The Human Medicines Regulations 2012

Type Statutory-Instrument
Publication 2012-07-19
Last updated 2026-03-31
State In force
Department King's Printer of Acts of Parliament
PDF Download
articles 4
Reform history JSON API
  • (d) reference to the class or description of medicinal product which may be prescribed or administered under the plan;
  • (e) any restrictions or limitations as to the strength or dose of any product which may be prescribed or administered under the plan, and any period of administration or use of any medicinal product which may be prescribed or administered under the plan;
  • (f) relevant warnings about the known sensitivities of the patient to, or known difficulties of the patient with, particular medicinal products;
  • (g) the arrangements for notification of—
  • (i) suspected or known adverse reactions to any medicinal product which may be prescribed or administered under the plan, and
  • (ii) suspected or known adverse reactions to any other medicinal product taken at the same time as any medicinal product prescribed or administered under the plan; and
  • (h) the circumstances in which the supplementary prescriber should refer to, or seek the advice of, the doctor or dentist who is a party to the plan.
  • Pharmacists.
  • Registered chiropodists and podiatrists.
  • Registered dental hygienist.
  • Registered dental therapist.
  • Registered dietitians.
  • Registered midwives.
  • Registered nurses.
  • Registered occupational therapists.
  • Registered optometrists.
  • Registered orthoptists.
  • Registered orthotists and prosthetists.
  • Registered paramedics.
  • Registered pharmacy technicians.
  • Registered physiotherapists.
  • Registered radiographers.
  • Registered speech and language therapists.
  • Ammonium bromide
  • Calcium bromide
  • Calcium bromidolactobionate
  • Embutramide
  • Fencamfamin hydrochloride
  • Fluanisone
  • Hexobarbitone
  • Hexobarbitone sodium
  • Hydrobromic acid
  • Meclofenoxate hydrochloride
  • Methohexitone sodium
  • Pemoline
  • Piracetam
  • Potassium bromide
  • Prolintane hydrochloride
  • Sodium bromide
  • Strychnine hydrochloride
  • Tacrine hydrochloride
  • Thiopentone sodium
  • Adrenaline 1:1000 up to 1mg for intramuscular use in anaphylaxis
  • Atropine sulphate and obidoxime chloride injection
  • Atropine sulphate and pralidoxime chloride injection
  • Atropine sulphate injection
  • Atropine sulphate, pralidoxime mesilate and avizafone injection
  • Chlorphenamine injection
  • Dicobalt edetate injection
  • Glucagon injection
  • Glucose injection
  • Hydrocortisone injection
  • Naloxone products
  • Pralidoxime chloride injection
  • Pralidoxime mesilate injection
  • Promethazine hydrochloride injection
  • Snake venom antiserum
  • Sodium nitrite injection
  • Sodium thiosulphate injection
  • Sterile pralidoxime
  • Agaricus muscarius
  • Ailanthus glandulosa
  • Apocynum cannabinum
  • Aurum lodatum
  • Belladonna
  • Bismuth Subgallate
  • Bryonia alba dioica
  • Calcium Fluoride
  • Cantharis
  • Cerium oxalicum
  • Chelidonium majus
  • Chenopodium oil
  • Cina
  • Colocynthis
  • Convallaria majalis
  • Gelsemium sempervirens
  • Hyoscyamus niger
  • Lycopodium
  • Manganese acetate
  • Ranunculus bulbosus
  • Terebinthinae oleum
  • Adonis vernalis
  • Agaricus bulbosus
  • Agaricus muscarius
  • Agnus castus
  • Ailanthus glandulosa
  • Alum
  • Amethyst
  • Ammonium Iodide
  • Amygdalae amarae
  • Apatite
  • Apocynum androsaemifolium
  • Apocynum cannabinum
  • Argentite
  • Argentum Chloride
  • Argentum Iodide
  • Arnica
  • Artemisia cina
  • Aspidium filix-mas
  • Aspidium anthelmintica
  • Aurum Sulphide
  • Balsamum copivae
  • Balsamum peruvianum
  • Barium Citrate
  • Barium Citrate
  • Barium Sulphate
  • Bismuth Metal
  • Bismuth Subgallate
  • Bismuth Subnitrate
  • Boletus laricis
  • Bovista
  • Cade Oil
  • Calcium Fluoride
  • Cantharis
  • Carduus marianus
  • Cedar Wood Oil
  • Cerium Oxalicum
  • Chalcocite
  • Chalcopyrite
  • Chelidonium majus
  • Chenopodium Oil
  • Colocynthis
  • Convallaria majalis
  • Copper Silicate, Nat.
  • Crotalus horridus
  • Cucurbita
  • Cucumis melo
  • Datura Stramonium
  • Derris
  • Diamond
  • Ephedra vulgaris
  • Ferric Acetate
  • Ferrous Iodide
  • Ferrous Oxalate
  • Ferrous Sulphide
  • Formic Acid
  • Gall
  • Gelsemium sempervirens
  • Gneiss
  • Granatum ( Pomegranate) Bark
  • Harmamelis Virginiana
  • Hepar Sulfuris
  • Hyoscyamus niger
  • Iris florentine
  • Jaborandi
  • Juniperus sabina
  • Kalinite
  • Lachmanthus tinctoria
  • Lapis Albus
  • Lycopodium
  • Magnesium
  • Magnesium Acetate
  • Magnesium Chloride
  • Magnetite
  • Manganese Acetate
  • Nicotiana tabacum
  • Nicotiana tabacum oil
  • Oleander
  • Opuntia vulgaris
  • Oxalic Acid
  • Petroleum
  • Phellandrium aquaticum
  • Pix Liquida
  • Platinum
  • Platinum Chloride
  • Potassium Hydroxide
  • Potassium Silicate
  • Pyrethrum
  • Pyrolusite
  • Ranunculus acris
  • Ranunculus bulbosus
  • Ranunculus flammula
  • Ranunculus repens
  • Ranunculus sceleratus
  • Rhodium Oxynitrate
  • Rhododendron chrysanthemum
  • Rhus toxicodendron
  • Salicylic Acid
  • Scrophularia aquatica
  • Sodium Aluminium Chloride
  • Sodium Auro-chloride
  • Sodium Hypochlorite
  • Sodium Nitrate
  • Squill
  • Stannum Metal
  • Staphisagria
  • Sulphur Iodide
  • Tamus communis
  • Tannic Acid
  • Terebinthinae Oleum
  • Theridion
  • Thuja occidentalis
  • Topaz
  • Uric Acid
  • Zinc Hypophosphite
  • Zinc Isovalerate
  • Abies excelsa
  • Abies nigra
  • Abies nobilis
  • Acalpha indica
  • Agate
  • Alisma plantago Aq.
  • Alstonia scholaris
  • Aluminium
  • Amber (Succinum)
  • Ambra grisea
  • Ammonium Phosphate
  • Angostura vera
  • Anthoxanthum
  • Apis mellifera
  • Aqua Marina
  • Aqua Mellis
  • Aralia racemosa
  • Aranea diadema
  • Arum maculatum
  • Arum triphyllum
  • Asarum
  • Asperula odorata
  • Astacus fluviatillis
  • Auric Chloride
  • Badiaga
  • Beech (fagus sylvestris)
  • Bellis perennis
  • Berberis aquifolium
  • Borago officinalis
  • Butyric Acid
  • Calcium Metal
  • Calcium Chloride
  • Calcium Oxide
  • Calcium Sulphate
  • Castoreum
  • Ceanothus americanus
  • Cedron
  • Cerato (Ceratostigma Willmottiana)
  • Cherry Plum (Prunus cerasifera)
  • Chestnut, Red and Sweet
  • Cholesterinum
  • Chrysolite
  • Cistus canadensis
  • Clematis erecta
  • Conchae vera
  • Conchiolinum
  • Corallium Rubrum
  • Crab Apple
  • Crocus sativus
  • Erbium
  • Erigeron Canadense
  • Fuligo
  • Genista tinctoria
  • Geum urbanum
  • Glycogen
  • Gnaphalium leontopodium
  • Gold
  • Gorse (Ulex europaeus)
  • Graphites
  • Gratiola officinalis
  • Gymnocladus (American Coffee Tree)
  • Haematoxylon Campechianum
  • Hecla Lava (Ash from Mount Hecla)
  • Hedeoma pulegioides
  • Hedra helix
  • Heliotrope
  • Heracleum spondylium
  • Herniaria
  • Hornbeam (Carpinus betulus)
  • Iberis amara
  • Impatiens
  • Iris germanica
  • Iris pseudacorus
  • Jacaranda procera
  • Jatropha curcas
  • Juncus communis
  • Justica adhatoda
  • Lamium album
  • Laurus nobilis oil
  • Laurocerasus
  • Ledum palustre
  • Lilium tigrinum
  • Lonicera caprifolium
  • Lysimachia vulgaris
  • Magnesium Phosphate
  • Magnesite
  • Magnolia
  • Marum verum
  • Melilotus officinalis
  • Menispermum canadense
  • Pephitis putorius
  • Mercurialis perennis
  • Mimulus (Mimullis guttatus)
  • Moschus
  • Myrica gale
  • Myrtus communis
  • Ocimum basilicum
  • Olive
  • Oxalis acetosella
  • Pangamic Acid
  • Paullinia cupana
  • Penthorum sedoides
  • Pollen (mixed)
  • Polygonatum multiflorum
  • Polygonum aviculare
  • Polypodium vulgare
  • Primula vulgaris
  • Prunella vulgaris
  • Ptellea trifoliata
  • Ratanhia
  • Robinia pseudoacacia
  • Rubia tinctorum
  • Rumex acetosella
  • Sal Marina
  • Sarcolactic Acid
  • Sarracenia purpurea
  • Scleranthus (Scleranthus annuus)
  • Silica
  • Silphium laciniathum
  • Sodium Benzoate
  • Spongia marina
  • Star of Bethlehem (Ornithogalum umbellatum)
  • Ulmus campestris
  • Vine
  • Walnut (juglerus regia)
  • Water Violet (Hottonia palustris)
  • Wild Oat
  • Wild Rose

Abies nigra

Abies nobilis

Acalpha indica

Agate

Alisma plantago Aq.

Alstonia scholaris

Aluminium

Amber (Succinum)

Ambra grisea

Ammonium Phosphate

Angostura vera

Anthoxanthum

Apis mellifera

Aqua Marina

Aqua Mellis

Aralia racemosa

Aranea diadema

Arum maculatum

Arum triphyllum

Asarum

Asperula odorata

Astacus fluviatillis

Auric Chloride

Badiaga

Beech (fagus sylvestris)

Bellis perennis

Berberis aquifolium

Borago officinalis

Butyric Acid

Calcium Metal

Calcium Chloride

Calcium Oxide

Calcium Sulphate

Castoreum

Ceanothus americanus

Cedron

Cerato (Ceratostigma Willmottiana)

Cherry Plum (Prunus cerasifera)

Chestnut, Red and Sweet

Cholesterinum

Chrysolite

Cistus canadensis

Clematis erecta

Conchae vera

Conchiolinum

Corallium Rubrum

Crab Apple

Crocus sativus

Erbium

Erigeron Canadense

Fuligo

Genista tinctoria

Geum urbanum

Glycogen

Gnaphalium leontopodium

Gold

Gorse (Ulex europaeus)

Graphites

Gratiola officinalis

Gymnocladus (American Coffee Tree)

Haematoxylon Campechianum

Hecla Lava (Ash from Mount Hecla)

Hedeoma pulegioides

Hedra helix

Heliotrope

Heracleum spondylium

Herniaria

Hornbeam (Carpinus betulus)

Iberis amara

Impatiens

Iris germanica

Iris pseudacorus

Jacaranda procera

Jatropha curcas

Juncus communis

Justica adhatoda

Lamium album

Laurus nobilis oil

Laurocerasus

Ledum palustre

Lilium tigrinum

Lonicera caprifolium

Lysimachia vulgaris

Magnesium Phosphate

Magnesite

Magnolia

Marum verum

Melilotus officinalis

Menispermum canadense

Pephitis putorius

Mercurialis perennis

Mimulus (Mimullis guttatus)

Moschus

Myrica gale

Myrtus communis

Ocimum basilicum

Olive

Oxalis acetosella

Pangamic Acid

Paullinia cupana

Penthorum sedoides

Pollen (mixed)

Polygonatum multiflorum

Polygonum aviculare

Polypodium vulgare

Primula vulgaris

Prunella vulgaris

Ptellea trifoliata

Ratanhia

Robinia pseudoacacia

Rubia tinctorum

Rumex acetosella

Sal Marina

Sarcolactic Acid

Sarracenia purpurea

Scleranthus (Scleranthus annuus)

Silica

Silphium laciniathum

Sodium Benzoate

Spongia marina

Star of Bethlehem (Ornithogalum umbellatum)

Ulmus campestris

Vine

Walnut (juglerus regia)

Water Violet (Hottonia palustris)

Wild Oat

Wild Rose

  • Adonis vernalis
  • Agricus bulbosus
  • Agricus muscarius
  • Agnus castus
  • Allanthus glandulosa
  • Alum
  • Amethyst
  • Ammonium Iodide
  • Amygdalae amarae
  • Apatite
  • Apocynum androsaemifolium
  • Apocynum cannabinum
  • Argentite
  • Argentum Chloride
  • Argentum Iodide
  • Artemisia cina
  • Aspidium filix-mas
  • Aspidium anthelmintica
  • Aurum Sulphide
  • Balsamum copaivae
  • Balsamum peruvianum
  • Barium Citrate
  • Barium Sulphate
  • Bismuth Metal
  • Bismuth Subgallate
  • Bismuth Subnitrate
  • Boletus laricis
  • Bovista
  • Cade Oil
  • Calcium Fluoride
  • Carduus marianus
  • Cedar Wood Oil
  • Cerium Oxalicum
  • Chalcocite
  • Chalcopyrite
  • Chelidonium majus
  • Chenopodium Oil
  • Colocynthis
  • Convallaria majalis
  • Copper Silicate, Nat
  • Crotalus horridus
  • Cucurbita
  • Cucumis melo
  • Datura stramonium
  • Derris
  • Diamond
  • Ephedra vulgaris
  • Ferric Acetate
  • Ferrous Iodide
  • Ferrous Oxalate
  • Ferrous Sulphide
  • Formic Acid
  • Gall
  • Gelsemium sempervirens
  • Gneiss
  • Hamamelis virginiana
  • Hepar Sulfuris
  • Hyoscyamus niger
  • Iris florentine
  • Jaborandi
  • Juniperus sabina
  • Kaolinite
  • Lachmanthus tinctoria
  • Lapis Albus
  • Lycopodium
  • Magnesium
  • Magnesium Acetate
  • Magnesium Chloride
  • Magnetite
  • Manganese Acetate
  • Nicotiana tabacum
  • Nicotiana tabacum oil
  • Oleander
  • Opuntia vulgaris
  • Oxalic Acid
  • Petroleum
  • Phellandrium aquaticum
  • Pix Liquida
  • Platinum
  • Platinum Chloride
  • Potassium Hydroxide
  • Potassium Silicate
  • Pyrethrum
  • Pyrolusite
  • Ranunculus acris
  • Ranunculus bulbosus
  • Ranunculus flammula
  • Ranunculus repens
  • Ranunculus scelerantus
  • Rhodium Oxynitrate
  • Rhododendron chrysanthemum
  • Rhus toxicidendron
  • Salicylic Acid
  • Scrophularia aquatica
  • Sodium Aluminium Chloride
  • Sodium Auro-chloride
  • Sodium Hypochlorite
  • Sodium Nitrate
  • Squill
  • Stannum Metal
  • Sulphur Iodide
  • Tannic Acid
  • Terebinthinae Oleum
  • Topaz
  • Uric Acid
  • Zinc Hypophosphite
  • Zinc Isovalerate

Doctors

Dentists

Persons lawfully conducting a retail pharmacy business within the meaning of section 69 of the Medicines Act 1968.

Authorities or persons carrying on the business of—

  • (a) an independent hospital, independent clinic or independent medical agency,
  • (b) a hospital or health centre which is not an independent hospital or independent clinic, or
  • (c) in Northern Ireland, a nursing home.

Holders of wholesale dealer's licences or persons to whom the restrictions imposed by regulation 18(1) do not apply by virtue of an exemption in these Regulations.

Ministers of the Crown and Government departments.

Scottish Ministers.

Welsh Ministers.

A Northern Ireland Minister.

An NHS trust.

An NHS foundation trust.

The Common Services Agency.

A health authority or a special health authority.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

A person other than an excepted person who carries on a business consisting (wholly or partly) of supplying medicinal products in circumstances corresponding to retail sale, or of administering such products, pursuant to an arrangement made with—

  • (a) an NHS trust or an NHS foundation trust;
  • (b) the Common Services Agency;
  • (ba) an integrated care board;
  • (bb) NHS England;
  • (bc) a local authority;
  • (bd) the United Kingdom Health Security Agency;
  • (be) Public Health Agency; or
  • (c) a health authority or a special health authority; ...
  • (d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

A person other than an excepted person who carries on a business consisting (wholly or partly) of the supply or administration of medicinal products for the purpose of assisting the provision of health care by or on behalf of, or under arrangements made by—

  • (a) a police force in England, Wales or Scotland;
  • (b) the Police Service of Northern Ireland;
  • (c) a prison service; ...
  • (d) Her Majesty’s Forces; or
  • (e) a contractor carrying out helicopter search and rescue operations on behalf of the Maritime and Coastguard Agency.

In this Schedule “excepted person” means—

  • (a) a doctor or dentist; or
  • (b) a person lawfully conducting a retail pharmacy business within the meaning of section 69 of the Medicines Act 1968.

Introductory

Division of sample

Notice to person named on container

Analysis or other examination

Provisions as to evidence

Analysis under direction of court

Proof by written statement

Payment for sample taken under compulsory powers

Continuity of the law

Product licences

Product licences of right

Classification of UK marketing authorisation and certificate of registration

Advanced therapy medicinal products

Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010 (S.I. 2010/1882)

Section 60 of the Medicines Act 1968 etc

Editorial notes

[^c21327901]: 1972 c.68. Section 2(2) was amended by section 27(1)(a) of the Legislative Reform Act 2006 (2006 c,51) and section 3(3) of and Part 1 of the Schedule to the European Union (Amendment) Act 2008 (2008 c.7). Section 2(5) was amended by section 41(1) of and Part 1 of Schedule 6 to the Northern Ireland Constitution Act 1973 (1973 c.36).

[^c21327911]: S.I. 1972/1811.

[^c21327921]: S.I. 1999/2027.

[^c21327931]: 1968 c.67.

[^c21327941]: Section 10(1) was amended by paragraph 10(a) of Part 1 of Schedule 8 to S.I. 2006/2407, paragraph 5(a) of Schedule 3 to the Regulation of Care (Scotland) Act 2001, and article 3 of S.I. 1971/1445. Section 10(2) was repealed by paragraph 10(b) and (3)(b) was repealed by paragraph 10(c) of Part 1 of Schedule 8 to S.I. 2006/2407. Section 10(4) was amended and section 10(5) and (6) inserted by article 3 of S.I. 1971/1445. Section 10(6A) was repealed by paragraph 10(d) of Part 1 of Schedule 8 to S.I. 2006/2407. Section 10(7) was inserted by article 3 of S.I. 1971/1445, and amended by regulation 3 of S.I. 1993/834. Section 10(7A) to (7C) was inserted by the Health Act 2006 section 26(1), and section 10(7A) was amended by paragraph 10(e) of Part 1 of Schedule 8 to S.I. 2006/2407. Section 10(8) was inserted by S.I. 1971/1445 article 3. Section 10(9) was inserted by paragraph 5(a) of Schedule 3 to the Regulation of Care (Scotland) Act 2001.

[^c21327961]: 2006 c.41.

[^c21327971]: S.I. 1972/1265 (N.I. 14).

[^c21327981]: 2009 c.1 (N.I.).

[^c21327991]: 2006 c.42.

[^c21328001]: 1978 c.29.

[^c21328011]: OJ No L 121, 1.5.2001, p.34. Directive 2001/20/EC was last amended by Regulation (EC) No 596/2009 (OJ No L 188, 18.7.2009, p.14).

[^c21328021]: S.I. 2004/1031, to which there are amendments not relevant to these Regulations.

[^c21328031]: 1984 c.24. Section 14 was substituted by the Dentists Act 1984 (Amendment) Order 2005 (S.I. 2005/2011) articles 2 and 6 and further amended by the European Qualifications (Health and Social Care Professions) Regulations 2007 (S.I. 2007/3101), regulations 109 and 111. Other amendments of the Dentists Act are not relevant to these Regulations.

[^c21328061]: 2003 c.21.

[^c21328081]: S.I. 2002/254, as amended by S.I. 2009/1182. There are other amendments that are not relevant.

[^c21328091]: S.I. 2010/231.

[^c21328101]: 1993 c.21. Section 41 was amended by S.I. 2007/3101 regulations 206 and 214.

[^c21328111]: 1994 c.17.

[^c21328131]: 1984 c.24. Section 36B was inserted by S.I. 2005/2011, articles 2(1) and 29.

[^c21328141]: S.I. 2006/1440, Schedule.

[^c21328151]: 2006 c.41.

[^c21328161]: 2006 c.42.

[^c21328171]: 1978 c.29. Concurrent functions under section 36(1) were transferred to the National Waiting Times Board by article 4(2)(c) and (4) of S.S.I. 2002/305.

[^c21328181]: S.I. 1972/1265 (N.I. 14), as amended by S.I. 1984/1158 (N.I. 8), S.I. 1986/595 ( N.I. 4) and 2004/311 (N.I. 2).

[^c21328191]: 1997 c.46.

[^c21328201]: S.I. 1997/1177 (N.I. 7).

[^c21328211]: OJ No L 378, 27.12.2006, p.1. Regulation (EC) No 1901/2006, as amended by Regulation (EC) No 1902/2006 (OJ No L 378, 27.12.2006, p.20) .

[^c21328221]: S.I. 2010/231.

[^c21328231]: S.I. 1976/1213 (N.I. 22), as amended by S.R. 2008 No. 192.

[^c21328241]: S.I. 2002/253, as amended by S.I. 2009/1182.

[^c21328251]: 1989 c.44; section 7(a) was amended by S.I. 2005/848, articles 2 and 7(1).

[^c21328271]: 1968 c.67. Sections 74A and 74J were inserted by article 68 of and paragraph 1 of Schedule 4 to S.I. 2010/231.

[^c21328281]: Section 75 was amended by article 68 of and paragraph 1 of Schedule 4 to S.I. 2010/231

[^c21328311]: OJ No L 334, 12.12.2008, p.7.

[^c21328431]: 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.

[^c21328461]: 1984 c.24. Section 36B was inserted by S.I. 2005/2011, articles 2(1) and 29.

[^c21328491]: 2006 c.42.

[^c21328501]: 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).

[^c21328521]: S.I. 1972/1265 (N.I. 14).

[^c21328541]: 1983 c.20.

[^c21328551]: 2000 c.14.

[^c21328561]: 1978 c.29. Section 10F was inserted by section 108 of the Public Services Reform (Scotland) Act 2010 (2010 asp 8).

[^c21328571]: S.I. 2003/431 (N.I. 9).

[^c21328581]: 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).

[^c21328591]: 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.

[^c21328601]: References to a nursing home in these Regulations concern Northern Ireland only.

[^c21328611]: 1952 c.52.

[^c21328621]: 1989 c.45.

[^c21328631]: 1953 c.18 (N.I.). Functions transferred by article 6(1) of, and Schedule 4 to, S.I. 2010/976.

[^c21328641]: 1989 c.44; section 7 was amended by S.I. 2005/848, articles 2 and 7(1).

[^c21328651]: Section 8B was inserted by S.I. 2007/3101, regulations 178 and 180.

[^c21328661]: 2008 c.14.

[^c21328671]: 1978 c.29. Section 10P was inserted by section 108 of the Public Services Reform (Scotland) Act 2010 (2010 asp 8).

[^c21328681]: Section 2(1)(b) was inserted by section 28(a) of the National Health Service and Community Care Act 1990 (1990 c.19).

[^c21328691]: 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.)).

[^c21328701]: 1998 c.29.

[^c21328711]: 1978 c.29.

[^c21328721]: 2008 c.14.

[^c21328731]: Regulated activities for the purposes of section 10 are defined in section 8 of that Act and set out in regulation 3 of, and Schedule 1 to, S.I. 2010/781.

[^c21328741]: 2008 No. 1976 (W. 185).

[^c21328771]: S.S.I. 2004/115

[^c21328781]: S.R. (NI) 2004 No. 140.

[^c21328791]: OJ No L 18, 22.1.2000, p.1, as amended by Regulation (EC) No 596/2009 (OJ No L 188, 18.7.2009, p.14.

[^c21328801]: 2003 c.21.

[^c21328811]: 2003 c.21.

[^c21328821]: 1990 c.42.

[^c21328831]: 1996 c.55.

[^c21328841]: Section 56(1) was amended by section 406(7) of and Schedule 19(1) to the Communications Act 2003.

[^c21328851]: 1994 c.39. There is an amendment to section 2(1) that is not relevant to this regulation.

[^c21328861]: 1972 c.9 (N.I.).

[^c21328871]: 1990 c.16. Section 27 was amended by the Local Government etc (Scotland) Act 1994 section 180(1) and Schedule 18 paragraph 163(3), the Food Standards Act 1999 section 40(1) and Schedule 5 paragraphs 7 and 8, the Local Government (Wales) Act 1994 section 22(3) and Schedule 9 paragraph 16(2), S.I. 1994/865 regulation 24, and the Local Government and Public Involvement in Health Act 2007 sections 22 and 241, Schedule 1 Part 2 paragraph 17, and Schedule 18 Part 1.

[^c21328881]: 1991 No. 762 (N.I. 7). There are amendments not relevant to these Regulations.

[^c21328891]: 2000 c.36.

[^c21328901]: 1995 c. 46.

[^c21328911]: 1987 c.43. Section 2(4) was repealed in relation to England and Wales by S.I. 2000/2771 article 2(1) and (3) and in relation to Scotland by S.S.I. 2001/265 article 2(1) and (3).

[^c21328921]: S.I. 1987/2049 (N.I. 20), as amended by 2001 c.13 (NI).

[^c21328941]: S.I. 1997/1830, as amended by S.I. 1997/2044, S.I. 1998/108, S.I. 1998/1178, S.I. 1998/2081, S.I. 1999/1044, S.I. 1999/3463, S.I. 2000/1917, S.I. 2000/2899, S.I. 2000/3231, S.I. 2001/2777, S.I. 2001/3942, S.I. 2003/696 and S.I. 2006/915 and these Regulations. There are other amendments, but none is relevant.

[^c21328981]: OJ No L 147, 9.6.1975, p.13, no longer in force.

[^c21328991]: OJ No L 18, 22.1.2000, p.1, as amended by Regulation (EC) No 596/2009 (OJ No L 188, 18.7.2009, p.14.

[^c21329001]: OJ No L 31, 1.2.2002, p.1, as last amended by Regulation (EC) No 596/2009 (OJ No L 188, 18.7.2009, p. 14).

[^c21329011]: OJ No L 334, 12.12.2008, p.7.

[^c21329021]: OJ No L 15, 17.1.1987. p.38.

[^c21329031]: 1996 c.16.

[^c21329041]: 1967 c.77.

[^c21329051]: 1990 c.16. Section 27 was amended by the Local Government etc (Scotland) Act 1994 section 180(1) and Schedule 18 paragraph 163(3), the Food Standards Act 1999 section 40(1) and Schedule 5 paragraphs 7 and 8, the Local Government (Wales) Act 1994 section 22(3) and Schedule 9 paragraph 16(2), S.I. 1994/865 regulation 24, and the Local Government and Public Involvement in Health Act 2007 sections 22 and 241, Schedule 1 Part 2 paragraph 17, and Schedule 18 Part 1.

[^c21329061]: 1991 No. 762 (N.I. 7). There are amendments not relevant to these Regulations.

[^c21329071]: 1990 c.16.

[^c21329081]: 1989 No. 846 (N.I. 6).

[^c21329091]: 2006 c. 41.

[^c21329101]: 1978 c. 29.

[^c21329111]: 2006 c. 42.

[^c21329121]: S.I. 1972/1265 (N.I. 14).

[^c21329131]: S.I. 2001/3998, to which there are amendments that are not relevant.

[^c21329141]: S.R. 2002 No. 1, to which there are amendments that are not relevant.

[^c21329151]: S.I. 2001/3998 as amended by S.I. 2007/2154. There are other amendments that are not relevant.

[^c21329161]: S.R. 2002 No. 1, as amended by S.R. 2007 No. 348. There are other amendments that are not relevant.

[^c21329171]: 1970 c.40: subsection (1) was amended by section 272(1) of and Schedule 30 to the Local Government Act 1972; section 16 of and Schedule 8 paragraph 15 to the Local Government Act 1985, and section 66(6) and (8) of, and Schedule 16 paragraph 38(5) and Schedule 18 to the Local Government (Wales) Act 1994. Subsection (1A) was inserted by section 66(6) of and Schedule 16 paragraph 38(5) to that Act. Subsection 2 was substituted by section 180(1) of and Schedule 13 paragraph 85(2) to the Local Government etc (Scotland) Act 1994, and subsection (7) was repealed by sections 1(1) and 194 of, and Schedule 1 paragraph 8 and Schedule 34 Part 1 to the Local Government, Planning and Land Act 1980.

[^c21329181]: 1967 c.80.

[^c21329191]: S.I. 1994/3144, as amended by S.I. 2004/3224 and S.I. 2005/2759. There are other amendments to those regulations that are not relevant to this paragraph..

[^c21329201]: S.I. 1976/1726, as amended by S.I. 1977/996 and 2168, S.I. 1978/41 and 1140, S.I. 1981/1791, S.I. 1983/1729, S.I. 1985/1558 and 2008, S.I. 1988/1009, S.I. 1989/1183, S.I. 1992/3273, S.I. 1994/104 and 3144, S.I. 2002/236, S.I. 2004/1031 and S.I. 2005/2745 and 2753.

[^c21329211]: S.I. 1977/1055, as amended by S.I. 1992/3274, 1994/104 and 3144, and 2005/2753..

[^c21329221]: Section 28(3) was amended by Schedule 1 to the Animal Health and Welfare Act 1984 (1984 c.40), regulation 4(5) of S.I. 1977/1050, regulation 2(2) of S.I. 1975/1169, regulation 6(2) of S.I. 1994/276, regulation 2(a)(iii) of S.I. 2002/236 and paragraph 14 of Schedule 8 to S.I. 2006/2407.

[^c21329231]: S.I. 1975/1326, as amended by S.I. 1979/1760 and S.I. 1994/1932.

[^c21329241]: S.I. 1976/1726, as amended by S.I. 1977/996, S.I. 1977/2168, S.I. 1978/41, S.I. 1978/1140, S.I. 1981/1791, S.I. 1983/1729, S.I. 1985/1558, S.I. 1985/2008, S.I. 1988/1009, S.I. 1989/1183, S.I. 1992/3273, S.I. 1994/104 S.I. 1994/3144, S.I. 2002/236, S.I. 2004/1031, S.I. 2005/2745 and S.I. 2005/2753.

[^c21329251]: S.I. 1977/1055, as amended by S.I. 1992/3274, S.I. 1994/104, S.I. 1994/3144, and S.I. 2005/2753.

[^c21329261]: S.I. 1978/41, as amended by S.I. 2004/1771.

[^c21329271]: S.I. 2010/1882.

[^c21329281]: S.I. 1978/1006, as amended by S.I. 1995/2147, S.I. 2005/2754. S.I. 2006/2407 and S.I. 2006/2806.

[^c21329291]: 1968 c.67. Schedule 1A was inserted by regulation 7(2) of S.I. 2005/1094.

[^c21329301]: 1968, c.67. Section 10(1), 10(3) and 10(7A) were amended and 10(2) repealed by Part 1 paragraphs 1 and 10 of Schedule 8 to S.I. 2006/2407, section 10(1), 10(4) were amended and 10(5) to (7) and 10(8) inserted by article 3 of S.I. 1971/1445, section 10(1) was amended and section 10(9) inserted by paragraph 5 Schedule 1 to the Regulations of Care (Scotland) Act 2001, and section 10(7A) to (7C) were inserted by section 26(1) of the Health Act 2006.

[^c21329311]: Section 15(3) was amended by paragraphs 1 and 11(b) of Part 1 of Schedule 8 to S.I. 2006/2407.

[^c21329321]: Section 58((1), (4) and (6) was amended by paragraph 29 of Part 1 of Schedule 8 to S.I. 2006/2407. Section 58(4) was amended by paragraph 2(b) of Schedule 5 to S.I. 2002/53. Section 58(4) was amended by section 63(1 and (4) of, and section 58(4A) and (4C) inserted by section 63(1) and (5) of, the Health and Social Care Act 2001.

[^c21329331]: Section 58A was inserted by regulation 2 of S.I. 1992/3271, and the heading substituted by and subsection (1) amended by paragraph 30 Part 1 of Schedule 8 to S.I. 2006/2407.

[^c21329341]: Section 62(7) was substituted by paragraph 12(5) of Schedule 1 to S.I. 2005/1094.

[^c21329351]: Section 67(1B) was inserted by section 63(7) of the Health and Social Care Act 2001, and section 67(3A) inserted and section 67(4) amended by paragraph 8 of Schedule 5 to S.I. 2005/2789

[^c21329361]: Section 72(1)(c) was amended by paragraph 12(a) of Schedule 5 to the Adults with Incapacity (Scotland) Act 2000 and paragraph 14(a) of Schedule 6 to the Mental Capacity Act 2005, and section 72(4)(c) by paragraph 14(d) of Schedule 6 to the Mental Capacity Act 2005.

[^c21329371]: S.I. 1986/594 (N.I. 4).

[^c21329381]: Section 87(1) was amended by paragraph 44 of Part 1 of Schedule 8 to S.I. 2006/2407.

[^c21329391]: Section 88(1) was amended by paragraph 45 of Part 1 of Schedule 8 to S.I. 2006/2407.

[^c21329401]: Section 91(2) and (3) was amended by paragraph 48(b) and (c) of Part 1 of Schedule 8 to S.I. 2006/2407, and section 91(2) was amended by section 32(2) of the Magistrates' Courts Act 1980.

[^c21329411]: Section 108(2) was amended and 108(12) inserted by paragraph 8 of Schedule 3 to the Food Safety Act 1990, section 108(6A) to (6D) was inserted and section 108(9) and (10) amended by section 31(1) of the Health Act 2006, section 108(9) was amended by paragraph 56(c), section 108(10) by paragraph 56(d) and section 108(11) by paragraph 56(e) of Part 1 of Schedule 8 to S.I. 2006/2407, and section . 108(12) was amended by paragraph 33 of Schedule 16 to the Local Government (Wales) Act 1994.

[^c21329421]: Section 109(2)(c) was repealed by paragraph 9(a) of Schedule 3 to the Food Safety Act 1990, and section 109(2)(d) was repealed by paragraph 57 of Part 1 of Schedule 8 to S.I. 2006/2407.

[^c21329431]: Section 110(1) was amended by paragraph 58(a) and section 110(5)(a) was amended by paragraph 58(c)(i) of Part 1 of Schedule 8 to S.I. 2006/2407, and section 110(3A) and (3B) were inserted by section 31(3)(b) and section 110(5)(a) amended by section 31(3)(c) of the Health Act 2006. In relation to Northern Ireland,

[^c21329441]: The amendments in paragraph 19(b)(iii) and (iv), (f) and (g) reproduce amendments already made with effect in Northern Ireland by article 2 and the Schedule to S.R. (NI) 1973 No 211.

[^c21329451]: 1972 c. 9 (N.I.).

[^c21329461]: Section 111(1)(aa) was inserted by paragraph 9 of Schedule 5 to S.I. 2005/2789.

[^c21329471]: Section 121(4) was amended by paragraph 61 of Part 1 of Schedule 8 to S.I. 2006/2407.

[^c21329481]: Section 122(2) was amended by paragraph 62 of Part 1 of Schedule 8 to S.I. 2006/2407.

[^c21329491]: Section 125(4) was amended by paragraph 63 of Part 1 of Schedule 8 to S.I. 2006/2407.

[^c21329501]: Section 126(3) was amended by paragraph 64(c) of Part 1 of Schedule 8 to S.I. 2006/2407.

[^c21329511]: Section 129(2) was amended by paragraph 65(a) of and section 129(3) was amended by paragraph 65(b) of Part 1 of Schedule 8 to S.I. 2006/2407.

[^c21329521]: Section 130(1) was amended by paragraph 66(a) of Part 1 of Schedule 8 to S.I. 2006/2407.

[^c21329531]: Section 131(5) was amended by paragraphs 43 and 44 of Schedule 1 to the National Health Service (Consequential Provisions) Act 2006, paragraph 30 of Schedule 16 to the National Health Service (Scotland) Act 1978 and paragraph 128(2) of Schedule 4 to the National Health Service Reorganisation Act 1973.

[^c21329541]: Paragraph 17 of Schedule 3 was amended by paragraph 66 of Part 1 of Schedule 8 to S.I. 2006/2407.

[^c21329551]: Paragraphs 2 to 5, 7 and 9(b) and (c) and following words of Schedule 4 were omitted by paragraphs 69(a), (c) and (e)(iii) and (iv) of Part 1 of Schedule 8 to S.I. 2006/2407. Paragraph 6 was amended by paragraph 69(b), paragraph 8 by paragraph 69(d), paragraph 9 by paragraph 69(e) and paragraph 10 by paragraph 69(f) of that Part.

[^c21329561]: 1971 c.69.

[^c21329571]: 1968 c.29. Paragraph (b) of section 2(5) was inserted by paragraph 16 of Schedule 5 to the Medicines Act 1968.

[^c21329581]: 1975 c.24.

[^c21329591]: 1975 c.25.

[^c21329601]: 1987 c.43. Section 19(1) was amended by paragraph 7 of Part 1 of Schedule 9 to S.I. 2006/2407; there are other amendments to that subsection, but none is relevant.

[^c21329611]: 1990 c.43. Section 142(7) was amended by paragraph 8 of Schedule 4 to the Radioactive Substances Act 1993 (1993 c.12), in relation to England and Wales by paragraph 5(1) and (12) of Part 1 of Schedule 26 to S.I. 2010/675, and by paragraph 8 of Part 1 of Schedule 9 to S.I. 2006/2407.

[^c21329621]: 1994 c.23. In Part II of Schedule 8, note (2B) to Group 12 was inserted by S.I. 2009/2972, and note (11)(a) to Group 15 was amended by paragraph 10(a), and (11)(d) inserted by paragraph 10(b), of Schedule 9 to S.I. 2006/2407.

[^c21329631]: 1999 c.8. Subsection (2A) was inserted by paragraph 1 of Schedule 8 to the Health and Social Care Act 2008 (2008 c.14).

[^c21329641]: 2003 c.21. Section 368R was inserted by regulation 2 of S.I. 2009/2979.

[^c21329651]: 2007 asp 13.

[^c21329661]: S.I. 1972/1265 (N.I. 14). Article 57D was inserted by article 4 of the Primary Medical Services (Northern Ireland) Order 2004 (S.I. 2004/311 (N.I. 2))

[^c21329671]: S.I. 1976/1213 (N.I. 22).

[^c21329681]: S.I. 1976/1214 (N.I. 23).

[^c21329691]: S.I. 1981/1115 (N.I. 22).

[^c21329701]: S.I. 1997/2778 (N.I. 19). Article 33(6) was amended by S.R. (NI) 2006 No 45.

[^c21329711]: S.I. 1997/2779 (N.I. 20).

[^c21329721]: S.I. 2004/1031, as amended by S.I. 2005/2754. There are other amendments, but none is relevant.

[^c21329731]: S.I. 1978/1006, as amended by S.I. 1995/2147 and S.I. 2006/2407. There are other amendments, but none is relevant.

[^c21329741]: S.I. 1980/14, as amended by S.I. 1994/2920, S.I. 1994/3142 and S.I. 1994/3144.

[^c21329751]: S.I. 1986/1700. There are amendments, but none is relevant.

[^c21329761]: S.I. 1986/1761, as amended by S.I. 2006/2407. There are other amendments, but none is relevant.

[^c21329771]: S.I. 1989/684, as amended by S.I. 1995/871, S.I. 2004/1031 and S.I. 2005/2754. There are other amendments, but none is relevant.

[^c21329781]: S.I. 1995/449

[^c21329791]: S.I. 1997/1830, as amended by S.I. 1997/2044, S.I. 1998/108, S.I. 1998/1178, S.I. 1998/2081, S.I. 1999/1044, S.I. 1999/3463, S.I. 2000/1917, S.I. 2000/2899, S.I. 2000/3231, S.I. 2001/2777, S.I. 2001/3942, S.I. 2003/696, and S.I. 2006/915. There are other amendments, but none is relevant.

[^c21329801]: S.I. 1999/3267, as amended by S.I. 2005/1476. There are other amendments, but none is relevant.

[^c21329811]: S.I. 2000/620, as amended by S.I. 2000/3189 and S.I. 2009/1166. There are other amendments, but none is relevant.

[^c21329821]: S.I. 2001/880, as amended by S.I. 2010/745. There are other amendments, but none is relevant.

[^c21329831]: S.I. 2001/1841, as amended by S.I. 2005/2750 and S.I. 2008/548.

[^c21329841]: S.I. 2001/3998, as amended by S.I. 2003/2429, S.I. 2005/271, S.I. 2006/986, S.I. 2006/1450, S.I. 2007/2154 and 2012/973. There are other amendments, but none is relevant.

[^c21329851]: S.I. 2002/3170, as amended by S.I. 2005/2750 and S.I. 2008/548.

[^c21329871]: S.I. 2003/1374. There are amendments, but none is relevant.

[^c21329881]: S.I. 2003/1376. There are amendments, but none is relevant.

[^c21329891]: S.I. 2003/1571, as amended by S.I. 2006/1996. There are other amendments, but none is relevant.

[^c21329901]: S.I. 2003/1680, as amended by S.I. 2004/3224, S.I. 2005/2750 and S.I. 2005/2754.

[^c21329911]: S.S.I. 2004/115, as amended by S.S.I. 2005/337. There are other amendments, but none is relevant.

[^c21329921]: S.S.I. 2004/116, as amended by S.S.I. 2005/336. There are other amendments, but none is relevant.

[^c21329941]: S.I. 2004/478, as amended by S.I. 2006/358 and S.I. 2010/1647. There are other amendments, but none is relevant.

[^c21329961]: S.I. 2004/1022, as amended by S.I 2005/366 and S.I. 2009/1977. There are other amendments, but none is relevant.

[^c21329971]: S.I. 2004/1975.

[^c21329981]: S.I. 2005/1478, as amended by S.I. 2008/1940. There are other amendments, but none is relevant.

[^c21329991]: S.I. 2007/121, as amended by S.I. 2009/1175 and S.I. 2010/1647. There are other amendments, but none is relevant.

[^c21330001]: S.I. 2007/1523.

[^c21330011]: S.I. 2007/3544, as amended by S.I. 2009/2981. There are other amendments, but none is relevant.

[^c21330021]: S.I. 2008/548.

[^c21330031]: S.I. 2008/944. There are amendments, but none is relevant.

[^c21330041]: S.I. 2008/1270. There are amendments, but none is relevant.

[^c21330051]: S.I. 2008/3258. There are amendments, but none is relevant.

[^c21330061]: S.S.I. 2009/45. There are amendments, but none is relevant.

[^c21330071]: S.S.I. 2009/183.

[^c21330081]: S.I. 2009/669. There are amendments, but none is relevant.

[^c21330091]: S.I. 2010/2880. There are amendments, but none is relevant.

[^c21330101]: S.R. (NI) 1987 No 414, as amended by S.R. (NI) 1997 No 469.

[^c21330111]: S.R. (NI) 1995 No 8, as amended by S.R. (NI) 2009 No 429. There are other amendments, but none is relevant.

[^c21330121]: S.R. (NI) 1996 No 81.

[^c21330131]: S.R. (NI) 1997 No 381, as amended by S.R. (NI) 1999 No 405. There are other amendments, but none is relevant.

[^c21330141]: S.R. (NI) 1998 No 28.

[^c21330151]: S.R. (NI) 1998 No 45, as amended by S.R. (NI) 2011 No 124.

[^c21330161]: S.R. (NI) 1999 No 433.

[^c21330171]: S.R. (NI) 2001 No 422.

[^c21330181]: S.R. (NI) 2002 No 1, as amended by S.R. (NI) 2003 No 324, S.R. (NI) 2003 No 420, S.R. (NI) 2005 No 119, S.R. (NI) 2005 No 564, S.R. (NI) 2006 No 214, S.R. (NI) 2006 No 264, and S.R. (NI) 2007 No 348.

[^c21330191]: S.R. (NI) 2003 No 34.

[^c21330201]: S.R. (NI) 2003 No 493.

[^c21330211]: S.R. (NI) 2004 No 140, as amended by S.R. (NI) 2005 No 368.

[^c21330221]: S.R. (NI) 2005 No 160.

[^c21330231]: S.R. (NI) 2005 No 161.

[^c21330241]: S.R. (NI) 2005 No 176.

[^c21330251]: S.R. (NI) 2006 No 478.

[^c21330261]: S.R. (NI) 2007 No 68.

[^c21330271]: S.R. (NI) 2007 No 234.

[^c21330281]: S.R. (NI) 2007 No 236.

[^c21330291]: S.R. (NI) 2007 No 420.

[^c21330301]: S.R. (NI) 2008 No 336.

[^c21330311]: S.R. (NI) 2009 No 225.

[^c21330321]: S.R. (NI) 2009 No 413.

[^key-1f934743ba151dda0227b4b2795e45ec]: Reg. 2 applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))

[^key-5b2d18279819ab7e60d0e162ed5d8e9e]: Reg. 8(1) applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))

[^key-664409ec9c556292eca98cec7fcb1235]: Reg. 322 applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))

[^key-a2979e76c09b0a18ccb1ca9bfbff3557]: Reg. 323(1) applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))

[^key-4336da89fcbab3bf584a4b563862a248]: Reg. 324(1) applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))

[^key-b9c3a11b1a06e57a48e33a2072a61b9e]: Regs. 325-330 applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))

[^key-c4949b5020a1a87af2646f645958ee98]: Regs. 332-339 applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))

[^key-32a438fd0f6b6445ebd32249e0d7406f]: Reg. 343 applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))

[^key-f1cd0278a4d1a4885f758172cd53cecc]: Sch. 31 applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))

[^key-8da75259d2d58d4ffda3bbaa3db54b5b]: Words in Sch. 16 Pt. 2 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(7)(a) (with Sch. 3 para. 28)

[^key-372aacd1865c2eb9309af9cc6205affe]: Words in Sch. 16 Pt. 2 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(7)(b) (with Sch. 3 para. 28)

[^key-f208e93b9617da90329ef6ef26a32702]: Words in Sch. 16 Pt. 2 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(7)(c)(i) (with Sch. 3 para. 28)

[^key-f8698ad31d07f69c4c5bd642281f264f]: Words in Sch. 16 Pt. 2 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(7)(c)(ii) (with Sch. 3 para. 28)

[^key-a2c8f125c4ba003edda928c0f4f605cc]: Words in Sch. 16 Pt. 2 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(7)(d)(i) (with Sch. 3 para. 28)

[^key-4ec383c4ca5b5a29e1fe59aa82cf2d0a]: Words in Sch. 16 Pt. 2 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(7)(d)(ii) (with Sch. 3 para. 28)

[^key-57df8a5d6c794a26d375999871c56aa6]: Words in Sch. 22 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(8)(a) (with Sch. 3 para. 28)

[^key-5d90fd7a9c52c4242d6ad69699eefc9e]: Words in Sch. 22 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(8)(b) (with Sch. 3 para. 28)

[^key-fa6874433f6e26b81e4a857b8b5c2b3a]: Words in Sch. 22 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(8)(c)(i) (with Sch. 3 para. 28)

[^key-e06296c2ed6145b4942b7d1890603ae4]: Words in Sch. 22 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(8)(c)(ii) (with Sch. 3 para. 28)

[^key-dc5e05f5a660354c086fd9c57446965a]: 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)

[^key-eff1fe1ef823a83354179f32f0aeee15]: 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)

[^key-ad08ce0b6fc58773a1f270b680e2b113]: 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)

[^key-f5c74605076a4572fb1217cb7cdd4581]: 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)

[^key-74c81fdaefd70fc86ea83d05e3807284]: 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)

[^key-22d0d0203915f759b2d581638ce0a0de]: Words in reg. 229 heading 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(3)(a) (with Sch. 3 para. 28)

[^key-e2e563fdfe9318016e58974ded3241c0]: Reg. 229(1)(da) 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(3)(b) (with Sch. 3 para. 28)

[^key-9e8891d9bb1dad46ef77fd06e0c21441]: Reg. 229(1)(e) 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(3)(c) (with Sch. 3 para. 28)

[^key-7faa2807accabba257b63ed28f714a5e]: Words in reg. 229(1)(f) 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(3)(d)(i) (with Sch. 3 para. 28)

[^key-828fca8ca79377d6be0ebb63bced4099]: Words in reg. 229(1)(f) substituted (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(3)(d)(ii) (with Sch. 3 para. 28)

[^key-96b2c20c4c8e2b41e619bea95ad31903]: Words in reg. 230(6)(a) substituted (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(4) (with Sch. 3 para. 28)

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