliance prescriptions Contractor
Code of practice on access to premises An NHS appliance...
- Have regard to the code of practice on access to premises Contractor
Division of responsibilities between individuals and corporate bodies
- Ensure only registered pharmacists perform tasks requiring a natural person Contractor
Duty to provide information about fitness to practise matters as they arise
- Notify Local Health Board of fitness-to-practise and criminal matters within 7 days Director or Officer
Home Local Health Board of bodies corporate
- Provide details of all Local Health Boards when using home LHB route Contractor
Complaints
- Have compliant complaints handling arrangements in place Contractor
Directed services
- Comply with terms and conditions of directed services arrangement Contractor
Information to be supplied
- Notify Local Health Board of changes to your information and supply requested details Contractor
Withdrawal from pharmaceutical services
- Notify Local Health Board of withdrawal from pharmaceutical list at least 3 months in advance Contractor
Inspections and access to information
- Allow inspections and access to information by Local Health Board Contractor
Welsh language
- Comply with Welsh language requirements for pharmaceutical services Contractor
Dispensing services
- Supply proper and sufficient appliances when prescribed Contractor
Dispensing of appliances
- Provide prescribed appliances promptly on valid prescription Contractor
Supply in accordance with a SSP
- Consider and supply in accordance with Serious Shortage Protocol (SSP) when applicable Contractor
Preliminary matters before providing appliances
- Provide time estimates and verify exemption evidence before supplying appliances Contractor
Providing appliances
- Provide NHS appliances correctly — signed valid prescription, and measure/fit if needed Contractor
Refusal to provide appliances ordered
- Know when you can or must refuse to supply NHS appliances Contractor
Inspections and access to information
- Allow inspections and provide information to the Local Health Board Self-Employed Person
Welsh language
- Provide Welsh language pharmaceutical services and notify the Local Health Board Contractor
Code of practice on access to premises A doctor who...
- Doctors providing pharmaceutical services must consider the code of practice on access to premises Any Person
Persons duly authorised to dispense on behalf of dispensing doctors
- Ensure authorised staff follow dispensing rules Any Person
Dispensing of drugs and appliances ordered by another prescriber
- Dispense drugs and appliances ordered by another prescriber promptly Any Person
Dispensing of drugs and appliances ordered by the dispensing doctor
- Follow dispensing rules for drugs and appliances you order as a dispensing doctor Self-Employed Person
Preliminary matters before providing ordered drugs or appliances
- Ask for proof of exemption or remission from prescription charges Trader
Provision of Scheduled drugs
- Do not provide Scheduled drugs to patients except under specified conditions Any Person
Refusal to provide drugs or appliances ordered
- Refuse or restrict repeat prescription supplies when conditions not met Any Person
Browse 100 other Schedules — structural / supplementary
Current provision of pharmaceutical services
Other NHS services
Gaps in provision of pharmaceutical services
How the assessment was carried out
Map of provision
Details of the application
Pharmaceutical services to be provided
Details of directed services that the applicant applies to provide....
If the application is to provide pharmaceutical services of a...
Where regulation 16 applies to the determination of an application,...
Where the prejudice test in regulation 16 applies to the...
Where the applicant applies to relocate (whether within the Local...
Where the application involves a relocation between neighbouring Local Health...
The applicant must provide details of whether—
If the application is for a temporary relocation, the applicant...
Name of the person included in the pharmaceutical list currently...
Type of consent applied for (full or preliminary).
The applicant must provide details of whether—
The applicant must give an undertaking that if the application...
Applicant’s details
Investigation, proceedings and convictions
If the applicant (and where the applicant is a body...
Pharmaceutical qualifications, referees etc.
Where the applicant (or where the applicant is a body...
Where the applicant is a body corporate, the name and...
The applicant must supply the name of any Local Health...
If the applicant is the director or superintendent of a...
Type of application (for example: new inclusion; relocation within a...
Undertakings
Information to be provided prior to the commencement of the provision of pharmaceutical services
Details of the application
Type of application (outline consent, premises approval or both).
Details of the applicant
The General Medical Council reference number under which the applicant...
Application for outline consent
Address of any pharmacy within the area described and delineated...
Application for premises approval
Distance between those premises and the nearest pharmacy (and the...
Details of the applicant
Whether the application is for premises approval for additional premises...
Whether the application arises because a practice amalgamation has taken...
If outline consent has already been granted a description and...
Details of any other medical practice premises which have been...
Pharmaceutical services to be provided
Prejudice test
Meeting identified needs
Applicant’s undertaking
If the applicant is an individual or a partnership carrying...
If the applicant is a body corporate carrying on a...
Details of the premises and opening hours
Whether the applicant is currently in possession of the premises...
The days on which the pharmacy will be open for...
General principles
Content of notification
Oral hearings
Information to which a Local Health Board must have regard
Imposition of conditions
Notification of decisions: applications for inclusion in or to make an amendment to a pharmaceutical list
Notification of decisions: applications for inclusion in or amendment to dispensing doctor lists
Notification of decisions: applications under regulation 24 for extension of the relevant period
Notification of decisions: applications under regulation 17(2)
Action following determination in respect of reserved locations
Timetable for determining applications
Persons prohibited from taking part in decision-making on applications
Notice of proposed determination in respect of controlled localities
Deferral of applications
Imposition of conditions
Notification of determination and action following determination
Notice of certain applications
Persons and bodies to be notified
General principles
Oral hearings
Right of appeal to the Welsh Ministers
Notification of appeals
Decision on appeals
Right of appeal to the Welsh Ministers
Notification of appeals
Decision on appeals
Effect of decisions by the Welsh Ministers
Interpretation
Further activities to be carried out in connection with the provision of dispensing services
Incorporation of provisions
Matters to be considered when issuing directions in respect of pharmacy opening hours
Temporary opening hours and closures during an emergency requiring the flexible provision of pharmaceutical services
Essential services
Workforce reporting
Urgent supply without a prescription
Incorporation of provisions
Charges for appliances
Urgent supply without a prescription
Interpretation
Complaints and concerns
Incorporation of provisions
Fees and charges
The National Health Service (Service Committees and Tribunal) Regulations 1992
The National Health Service (Indicative Amounts) Regulations 1997
The National Health Service (Payments by Local Authorities to Health Authorities) (Prescribed Functions) (Wales) Regulations 2001
The National Health Service (General Medical Services Contracts) (Wales) Regulations 2004
The National Health Service (Free Prescriptions and Charges for Drugs and Appliances) (Wales) Regulations 2007
The Single Use Carrier Bags Charge (Wales) Regulations 2010
Discontinuation of arrangements for the provision of pharmaceutical services by doctors
Other duties (1) — Crown / regulator
- Local Health Board must notify doctors to stop providing pharmaceutical services Local authority
Premises approval: practice amalgamations
- Notify Local Health Boards of your practice amalgamation Any Person
Core opening hours conditions
Other duties (1) — Crown / regulator
- Local Health Board must direct opening hours for pharmacy and appliance contractors who agreed extended hours Local authority
Breaches of terms of service: remedial notices
- Respond to a remedial notice from your Local Health Board Contractor
Browse 62 other sections — procedural / definitional / commencement
Title, commencement and application
Interpretation
Pharmaceutical needs assessments
Information to be contained in pharmaceutical needs assessments
Date by which the first pharmaceutical needs assessment is to be published
Subsequent assessments
Consultation on pharmaceutical needs assessments
Matters for consideration when making assessments
Publication of pharmaceutical needs assessments
Preparation and maintenance of pharmaceutical lists
Preparation and maintenance of dispensing doctor lists
Terms of service
Areas that are controlled localities
Appeals against decisions under Part 4
Applications to be included in or make amendment to a pharmaceutical list
Determination of applications to be included in or to make amendment to a pharmaceutical list
Locations in controlled localities that are reserved locations
Applications for preliminary consent and effect of preliminary consent
Applications involving relocation within a Local Health Board’s area
Applications involving relocation between neighbouring Local Health Board areas
Applications involving temporary relocation
Applications involving a change of ownership
Procedure following grant of an application
Application to extend the relevant period
Appeals
Arrangements for the provision of pharmaceutical services by doctors
Necessary services for temporary patients
Provision of pharmaceutical services for immediate treatment or personal administration
Outline consent and premises approval
Taking effect of outline consent and premises approval
Lapse of outline consent and premises approval
Premises approval: change of premises before outline consent takes effect
Premises approval: additional and new premises after outline consent has taken effect
Deferral of applications on fitness grounds
Refusal of applications on fitness grounds
Conditional inclusion on fitness grounds
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
Removal from a pharmaceutical list for other reasons
Suspension from a pharmaceutical list
Notification of a decision to impose conditions
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
Review of a decision to impose conditions
Appeals
Conditions relating to providing directed services
Conditions relating to local resolution of disputes over terms of service
Local dispute resolution before serving remedial notices or breach notices
Breaches of terms of service: breach notices
Payment withholdings: supplementary matters
Removal of listings: cases relating to remedial notices and breach notices
Appeals against decisions under Part 9
The Drug Tariff and remuneration of NHS pharmacists and NHS appliance contractors
Zero or nominal product reimbursement for coronavirus vaccines, coronavirus antivirals and influenza virus vaccines
Local Health Boards as determining authorities
Overpayments
Reward scheme
Payments to suspended NHS pharmacists and NHS appliance contractors
Home Local Health Board
Publication of particulars
Exercise of choice in certain cases
Transitional provisions
Minor and consequential amendments
Revocation
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