The National Health Service (Pharmaceutical Services) (Wales) Regulations 2020
| Jurisdiction | Wales |
2020 No. 1073 (W. 241)
National Health Service, Wales
The National Health Service (Pharmaceutical Services) (Wales) Regulations 2020
Made 29th September 2020
Coming into force in accordance with regulation 1(2) and (3)
The Welsh Ministers, in exercise of the powers conferred on them by sections 15, 80, 82A, 83, 84, 86, 88, 104, 107, 110, 115, 116, 118, 203(9) and (10) and 205 of the National Health Service (Wales) Act 20061, make the following Regulations.
A draft of these Regulations has been approved by a resolution of Senedd Cymru in accordance with section 203(6A) of that Act.
PART 1
Introductory
Title, commencement and application
1.—(1) The title of these Regulations is the National Health Service (Pharmaceutical Services) (Wales) Regulations 2020.
(2) The following provisions come into force on 1 October 2020—
(a)
(a) this Part;
(b)
(b) Parts 2 to 4;
(c)
(c) Parts 9 to 11.
(3) Parts 5 to 8 come into force on 1 October 2021.
(4) These Regulations apply in relation to Wales.
Interpretation
2.—(1) In these Regulations—
“the 2006 Act” (“Deddf 2006”) means the National Health Service (Wales) Act 2006;
“the 1992 Regulations” (“Rheoliadau 1992”) means the National Health Service (Pharmaceutical Services) Regulations 19922as in force immediately before 10 May 2013;
“the 2005 Regulations” (“Rheoliadau 2005”) means the National Health Service (Pharmaceutical Services) Regulations 20053as in force immediately before 1 September 2012;
“the 2013 Regulations” (“Rheoliadau 2013”) means the National Health Service (Pharmaceutical Services) (Wales) Regulations 20134as in force immediately before 1 October 2020;
“additional opening hours” (“oriau agor ychwanegol”) is to be construed, as the context requires, in accordance with paragraph 23(11) of Schedule 5 or paragraph 13(10) of Schedule 6, or both;
“advanced electronic signature” (“llofnod electronig uwch”) means an electronic signature which meets the following requirements—
(a) it is uniquely linked to the signatory,
(b) it is capable of identifying the signatory,
(c) it is created using electronic signature creation data that the signatory can, with a high level of confidence, use under the signatory’s sole control, and
(d) it is linked to the data signed in such a way that any subsequent change in the data is detectable;
“APMS” (“GMDdA”) means primary medical services provided in accordance with an APMS contract;
“APMS contract” (“contract GMDdA”) means an arrangement to provide primary medical services made with a Local Health Board under section 41(2)(b) of the 2006 Act (primary medical services);
“APMS contractor” (“contractwr GMDdA”) means a party to an APMS contract, other than a Local Health Board;
“appliance” (“cyfarpar”) means an appliance which is included in a list approved by the Welsh Ministers for the purposes of section 80 of the 2006 Act (arrangements for pharmaceutical services);
“appliance use review service” (“gwasanaeth adolygu defnyddio cyfarpar”) means arrangements made in accordance with directions under section 81 of the 2006 Act (arrangements for additional pharmaceutical services) for an NHS pharmacist or NHS appliance contractor to review a person’s use of any specified appliance;
“appropriate batch issue” (“swp-ddyroddiad priodol”) means, in relation to a non-electronic repeatable prescription, one of the batch issues relating to that prescription and containing the same date as that prescription;
“appropriate non-proprietary name” (“enw amherchnogol priodol”) means a non-proprietary name which is not mentioned in Schedule 1 to the Prescription of Drugs Regulations or, except where the conditions in paragraph 42(2) of Schedule 6 to the GMS Regulations are satisfied, in Schedule 2 to the Prescription of Drugs Regulations;
“bank holiday” (“gŵyl banc”) means any day that is specified or proclaimed as a bank holiday in Wales pursuant to section 1 of the Banking and Financial Dealings Act 19715;
“batch issue” (“swp-ddyroddiad”) means a form provided by a Local Health Board and issued by a repeatable prescriber at the same time as a non-electronic repeatable prescription to enable a NHS pharmacist or NHS appliance contractor to receive payment for the provision of repeat dispensing services which is in the required format, and which—
(a) is generated by a computer and not signed by a repeatable prescriber,
(b) relates to a particular non-electronic repeatable prescription and contains the same date as that prescription,
(c) is issued as one of a sequence of forms, the number of which is equal to the number of occasions on which the drugs or appliances ordered on the non-electronic repeatable prescription may be provided, and
(d) specifies a number denoting its place in the sequence referred to in paragraph (c);
“Charges Regulations” (“Rheoliadau Ffioedd”) means the National Health Service (Free Prescriptions and Charges for Drugs and Appliances) (Wales) Regulations 20076;
“child” (“plentyn”) means a person who has not attained the age of 16 years;
“Community Health Council” (“Cyngor Iechyd Cymuned”) means a Community Health Council retained or established under section 182 of the 2006 Act (community health councils);
“conditional inclusion” (“cynnwys yn amodol”) means inclusion in a pharmaceutical list or the grant of preliminary consent to be included in a pharmaceutical list subject to conditions imposed under Part 7 of these Regulations;
“contingent removal” (“dileu yn ddigwyddiadol”) means removal from a pharmaceutical list contingently, within the meaning of section 108 of the 2006 Act (contingent removal);
“controlled locality” (“ardal reoledig”) means an area which a Local Health Board has determined to be rural in accordance with regulation 13 (areas that are controlled localities), which the Welsh Ministers have determined on appeal, in accordance with Parts 1 and 2 of Schedule 4, to be rural or which is a controlled locality by virtue of the operation of regulation 13(1);
“core hours” (“oriau craidd”) means the hours during which pharmacy, or appliance contractor, premises must be open by virtue of paragraph 23(1) of Schedule 5, or paragraph 13(1) of Schedule 6;
“dentist” (“deintydd”) means a dental practitioner;
“directed services” (“gwasanaethau cyfeiriedig”) means additional pharmaceutical services provided in accordance with directions under section 81 of the 2006 Act (arrangements for additional pharmaceutical services);
“director” (“cyfarwyddwr”) means—
(a) a director of a body corporate, or
(b) a member of the body of persons controlling a body corporate (whether or not a limited liability partnership);
“dispensing doctor” (“meddyg fferyllol”) means a doctor who provides pharmaceutical services under arrangements with a Local Health Board made under regulation 26 (arrangements for the provision of pharmaceutical services by doctors);
“dispensing doctor list” (“rhestr meddygon fferyllol”) means a list that a Local Health Board is required to prepare and maintain under regulation 11 (preparation and maintenance of dispensing doctor lists);
“doctor” (“meddyg”) means a registered medical practitioner;
“Drug Tariff” (“Tariff Cyffuriau”) has the meaning given to it in regulation 55 (the Drug Tariff and remuneration of NHS pharmacists and NHS appliance contractors);
“drugs” (“cyffuriau”) includes medicines;
“EEA” (“AEE”) means the European Economic Area created by the EEA agreement;
“electronic communication” (“cyfathrebiad electronig”) has the meaning given in section 15(1) of the Electronic Communications Act 20007(general interpretation);
“electronic prescription” (“presgripsiwn electronig”) means an electronic prescription form or an electronic repeatable prescription;
“electronic prescription form” (“ffurflen bresgripsiwn electronig”) means data created in an electronic form for the purpose of ordering a drug or appliance which—
(a) is signed with a prescriber’s advanced electronic signature,
(b) is transmitted as an electronic communication to a nominated NHS pharmacist, NHS appliance contractor or dispensing doctor by the ETP service, and
(c) does not indicate that the drug or appliance ordered may be provided more than once;
“electronic repeatable prescription” (“presgripsiwn amlroddadwy electronig”) means a prescription which falls within paragraph (a)(ii) of the definition of “repeatable prescription”;
“electronic signature” (“llofnod electronig”) means data in electronic form which is attached to or logically associated with other data in electronic form and which is used by the signatory to sign;
“electronic signature creation data” (“data creu llofnod electronig”) means unique data which is used by the signatory to create an electronic signature;
“employment” (“cyflogaeth”) includes unpaid employment and employment under a contract for services;
“equivalent body” (“corff cyfatebol”) means the National Health Service Commissioning Board in England, a Health Board in Scotland, a Health and Social Services Board in Northern Ireland or any successor body in England, Scotland or Northern Ireland and, in relation to any time prior to 1 April 2003, a Health Authority in Wales or in relation to any time prior to 1 April 2013 and after 30 September 2002 a Primary Care Trust in England, or in relation to any time prior to 1 October 2002, a Health Authority in England;
“equivalent list” (“rhestr gyfatebol”) means a list kept by an equivalent body;
“essential services” (“gwasanaethau hanfodol”) for NHS pharmacists means the services specified in paragraph 3 of Schedule 5 and for NHS appliance contractors means the services specified in paragraphs 3 to 12 of Schedule 6;
“ETP service” (“gwasanaeth TPE”) means the 2-dimensional barcoded prescription service which forms part of the information technology systems in prescribing and dispensing systems in Wales and used by the health service in Wales to transfer and hold prescription...
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