The National Health Service (Pharmaceutical Services) Regulations 2012
| Jurisdiction | UK Non-devolved |
| Citation | SI 2012/1909 |
2012No. 1909
NATIONAL HEALTH SERVICE, ENGLAND
The National Health Service (Pharmaceutical Services) Regulations 2012
18thJuly2012
23rdJuly2012
1stSeptember2012
The Secretary of State makes the following Regulations in exercise of the powers conferred by sections 8, 22, 126, 128A, 129, 130, 132, 148, 150A, 151(5) and (7), 154, 159(9), 160, 162, 163(3), 164, 172, 182 and 272(7) and (8) of the National Health Service Act 2006( 1) and section 37(1) of the Health Act 2009( 2).
PART 1
Introductory
Citation and commencement
1. These Regulations may be cited as the National Health Service (Pharmaceutical Services) Regulations 2012 and come into force on 1st September 2012.
Interpretation
2.-(1) Subject to paragraph (5), in these Regulations-
"100 hours condition" is to be construed in accordance with regulation 65(1);
"the 1968 Act" means the Medicines Act 1968( 3);
"the 1992 Regulations" means the National Health Service (Pharmaceutical Services) Regulations 1992( 4), as in force on 31st March 2005;
"the 2005 Regulations" means the National Health Service (Pharmaceutical Services) Regulations 2005( 5), as in force immediately before the appointed day;
"the 2006 Act" means the National Health Service Act 2006;
"additional opening hours" is to be construed, as the context requires, in accordance with paragraph 23(13) of Schedule 4 or paragraph 13(12) of Schedule 5, or both;
"advanced electronic signature" means an electronic signature which is-
(a) uniquely linked to the signatory;
(b) capable of identifying the signatory;
(c) created using means that the signatory can maintain under their sole control; and
(d) linked to the date to which it relates in such a manner that any subsequent change of data is detectable;
"advanced services" means the directed services for which the Secretary of State determines the remuneration under section 164 of the 2006 Act( 6) (remuneration for persons providing pharmaceutical services);
"APMS contractor" means a person or partnership that provides primary medical services under contractual arrangements with a Primary Care Trust under section 83(2)(b) of the 2006 Act (primary medical services);
"APMS practice" means an APMS contractor that has a patient list;
"appliance" means an appliance included in a list approved by the Secretary of State for the purposes of section 126 of the 2006 Act( 7) (arrangements for pharmaceutical services);
"appliance contractor premises" means listed chemist premises (or in the context of an applicant seeking the listing of premises, proposed listed chemist premises) of an NHS appliance contractor;
"appliance use review service" means arrangements made in accordance with directions under section 127 of the 2006 Act (arrangements for additional pharmaceutical services) for a pharmacist or a specialist nurse to review a person's use of a specified appliance;
"appointed day" means 1st September 2012;
"armed forces of the Crown" means the forces that are "regular forces" or "reserve forces" within the meanings given in section 374 of the Armed Forces Act 2006( 8) (definitions applying for the purposes of whole Act).
"bank holiday" means any day that is by virtue of section 1 of or Schedule 1 to the Banking and Financial Dealings Act 1971( 9) (which relate to bank holidays) a bank holiday in England;
"batch issue" means a form, provided by a Primary Care Trust and in the format required by the NHS BSA, which-
(a) is issued by a repeatable prescriber at the same time as a non-electronic repeatable prescription to enable an NHS chemist or dispensing doctor to receive payment for the provision of repeat dispensing services;
(b) relates to a particular non-electronic repeatable prescription and contains the same date as that prescription;
(c) is generated by a computer and not signed by a repeatable prescriber;
(d) 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
(e) has included on it a number denoting its place in the sequence referred to in sub-paragraph (d);
"best estimate", in the context of the location of proposed appliance contractor premises or pharmacy premises mentioned in a routine application, is to be construed in accordance with paragraph 1(10) of Schedule 2;
"breach notice" is to be construed in accordance with regulation 71(1);
"change of ownership application" means an application pursuant to regulation 26;
"Charges Regulations" means the National Health Service (Charges for Drugs and Appliances) Regulations 2000( 10);
"child" means a person who has not attained the age of 16 years;
"controlled locality" means an area that is a controlled locality by virtue of regulation 36(1) or is determined to be so in accordance with regulation 36(2);
"core opening hours" is to be construed, as the context requires, in accordance with paragraph 23(2) of Schedule 4 or paragraph 13(2) of Schedule 5, or both;
"directed services" means additional pharmaceutical services provided in accordance with directions under section 127 of the 2006 Act;
"dispensing contractor", except in the context of Schedule 7, means an NHS chemist or a dispensing doctor whom or which a patient wishes to dispense their electronic prescriptions;
"dispensing doctor" is to be construed in accordance with regulation 46(1);
"dispensing doctor list" is to be construed in accordance with regulation 46(1);
"distance selling premises" are listed chemist premises, or potential pharmacy premises, at which essential services are or are to be provided but the means of providing those services are such that all persons receiving those services do so otherwise than at those premises;
"drugs" includes medicines;
"Drug Tariff" is to be construed in accordance with regulation 89(1);
"electronic communication" has the meaning given in section 15(1) of the Electronic Communications Act 2000( 11) (general interpretation);
"electronic prescription" means an electronic prescription form or an electronic repeatable prescription;
"electronic prescription form" 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 dispensing contractor by the Electronic Prescription Service; and
(c) does not indicate that the drug or appliance ordered may be provided more than once;
"electronic repeatable prescription" means data created in an electronic form, which-
(a) is signed with a repeatable prescriber's advanced electronic signature;
(b) is transmitted as an electronic communication to a nominated dispensing contractor by the Electronic Prescription Service;
(c) indicates that the drugs or appliances ordered may be provided more than once; and
(d) specifies the number of occasions on which they may be provided;
"emergency requiring the flexible provision of pharmaceutical services" has the meaning given in regulation 29(4);
"employment" includes unpaid employment and employment under a contract for services, and "employed", "employer" and "employs" are to be construed accordingly;
"enhanced services" means the directed services that are not advanced services;
"essential services", except in the context of the definition of "distance selling premises", is to be construed in accordance with paragraph 3 of Schedule 4;
"EPS list" is to be construed in accordance with regulation 10(4)(a);
"Electronic Prescription Service" means the service of that name which is operated under the auspices of the Informatics Division of the Department of Health;
"excepted application" means an application to which section 129(2A) and (2B) of the 2006 Act( 12) (regulations as to pharmaceutical services) do not apply by virtue of any provision of Part 4;
"general practitioner" means a medical practitioner who is on a medical performers list;
"GMS contract" means a general medical services contract;
"GMS practice" means a party (which may be a partnership) to a GMS contract other than a Primary Care Trust;
"GMS Regulations" means the National Health Service (General Medical Services Contracts) Regulations 2004( 13), but in the context of Schedule 7 means those Regulations as in force immediately before the appointed day;
"GPhC register" means the register maintained under article 19 of the Pharmacy Order 2010( 14) (establishment, maintenance of and access to the register);
"Health Board", except in the context of "Local Health Board", means a Health Board constituted under section 2 of the National Health Service (Scotland) Act 1978( 15) (Health Boards);
"health care professional" means a person other than a social worker who is a member of a profession regulated by a body mentioned in section 25(3) of the National Health Service Reform and Health Care Professions Act 2002( 16) (which relates to the Council for Healthcare Regulatory Excellence);
"home Primary Care Trust", in relation to any body corporate with a registered office in England, means the Primary Care Trust in whose area that office is situated;
"independent nurse prescriber" means a person-
(a) who is registered in the Nursing and Midwifery Register; and
(b) against whose name in that register is recorded an annotation signifying that they are qualified to order drugs and appliances as a community practitioner nurse prescriber, a nurse independent prescriber or a nurse independent/supplementary prescriber;
"Independent Prescribing Service" means a directed service commissioned as an Independent Prescribing Service by a Primary Care Trust;
"licensing body" means any body anywhere in the world that licenses or regulates any profession;
"listed chemist premises" is to be construed in accordance with regulation 10(3)(a);
"listed dispensing premises" is to be construed in accordance with regulation 46(2)(a);
"Local Health...
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