Legalize / United Kingdom / Statutory-Instrument

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

Source legislation.gov.uk

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*Column 1*	*Column 2*	*Column 3*
Persons exempted	Prescription only medicines to which the exemption applies	Conditions
1. Registered chiropodists or podiatrists against whose names are recorded in the relevant register annotations signifying that they are qualified to use the medicines specified in column 2.	1. Prescription only medicines for parenteral administration that contain— Adrenaline, Bupivacaine hydrochloride, Bupivacaine hydrochloride with adrenaline where the maximum strength of adrenaline does not exceed 1 mg in 200 ml of bupivacaine hydrochloride, Levobupivacaine hydrochloride, Lidocaine hydrochloride, Lidocaine hydrochloride with adrenaline where the maximum strength of adrenaline does not exceed 1 mg in 200 ml of lignocaine hydrochloride, Mepivacaine hydrochloride, Methylprednisolone, Prilocaine hydrochloride, Ropivacaine hydrochloride.	1. The administration shall only be in the course of their professional practice and where the medicine includes a combination of substances in column 2, those substances shall not have been combined by the chiropodist or podiatrist.
2. Registered midwives and student midwives.	2. Prescription only medicines for parenteral administration containing any of the following substances but no other substance that is classified as a product available on prescription only— Adrenaline, Anti-D immunoglobulin, Carboprost, Cyclizine lactate, Diamorphine, Ergometrine maleate, Gelofusine, Hartmann’s solution, Hepatitis B vaccine, Hepatitis immunoglobulin, Lidocaine hydrochloride, Morphine, Naloxone hydrochloride, Oxytocins, natural and synthetic, Pethidine hydrochloride, Phytomenadione, Prochloperazine, Sodium chloride 0.9%.	2. The medicine shall— in the case of Lidocaine and Lidocaine hydrochloride, be administered only while attending on a woman in childbirth, and where administration is— by a registered midwife, be administered in the course of their professional practice; by a student midwife— be administered under the direct supervision of a registered midwife; and not include Diamorphine, Morphine or Pethidine hydrochloride.
3. Persons who are authorised as members of a group by a group authority granted under regulations 8(3) or 9(3) of the Misuse of Drugs Regulations 2001¹²⁶ or, regulations 8(3) or 9(3) of the Misuse of Drugs Regulations (Northern Ireland) 2002¹²⁷, to supply a controlled drug by way of administration only.	3. Prescription only medicines that are specified in the group authority.	3. The administration shall be subject to such conditions and in such circumstances and to such extent as may be specified in the group authority.
4. The owner or master of a ship which does not carry a doctor on board as part of the ship’s complement.	4. All prescription only medicines that are for parenteral administration.	4. The administration shall be only so far as is necessary for the treatment of persons on the ship.
5. Persons operating an occupational health scheme.	5. Prescription only medicines that are for parenteral administration sold or supplied to the person operating an occupational health scheme in response to an order in writing signed by a doctor or a registered nurse.	5. The prescription only is administered in the course of an occupational health scheme, and the individual administering the medicine is— a doctor, or a registered nurse acting in accordance with the written instructions of a doctor as to the circumstances in which prescription only medicines of the description in question are to be used.
6. The operator or commander of an aircraft.	6. Prescription only medicines for parenteral administration which have been sold or supplied to the operator or commander of the aircraft in response to an order in writing signed by a doctor.	6. The administration shall be only so far as is necessary for the immediate treatment of sick or injured persons on the aircraft and shall be in accordance with the written instructions of the doctor as to the circumstances in which prescription only medicines of the description in question are to be used on the aircraft.
7. Persons employed as qualified first-aid personnel on off-shore installations.	7. All prescription only medicines that are for parenteral administration.	7. The administration shall be only so far as is necessary for the treatment of persons on the installation.
8. Persons who are registered paramedics.	8. The following prescription only medicines for parenteral administration— Diazepam 5 mg per ml emulsion for injection, Succinylated Modified Fluid Gelatin 4 per cent intravenous infusion, medicines containing the substance Ergometrine Maleate 500 mcg per ml with Oxytocin 5 iu per ml, but no other active ingredient, prescription only medicines containing one or more of the following substances, but no other active ingredient— Adrenaline Acid Tartrate, Adrenaline hydrochloride, Amiodarone, Anhydrous glucose, Benzlypenicillin, Compound Sodium Lactate Intravenous Infusion (Hartmann’s Solution), Ergometrine Maleate, Furosemide, Glucose, Heparin Sodium, Lidocaine Hydrochloride, Metoclopramide, Morphine Sulphate, Nalbuphine Hydrochloride, Naloxone Hydrochloride, Ondansetron Paracetamol, Reteplase, Sodium Chloride, Streptokinase, Tenecteplase.	8. The administration shall be only for the immediate, necessary treatment of sick or injured persons and in the case of prescription only medicine containing Heparin Sodium shall be only for the purpose of cannula flushing.
9. Persons who hold the advanced life support provider certificate issued by the Resuscitation Council (UK).	9. The following prescription only medicines for parenteral administration — Adrenaline 1:10,000 up to I mg; and Amiodarone.	9. The administration shall be only in an emergency involving cardiac arrest, and in the case of adrenaline the administration shall be intravenous only.

PART 4 — Exemptions from the restrictions in regulations 220 and 221 for certain persons who sell, supply, or offer for sale or supply certain medicinal products

*Column 1*	*Column 2*	*Column 3*
Persons exempted	Medicinal products to which exemption applies	Conditions
1. Registered chiropodists and podiatrists.	1. Medicinal products on a general sale list which are for external use and are not veterinary drugs and the following pharmacy medicines for external use— Potassium permanganate crystals or solution; ointment of heparinoid and hyaluronidase; and products containing, as their only active ingredients, any of the following substances, at a strength, in the case of each substance, not exceeding that specified in relation to that substance— 9.0 per cent Borotannic complex 10.0 per cent Buclosamide 3.0 per cent Chlorquinaldol 1.0 per cent Clotrimazole 10.0 per cent Crotamiton 5.0 per cent Diamthazole hydrochloride 1.0 per cent Econazole nitrate 1.0 per cent Fenticlor 10.0 per cent Glutaraldehyde 1.0 per cent Griseofulvin 0.4 per cent Hydrargaphen 2.0 per cent Mepyramine maleate 2.0 per cent Miconazole nitrate 2.0 per cent Phenoxypropan-2-ol 20.0 per cent Podophyllum resin 10.0 per cent Polynoxylin 70.0 per cent Pyrogallol 70.0 per cent Salicylic acid 1.0 per cent Terbinafine 0.1 per cent Thiomersal.
2. Registered chiropodists and podiatrists against whose names are recorded in the relevant register annotations signifying that they are qualified to use the medicines in column 2.	2. The following prescription only medicines— Amorolfine hydrochloride cream where the maximum strength of the Amorolfine in the cream does not exceed 0.25 per cent by weight in weight, Amorolfine hydrochloride lacquer where the maximum strength of Amorolfine in the lacquer does not exceed 5 per cent by weight in volume, Amoxicillin, Co-Codamol, Co-dydramol 10/500 tablets, Codeine Phosphate, Erythromycin, Flucloxacillin, Silver Sulfadiazine, Tioconazole 28%, Topical hydrocortisone where the maximum strength of the hydrocortisone in the medicinal product does not exceed 1 per cent by weight in weight; and Ibuprofen, other than preparations of ibuprofen which are prescription only medicines.	2. The sale or supply shall be only in the course of their professional practice, and the medicinal product must have been made up for sale or supply in a container elsewhere than at the place at which it is sold or supplied.
3. Registered optometrists.	3. All medical products on a general sale list, all pharmacy medicines and prescription only medicines which are not for parenteral administration and which— are eye drops and are prescription only medicines by reason only that they contain not more than— 30.0 per cent Sulphacetamide Sodium, or 0.5 per cent Chloramphenicol, or are eye ointments and are prescription only medicines by reason only that they contain not more than— 30.0 per cent Sulphacetamide Sodium, or 1.0 per cent Chloramphenicol, or are prescription only medicines by reason only that they contain any of the following substances— Cyclopentolate hydrochloride, Fusidic acid, Tropicamide.	3. The sale or supply shall be only— in the case of medicinal products on a general sale list and pharmacy medicines, in the course of their professional practice; in the case of prescription only medicines, in the course of their professional practice and in an emergency.
4. Additional supply optometrists.	4. Medicinal products which are prescription only medicines by reason only that they contain any of the following substances— Acetylcysteine, Atropine sulphate, Azelastine hydrochloride, Diclofenac sodium, Emedastine, Homotropine hydrobromide, Ketotifen, Levocabastine, Lodoximide, Nedocromil sodium, Olopatadine, Pilocarpine hydrochloride, Pilocarpine nitrate, Polymyxin B/bacitracin, Polymyxin B/trimethoprim, Sodium Cromoglycate.	4. The sale or supply shall be only in the course of their professional practice and only in an emergency.
5. Holders of manufacturer’s licences where the licence in question contains a provision that the licence holder shall manufacture the medicinal product to which the licence relates only for a particular person after being requested by or on behalf of that person and in that person’s presence to use his own judgement as to the treatment required.	5. Medicinal products on a general sale list which are for external use and are not veterinary drugs and pharmacy medicines which are for external use in the treatment of hair and scalp conditions and which contain any of the following— not more than 5.0 per cent of Boric acid, Isopropyl myristate or Lauryl sulphate, not more than 0.004 per cent Oestrogens, not more than 1.0 per cent of Resorcinol, not more than 3.0 per cent of Salicylic acid, not more than 0.2 per cent of Sodium pyrithione.	5. The licence holder shall sell or supply the medicinal product in question only to a particular person after being requested by or on behalf of that person and in that person’s presence to use his own judgement as to the treatment required.
6. Persons selling or supplying medicinal products to universities, other institutions concerned with higher education or institutions concerned with research.	6. All medicinal products.	6. The sale or supply shall be— Subject to the presentation of an order signed by the principal of the institution concerned with education or research or the appropriate head of department in charge of the specified course of research stating— the name of the institution for which the medicinal product is required, the purpose for which the medicinal product is required, and the total quantity required, and for the purposes of the education or research with which the institution is concerned.
7. Persons selling or supplying medicinal products to organisations for research purposes.	7. All medicinal products.	7. The sale or supply is only for the purposes of research and shall be— subject to the presentation of an order signed by the representative of the organisation concerned stating— who requires the medicine, the purposes for which it is required, the quantity required, and the purposes of the research with which the organisation is concerned; and not for administration to humans.
8. Persons selling or supplying medicinal products to any of the following— a public analyst appointed under section 27 of the Food Safety Act 1990 or under article 27 of the Food Safety (Northern Ireland) Order 1991; an agricultural analyst appointed under section 67 of the Agriculture Act 1970¹²⁸, a person duly authorised by an enforcement authority under regulations 325 to 328, a sampling officer within the meaning a sampling officer within the meaning of Schedule 31.	8. All medicinal products.	8. The sale or supply is in connection with the exercise of any statutory function carried out by any person listed in sub-paragraphs (a) to (d) of column 1 provided that— the medicinal products are requested on an order signed by or on behalf of a person listed in sub-paragraph (a) to (d) of column 1, and the order gives— the status of the person signing it, the amount of medicinal product required.
9. Holders of a marketing authorisation, a certificate of registration or a manufacturer’s licence.	9. Medicinal product referred to in the marketing authorisation, certificate of registration or manufacturer’s licence.	The sale or supply shall be only— to a pharmacist, so as to enable that pharmacist to prepare an entry relating to the medical product in question in a tablet or capsule identification guide or similar publication, and of no greater quantity than is reasonably necessary for that purpose.
10. Registered dispensing opticians.	10. Pharmacy medicines for external use containing chloramphenicol at a strength not exceeding— 0.5 per cent in eye drops; 1 per cent in ointment.	10. The sale or supply shall only be in the course of their professional practice.

PART 5 — Exemptions from the restrictions in regulations 220 and 221 for certain persons who supply certain medicinal products

*Column 1*	*Column 2*	*Column 3*
Persons exempted	Medicinal products to which exemption applies	Conditions
1. Royal National Lifeboat Institution and certificated first aiders of the Institution.	1. All medicinal products.	1. The supply shall be only so far as is necessary for the treatment of sick or injured persons.
2. British Red Cross Society and certificated first aid and certificated nursing members of the Society.	2. All pharmacy medicines and all medicinal products on a general sale list.	2. The supply shall be only so far as is necessary for the treatment of sick or injured persons.
3. St John Ambulance Association and Brigade and certificated first aid and certificated nursing members of the Association and Brigade.	3. All pharmacy medicines and all medicinal products on a general sale list.	3. The supply shall be only so far as is necessary for the treatment of sick or injured persons.
4. St. Andrew’s Ambulance Association and certificated first aid and certificated nursing members of the Association.	4. All pharmacy medicines and all medicinal products on a general sale list.	4. The supply shall be only so far as is necessary for the treatment of sick and injured persons.
5. Order of Malta Ambulance Corps and certificated first aid and certificated nursing members of the Corps.	5. All pharmacy medicines and all medicinal products on a general sale list.	5. The supply shall be only so far as is necessary for the treatment of sick or injured persons.
6. Persons authorised by licences granted under regulation 5 of the Misuse of Drugs Regulations 2001 or regulation 5 of the Misuse of Drugs Regulations (Northern Ireland) 2002.	6. Such prescription only medicines and such pharmacy medicines as are specified in the licence.	6. The supply shall be subject to such conditions and in such circumstances and to such an extent as may be specified in the licence.
7. Persons employed or engaged in the provision of lawful drug treatment services.	7. Ampoules of sterile water for injection that contain no more than 5ml of water each.	7. The supply shall be only in the course of provision of lawful drug treatment services.
8. Persons requiring medicinal products for the purpose of enabling them, in the course of any business carried on by them, to comply with any requirements made by or in pursuance of any enactment with respect to the medical treatment of their employees.	8. Such prescription only medicines and such pharmacy medicines as may be specified in the relevant enactment and medicinal products on a general sale list.	8. The supply shall be— for the purpose of enabling compliance with any requirement made by or in pursuance of any such enactment, and subject to such conditions and in such circumstances as may be specified in the relevant enactment.
9. The owner or master of a ship which does not carry a doctor on board as part of the ship’s complement.	9. All medicinal products.	9. The supply shall be only so far as is necessary for the treatment of persons on the ship.
10. Persons operating an occupational health scheme.	10. All pharmacy medicines, all medicinal products on a general sale list and such prescription only medicines as are sold or supplied to a person operating an occupational health scheme in response to an order signed by a doctor or a registered nurse.	10. The supply shall be in the course of an occupational health scheme. The individual supplying the medicinal product, if not a doctor, shall be— a registered nurse, and where the medicinal product in question is a prescription only medicine, acting in accordance with the written instructions of a doctor as to the circumstances in which prescription only medicines of the description in question are to be used in the course of an occupational health scheme.
11. Persons carrying on the business of a school providing full-time education.	11. Pharmacy medicines that are for use in the prevention of dental caries and consist of or contain Sodium Fluoride.	11. The supply shall be— in the course of a school dental scheme, and if to a child under 16 only where the parent or guardian of that child has consented to such supply.
12. Health authorities or Primary Health Trusts.	12. Pharmacy medicines that are for use in the prevention of dental caries and consist of or contain Sodium Fluoride.	12. The supply shall be in the course of— a pre-school dental scheme, and the individual supplying the medicinal product shall be a registered nurse, or a school dental scheme, and if to a child under 16 only where the parent or guardian of that child has consented to such supply.
13. The operator or commander of an aircraft.	13. All pharmacy medicines, all medicinal products on a general sale list and such prescription only medicines which are not for parenteral administration and which have been sold or supplied to the operator or commander of an aircraft in response to an order in writing signed by a doctor.	13. The supply shall be only so far as is necessary for the immediate treatment of sick or injured persons on the aircraft and, in the case of a prescription only medicine, shall be in accordance with the written instructions of a doctor as to the circumstances in which the prescription only medicines of the description in question are to be used on the aircraft.
14. Persons employed as qualified first-aid personnel on offshore installations.	14. All medicinal products.	14. The supply shall be only so far as is necessary for the treatment of persons on the installation.
15. A prison officer.	15. All medicinal products on the general sale list.	15. The supply shall only be so far as is necessary for the treatment of prisoners.
16. Persons who hold a certificate in first aid from the Mountain Rescue Council of England and Wales, or from the Northern Ireland Mountain Rescue Co-ordinating Committee.	16. All pharmacy medicines, all medicinal products on a general sale list and such prescription only medicines which are sold or supplied to a person specified in column 1 of this paragraph in response to an order in writing signed by a doctor.	16. The supply shall be only so far as is necessary for the treatment of sick or injured persons in the course of providing mountain rescue services.
17. Her Majesty’s armed forces.	17. All medicinal products.	17. The supply shall be only so far as is necessary for the treatment of a sick or injured person or the prevention of ill-health.

SCHEDULE 18 — Substances that may not be sold or supplied by a pharmacist without a prescription in reliance on regulation 225

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

SCHEDULE 19 — Medicinal products for parenteral administration in an emergency

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 hydrochloride

Pralidoxime chloride injection

Pralidoxime mesilate injection

Promethazine hydrochloride injection

Snake venom antiserum

Sodium nitrite injection

Sodium thiosulphate injection

Sterile pralidoxime

SCHEDULE 20 — Herbal medicinal products specified for the purposes of regulation 241

PART 1

Botanical Source	Common Name
Apocynum cannabinum	Canadian hemp
Areca catechu	Areca
Artemisia cina	Santonica
Brayera anthelmintica	Kousso
Catha edulis	Catha
Chenopodium ambrosioides var anthelminticum	Chenopodium
Crotalaria berberoana	Crotalaria fulva
Crotalaria spectabilis	Crotalaria spect.
Cucurbita maxima	Cucurbita
Delphinium staphisagria	Stavesacre seeds
Dryopteris filix-mas	Male fern
Duboisia leichardtii Duboisia myoporoides	Duboisia
Ecballium elaterium	Elaterium
Embelia ribes Embelia robusta	Embelia
Erysimum canescens	Erysimum
Holarrhena antidysenterica	Holarrhena
Juniperus sabina	Savin
Mallotus philippinensis	Kamala
Pausinystalia yohimbe	Yohimbe bark
Punica granatum	Pomegranate bark
Rhus radicans	Poison ivy
Scopolia carniolica Scopolia japonica	Scopolia
Strophanthus courmonti Strophanthus emini Strophanthus gratus Strophanthus hispidus Strophanthus kombe Strophanthus nicholsoni Strophanthus sarmentosus	Strophanthus
Ulmus fulva Ulmus rubra	Slippery elm bark (whole or unpowdered)
Viscum album	Misletoe berry

PART 2

*Column 1*	*Column 1*	*Column 2*	*Column 3*
*Substance*	*Substance*
*Botanical Source*	*Common Name*	*Maximum dose and maximum daily dose*	*Percentage*
Aconitum balfourni Aconitum chasmanthum Aconitum deinorrhizum Aconitum lycoctonum Aconitum napellus Aconitum spicatum Aconitum stoerkianum Aconitum uncinatum var japonicum	Aconite		1.3 per cent
Adonis vernalis	Adonis vernalis	100 mg (MD) 300mg (MDD)
Aspidosperma quebrachoblanco	Quebracho	50 mg (MD) 150 mg (MDD)
Atropa acuminata Atropa belladonna	Belladonna herb, belladonna root	In the form of belladonna herb: 50 mg (MD) 150 mg (MDD); In the form of belladonna root: 30 mg (MD) 90 mg (MDD)
Chelidonium majus	Celandine	2 g (MD) 6 g (MDD)
Cinchona calisaya Cinchona ledgerana Cinchona micrantha Cinchona officinalis Cinchona succirubra	Cinchona bark	250 mg (MD) 750 mg (MDD)
Colchicum autumnale	Colchicum corm	100 mg (MD) 300 mg (MDD)
Conium maculatum	Conium fruits, conium leaf		7.0 per cent
Convallaria majalis	Convallaria	150 mg (MD) 450 mg (MDD)
Datura innoxia Datura stramonium	Stramonium	50 mg (MD) 150 mg (MDD)
Ephedra distachya Ephedra equisetina Ephedra gerardiana Ephedra intermedia Ephedra sinica	Ephedra	600 mg (MD) 1800 mg (MDD)
Gelsemium sempervirens	Gelsemium	25 mg (MD) 75 mg (MDD)
Hyoscyamus albus Hyoscyamus muticus Hyoscyamus niger	Hyoscyamus	100mg (MD) 300 mg (MDD)
Lobelia inflata	Lobelia	200 mg (MD) 600 mg (MDD)
Pilocarpus jaborandi Pilocarpus microphyllus	Jaborandi		5.0 per cent
Rhus toxicodendron	Poison oak		10.0 per cent
Senecio jacobaea	Ragwort		10.0 per cent

SCHEDULE 21 — Medicinal products at high dilutions

PART 1 — Dilutions of unit preparations diluted to at least one part in a thousand (3x)

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

PART 2 — Dilutions of unit preparations diluted to at least one part in a million (6x)

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

PART 3 — Dilutions of unit preparations diluted to at least one part in ten (1x)

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

PART 4 — Dilutions of unit preparations diluted to at least one part in ten (1x) for external use

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

SCHEDULE 22 — Classes of person for the purposes of regulation 249

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— an independent hospital, independent clinic or independent medical agency, a hospital or health centre which is not an independent hospital or independent clinic, or 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 Primary Care Trust.

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— an NHS trust or an NHS foundation trust; the Common Services Agency; a health authority or a special health authority; or a Primary Care Trust.

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 police force in England, Wales or Scotland; the Police Service of Northern Ireland; a prison service; or Her Majesty’s Forces.

In this Schedule “excepted person” means— a doctor or dentist; or a person lawfully conducting a retail pharmacy business within the meaning of section 69 of the Medicines Act 1968.

SCHEDULE 23 — Particulars in pharmacy records

1

Paragraph 2 applies, subject to paragraph 3, where the sale or supply of a prescription only medicine is—

(a) in pursuance of a prescription given by—

(i) a doctor or dentist,

(ii) a supplementary prescriber,

(iii) a community practitioner nurse prescriber,

(iv) a nurse independent prescriber,

(v) an optometrist independent prescriber,

(vi) a pharmacist independent prescriber,

(vii) a podiatrist independent prescriber,

(viii) a physiotherapist independent prescriber, ...

(ix) a therapeutic radiographer independent prescriber; or

(x) a paramedic paramedic independent prescriber; or

(b) under regulation 224 (emergency sale etc by pharmacist: prescriber unable to provide prescription).

2

In such a case, the particulars referred to in regulation 253(2)(a) are—

(a) the date on which the prescription only medicine was sold or supplied;

(b) the name, quantity and, except where it is apparent from the name, the pharmaceutical form and strength of the prescription only medicine sold or supplied;

(d) the name and address of the person for whom the prescription only medicine was prescribed;

(e) the date on the prescription; and

(f) in relation to the sale or supply of a prescription only medicine under regulation 224 the date on which the prescription relating to that sale or supply is received.

3

Where the sale or supply is in pursuance of a repeatable prescription and is not the first sale or supply in pursuance of that prescription, the particulars referred to in regulation 253(2)(a) are either—

(a) the date on which the prescription only medicine is sold or supplied and a reference to the entry in the record referred to in regulation 253(1) which was made in respect of the first sale or supply in pursuance of that prescription and which contains the particulars specified in paragraph 2; or

(b) the particulars specified in paragraph 2.

4

Where the sale or supply of a prescription only medicine is a sale or supply under regulation 225 (emergency sale etc by pharmacist: at patient's request), the particulars referred to in regulation 253(2)(a) are—

(a) the date on which the prescription only medicine was sold or supplied;

(b) the name, quantity and, except where it is apparent from the name, the pharmaceutical form and strength of the prescription only medicine sold or supplied;

(d) the nature of the emergency.

5

Paragraph 6 applies where—

(a) the sale or supply of a prescription only medicine is by way of wholesale dealing and no order or invoice or copy of the order or invoice has been retained under regulation 224 or 225; or

(b) the sale or supply is one to which regulation 214(1) does not apply by reason of an exemption other than that in regulation 224 or 225.

6

In such a case, the particulars referred to in regulation 253(2)(a) are—

(a) the date on which the prescription only medicine is sold or supplied;

(b) the name, quantity and, except where it is apparent from the name, the pharmaceutical form and strength of the prescription only medicine sold or supplied;

(c) the name and address and trade, business or profession of the person to whom the prescription only medicine is sold or supplied; and

(d) the purpose for which the prescription only medicine is sold or supplied.

SCHEDULE 24 — Packaging information requirements

PART 1 — Outer and immediate packaging

1

The name of the medicinal product.

2

The strength and pharmaceutical form of the product.

3

Where appropriate, whether the product is intended for babies, children or adults.

4

Where the product contains up to three active substances, the common name of each active substance.

5

A statement of the active substances in the product, expressed qualitatively and quantitatively per dosage unit or according to the form of administration for a given volume or weight, using their common names.

6

The pharmaceutical form and the contents by weight, by volume or by number of doses of the product.

7

A list of—

(a) where the product is injectable or is a topical or eye preparation, all excipients; or

(b) in any other case, those excipients known to have a recognized action or effect and included in the guidance published under regulation 257D ....

8

The method of administration of the product and if necessary the route of administration.

9

Where appropriate, space for the prescribed dose to be indicated.

10

A warning that the product must be stored out of the reach and sight of children.

11

Any special warning applicable to the product.

12

The product's expiry date (month and year), in clear terms.

13

Any special storage precautions relating to the product.

14

Any special precautions relating to the disposal of an unused product or part of a product, or waste derived from the product, and reference to any appropriate collection system in place.

15

The name and address of the holder of the UK marketing authorisation, ... Article 126a authorisation or traditional herbal registration relating to the product and, where applicable, the name of the holder's representative.

16

The number of the UK marketing authorisation, ... Article 126a authorisation or traditional herbal registration for placing the medicinal product on the market.

17

The manufacturer's batch number.

18

In the case of a product that is not a prescription only medicine, instructions for use.

PART 2 — Immediate packaging: blister packs

19

The name of the medicinal product.

20

The strength and pharmaceutical form of the product.

21

Where appropriate, whether the product is intended for babies, children or adults.

22

Where the product contains up to three active substances, the common name of each active substance.

23

The name of the holder of the UK marketing authorisation, ..., Article 126a authorisation or traditional herbal registration relating to the product.

24

The product's expiry date (month and year), in clear terms.

25

The manufacturer's batch number.

PART 3 — Immediate packaging: small packages

26

The name of the medicinal product.

27

The strength and pharmaceutical form of the product.

28

Where appropriate, whether the product is intended for babies, children or adults.

29

Where the product contains up to three active substances, the common name of each active substance.

30

The method of administration of the product and if necessary the route of administration.

31

The product's expiry date (month and year), in clear terms.

32

The manufacturer's batch number.

33

The contents of the packaging by weight, by volume or by unit.

SCHEDULE 25 — Packaging requirements: specific provisions

PART 1 — Medicines on prescription

1

Where the product is to be administered to a particular individual, the name of that individual.

2

The name and address of the person who sells or supplies the product.

3

The date on which the product is sold or supplied.

4

Unless paragraph 5, applies, such of the following particulars as the appropriate practitioner who prescribed the product may specify—

(a) the name of the product or its common name;

(b) directions for use of the product; and

5

This paragraph applies if the pharmacist, in the exercise of professional skill and judgement, is of the opinion that the inclusion of one or more of the particulars mentioned in paragraph 4 is inappropriate.

6

Where paragraph 5 applies, the pharmacist may include such particulars, of the same kind as those mentioned in paragraph 4, as the pharmacist thinks appropriate.

PART 2 — Transport, delivery and storage

7

Any special requirements for the storage and handling of the product.

8

The expiry date of the product.

9

The manufacturer's batch number.

PART 3 — Pharmacy and prescription only medicines

10

Paragraph 11 applies if a pharmacy medicine is—

(a) sold by retail;

(b) supplied in circumstances corresponding to retail sale;

(d) distributed by way of wholesale dealing.

11

Where this paragraph applies, the capital letter “P” within a rectangle within which there is to be no other matter of any kind.

12

Paragraph 13 applies if a prescription only medicine is—

(a) sold by retail;

(b) supplied in circumstances corresponding to retail sale;

(d) distributed by way of wholesale dealing.

13

Where this paragraph applies, the capital letters “POM” within a rectangle within which there is to be no other matter of any kind.

PART 4 — Medicines containing paracetamol

14

If the product contains paracetamol, except where the name of the product includes the word “paracetamol” and appears on the outer and immediate packaging, the words “Contains paracetamol”.

15

If the product contains paracetamol the words “Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor”, which must appear adjacent to either the directions for use or the recommended dosage.

16

If the product contains paracetamol, unless the product is wholly or mainly intended for children twelve years old or younger, the words “Do not take anything else containing paracetamol while taking this medicine” and—

(a) if a package leaflet accompanying the product includes the words in quotation marks in paragraph 16 of Schedule 27 (package leaflets), the words “Talk to a doctor at once if you take too much of this medicine, even if you feel well”; or

(b) if no package leaflet accompanies the product or the package leaflet does not include those words, the words “Talk to a doctor at once if you take too much of this medicine, even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage”.

17

If the product contains paracetamol and is wholly or mainly intended for children twelve years old or younger, the words “Do not give anything else containing paracetamol while giving this medicine” and—

(a) if a package leaflet accompanying the product includes the words in quotation marks in paragraph 17 of Schedule 27 (package leaflets), the words “Talk to a doctor at once if your child takes too much of this medicine, even if they seem well”; or

(b) if no package leaflet accompanies the product or the package leaflet does not include those words, the words “Talk to a doctor at once if your child takes too much of this medicine, even if they seem well. This is because too much paracetamol can cause delayed, serious liver damage”.

18

If the product is required by this Part of this Schedule to show the words set out in paragraphs 14, 16 or 17, those words must appear in a prominent position.

SCHEDULE 26 — Packaging requirements: special provisions

PART 1 — Supply by doctors, dentists, nurses, midwives and pharmacists

1

Where the product is to be administered to a particular individual, the name of that individual.

2

The name and address of the person who sells or supplies the product.

3

The date on which the product is sold or supplied.

4

Such of the following particulars as the person under whose responsibility the product is sold or supplied considers appropriate—

(a) the name of the product or its common name;

(b) directions for use of the product; and

PART 2 — Pharmacy exceptions

5

Where the product is to be administered to a particular individual, the name of that individual.

6

The name and address of the person who sells or supplies the product.

7

The date on which the product is sold or supplied.

8

Where the product is prescribed by an appropriate practitioner, such of the following particulars as the appropriate practitioner who prescribed the product may specify, unless paragraph 9 applies —

(a) the name of the product or its common name;

(b) directions for use of the product; and

9

This paragraph applies if a pharmacist, in the exercise of professional skill and judgement, is of the opinion that the inclusion of one or more of the particulars specified in paragraph 8 by the appropriate practitioner who prescribed the product is inappropriate.

10

Where paragraph 9 applies, the pharmacist may include such particulars, of the same kind as those mentioned in paragraph 8, as the pharmacist thinks appropriate.

11

Where the product is not prescribed by an appropriate practitioner, directions for use of the product, but these may be omitted in circumstances where section 10(3) of the Medicines Act 1968 applies.

SCHEDULE 27 — Package leaflets

PART 1 — General requirements

1

The name of the medicinal product.

2

The strength and pharmaceutical form of the product.

3

Where appropriate, whether the product is intended for babies, children or adults.

4

Where the product contains up to three active substances, the common name of each active substance.

5

The pharmaco-therapeutic group, or type of activity, of the product, in terms easily comprehensible for the patient.

6

The product's therapeutic indications.

7

A list of—

(a) contra-indications;

(b) appropriate precautions for use;

(d) interactions with other substances, including alcohol, tobacco and foodstuffs, which may affect the action of the product; and

(e) special warnings, if any, relating to the product.

8

The list mentioned in paragraph 7 must—

(a) take into account the special requirements of particular categories of users (including, in particular, children, pregnant or breastfeeding women, the elderly and persons with specific pathological conditions);

(b) mention, if appropriate, possible effects on the ability to drive vehicles or to operate machinery; and

(i) if knowledge of the excipients is important for the safe and effective use of the product, and

(ii) the excipients are included in the guidance published pursuant to published under regulation 257D ....

9

Instructions for proper use of the product including in particular—

(a) the dosage;

(b) the method and, if necessary, route of administration;

(c) the frequency of administration (including, if necessary, specifying times at which the product may or must be administered);

(d) the duration of treatment if this is to be limited;

(e) symptoms of an overdose and the action, if any, to be taken in case of an overdose;

(f) what to do if one or more doses have not been taken;

(g) an indication, if necessary, of the risk of withdrawal effects; and

(h) a specific recommendation to consult a doctor or pharmacist, as appropriate, for further explanation of the use of the product.

10

A description of the adverse reactions which may occur in normal use of the medicinal product and, if necessary, the action to be taken in such a case.

11

A reference to the expiry date printed on the packaging of the product with—

(a) a warning against using the product after that date;

(b) if appropriate, details of special storage precautions to be taken;

(d) the full qualitative composition (in active substances and excipients), and the quantitative composition in active substances, using common names, of each presentation of the medicinal product;

(e) for each presentation of the product, the pharmaceutical form and content in weight, volume or units of dosage;

(f) the name and address of the holder of the UK marketing authorisation ..., Article 126a authorisation or traditional herbal registration relating to the product and, if applicable, the name of the holder's appointed representative; and

(g) the name and address of the manufacturer of the product.

12

Where the product is authorised for sale or supply in Northern Ireland and is authorised under different names in different member States in accordance with Articles 28 to 39 of the 2001 Directive, a list of the names authorised in each member State.

13

For medicinal products included in the list referred to in Article 23 of Regulation (EC) No 726/2004 in the case of products for sale or supply in Northern Ireland, or the list referred to in regulation 202A, in the case of products for sale or supply in Great Britain, the symbol and statement: “▼ This medicinal product is subject to additional ... monitoring”.

14

A standardised text relating to adverse event reporting in accordance with the third sub-paragraph of Article 59(1) of the 2001 Directive.

15

The date on which the package leaflet was last revised.

PART 2 — Paracetamol

16

If a medicinal product contains paracetamol, unless the product is wholly or mainly intended for children twelve years old or younger, the words “Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage”.

17

If a medicinal product contains paracetamol and is wholly or mainly intended for children twelve years old or younger, the words “Talk to a doctor at once if your child takes too much of this medicine even if they seem well. This is because too much paracetamol can cause delayed, serious liver damage”.

SCHEDULE 28 — Labelling requirements for registrable homoeopathic medicinal products

PART 1 — Outer and immediate packaging

1

The scientific name of the stock or stocks (which may be supplemented by an invented name if the product contains two or more stocks), and the degree of dilution, making use of the symbols of the European Pharmacopoeia or, in the absence of an entry in the European Pharmacopoeia, of the British Pharmacopoeia.

2

The name and address of the holder of the certificate of registration and, if different, the manufacturer.

3

The method and, if necessary, route of administration.

4

The product's expiry date (month and year), in clear terms.

5

The product's pharmaceutical form.

6

The contents of the presentation, specified by weight, volume or number of doses.

7

Special storage precautions, if any.

8

A special warning, if necessary in relation to the product.

9

The manufacturer's batch number.

10

The number of the certificate of registration.

11

The words “homoeopathic medicinal product without therapeutic indications”.

12

A warning advising the user to consult a doctor if symptoms persist.

PART 2 — Blister packs etc contained in outer packaging

13

14

The name and address of the holder of the certificate of registration.

15

The product's expiry date (month and year), in clear terms.

16

The manufacturer's batch number.

17

The words “homoeopathic medicinal product without therapeutic indications”.

PART 3 — Small immediate packaging

18

19

The name and address of the holder of the certificate of registration.

20

The method and, if necessary, route of administration.

21

The product's expiry date (month and year), in clear terms.

22

The contents of the presentation, specified by weight, volume or number of doses.

23

The manufacturer's batch number.

24

The words “homoeopathic medicinal product without therapeutic indications”.

SCHEDULE 29 — Labelling of traditional herbal medicinal products

PART 1 — Traditional herbal medicinal products: general

1

A statement to the effect that the product is a traditional herbal medicinal product, for use for specific purposes by reason of long-standing use.

2

A statement that the user should consult a doctor or other health care practitioner if symptoms persist during use of the medicinal product, or if adverse effects not mentioned on the package or package leaflet occur.

PART 2 — Traditional herbal medicinal products not subject to general sale

3

Subject to the provisions of regulation 265(2), paragraph 4 applies where a traditional herbal medicinal product that is a pharmacy medicine is—

(a) sold by retail;

(b) supplied in circumstances corresponding to retail sale;

(d) distributed by way of wholesale dealing.

4

Where this paragraph applies, the outer packaging and the immediate packaging of the product must be labelled to show the capital letter “P” within a rectangle, within which there is to be no other matter of any kind.

SCHEDULE 30 — Particulars for advertisements to persons qualified to prescribe or supply

1

The number of the UK marketing authorisation ..., certificate of registration, traditional herbal registration or Article 126a authorisation for the medicinal product.

2

The name and address of the holder of the temporary authorisation or the UK marketing authorisation ..., certificate of registration, traditional herbal registration or Article 126a authorisation for the medicinal product or the business name and address of the part of the holder's business that is responsible for its sale or supply.

3

The classification of the medicinal product as—

(a) a product that is subject to general sale;

(b) a prescription only medicine; or

4

The name of the medicinal product.

5

A list of the active ingredients of the medicinal product that uses their common names and is placed immediately adjacent to the most prominent display of the name of the product.

6

One or more of the indications for the medicinal product consistent with the terms of the UK marketing authorisation ..., certificate of registration, traditional herbal registration or Article 126a authorisation for the product or, in the case of a product in relation to which there is in force an authorisation by the licensing authority on a temporary basis under regulation 174, the indications for the medicinal product consistent with the recommendation or requirement of the licensing authority as to the use of that product.

7

The entries or a succinct statement of the entries (if any) in the summary of the product characteristics, or in any equivalent summary published by the holder of a temporary authorisation, relating to—

(a) adverse reactions, precautions and relevant contra-indications;

(b) dosage and method of use so far as relevant to the indications shown in the advertisement, and

8

The cost excluding value added tax of—

(a) a specified package of the medicinal product; or

(b) a specified quantity or recommended daily dose of the medicinal product calculated by reference to a specified package of the medicinal product.

9

(1) The particulars specified in paragraph 7 must be printed in a clear and legible manner.

(2) Those particulars must be placed in such a position in the advertisement that their relationship to the claims and indications for the product can readily be appreciated by the reader.

SCHEDULE 31 — Sampling

Introductory

1

(1) This Schedule has effect where a person authorised by an enforcement authority (in this Schedule referred to as a “sampling officer”) obtains a sample of a substance or article—

(a) in order to determine whether there has been a contravention of any provision of these Regulations which the enforcement authority (“the relevant enforcement authority”) must or may enforce by virtue of regulations 323 and 324; or

(b) otherwise for a purpose connected with the performance of the relevant enforcement authority of its functions under these Regulations.

(2) This Schedule has effect whether the sample is obtained by purchase or in exercise of a power conferred by regulation 327.

(3) In this Schedule “medicines control laboratory” means a laboratory that is—

(a) designated by the licensing authority in accordance with Article 111(1) of the 2001 Directive for the purpose of the analysis of samples of one or more types of medicinal product; and

(b) is so designated in relation to a particular medicinal product that is submitted to it for analysis.

Division of sample

2

The sampling officer must as soon as practicable—

(a) divide the sample into three parts;

(b) mark each part;

(d) deal with the parts in accordance with paragraphs 3 to 10.

3

If the sample was purchased by the sampling officer otherwise than from a vending machine the officer must supply one part of the sample to the seller.

4

If the sampling officer obtained the sample from a vending machine—

(a) if a person's name and an address in the United Kingdom are stated on the machine as being the name and address of the owner of the machine, the sampling officer must supply one part of the sample to that person; and

(b) in any other case, the sampling officer must supply one part of the sample to the occupier of the premises on which the machine stands or to which it is affixed.

5

If the sample is a sample of goods consigned from outside the United Kingdom, and was taken by the sampling officer before delivery to the consignee, the sampling officer must supply one part of the sample to the consignee.

6

If, in a case not falling within any of paragraphs 3 to 5 of this Schedule, the sample was obtained by the sampling officer at the request or with the consent of a purchaser, the sampling officer must supply one part of the sample to the seller.

7

If, in a case not falling within any of paragraphs 3 to 6 of this Schedule, the sample was taken in transit, the sampling officer must supply one part of the sample to the consignor.

8

In any case not falling within any of paragraphs 3 to 7 of this Schedule, the sampling officer must supply one part of the sample to the person appearing to the sampling officer to be the owner of the substance or article from which the sample was taken.

9

In every case falling within any of paragraphs 3 to 8 of this Schedule, the sampling officer must inform the person to whom the part of the sample in question is supplied that the sample has been obtained for the purpose of analysis or other examination.

10

Unless the sampling officer decides not to submit the sample for analysis or other examination the sampling officer must—

(a) retain one of the two remaining parts for future comparison; and

(b) submit the other part for analysis or examination in accordance with the following provisions of this Schedule.

11

If a sample consists of substances or articles in unopened containers, the sampling officer may divide the sample into parts by dividing the containers into three lots without opening them if it appears to the sampling officer that—

(a) it is not reasonably practicable to open the containers and divide the contents into parts; or

(b) opening the containers and dividing the contents into parts might affect the composition or impede the analysis or other examination of the contents.

12

Regulation 343(1)(a) to (d) has effect in relation to supplying a part of a sample in pursuance of the preceding paragraphs as it has effect in relation to the service of a document.

13

If after reasonable inquiry the sampling officer is unable to ascertain the name of a person to whom, or the address at which, a part of a sample should be supplied, the sampling officer may retain that part of the sample.

Notice to person named on container

14

(1) This paragraph applies where the sampling officer has obtained a sample of a substance or article and it appears to the sampling officer that—

(a) the substance or article was manufactured in the United Kingdom by a person (“M”) whose name and address in the United Kingdom are stated on its container or packaging; and

(b) M is not a person to whom a part of the sample must be supplied under the preceding provisions of this Schedule.

(2) Unless the sampling officer decides not to submit the sample for analysis or other examination, the sampling officer must give notice to M—

(a) stating that the sample has been obtained; and

(b) specifying the person from whom the sampling officer purchased it or, if it was obtained otherwise than by purchase, the place from which the sampling officer obtained it.

(3) Notice under sub-paragraph (2) must be given to M within the period of three days beginning immediately after the day on which the sample was obtained.

Analysis or other examination

15

Where the enforcing authority that authorises the sampling officer is the Secretary of State or the Minister for Health, Social Services and Public Safety, if the sampling officer decides to submit the sample for analysis the officer must do so—

(a) to a medicines control laboratory; or

(b) to a laboratory available for the purpose in accordance with any arrangements made by the enforcing authority in question.

16

Where any other enforcing authority authorises the sampling officer, if the sampling officer decides to submit the sample for analysis the officer must do so to a laboratory available for the purpose in accordance with any arrangements made by the enforcing authority in question.

17

(1) Arrangements of the kind mentioned in paragraphs 15(b) and 16 made by an enforcement authority in England, Wales or Scotland other than the Secretary of State must be approved by the Secretary of State.

(2) Arrangements of the kind mentioned in paragraph 15(b) made by a district council in Northern Ireland must be approved by the Minister for Health, Social Services and Public Safety.

18

A laboratory to which a sample is submitted under paragraph 15 or 16 must analyse or examine the sample as soon as practicable,

19

A laboratory that has analysed or examined a sample submitted under the preceding provisions of this Schedule must issue and send to the sampling officer a certificate specifying the result of the analysis or examination.

20

A person to whom a part of the sample is to be supplied in accordance with paragraphs 2 to 8 is entitled, on payment of the required fee, to be given a copy of any certificate as to the result of an analysis or examination which is sent to the sampling officer under paragraph 19.

Provisions as to evidence

21

(1) In proceedings for an offence under these Regulations, a document produced by one of the parties to the proceedings and purporting to be a certificate issued under paragraph 19 is to be sufficient evidence of the facts stated in the document unless sub-paragraph (2) applies.

(2) A party to proceedings, other than the party who produced the document mentioned in paragraph (1), may require that the person who issued the certificate be called as a witness.

(3) In proceedings in Scotland, if the person who issued the certificate is called as a witness, that person's evidence is to be sufficient evidence of the facts stated in the certificate.

22

In proceedings for an offence under these Regulations, a document produced by one of the parties to the proceedings which has been supplied by another party to the proceedings as a copy of a certificate issued under paragraph 19 is to be sufficient evidence of the facts stated in the document.

23

(1) If, in proceedings before a magistrates' court for an offence under these Regulations, a defendant intends to produce a certificate issued under paragraph 19, or to require that the person by whom a certificate was issued be called as a witness, the defendant must give notice of that intention and (where a certificate is to be produced) a copy of the certificate to the other party at least three clear days before the day on which the summons is returnable.

(2) If sub-paragraph (1) is not complied with the court may adjourn the hearing on such terms as it thinks fit.

(3) In Scotland, if in proceedings in the sheriff court for an offence under these Regulations the accused intends to produce a certificate under paragraph 19, or to require that the person by whom a certificate was issued be called as a witness, the accused must give notice of that intention and (where a certificate is to be produced) a copy of the certificate to the procurator fiscal at least three clear days before the day on which the case proceeds to trial.

(4) If sub-paragraph (3) is not complied with the sheriff may adjourn the diet on such terms as the sheriff thinks fit.

Analysis under direction of court

24

(1) This paragraph applies where proceedings for an offence under these Regulations relate to a substance or article of which a sample has been taken as mentioned in paragraph 1 of this Schedule.

(2) Where this paragraph applies, the part of the sample retained in pursuance of paragraph 10(a) is to be produced as evidence.

(3) The court must, if requested by a party to the proceedings, and may, in the absence of such a request, cause that part of the sample to be sent for analysis to the Government Chemist (or, in Northern Ireland, to the Government Chemist in Northern Ireland) or to be sent for other examination to a laboratory specified by the court.

(4) If, in a case where an appeal is brought, no action has been taken under sub-paragraph (3), that sub-paragraph applies to the court by which the appeal is heard.

(5) A person or laboratory to whom or to which a part of a sample is sent under this paragraph for analysis or other examination must—

(a) analyse or examine it; and

(b) issue and give to the court a certificate specifying the results of the analysis or examination.

(6) A certificate under sub-paragraph (5)(b) is to be evidence (and, in Scotland, is to be sufficient evidence) of the facts stated in the certificate unless a party to the proceedings requires that the person by whom it was issued be called as a witness.

(7) In Scotland, if the person by whom a certificate is issued is called as a witness that person's evidence is sufficient evidence of the facts stated in the certificate.

25

The costs of analysis or examination under paragraph 24 are to be paid by the prosecutor or the defendant (or, in Scotland, the accused) as the court may order.

Proof by written statement

26

(1) In relation to England and Wales section 9 of the Criminal Justice Act 1967 does not have effect with respect to a document produced as mentioned in paragraph 21 or 22, or with respect to any certificate transmitted to a court under paragraph 24.

(2) In relation to Northern Ireland any enactment corresponding to section 9 of the Criminal Justice Act 1967 does not have effect with respect to a document produced as mentioned in paragraph 21 or 22, or with respect to any certificate transmitted to a court under paragraph 24.

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