C1PART 12Dealings with medicinal products
CHAPTER 1Interpretation
Interpretation213
1
In this Part—
F1“clinical commissioning group” means a body established under section 14D of the National Health Service Act 2006;
“the Common Services Agency” means the Common Services Agency for the Scottish Health Service established under section 10 of the National Health Service (Scotland) Act 1978 M1;
F8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
“the dental care professionals register” means the register established and maintained under section 36B of the Dentists Act 1984 M2;
F9“Council Directive 2005/36/EC” means Council Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications;
F10“EEA health professional” means F14a person in a relevant European State who is—
- a
a doctor of medicine, a nurse responsible for general care, a dental practitioner, a midwife or a pharmacist as those professionals are defined within the meaning of Council Directive 2005/36/EC;
- b
a professional exercising activities in the health care sector which are restricted to a regulated profession as defined in Article 3(1)(a) of Directive 2005/36/EC; or
- c
a person of equivalent professional status to a health care professional within the meaning of regulation 8;
- a
F11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F24. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
“food” includes—
- a
beverages;
- b
confectionery;
- c
articles and substances used as ingredients in the preparation of food; and
- d
any manufactured substance—
- i
to which there has been added any vitamin, and
- ii
which is advertised as available and for sale to the general public as a dietary supplement;
- i
- a
“health authority” means—
- a
F2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
- b
in relation to Wales, a Local Health Board established under section 11 of the National Health Service (Wales) Act 2006 M3;
- c
in relation to Scotland, a Health Board constituted under section 2(1)(a) of the National Health Service (Scotland) Act 1978 M4; and
- d
in relation to Northern Ireland, the Regional Health and Social Care Board established under section 7 of the Health and Social Care (Reform) Act (Northern Ireland) 2009 M5;
- a
“health care” means services for or in connection with the prevention, diagnosis or treatment of disease;
“health prescription” means a prescription issued by a doctor, dentist, supplementary prescriber, nurse independent prescriber, optometrist independent prescriber, F18pharmacist independent prescriber, physiotherapist independent prescriber, podiatrist independent prescriber, therapeutic radiographer independent prescriberF25, paramedic independent prescriber or community practitioner nurse prescriber under—
- a
in England, the National Health Service Act 2006;
- b
in Wales, the National Health Service (Wales) Act 2006;
- c
in Scotland, the National Health Service (Scotland) Act 1978; and
- d
in Northern Ireland, the Health and Personal Social Services (Northern Ireland) Order 1972 M6;
- a
F3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
“independent clinic”—
- a
in relation to England, means an establishment of either of the following kinds—
- i
a walk-in centre, in which one or more medical practitioners provides services of a kind which, if provided in pursuance of the National Health Services Act 2006, would be provided as primary medical services under Part 4 of that Act, or
- ii
a surgery or consulting room in which a medical practitioner who provides no services in pursuance of the National Health Services Act 2006 provides medical services of any kind (including psychiatric treatment), except where such medical services are provided only under arrangements made on behalf of the patients by—
- aa
their employer,
- bb
a government department or any executive agency of any government department,
- cc
a prison or other establishment in which patients are held under custody, other than pursuant to any provision under the Mental Health Act 1983 M7, or
- dd
an insurance provider with whom the patients hold an insurance policy, other than an insurance policy which is solely or primarily intended to provide benefits in connection with the diagnosis or treatment of physical or mental illness, disability or infirmity,
and where two or more medical practitioners use different parts of the same premises as a surgery or consulting room, or use the same surgery or consulting room at different times, each of the medical practitioners shall be regarded as carrying on a separate independent clinic unless they practise together;
- aa
- i
- b
in relation to Wales, has the meaning given by section 2(4) of the Care Standards Act 2000 M8;
- c
in relation to Scotland, has the meaning given by section 10F(2) of the National Health Service (Scotland) Act 1978 M9; and
- d
in relation to Northern Ireland, has the meaning given by article 2(2) of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003 M10;
- a
“independent hospital”—
- a
in relation to England, means a hospital as defined by section 275 of the National Health Service Act 2006 that is not a health service hospital as defined by that section;
- b
in relation to Wales, has the meaning given by section 2(2) of the Care Standards Act 2000;
- c
in relation to Scotland, has the meaning given by section 10F(2) of the National Health Act 1978; and
- d
in relation to Northern Ireland, has the meaning given by article 2(2) of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003;
- a
“independent medical agency”—
- a
in relation to England, means an undertaking (not being an independent hospital) which consists of or includes the provision of services by medical practitioners, and the term “undertaking” in this definition includes any business or profession and—
- i
in relation to a public or local authority includes the exercise of any functions of that authority, and
- ii
in relation to any other body of persons, whether corporate or unincorporated, includes any of the activities of that body;
- i
- b
in relation to Wales, has the meaning given by section 2(5) of the Care Standards Act 2000;
- c
in relation to Scotland means an undertaking which is neither an independent clinic nor an undertaking comprised in a hospital and which consists of or includes the provision of services, other than in pursuance of the National Health Service (Scotland) Act 1978, by a medical practitioner; and
- d
in relation to Northern Ireland, has the meaning given by article 2(2) of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003;
- a
F4“local authority” has the same meaning as in section 2B of the National Health Service Act 2006;
F16“Maritime and Coastguard Agency” means the executive agency of that name of the Department for Transport;
“maximum daily dose” or “MDD”, in relation to a product for internal use, means the maximum quantity of the substance contained in the amount of the product that it is recommended should be taken or administered in any period of 24 hours;
“maximum dose” or “MD”, in relation to a product for internal use, means the maximum quantity of the substance contained in the amount of the product that it is recommended should be taken or administered at any one time;
“NHS body” means—
“NHS foundation trust” has the meaning given by section 30(1) of the National Health Service Act 2006;
“NHS trust”—
- a
in relation to England, means an NHS trust established under section 25(1) of the National Health Service Act 2006;
- b
in relation to Wales, means an NHS trust established under section 18(1) of the National Health Service (Wales) Act 2006;
- c
in relation to Scotland, means an NHS trust established under section 12A of the National Health Service (Scotland) Act 1978 M11; and
- d
in relation to Northern Ireland, means a Health and Social Care trust established under Article 10 of the Health and Personal Social Services (Northern Ireland) Order 1991 M12;
- a
“nursing home” has the meaning given by article 11 of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003 M13;
“parenteral administration” means administration by breach of the skin or mucous membrane;
“patient group direction” or “PGD” means a written direction that relates to the sale or supply and to the administration of a description or class of medicinal product and that—
- a
is signed—
- i
by a doctor or dentist and by a pharmacist, and
- ii
by any other person who may be required to sign it in the circumstances specified for its use in any provision of this Part; and
- i
- b
relates to sale or supply and to administration to persons generally (subject to any exclusions that may be specified in the PGD);
- a
F7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
“prison service” means—
- a
in relation to England and Wales, a Minister of the Crown exercising functions in relation to prisons (within the meaning of the Prison Act 1952 M14);
- b
in relation to Scotland, the Scottish Ministers exercising functions in relation to prisons (within the meaning of the Prisons (Scotland) Act 1989 M15); and
- c
in relation to Northern Ireland, the Department of Justice exercising functions in relation to prisons (within the meaning of the Prison Act (Northern Ireland) 1953 M16);
- a
F12“product subject to special medical prescription” means a prescription only medicine that has been designated as subject to special medical prescription in accordance with paragraph (3);
F17“Public Health Agency” means the Regional Agency for Public Health and Social Well-being established by section 12 of the Health and Social Care (Reform) Act (Northern Ireland) 2009;
“Public Health England” means the executive agency of that name of the Department of Health F28and Social Care;
“registered chiropodist” means a person who is registered in Part 2 of the Health and Care Professions Council register;
“registered dental hygienist” means a person registered under that title in the dental care professionals register;
“registered dental therapist” means a person registered under that title in the dental care professionals register;
F19. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
“registered dispensing optician” means a person whose name is entered in the register of dispensing opticians maintained under section 7(b) of the Opticians Act 1989 M17 or the register of visiting dispensing opticians from relevant European States maintained under section 8B(1)(b) M18 of that Act;
“registered occupational therapist” means a person who is registered in Part 6 of the Health and Care Professions Council register;
“registered orthoptist” means a person who is registered in Part 7 of the Health and Care Professions Council register;
“registered orthotist and prosthetist” means a person who is registered in Part 10 of the Health and Care Professions Council register;
F26. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F20. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F21. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
“registered provider”—
- a
in England, in relation to an independent hospital, independent clinic, an independent medical agency, a dental clinic or a dental practice means the person who is registered as a service provider under Chapter 2 of Part 1 of the Health and Social Care Act 2008 M19 in respect of regulated activities (within the meaning of that Part) carried on in that hospital, clinic, agency, dental clinic or dental practice;
- b
in Wales, in relation to an independent hospital, an independent clinic or an independent medical agency, means the person who is registered under Part 2 of the Care Standards Act 2000 as the person who carries on the hospital, clinic or agency;
- c
in Scotland, in relation to an independent hospital, an independent clinic or an independent medical agency, means the person who is registered under section 10P of the National Health Service (Scotland) Act 1978 M20; and
- d
in Northern Ireland, in relation to an independent hospital, an independent clinic, a nursing home or an independent medical agency, means the person who is registered under Part 3 of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003 as the person who carries on the hospital, clinic, nursing home or agency;
- a
F22. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
“registered speech and language therapist” means a person who is registered in Part 12 of Health and Care Professions Council register;
“relevant manager”—
- a
in England, means—
- i
a person, other than the registered provider, who is registered under Chapter 2 of Part 1 of the Health and Social Care Act 2008 as the manager of an independent hospital, independent clinic, an independent medical agency, a dental clinic or a dental practice, or
- ii
if there is no such person, but the registered provider has appointed a person to manage the hospital, clinic, agency, dental clinic or dental practice, that person;
- i
- b
in Wales, means—
- i
a person, other than the registered provider, who is registered under Part 2 of the Care Standards Act 2000 as the manager of an independent hospital, an independent clinic or an independent medical agency, or
- ii
if there is no such person, but the registered provider has appointed a person to manage the hospital, clinic or agency, that person;
- i
- c
in Scotland, means a person, other than the registered provider, who was identified as an individual who is to manage an independent hospital, an independent clinic or an independent medical agency on the application for registration of that clinic, hospital or agency under section 10P of the National Health Service (Scotland) Act 1978; and
- d
in Northern Ireland, means—
- i
a person, other than the registered provider, who is registered under Part 3 of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003 as the manager of an independent hospital, an independent clinic, a nursing home or an independent medical agency, or
- ii
if there is no such person, but the registered provider has appointed a person to manage the hospital, clinic, nursing home or agency, that person;
- i
- a
“relevant prescriber” means any of the following—
- a
a doctor;
- b
a dentist;
- c
a supplementary prescriber;
- d
a nurse independent prescriber;
- e
a pharmacist independent prescriber;
- f
a community practitioner nurse prescriber;
- fa
F23a physiotherapist independent prescriber;
- fb
a podiatrist independent prescriber;
- fc
a therapeutic radiographer independent prescriber;
- fd
F27a paramedic independent prescriber;
- g
an optometrist independent prescriber; and
- h
an EEA health professional;
- a
“repeatable prescription” means a prescription that contains a direction that it may be dispensed more than once;
F15“school” means—
- a
a maintained school (as defined in section 20(7) of the School Standards and Framework Act 1998);
- b
a maintained nursery school (as defined in section 22(9) of the School Standards and Framework Act 1998);
- c
an independent school (as defined in section 463 of the Education Act 1996) entered on a register of independent schools kept under section 158 of the Education Act 2002;
- d
an independent educational institution (as defined in section 92(1) of the Education and Skills Act 2008) entered on a register of independent educational institutions kept under section 95 of that Act;
- e
a school approved under section 342 of the Education Act 1996 (non-maintained special schools);
- f
a pupil referral unit (as defined in section 19 of the Education Act 1996);
- g
an alternative provision Academy (as defined in section 1C(3) of the Academies Act 2010);
- h
a school as defined in section 135(1) of the Education (Scotland) Act 1980; and
- i
a school as defined in Article 2(2) of the Education and Libraries (Northern Ireland) Order 1986.
- a
“sell” means sell by retail (and “sale” has a corresponding meaning);
“special health authority” means—
- a
in relation to England, a Special Health Authority established under section 28 of the National Health Service Act 2006;
- b
in relation to Wales, a Special Health Authority established under section 22 of the National Health Service (Wales) Act 2006;
- c
in relation to Scotland, a Special Health Board constituted under section 2(1)(b) of the National Health Service (Scotland) Act 1978 M21; and
- d
in relation to Northern Ireland, a special health and social care agency established under Article 3 of the Health and Personal Social Services (Special Agencies) (Northern Ireland) Order 1990 M22;
- a
“supply” means supply in circumstances corresponding to retail sale;
“unit preparation” means a preparation, including a mother tincture, that—
- a
is prepared by a process of—
- i
solution,
- ii
extraction, or
- iii
trituration,
with a view to being diluted tenfold or one hundredfold, either once or repeatedly, in an inert dilutent; and
- i
- b
is used—
- i
in that diluted form, or
- ii
where applicable, by impregnating tablets, granules, powders or other inert substances,
for the purpose of being administered to human beings.
- i
- a
2
In this Part—
a
a reference to a product being sold or supplied for the purpose of being administered in accordance with the written directions of a doctor or dentist relating to a person includes a reference to it being supplied in accordance with such directions; and
b
a reference to a product being sold or supplied for the purpose of being administered in accordance with a patient group direction includes a reference to it being supplied in accordance with a patient group direction.
F133
In this Part any substance or product for the time being specified in Schedule 1, 2 or 3 to the Misuse of Drugs Regulations 2001 or in Schedule 1, 2 or 3 to the Misuse of Drugs Regulations (Northern Ireland) 2002 is designated as a product subject to special medical prescription.
Pt. 12 modified (E.W.) (1.10.2015) by The Nicotine Inhaling Products (Age of Sale and Proxy Purchasing) Regulations 2015 (S.I. 2015/895), regs. 1(3), 4(2)