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Statutory Instruments

1980 No. 1924

MEDICINES

The Medicines (Pharmacy and General Sale- Exemption) Order 1980

Made

8th December 1980

Laid before Parliament

29th December 1980

Coming into Operation

30th January 1981

The Secretary of State Concerned with health in England, the Secretaries of State respectively concerned with health and with agriculture in Wales and in Scotland, the Minister of Agriculture, Fisheries and Food, the Department of Health and Social Services for Northern Ireland and the Department of Agriculture for Northern Ireland, acting jointly, in exercise of powers conferred by sections 57(1) and (2) and 129(4) of the Medicines Act 1968 and now vested in them(1) and the Secretaries of State concerned with health in England, in Wales and in Scotland and the Department of Health and Social Services for Northern Ireland, acting jointly, in exercise of powers conferred by sections 55(2)(b) and 129(4) of the Act and now vested in them (2) and of all other powers enabling them in that behalf, after consulting such organisations as appear to them to be representative of interests likely to be substantially affected by the following order, and after taking into account the advice of the Medicines Commission, hereby make the following order:-

Citation, commencement and interpretation

1.-(1) This order may be cited as the Medicines (Pharmacy and General Sale-Exemption) Order 1980 and shall come into operation on 30th January 1981.

(2) In this order, unless the context otherwise requires,-

"the Act" means the Medicines Act 1968;

"controlled drug" has the meaning assigned to it by section 2 of the Misuse of Drugs Act 1971;

"cosmetic" means any substance or preparation intended to be applied to the various surfaces of the human body including epidermis, pilary system and hair, nails, lips and external genital organs, or the teeth and buccal mucosa wholly or mainly for the purposes of perfuming them, cleaning them, protecting them, caring for them or keeping them in condition, modifying their appearance (whether for aesthetic purposes or otherwise) or combating body odours or normal body perspiration;

"enrolled nurse" means a person for the time being enrolled as a nurse-

(i)

in relation to England and Wales, under the Nurses Act 1957,

(ii)

in relation to Scotland, under the Nurses (Scotland) Act 1951, and

(iii)

in relation to Northern Ireland, under section 17 of the Nurses and Midwives Act (Northern Ireland) 1970;

"external use" means-

(i)

in relation to medicinal products for use by being administered to human beings, application to the skin, hair, teeth, mucosa of the mouth, throat, nose, ear, eye, vagina or anal canal,

(ii)

in relation to veterinary drugs, application to the skin, hair, fur, feathers, scales, hoof, horn, ear, eye, mouth or mucosa of the throat or prepuce,

in either case when a local action only is intended and extensive systemic absorption is unlikely to occur; and references to medicinal products for external use shall be read accordingly except that in relation to paragraph (i) in this definition such references shall not include throat sprays, throat pastilles, throat lozenges, throat tablets, nasal drops, nasal sprays, nasal inhalations or teething preparations;

"food" includes beverages, confectionery and articles and substances used as ingredients in the preparation of food and includes any manufactured substance to which there has been added any vitamin and which is advertised (within the meaning of section 92) as available and for sale to the general public as a dietary supplement;

"health authority"-

(i)

in relation to England and Wales, has the same meaning as in the National Health Service Act 1977(3)

(ii)

in relation to Scotland, means a Health Board Constituted under section 2 of the National Health Service (Scotland) Act 1978, and

(iii)

in relation to Northern Ireland, means a Health and Social Services Board established under Article 16 of the Health and Personal Social Services (Northern Ireland) Order 1972;

"master" has the same meaning as in the Merchant Shipping Act 1894;

"occupational health scheme" means a scheme in which a person, in the course of a business carried on by him, provides facilities for his employees for the treatment or prevention of disease;

"operator", in relation to an aircraft, means the person for the time being having the management of the aircraft;

"parenteral administration" means administration by breach of the skin or mucous membrane;

"pharmacy medicine" means a medicinal product which is not a prescription only medicine or a medicinal product on a general sale list;

"pre-school dental scheme" means a scheme supervised by a doctor or dentist in which medicinal products are supplied to parents or guardians of children under five, for use by such children for the purpose of preventing dental caries;

"prescription only medicine" means a medicinal product of a description for falling within a class specified in Article 3 of the Medicines (Prescription Only) Order 1980;

"registered nurse" has the same meaning as in section 11;

"registered ophthalmic optician" means a person who is registered in either of the registers of ophthalmic opticians established and maintained under section 2(a) of the Opticians Act 1958;

"school dental scheme" means a scheme supervised by a doctor or dentist in which medicinal products are supplied at a school to pupils of that school for the purpose of preventing dental caries;

"sell" means sell by retail as defined in section 131 and "sale" has a corresponding meaning;

"state registered chiropodist" means a person who is registered in the register established and maintained under section 2(1) of the Professions Supplementary to Medicine Act 1960 by the Chiropodists Board;

"supply" means supply in circumstances corresponding to retail sale as defined in section 131;

"unit preparation" means a preparation, including a mother tincture, prepared by a process of solution, extraction or trituration with a view to being diluted tenfold or one hundredfold, either once or repeatedly, in an inert diluent, and then used either in this diluted form or, where applicable, by impregnating tablets, granules, powders, or other inert substances for the purposes of being administered to human beings; and

(b)a reference to a numbered section is to the section of the Act which bears that number, a reference to a numbered Article or Schedule is to the Article of or Schedule to this order which bears that number and a reference in an Article or Schedule to a numbered paragraph is to the paragraph which bears that number in that Article or Schedule.

Temporary exemption for certain products for human use

2.-(1) The restrictions imposed by section 52 shall not apply during the period set out in paragraph (2) to the sale, offer or exposure for sale or supply of any medicinal product which is for use by being administered to human beings and in respect of which a product licence has been granted containing, or has been varied so as to contain, a provision to the effect that the method of sale or supply of that product may be otherwise than by or under the supervision of a pharmacist (whether the grant or variation is made before, on or after the date on which this order comes into operation), if and so long as the conditions specified in section 53 are fulfilled.

(2) The period referred to in paragraph (1) is-

(a)where the product licence is granted containing the provision referred to in paragraph (1), that of two years from the date of the grant of that licence, and

(b)where the product licence is varied so as to contain the provision referred to in paragraph (1), that of one year from the date of that variation of that licence.

Exemption in cases involving another's default

3. The restrictions imposed by section 52 shall not apply to the sale, offer or exposure for sale or supply of a medicinal product by a person who, having exercised all due diligence, believes on reasonable grounds that the product is a medicinal product-

(a)on a general sale list, or

(b)which he may lawfully sell, offer or expose for sales or supply, as the case may be, free from the restrictions imposed by section 52, by reason of the exemption conferred by Article 2,

where, due to the act or default of another person, that product is not such a medicinal product, if and so long as the conditions specified in section 53 are fulfilled.

Exemption for products used by midwives in the course of their professional practice

4. There are hereby specified for the purposes of section 55(2)(b) (exemptions for certified midwives) the following classes of medicinal products-

(a)all medicinal products that are not prescription only medicines, and

(b)prescription only medicines which, by virtue of an exemption conferred by an order made under section 58(4)(a), may be sold or supplied by a certified midwife otherwise than in accordance with a prescription given by a practitioner.

Exemption for certain persons

5.-(1) The restrictions imposed by section 52 shall not apply-

(a)to the sale, offer or exposure for sale or supply by any person listed in column 1 of Part I of Schedule 1, or

(b)to the supply by any person listed in column 1 of Part II of Schedule 1,

of the prescription only medicines and the pharmacy medicines referred to in column 2 of Part I or Part II, as the case may be, of Schedule 1 in relation to that person, if and so long as the conditions specified in the corresponding paragraphs in column 3 of Part I or Part II, as the case may be, of Schedule 1 are fulfilled.

(2) The restrictions imposed by section 53 shall not apply to the sale, offer or exposure for sale or supply by any person listed in column 1 of Part I or Part II of Schedule 1 of any medicinal product on a general sale list referred to in column 2 of Part I or Part II, as the case may be, of Schedule 1 in relation to that person if and so long as the conditions specified in the corresponding paragraphs in column 3 of Part I or Part II, as the case may be, of Schedule 1 are fulfilled.

(3) For the purposes of the sale, offer or exposure for sale or supply of any veterinary drug on a general sale list, section 53 shall have effect without the conditions in subsection (3) of that section being required to be fulfilled if and so long as the sale or supply is by the holder of a product licence granted under Part II of the Act in respect of the veterinary drug in question and is to a person who has in his charge or maintains animals for the purposes of and in the course of carrying on a business, either as his sole business activity or as a substantial part of his business activities.

Exemption for medicinal products at high dilutions

6.-(1) The restrictions imposed by sections 52 and 53 shall not apply to the sale, offer or exposure for sale or supply of a medicinal product which is neither for parenteral administration nor a controlled drug and which consists solely of one or more unit preparations of-

(a)any substance where the unit preparation has been diluted to at least one part in a million (6x), or

(b)any substance listed in Part I of Schedule 2 where the unit preparation has been diluted to at least one part in a thousand (3x), or

(c)any substance listed in column 1 of Table A of Schedule 3 to the Medicines (General Sale List) Order 1980 or in Part III of Schedule 2 to this order or, if the medicinal product in question is for external use only, any substance listed in column 1 of Table B of Schedule 3 to the Medicines (General Sale List) Order 1980 or in Part IV of Schedule 2 to this order, in each case where the unit preparation has been diluted to at least one part in ten (1x),

if and so long as the person selling or supplying the medicinal product has been requested by or on behalf of a particular person and in that person's presence to use his own judgment as to the treatment required.

(2) The restrictions imposed by section 52 shall not apply to the sale, offer or exposure for sale or supply of a medicinal product which is neither for parenteral administration nor a controlled drug and which consists solely of one or more unit preparations of-

(a)any substance where the unit preparation has been diluted to at least one part in a million (6c), or

(b)any substance listed in Part II of Schedule 2 where the unit preparation has been diluted to at least one part in a million (6x), or

if and so long as the conditions specified in section 53 are fulfilled.

Exemption for foods and cosmetics

7. For the purposes of the sale, offer or exposure for sale or supply of any medicinal product on a general sale list which is for sale either for oral administration as a food or for external use as a cosmetic, section 53 shall have effect without the condition in subsection (2) of that section being required to be fulfilled.

Revocations

8. The Medicines (Pharmacy and General Sale-Exemption) Order 1977 and the Medicines (Pharmacy and General Sale-Exemption) Amendment Order 1978 are revoked.

Patrick Jenkin

Secretary of State for Social Services

27th November 1980

Nicholas Edwards

Secretary of State for Wales

27th November 1980

George Younger

Secretary of State for Scotland

1st December 1980

In witness whereof the official seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on 3rd December 1980.

L.S.

Peter Walker

Minister of Agriculture, Fisheries and Food

Sealed with the official seal of the Department of Health and Social Services for Northern Ireland this 8th day of December 1980.

L.S.

N. Dugdale

Permanent Secretary

Sealed with the official seal of the Department of Agriculture for Northern Ireland this 5th day of December 1980.

L.S.

J. A. Young

Permanent Secretary

SCHEDULE 1EXEMPTIONS FOR CERTAIN PERSONS FROM SECTIONS 52 AND 53

Article 5(1)(a) and (2)

PART I

Column 1	Column 2	Column 3
Persons exempted	Medicinal products to which the exemption applies	Conditions
1. State registered chiropodists.	1. Medicinal products on a general sale list which are for external use and are not veterinary drugs and the following pharmacy medicines- Paint containing not more than 9.0 per cent Borotannic complex Ointment, tincture or dusting powder containing not more than 5.0 per cent Diamthazole hydrochloride Ointment or lotion containing not more than 10.0 per cent Buclosamide or not more than 10.0 per cent Crotamiton Cream, jelly or powder containing not more than 1.0 per cent Fenticlor Pastes containing not more than 70.0 per cent Salicylic acid or not more than 70.0 per cent Pyrogallol Powder or cream containing not more than 2.0 per cent 1-Phenoxypropan-2-01 Dusting powder or jelly or tincture containing not more than 0.4 per cent Hydrargaphen Potassium permanganate crystals or solution Cream, powder or solution containing not more than 1.0 per cent Clotrimazole Ointment containing not more than 3.0 per cent Chlorquinaldol Solution containing not more than 10.0 per cent Glutaraldehyde Ointment containing Hyaluronidase and a heparinoid Cream containing not more than 2.0 per cent Mepyramine maleate Cream or powder containing not more than 2.0 per cent Miconazole nitrate Cream, jelly or powder containing not more than 10.0 per cent Polynoxylin Salicylic Acid Lotion BPC Cream or tincture containing not more than 0.1 per cent Thiomersal.	1. 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.
2. Registered ophthalmic opticians.	2. All medicinal products on a general sale list, all pharmacy medicines and prescription only medicines which are not for parenteral administration and which- (a) are eye drops or eye ointments and are prescription only medicines by reason only that they contain: (i) Mafenide propionate, (ii) not more than 30.0 per cent Sulphacetamide Sodium, or (iii) Sulphafurazole diethanolamine equivalent to not more than 4.0 per cent Sulphafurazole, or (b) are prescription only medicines by reason only that they contain any of the following substances: Atropine sulphate Bethanecol chloride Carbachol Cyclopentolate hydrochloride Homatropine hydrobromide Hyoscine hydrobromide Naphazoline hydrochloride Naphazoline nitrate Neostigmine methylsulphate Physostigmine salicylate Physostigmine sulphate Pilocarpine hydrochloride Pilocarpine nitrate Tropicamide.	2. The sale or supply shall be only in the course of their professional practice and only in an emergency.
3. 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 judgment as to the treatment required.	3. 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 or Zinc pyrithione.	3. 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 judgment as to the treatment required.
4. Persons selling or supplying medicinal products to universities, other institutions concerned with higher education or institutions concerned with research.	4. All medicinal products.	4. The sale or supply shall be- (a) 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 a specified course of research stating- (i) the name of the institution for which the medicinal product is required, (ii) the purpose for which the medicinal product is required, and (iii) the total quantity required, and (b) for the purposes of the education or research with which the institution is concerned.
5. Persons selling or supplying medicinal products to any of the following- (1) a public analyst appointed under section 89 of the Food and Drugs Act 1955, section 27 of the Food and Drugs (Scotland) Act 1956 or section 31 of the Food and Drugs Act (Northern Ireland) 1958 (2) an agricultural analyst appointed under section 67 of the Agriculture Act 1970, (3) a person duly authorised by an enforcement authority under sections 111 and 112, (4) a sampling officer within the meaning of the Food and Drugs Act 1955, the Food and Drugs (Scotland) Act 1956 or the Food and Drugs Act (Northern Ireland) 1958, or (5) a sampling officer within the meaning of Schedule 3 to the Act	5. All medicinal products.	5. The sale or supply shall be subject to the presentation of an order signed by, or on behalf of, any person listed in sub-paragraphs (1), (2), (3), (4) or (5) of column 1 of this paragraph stating the status of the person signing it and the amount of the medicinal product required, and shall be only in connection with the exercise by those persons of their statutory functions.
6. Persons selling or supplying medicinal products to any person employed or engaged in connection with a scheme for testing the quality and checking the amount of the drugs and appliances supplied under the National Health Service Act 1977, the National Health Service (Scotland) Act 1978 and the Health and Personal Social Services (Northern Ireland) Order 1972 or under any subordinate legislation made under those Acts or that order.	6. All medicinal products.	6. The sale or supply shall be- (a) subject to the presentation of an order signed by or on behalf of the person so employed or engaged stating the status of the person signing it and the amount of the medicinal product required, and (b) for the purposes of a scheme referred to in column 1 in this paragraph.
7. Persons providing a poultry vaccination service.	7. The poultry vaccines listed in paragraph 11 of Schedule 1 to the Medicines (Exemptions from Restrictions on the Retail Sale or Supply of Veterinary Drugs) Order 1979.(4).	7. The sale or supply shall be only to a person who has charge of animals for the purposes of and in the course of carrying on a business, either as his sole business activity or as a substantial part of his business activities.
8. Persons selling or supplying medicinal products to the persons referred to in paragraph 7.	8. The poultry vaccines referred to in paragraph 7.	8. The sale or supply shall be subject to the presentation of an order signed by the purchaser stating the amount of the poultry vaccine required.
9. Persons selling or supplying medicinal products to veterinary surgeons and veterinary practitioners.	9. All medicinal products.	9. No conditions.
10. Persons selling or supplying medicinal products to the British Standards Institution.	10. All medicinal products.	10. The sale or supply shall be- (a) subject to the presentation of an order signed on behalf of the British Standards Institution stating the status of the person signing it and the amount of the medicinal of the medicinal product required, and (b) only for the purpose of testing containers of medicinal products or determining the standards for such containers.
11. Holders of product licences and holders of manufacturer's licences.	11. Medicinal products referred to in the licences.	11. The sale or supply shall be only- (a) to a pharmacist, (b) so as to enable that pharmacist to prepare an entry relating to the medicinal product in question in a tablet or capsule identification guide or similar publication, and (c) of no greater quantity than is reasonably necessary for that purpose.

Article 5(1)(b) and (2)

PART II

Column 1	Column 2	Column 3
Persons exempted	Medicinal products to which the 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 or 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 1973(5) or regulation 5 of the Misuse of Drugs (Northern Ireland) Regulations 1974(6) to supply a controlled drug.	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 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.	7. Such prescription only medicines and such pharmacy medicines as may be specified in the relevant enactment and medicinal products on a general sale list.	7. The supply shall be- (a) for the purpose of enabling them to comply with any requirements made by or in pursuance of any such enactment, and (b) subject to such conditions and in such circumstances as may be specified in the relevant enactment.
8. The owner or the master of a ship which does not carry a doctor on board as part of her complement.	8. All medicinal products.	8. The supply shall be only so far as is necessary for the treatment of persons on the ship.
9. Persons operating an occupational health scheme.	9. 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 in writing signed by a doctor, a registered nurse or an enrolled nurse.	9.-(1) The supply shall be in the course of an occupational health scheme. (2) The individual supplying the medicinal product, if not a doctor, shall be- (a) a registered nurse or an enrolled nurse, and (b) 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 the occupational health scheme.
10. Persons carrying on the business of a school providing full-time education.	10. Pharmacy medicines that are for use in the prevention of dental caries and consist of or contain Sodium Fluoride.	10. The supply shall be- (a) in the course of a school dental scheme, and (b) if to a child under 16 only where the parent or guardian of that child has consented to such supply.
11. Health authorities.	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) a pre-school dental scheme, and the individual supplying the medicinal product shall be a registered nurse or an enrolled nurse, or (b) 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. The operator or commander of an aircraft.	12. All pharmacy medicines, all medicinal products on a general sale list and prescription only medicines which are not for parenteral administration and 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.	12. 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 prescription only medicines of the description in question are to be used on the aircraft.

Article 6

SCHEDULE 2

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

Agaricus muscarius
Ailanthus glandulosa
Apocynum cannabinum
Aurum iodatum
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 IIDilutions of unit preparations diluted to at least one part in a million (6x)

Adonisvernalis
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 copaivae
Balsamum peruvianum
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)
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
Phellandrum 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 IIIDilutions of unit preparations diluted to at least one part in ten (1x)

Abies excelsa
Abies nigra
Abies nobilis
Acalypha 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 fluviatilis
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 europocus)
Graphites
Gratiola officinalis
Gymnocladus (American Coffee Tree)
Haematoxylon campechianum
Hecla Lava (Ash from Mount Hecla)
Hedeoma pulegioides
Hedera helix
Heliotrope
Heracleum spondylium
Herniaria
Hornbeam (Carpinus betulus)
Iberis amara
Impatiens
Iris germanica
Iris pseudacorus
Jacaranda procera
Jatropha curcas
Juncus communis
Justicia 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
Mephitis 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
Ptelea trifoliata
Ratanhia
Robinia pseudoacacia
Rubia tinctorum
Rumex acetosella
Sal Marina
Sarcolactic Acid
Sarracenia purpurea
Scleranthus (Sclcranthus annuus)
Silica
Silphium laciniatum
Sodium Benzoate
Spongia marina
Star of Bethlehem (Ornithogalum umbellatum)
Ulmus campestris
Vine
Walnut (juglerus regia)
Water Violet (Hottonia palustris)
Wild Oat
Wild Rose

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

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
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 sceleratus
Rhodium Oxynitrate
Rhododendron chrysanthemum
Rhus toxicodendron
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

EXPLANATORY NOTE

This Order consolidates, with amendments, provisions granting exemption from the restrictions imposed by sections 52 and 53 of the Medicines Act 1968. Section 52 provides that medicinal products not on a general sale list shall be sold or supplied only on premises that are a registered pharmacy and by or under the supervision of a pharmacist. Section 53 provides that medicinal products on a general sale list may be sold elsewhere than at a registered pharmacy only if certain specified conditions are fulfilled.

The principal changes made by this order are-

(a)

to alter the period of duration of a temporary exemption from the restrictions imposed by section 52 for certain medicinal products for human use following the grant or variation of a product licence;

(b)

to extend the scope of an exemption from those restrictions for certain medicinal products at high dilutions;

(c)

to vary the ranges of medicinal products which may be sold or supplied by state registered chiropodists and registered ophthalmic opticians free from the restrictions imposed by sections 52 and 53, and to vary the conditions relating to the exemption for registered ophthalmic opticians;

(d)

to add exemptions from the restrictions imposed by sections 52 and 53 in respect of certain sales or supplies by manufacturers and product licence holders to those compiling tablet and capsule identification guides, and certain supplies to those on board aircraft.

The Medicines (Pharmacy and General Sale-Exemption) Order 1977, as amended, is revoked by this order.

(1)

In the case of the Secretaries of State concerned with health in England and in Wales by virtue of Article 2(2) of, and Schedule 1 to the Transfer of Functions (Wales) Order 1969 (S.I. 1969/388), in the case of the Secretary of State concerned with agriculture in Wales by virtue of Article 2(3) of, and Schedule 1 to, the Transfer of Functions (Wales) (No. 1) Order 1978 (S.I. 1978/272) and in the case of the Northern Ireland Departments by virtue of section 40 of, and Schedule 5 to, the Northern Ireland Constitution Act 1973 (c. 36) and Section 1(3) of, and paragraph 2(1)(b) of Schedule 1 to, the Northern Ireland Act 1974 (c. 28).

(2)

In the case of the Secretaries of State concerned with health in England and in Wales by virtue of Article 2(2) of, and Schedule 1 to, the Transfer of Functions (Wales) Order 1969 (S.I. 1969/388), in the case of the Secretary of State concerned with agriculture in Wales by virtue of Article 2(3) of, and Schedule 1 to, the Transfer of Functions (Wales) (No. 1) Order 1978 (S.I. 1978/272) and in the case of the Northern Ireland Departments by virtue of section 40 of, and Schedule 5 to, the Northern Ireland Constitution Act 1973 (c. 36) and Section 1(3) of, and paragraph 2(1)(b) of Schedule 1 to, the Northern Ireland Act 1974 (c. 28).

(3)

the definition of health authority was amended by the Health Services Act 1980 (c. 53) section 1(7) and Schedule 1, Part I, paragraph 77(b).

(4)

relevant amending instruments are S.I. 1980/283, 1650.

(5)

to which there are no amendments relevant to this order.

(6)

to which there are no amendments relevant to this order.