The National Health Service (Pharmaceutical Services) Regulations 2005
| Jurisdiction | UK Non-devolved |
| Citation | SI 2005/641 |
| Year | 2005 |
2005 No. 641
NATIONAL HEALTH SERVICE, ENGLAND
The National Health Service (Pharmaceutical Services) Regulations 2005
Made 10th March 2005
Laid before Parliament 11th March 2005
Coming into force 1st April 2005
The Secretary of State for Health, in exercise of the powers conferred upon him by sections 41, 42, 43, 43ZA, 49F, 49I, 49N, 49O, 49P, 49Q and 126(4) of the National Health Service Act 19771hereby makes the following Regulations:—
PART 1
General
Citation, commencement and extent
1.—(1) These Regulations may be cited as the National Health Service (Pharmaceutical Services) Regulations 2005 and shall come into force on 1st April 2005.
(2) Subject to paragraph (3), these Regulations shall apply in relation to England only2.
(3) The amendments and revocations of enactments made by regulation 75 and Schedules 5 and 6 have, subject to paragraph (4), no application to Wales but, subject to that, the extent of those provisions is the same as that of the enactment amended or revoked.
(4) The amendments made by regulation 75 and paragraph 4 of Schedule 5 apply to Wales.
Interpretation
2.—(1) In these Regulations—
“the Act” means the National Health Service Act 1977;
“the 1992 Regulations” means the National Health Service (Pharmaceutical Services) Regulations 19923, as in force on 31st March 2005;
“the 1997 Act” means the National Health Service (Primary Care) Act 19974;
“the 2001 Act” means the Health and Social Care Act 20015;
“the 2002 Act” means the National Health Service Reform and Health Care Professions Act 20026;
“Abolition of the Tribunal Regulations” means the Abolition of the National Health Service Tribunal (Consequential Provisions) Regulations 20017;
“Abolition of the Tribunal (Wales) Regulations” means the Abolition of the National Health Service Tribunal (Consequential Provisions) Regulations 20028;
“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 his sole control; and
(d) linked to the data to which it relates in such a manner that any subsequent change of data is detectable;
“APMS” means primary medical services provided in accordance with an APMS contract;
“APMS contract” means an arrangement to provide primary medical services made under section 16CC(2)(b) (primary medical services)9of the Act;
“APMS contractor” means a party to an APMS contract other than a Primary Care Trust;
“appliance” means an appliance which is included in a list for the time being approved by the Secretary of State for the purposes of section 41 (arrangements for pharmaceutical services) of the Act;
“appropriate non-proprietary name” means a non-proprietary name which is not mentioned in Schedule 1 (drugs, medicines and other substances not to be ordered under a general medical services contract) 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 (drugs, medicines and other substances that may be ordered only in certain circumstances) to the Prescription of Drugs Regulations;
“associated batch issue” 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;
“bank holiday” means any day that is specified or proclaimed as a bank holiday in England pursuant to section 1 of the Banking and Financial Dealings Act 197110;
“batch issue” means a form provided by a Primary Care Trust and issued by a repeatable prescriber at the same time as a non-electronic repeatable prescription to enable a chemist to receive payment for the provision of repeat dispensing services which is in the format specified in Part 2 of Schedule 1 to the GMS Regulations, 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 sub-paragraph (c);
“Charges Regulations” means the National Health Service (Charges for Drugs and Appliances) Regulations 200011;
“chemical reagent” means a chemical reagent included in a list for the time being approved by the Secretary of State for the purposes of section 41 of the Act;
“chemist”, except in the expression “LPS chemist”, means—
(a) a registered pharmacist;
(b) a person lawfully conducting a retail pharmacy business in accordance with section 69 of the Medicines Act 196812; or
(c) a supplier of appliances,
who is included in the list of a Primary Care Trust under section 42 (regulations as to pharmaceutical services) of the Act, and includes a person suspended from such a list;
“child” means a person who has not attained the age of 16 years;
“Community Health Council” means a body of that name established in accordance with section 20 of the Act;
“conditional inclusion” means inclusion in a pharmaceutical list (or the grant of preliminary consent to be included in a pharmaceutical list) subject to conditions imposed under regulation 21, 30, 42 or 43 and “conditionally include” shall be construed accordingly;
“contingent removal” means removal from a pharmaceutical list contingently, within the meaning of section 49G (contingent removal)13of the Act, and “contingently remove” shall be construed accordingly;
“controlled locality” means an area which the Primary Care Trust, or on appeal, the Secretary of State, has determined is rural in character in accordance with regulation 31 or, as the case may be, regulation 32;
“dentist” means a dental practitioner;
“directed services” means additional pharmaceutical services provided in accordance with a direction under section 41A14(arrangements for providing additional pharmaceutical services) of the Act;
“director” 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 contractor” means a chemist, doctor, GMS contractor or PMS contractor whom a patient wishes to dispense his electronic prescriptions;
“dispensing doctor” means a doctor who provides pharmaceutical services under arrangements with a Primary Care Trust under Part 5;
“dispensing doctor list” shall be construed in accordance with regulation 68;
“distance selling chemist” means a chemist who provides pharmaceutical services from distance selling premises;
“distance selling premises” has the meaning given to it in regulation 13(1)(d);
“doctor” means a medical practitioner;
“drugs” includes medicines;
“Drug Tariff” has the meaning given to it in regulation 56;
“electronic communication” has the same meaning as in section 15 of the Electronic Communications Act 200015;
“electronic prescription” means an electronic prescription form or an electronic repeatable prescription;
“electronic prescription form” means a prescription which falls within paragraph (b) of the definition of “prescription form”;
“electronic repeatable prescription” means a prescription which falls within paragraph (a)(ii) of the definition of “repeatable prescription”;
“employment” means any employment whether paid or unpaid and whether under a contract for services or a contract of service, and “employed” and “employer” shall be construed accordingly;
“equivalent body” means a Local Health Board in Wales, a Health Board or an NHS trust in Scotland, a Health and Social Services Board in Northern Ireland, (in relation to any time prior to 1st October 2002) a Health Authority in England or (in relation to any time prior to 1st April 2003) a Health Authority in Wales;
“equivalent lists” means lists kept by an equivalent body;
“essential services” has the meaning given to it in paragraph 3 of Schedule 1 (essential services);
“ETP list” means the list prepared, maintained and published by a Primary Care Trust pursuant to regulation 71.
“ETP service” means the electronic prescription service which forms part of the NHS Care Record Service;
“FHSAA” means the Family Health Services Appeal Authority constituted under section 49S of the Act16;
“finally granted” and “final grant” (except in regulations 40 and 41) have the meaning given to them in regulation 39(14) and “finally refused” and “finally determined” shall be construed accordingly;
“fraud case” means a case where a person satisfies the second condition for removal from the pharmaceutical list, set out in section 49F(3) (disqualification of practitioners) of the Act, or by virtue of section 49H (fraud and unsuitability cases: supplementary)17of the Act is treated as doing so;
“GMS contract” means a general medical services contract18;
“GMS contractor” means a party to a GMS contract other than a Primary Care Trust;
“the GMS Regulations” means the National Health Service (General Medical Services Contracts) Regulations 200419;
“Health and Social Services Board” means a Health and Social Services Board established under the Health and Personal Social Services (Northern Ireland) Order 197220;
“Health Board” means a Health Board established under section 2 of the National Health Service (Scotland) Act 197821;
“health care professional” means a person who is a member of a profession regulated by a body mentioned in section 25(3) of the 2002 Act;
“independent nurse prescriber” means a person—
(a) who is registered in the Nursing and Midwifery Register; and
(b) in respect of whom an annotation signifying that he is qualified to order drugs and appliances from—
(i) the Nurse Prescribers'...
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