The Human Medicines Regulations 2012

CHAPTER 1 U.K. Interpretation

Interpretation U.K.

213.—(1) In this Part—

[F1 “approved country health professional” means a person who is practising in a profession included in the list published under regulation 214(6A) in a country that is included in that list in relation to that profession;]

F2 ...

“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 ;

F3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

“the dental care professionals register” means the register established and maintained under section 36B of the Dentists Act 1984 M2 ;

[F4 “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;]

F5 ...

F6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

“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;

“health authority” means—

(a)

F8 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(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 ;

“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, [F9 pharmacist independent prescriber, physiotherapist independent prescriber, podiatrist independent prescriber, therapeutic radiographer independent prescriber][F10 , 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 ;

F11 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

“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;

(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 ;

“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;

“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;

(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;

[F12 “integrated care board” means an integrated care board established under Chapter A3 of Part 2 of the National Health Service Act 2006;]

[F13 “local authority” has the same meaning as in section 2B of the National Health Service Act 2006;]

[F14 “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—

(a)

the Common Services Agency;

(b)

a health authority;

(c)

a special health authority;

(ca)

[F15 an integrated care board];

(cb)

[F16 NHS England];

(d)

F17 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(e)

an NHS trust; or

(f)

an NHS foundation trust;

“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 ;

“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

(b)

relates to sale or supply and to administration to persons generally (subject to any exclusions that may be specified in the PGD);

F18 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

“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 );

[F19 “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);]

[F20 “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 [F21 and 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;

F22 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

“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;

[F23 “registered pharmacy technician” means a person registered in Part 2 of the Register of pharmacists and pharmacy technicians established and maintained under article 19(1) and (2) of the Pharmacy Order 2010;]

F24 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F25 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F26 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

“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;

F27 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

“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;

(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;

(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;

“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)

[F28 a physiotherapist independent prescriber;

(fb)

a podiatrist independent prescriber;

(fc)

a therapeutic radiographer independent prescriber;]

(fd)

[F29 a paramedic independent prescriber;]

(g)

an optometrist independent prescriber; and

(h)

an [F30 approved country health professional];

“repeatable prescription” means a prescription that contains a direction that it may be dispensed more than once;

[F31 “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.]

“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 ;

“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

(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.

(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.

[F32 (3) 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.]

Textual Amendments

F1 Words in reg. 213(1) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 179(a); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in reg. 213(1) omitted (1.7.2022) by virtue of The Health and Care Act 2022 (Consequential and Related Amendments and Transitional Provisions) Regulations 2022 (S.I. 2022/634), regs. 1(2), 57(2)(a)

F3 Words in reg. 213(1) omitted (E.W.S.) (31.3.2014) by virtue of The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 4(a)(i) and words in reg. 213(1) omitted (N.I.) (31.3.2014) by virtue of The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 4(a)(i)

F4 Words in reg. 213(1) inserted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 4(a)(ii) and words in reg. 213(1) inserted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 4(a)(ii)

F5 Words in reg. 213(1) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 179(b); 2020 c. 1, Sch. 5 para. 1(1)

F6 Words in reg. 213(1) omitted (E.W.S.) (31.3.2014) by virtue of The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 4(a)(iv) and words in reg. 213(1) omitted (N.I.) (31.3.2014) by virtue of The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 4(a)(iv)

F7 Words in reg. 213(1) omitted (1.10.2017) by virtue of The Human Medicines (Amendment) Regulations 2017 (S.I. 2017/715), regs. 1, 6 and words in reg. 213(1) omitted (N.I.) (1.10.2017) by virtue of The Human Medicines (Amendment) Regulations 2017 (S.R. 2017/241), regs. 1, 6

F8 Words in reg. 213(1) omitted (1.4.2013) by virtue of The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(2)(b) (with Sch. 3 para. 28)

F9 Words in reg. 213(1) substituted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 8(2)(a) and words in reg. 213(1) substituted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 8(2)(a)

F10 Words in reg. 213(1) inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 5(2)(a) and words in reg. 213(1) inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 5(2)(a)

F11 Words in reg. 213(1) omitted (1.4.2013) by virtue of The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(2)(c) (with Sch. 3 para. 28)

F12 Words in reg. 213(1) inserted (1.7.2022) by The Health and Care Act 2022 (Consequential and Related Amendments and Transitional Provisions) Regulations 2022 (S.I. 2022/634), regs. 1(2), 57(2)(b)

F13 Words in reg. 213(1) inserted (1.4.2013) by The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(2)(d) (with Sch. 3 para. 28)

F14 Words in reg. 213(1) inserted (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 3(2)(a) and words in reg. 213(1) inserted (N.I.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 3(2)(a)

F15 Words in Regulations substituted (1.7.2022) by The Health and Care Act 2022 (Consequential and Related Amendments and Transitional Provisions) Regulations 2022 (S.I. 2022/634), reg. 1(2), Sch. para. 1(1)(3) (with Sch. para. 1(2))

F16 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

F17 Words in reg. 213(1) omitted (1.4.2013) by virtue of The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(2)(e)(ii) (with Sch. 3 para. 28)

F18 Words in reg. 213(1) omitted (1.4.2013) by virtue of The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(2)(f) (with Sch. 3 para. 28)

F19 Words in reg. 213(1) inserted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 4(a)(v) and words in reg. 213(1) inserted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 4(a)(v)

F20 Words in reg. 213(1) inserted (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 3(2)(b) and words in reg. 213(1) inserted (N.I.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 3(2)(b)

F21 Words in reg. 213(1) inserted (11.4.2018) by The Secretaries of State for Health and Social Care and for Housing, Communities and Local Government and Transfer of Functions (Commonhold Land) Order 2018 (S.I. 2018/378), art. 1(2), Sch. para. 20(w) (with art. 14)

F22 Words in reg. 213(1) omitted (E.W.S.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 8(2)(b) and words in reg. 213(1) omitted (N.I.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 8(2)(b)

F23 Words in reg. 213(1) inserted (26.6.2024) by The Human Medicines (Amendments relating to Registered Dental Hygienists, Registered Dental Therapists and Registered Pharmacy Technicians) Regulations 2024 (S.I. 2024/729), regs. 1(2), 3

F24 Words in reg. 213(1) omitted (1.4.2018) by virtue of The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 5(2)(b) and words in reg. 213(1) omitted (N.I.) (1.4.2018) by virtue of The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 5(2)(b)

F25 Words in reg. 213(1) omitted (E.W.S.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 8(2)(c) and words in reg. 213(1) omitted (N.I.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 8(2)(c)

F26 Words in reg. 213(1) omitted (E.W.S.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 8(2)(d) and words in reg. 213(1) omitted (N.I.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 8(2)(d)

F27 Words in reg. 213(1) omitted (E.W.S.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 8(2)(e) and words in reg. 213(1) omitted (N.I.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 8(2)(e)

F28 Words in reg. 213(1) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 8(2)(f) and words in reg. 213(1) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 8(2)(f)

F29 Words in reg. 213(1) inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 5(2)(c) and words in reg. 213(1) inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 5(2)(c)

F30 Words in reg. 213(1) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 179(c); 2020 c. 1, Sch. 5 para. 1(1)

F31 Words in reg. 213(1) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 22(b) and words in reg. 213(1) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 22(b)

F32 Reg. 213(3) inserted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 4(b) and reg. 213(3) inserted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 4(b)

Marginal Citations

M1 1978 c.29. Section 10(1) was amended by the Health Services Act 1980 (1980 c.53), Schedule 6 paragraph 2. There are other amendments not relevant to these Regulations.

M2 1984 c.24. Section 36B was inserted by S.I. 2005/2011, articles 2(1) and 29.

M3 2006 c.42.

M4 1978 c.29. Section 2(1)(a) was amended by section 28(a)(i) of the National Health Service and Community Care Act 1990 (1990 c.19) and section 14(2) of, and paragraph 1 of Schedule 7 to, the Health and Social Services and Social Security Adjudications Act 1983 (1983 c.41).

M5 2009 c.1 (N.I.).

M6 S.I. 1972/1265 (N.I. 14).

M7 1983 c.20.

M8 2000 c.14.

M9 1978 c.29. Section 10F was inserted by section 108 of the Public Services Reform (Scotland) Act 2010 (2010 asp 8).

M10 S.I. 2003/431 (N.I. 9).

M11 1978 c.29. Section 12A was inserted by section 31 of the National Health Service and Community Care Act 1990 (1990 c.19), and amended by section 46(1)(a) of the Health Act 1999 (1999 c.8).

M12 S.I. 1991/194 (N.I. 1), Health and Social Services trusts were renamed Health and Social Care trusts by section 1(3) of the Health and Social Care (Reform) Act (Northern Ireland) 2009 (2009 c.1 (N.I.)). There are other amendments not relevant to this regulation.

M13 References to a nursing home in these Regulations concern Northern Ireland only.

M14 1952 c.52.

M15 1989 c.45.

M16 1953 c.18 (N.I.). Functions transferred by article 6(1) of, and Schedule 4 to, S.I. 2010/976.

M17 1989 c.44; section 7 was amended by S.I. 2005/848, articles 2 and 7(1).

M18 Section 8B was inserted by S.I. 2007/3101, regulations 178 and 180.

M19 2008 c.14.

M20 1978 c.29. Section 10P was inserted by section 108 of the Public Services Reform (Scotland) Act 2010 (2010 asp 8).

M21 Section 2(1)(b) was inserted by section 28(a) of the National Health Service and Community Care Act 1990 (1990 c.19).

M22 S.I. 1990/247 (N.I. 3). Special Health and Social Services Agencies were renamed Special Health and Social Care Agencies by section 1(4) of the Health and Social Care (Reform) Act (Northern Ireland) 2009 (2009 c.1 (N.I.)).